louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00259363: Oxaliplatin in Rectal Cancer
Official title: Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Rectal Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
* Phase II: To determine the treatment efficacy according to response rates from phase I.


Eligibility criteria: The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

* ECOG: 0-2
* Histological proved rectal adenocarcinoma
* No chemotherapy treatment on the previous 6 months before inclusion.
* No previous pelvic radiotherapy treatment

Exclusion Criteria:

* Important Biological abnormality (renal, hepatic and/or hematological)
* Intestinal occlusion or subocclusion
* Peripheral neuropathy
* Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
* Participation in other trials on the previous 4 months.

Primary outcomes:
measure: Phase I : Maximum Tolerated Dose & Recommended Dose
timeFrame: Days 1, 15, 29
measure: Phase II : Response and resectability rate.
timeFrame: 6 cycles in 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: José Mª Taboada
role: STUDY_DIRECTOR
References:
Clinical trial NCT03631563: ATG-F VS ATG for the Prevention of GVHD
Official title: Comparing ATG-Fresenius vs Thymoglobulin for the Prevention of Graft-versus-host Disease in the Setting of Haplo-identical Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: GVHD in the Setting of Haplo-HSCT
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 120
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anti-thymocyte globulin (ATG) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-HSCT) is vital for inducing immune tolerance.The study aims to compare the efficacy and safety of ATG-F vs ATG, incorporated into the preparative regimens for haplo-identical transplants.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Aged \<65 years
* Patients undergoing Haplo-identical hematopoietic stem cell transplantation.
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of ATG or ATG-F.

Primary outcomes:
measure: incidence of GVHD
timeFrame: 1 year
Secondary outcomes:
measure: leukemia-free survival
timeFrame: 1 year
measure: treatment-related mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT06525363: Clinical Assessment of Chitosan Nanoparticles on Periodontal Problems Post Steroidal Inhalation in Asthmatic Patients: Phase I Trial
Official title: Clinical Assessment of Chitosan Nano-particles on Periodontal Problems Post Steroidal Inhalation in Asthmatic Patients: Phase I Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Periodontal Diseases
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontal problems management is the most important goals of chronic asthmatic patients that adapted to use steroid inhalation for long time. Gram negative anaerobic bacteria are generally suggested as the primary cause of Periodontal problems and mechanical procedure is the treatment approach, which is performed nonsurgical or surgically. The understanding of the role of bacteria in the initiation and progression of periodontal disease has led to great interest in the use of antibiotics to suppress or eradicate pathogenic macrobiotic. Systemic antibiotics have been used in different forms of periodontal disease treatment. Systemic antibiotics can penetrate soft tissues and may target invasive organisms, can be used to treat multiple sites simultaneously, and may also affect reservoirs of bacterial reinfection such as saliva, the tonsils, and the oral mucosa. However, there may be problems associated with the use of systemic antibiotics such as the development of resistant bacteria, and potential side effects (hypersensitivity reactions, gastrointestinal discomfort, etc.). so in this study we aimed at To evaluate the effect of chitosan nanoparticle spray in management of dental problems in asthmatic patients receiving corticosteroids inhaler that support the growth of bacteria in periodontal area.


Eligibility criteria: Inclusion Criteria:

* Age from 18-50 years old
* Both sex male and female
* Patients diagnosed as Asthmatic
* Patients treated with corticosteroids inhaler or ( beta2-adrenergic agonist inhaler or nebulizer for their symptoms)

Exclusion Criteria:

* Patients treated with other medication
* Patients not diagnosed as asthmatic
* Comorbidity

Primary outcomes:
measure: Levels of oral Streptococcus mutans
timeFrame: each 3 weeks for 12 weeks
measure: Plaque Examination
timeFrame: each 3 weeks for 12 weeks
measure: The inflammatory status of the gingiva
timeFrame: each 3 weeks for 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03287063: Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma
Official title: A Prospective Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioblastoma
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 6
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: Patients with glioblastoma eligible for surgical biopsy and/or resection

Brief summary: Glioblastomas (GBM) demonstrate in vivo genetic and histologic heterogeneity that can be non-invasively identified using imaging phenotypes that identify regionally distinct areas of tumor with genetic alterations that drive tumor resistance pathways. The researchers propose a unique approach to assess initial GBM heterogeneity by performing histological and genomic analysis of biopsies targeted by advanced MRI before treatment.


Eligibility criteria: Inclusion Criteria:

* Suspected newly diagnosed or recurrent supratentorial glioblastoma eligible for surgical biopsy and/or resection
* Patients must be 18 years of age or older
* Study-specific informed consent approved for this purpose by the IRB of the University of Michigan

Exclusion Criteria:

* Patients unable to undergo MRI

Primary outcomes:
measure: Identify candidate genes with differential expression in therapy-resistant imaging subvolumes
timeFrame: At time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michelle Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02479763: A Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks
Official title: A Randomized Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anesthesia
Keywords: Epidural waveform analysis
Loss of resistance
Lead sponsor: Montreal General Hospital
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 106
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: In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%. This stems from the prevalence of trainee operators coupled with the non-specific nature of loss-of-resistance. In the current randomized trial, we will set out to compare conventional and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease the failure rate of thoracic epidural blocks.


Eligibility criteria: Inclusion Criteria:

* the patients undergoing thoracic epidural catheter insertion for thoracic and abdominal surgery or rib fractures with American Society of Anesthesiologists (ASA) classification 1-3 and body mass index between 18 and 35

Exclusion Criteria:

* adults who are unable to give their own consent
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, or International Normalized Ratio ≥ 1.4)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
* allergy to local anesthetic (LA)
* pregnancy
* prior surgery in the thoracic spine

Primary outcomes:
measure: Percentage of Patients With Successful Epidural Blocks
timeFrame: up to 15 minutes after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital, McGill University
state: Quebec
city: Ratchathewi
country: Thailand
facility: Ramathibodi Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: McGill University
name: De QH Tran
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547963: Brief Counseling to Reduce Injuries Among Emergency Department Patients Who Report Alcohol and Substance Use
Official title: Reducing Injury, ETOH and THC Use Among ED Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Alcohol Drinking
Marijuana Smoking
Keywords: Alcohol Drinking
Marijuana Smoking
Substance Use
Emergency Department (ED)
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 2007-10-23
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of two brief counseling sessions delivered to emergency department (ED) patients who report conjoint alcohol and marijuana use, in reducing injuries and other negative consequences, in comparison to an assessment only group.

Detailed description: Alcohol and substance use remain a significant predictor of injuries, health and psychosocial consequences.

ED patients who were not being treated for critical conditions were asked about their use of alcohol and marijuana. Patients who self-reported the use of both substances were asked to participate in the study.

Recruited participants were given a baseline assessment and then randomized a treatment or a control condition. The treatment condition consisted of two 40 minute sessions of brief counseling. The first session took place in the ED the second session occurred within two weeks of being seen in the ED.

Participants completed assessments three and twelve months after being recruited in the ED. The primary dependent variables for this study are 12 month injuries and self-reported levels of negative life consequences associated with alcohol and marijuana use.

Eligibility criteria: Inclusion Criteria:

* Male and female outpatients 18 years of age or older.
* Participants will have a current DSM-IV diagnosis of alcohol dependence.
* Participants will have signed a witnessed informed consent.

Exclusion Criteria:

* Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, dementia, or a psychological disorder requiring medication.
* Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.

Primary outcomes:
measure: Substance use; injuries, alcohol and marijuana negative consequences
timeFrame: 3 and 12 months
Secondary outcomes:
measure: Mediators and moderators of treatment efficacy
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Injury Prevention Center, Rhode Island Hospital, Brown University
state: Rhode Island
Study officials:
affiliation: Injury Prevention Center, Rhode Island Hospital, Brown University
name: Janette Baird, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01710163: Potentiation of Quetiapine Treatment With Lithium or Aripiprazole in Bipolar 1 Nonresponders Patients
Official title: ARIQUELI: Potentiation of Quetiapine Treatment in Bipolar 1 Nonresponders Patients With Lithium or Aripiprazole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bipolar I Disorder
Keywords: Lithium Carbonate
Lithium
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sensory System Agents
Antipsychotic Agents
Antidepressive Agents
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Bipolar I Disorder refractory treatment with Quetiapine monotherapy could be better potentiated with Lithium or Aripiprazole. The investigators hypothesized that Lithium or Aripiprazole would provide similar compliance and tolerability in maintenance treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
* The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent

Exclusion Criteria:

* Schizophrenia or schizoaffective disorder
* Mental retardation
* Unstable clinical diseases

Primary outcomes:
measure: The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Institute of Psychiatry, University of São Paulo
city: São Paulo
country: Brazil
facility: Institute of Psychiatry
Study officials:
affiliation: Institute of Psychiatry, University of São Paulo
name: Ricardo Alberto Moreno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Psychiatry, University of São Paulo
name: Giovani Missio, MD
role: STUDY_CHAIR
References:
citation: Missio G, Moreno DH, Fernandes F, Bio DS, Soeiro-de-Souza MG, Rodrigues dos Santos D Jr, David DP, Costa LF, Demetrio FN, Moreno RA. The ARIQUELI study: potentiation of quetiapine in bipolar I nonresponders with lithium versus aripiprazole. Trials. 2013 Jun 27;14:190. doi: 10.1186/1745-6215-14-190.
Clinical trial NCT06769763: MHealth Effect on Multiple Sclerosis Patients' Quality of Life and Self-care Practices
Official title: Arabic Mobile Application for Multiple Sclerosis (MS) Patients and Its Effect on Their Quality of Life and Self-care Practices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Quality of life
Self-care
mHealth
Arabic Application
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn if an Arabic mobile application for multiple sclerosis patients will improve self-care practice and the quality of life of patients or not. The main question it aims to answer is:

Does the Arabic mobile application for MS patients will improve their self-care and quality of life?

Participants will:

Use the developed application or usual care without using the application for 3 months Be followed up during the 12 week period and asked to follow the instructions in the application

Detailed description: This study aims to build and test a culturally appropriate mobile application in Arabic for MS (multiple sclerosis) patients in Egypt. It will focus on self-care practices and quality of life enhancement via educational material provision, symptom tracking as well as medication adherence reminders among other possible functions depending on user preferences. The study shall evaluate how effective the developed app is in promoting self-care practices and improving the quality of life for MS patients compared to a control group who do not use the app.

Eligibility criteria: Inclusion Criteria:

* Diagnosed clinically with multiple sclerosis.
* From 18 to 50 years old (adult).
* With smartphones.
* Willing to participate in the study and use the mobile application.

Exclusion Criteria:

* Patients who are bedridden or in a wheelchair
* Illiterate patients.

Primary outcomes:
measure: The effect of mHealth on the self-care practices of multiple sclerosis patients
timeFrame: From enrollment to the end of follow-up at 12 weeks
measure: The effect of mHealth on the quality of life of multiple sclerosis patients
timeFrame: From enrollment to the end of follow-up at 12 weeks
Secondary outcomes:
measure: The usability of the developed application
timeFrame: After 12 weeks of enrollment
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
affiliation: Professor of public Health and Community Medicine, Faculty of Medicine, Cairo University
name: Nargis Albert Labib
role: STUDY_CHAIR
References:
Clinical trial NCT02695563: Effects of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on Inflammatory Mediators
Official title: Influence of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on PGE2, MMP-9, MMP-2, TIMP-1 and TIMP-2 Amniotic Fluid Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy
Keywords: Amniocentesis
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 111
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of vaginal lactoferrin administration on amniotic fluid PGE2 level and MMP-TIMP system in women undergoing genetic amniocentesis. Two groups of patients will be prospectively enrolled: not treated with lactoferrin and treated with vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.

Detailed description: Pregnant women undergoing genetic amniocentesis within the 16th-18th gestational week will be enrolled at the Obstetric Unit, University of Ferrara.

The selected patients will be randomly assigned to receive a vaginal compound containing 300 mg of lactoferrin 4 hours before amniocentesis or they will be untreated (controls).

Amniotic fluid samples will be obtained by transabdominal amniocentesis and the sample not required for clinical purposes will be centrifuged to remove particulate material and the supernatants will be aliquoted and stored at -80°C until assay.

Eligibility criteria: Inclusion Criteria:

* singleton gestation
* maternal age as indication to fetal karyotyping

Exclusion Criteria:

* consumption of drugs interfering with the immune system
* previous miscarriages
* pregnancy at risk for maternal or fetal disease
* lactose intolerance

Primary outcomes:
measure: Measurement of inflammatory markers in the amniotic fluid
timeFrame: 1 month after the enrollment of patients will be concluded.
Secondary outcomes:
Other outcomes:
Locations:
city: Cona
country: Italy
facility: Obstetric Unit, University of Ferrara
state: Ferrara
Study officials:
affiliation: Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara
name: Carlo Contini, Professor
role: STUDY_DIRECTOR
References:
citation: Trentini A, Maritati M, Rosta V, Cervellati C, Manfrinato MC, Hanau S, Greco P, Bonaccorsi G, Bellini T, Contini C. Vaginal Lactoferrin Administration Decreases Oxidative Stress in the Amniotic Fluid of Pregnant Women: An Open-Label Randomized Pilot Study. Front Med (Lausanne). 2020 Sep 8;7:555. doi: 10.3389/fmed.2020.00555. eCollection 2020.
citation: Trentini A, Maritati M, Cervellati C, Manfrinato MC, Gonelli A, Volta CA, Vesce F, Greco P, Dallocchio F, Bellini T, Contini C. Vaginal Lactoferrin Modulates PGE2, MMP-9, MMP-2, and TIMP-1 Amniotic Fluid Concentrations. Mediators Inflamm. 2016;2016:3648719. doi: 10.1155/2016/3648719. Epub 2016 Oct 31.