louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01961882: A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: OCV-501
Acute Myeloid Leukemia
Antigen specific cancer immunotherapeutic
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-10-14
Enrollment: 134
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare disease-free survival in patients 60 years or older with acute myeloid leukemia (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.


Eligibility criteria: Inclusion Criteria:

* Patients with AML who achieved first complete remission within one or two courses of standard induction therapy, and completed standard consolidation therapy (more than one course).
* Patients who are 60 years or older.
* Patients who have provided written informed consent within 90 days from the last dose of consolidation therapy on an informed consent form that has been approved by an institutional review board or independent ethics committee.

Exclusion Criteria:

* Patients who have acute promyelocytic leukemia (APL) with t(15;17) (q22;q12), (PML/RARA) karyotype abnormalities, and other variant types.
* Patients who are scheduled for hematopoietic stem cell transplantation.
* Patients who have received drugs potentially affecting the immune system within 4 weeks before starting IMP administration or who may receive such drugs after start of the trial.
* Patients who have a severe concurrent disease or psychiatric illness likely to interfere with participation in this trial.
* Patients who are HIV antibody positive, HBV-DNA positive or have unrecovered chronic hepatitis C with positive HCV antibody.
* Patients who have cirrhosis.
* Patients judged to be ineligible by the investigator (or subinvestigator) for any other reasons.

Primary outcomes:
measure: Disease-Free Survival
timeFrame: 2 years (treatment period)
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years (treatment period)
Other outcomes:
Locations:
city: Chubu Region
country: Japan
city: Chugoku Region
country: Japan
city: Hokkaido Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
city: Shikoku Region
country: Japan
city: Tohoku Region
country: Japan
city: Daegu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kaoshiung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Jun-ichi Hashimoto, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00332982: Ontario ICU Clinical Best Practices Demonstration Project
Official title: Ontario ICU Clinical Best Practices Demonstration Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Acquired Pneumonia
Catheter Related Blood Stream Infections
Pressure Ulcer Prophylaxis
DVT Prophylaxis
Restrictive Blood Transfusion Strategy
Daily Spontaeous Breathing Trials
Keywords: best practices, performance improvement, intensive care, measurement
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
name: Huntsville District Memorial Hospital
name: Lake Of The Woods District Hospital
name: Lakeridge Health Corporation
name: North Bay General Hospital
name: North York General Hospital
name: Northumberland Hills Hospital
name: Orillia Soldiers' Memorial Hospital
name: Peterborough Regional Health Centre
name: Sault Area Hospital
name: Scarborough General Hospital
name: Scarborough Grace Hospital
name: Sudbury Regional Hospital
name: Royal Victoria Hospital Of Barrie
name: Michael Garron Hospital
name: West Parry Sound Health Centre
First posted: 2006-06-02
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The pragmatic issue at hand how to get physicians and nurses to use best practices... and how to measure consequences of their implementation. This is the science of "knowledge translation", which we are realizing is an "organic" entity. As part of our Critical Care Strategy our goal is to improve the quality and continuity of critical care within our health care system. Toward this goal we are implementing a program which links 16 Ontario hospitals through their critical care units in a Provincial Network.


Eligibility criteria: Inclusion Criteria:

* Cohort of hospitals with Intensive Care Units in Ontario

Primary outcomes:
measure: Relative risk of receiving best practices in the ICU.
Secondary outcomes:
measure: ICU length of stay
measure: Barriers to best practice use in the ICU
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Science Centre
state: Ontario
Study officials:
affiliation: Sunnybrook & Women's College Health Science Centre
name: William J Sibbald, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook & Women's College Health Sciences Centre
name: Damon Scales, MD, MSc
role: STUDY_DIRECTOR
References:
citation: Scales DC, Dainty K, Hales B, Pinto R, Fowler RA, Adhikari NK, Zwarenstein M. A multifaceted intervention for quality improvement in a network of intensive care units: a cluster randomized trial. JAMA. 2011 Jan 26;305(4):363-72. doi: 10.1001/jama.2010.2000. Epub 2011 Jan 19.
Clinical trial NCT01743482: Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors
Official title: Phase II Study of Single-agent Pazopanib (Votrient®) for Patients With Relapsed or Refractory Germ-cell Tumors (GCT).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Germ Cell Tumors
Measurable Disease
Keywords: Testicular Cancer
Germ Cell Tumors
Salvage Therapy
Pazopanib
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2012-12-06
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label, single arm, single center, phase 2 study with the use of the antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell tumors who are not cured following first or subsequent chemotherapy lines for metastatic disease, followed by eventual surgery.


Eligibility criteria: Inclusion Criteria:

* Male gender.
* Confirmation of GCT histology based on pathologic review at Fondazione INT Milan.
* Unequivocal progression of measurable disease.
* A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.
* First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.
* Prior single, tandem or triple high-dose chemotherapy course given as front-line or salvage therapy is allowed.

Exclusion Criteria:

* Failure to meet any of the above inclusion criteria.
* Concurrent treatment with other cytotoxic drugs or targeted therapies.
* Prior radiation therapy within 14 days of trial start.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 3-months
Secondary outcomes:
measure: Safety and tolerability of pazopanib according to the Common Terminology Criteria for Adverse Events version 4.03
timeFrame: 3 months
measure: Response Rate
timeFrame: 3 months
measure: Overall survival (OS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Mi
Study officials:
References:
Clinical trial NCT02302482: Predictive Factors and Autonomy Level Change
Official title: Predictive Factors of the Autonomy Level Change Related to Memory Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Memory Impairment
Keywords: Alzheimer's disease or related disorders
Functional autonomy level
Cognitive function
Predictive factors
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 10860
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The investigators aimed at developing a database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative personal and with the University hospital computer science department. The main objective is to study the predictive factors associated with the change of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory Clinic. The study population would consist in about 1000 patients with ADRD. The length of follow-up of each patient will be 3 years.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo a medical visit in the Memory Clinic for the 1st time
* Patients living at home or in housing
* Patients with memory impairment, at all stage of the disease

Exclusion Criteria:

* Patients in institution
* Patients under legal protection
* Patients with a hearing or visual impairment, which dot not allow to carry out the examination

Primary outcomes:
measure: Functional autonomy level
timeFrame: 3 years
Secondary outcomes:
measure: Cognitive function level
timeFrame: 3 years
Other outcomes:
Locations:
city: Caluire-et-Cuire
country: France
facility: Hôpital Dugoujon
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital des Charpennes
Study officials:
References:
citation: Dauphinot V, Moutet C, Rouch I, Verdurand M, Mouchoux C, Delphin-Combe F, Gaujard S, Krolak-Salmon P; MEMORA group. A multicenter cohort study to investigate the factors associated with functional autonomy change in patients with cognitive complaint or neurocognitive disorders: the MEMORA study protocol. BMC Geriatr. 2019 Jul 18;19(1):191. doi: 10.1186/s12877-019-1204-1.
Clinical trial NCT03690882: Medical Imaging Characteristics of Patient With Unclassified Acute Cervical Pain
Official title: Medical Imaging Characteristics of Patient With Unclassified Acute Cervical Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotidynia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-10-01
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients from 10 centers in France, who presented from January 2009 through April 2016 with acute cervical pain and with at least 1 diagnostic image (MR imaging, CT, or US including a dedicated vessel analysis) in which no clearly identified and classified vascular or musculoskeletal cause of the pain was found.

Brief summary: Some cases of acute antero-lateral cervical pain cannot be accurately classified by medical imaging (ultrasound and/or magnetic resonance imaging and/or CT-scan) : imaging rules out carotid dissection, carotid occlusion or vasculitis as well as musculoskeletal causes and thus the pain is considered "of unknown origin".

The investigators hypothesize that in such cases perivascular inflammation of the carotid may be involved.

This study aims at systematically reviewing medical files (including imaging) of patients suffering from acute cervical pain in which carotid dissection, carotid occlusion or vasculitis as well as musculoskeletal causes have been ruled out by ultrasound and/or magnetic resonance imaging and/or CT-scan


Eligibility criteria: Inclusion Criteria:

* Adult patient with acute cervical pain
* Presence of at least one medical imaging modality of the neck : ultrasound with doppler imaging, magnetic resonance imaging, CT-scan
* Medical imaging of the neck includes dedicated vessel analysis
* Absence of definite diagnosis for the cause of the pain after imaging

Exclusion Criteria:

* Musculoskeletal cause of the pain
* Carotid dissection
* Carotid occlusion
* Carotid vasculitis

Primary outcomes:
measure: Proportion of cases with perivascular inflammation of the carotid on medical imaging
timeFrame: Within 2 weeks after the first consultation for acute cervical pain
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rotchschild
Study officials:
References:
Clinical trial NCT03343782: Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes
Official title: Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
BM mesenchymal stem cell
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in the treatment of type 2 diabetes mellitus

Detailed description: Bone marrow-derived mesenchymal stem cells have the immunosuppressive effect and secrete a variety of cytokines, improve the microenvironment of diabetic patients, targeting insulin resistance tissue, ameliorate the metabolic disorder of islet damage, protect and regeneration of the islet beta cells; reduce high blood sugar.The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in treatment 30 patients with type 2 diabetes mellitus at Vinmec International Hospital, Hanoi, Vietnam

Eligibility criteria: Inclusion Criteria:

* Males and females
* Age from 18 years and above.
* Hemoglobin A1c (HbA1c) is ranged from 7.5% to 9% at baseline.
* Type 2 diabetes duration 5 years or more.
* Before the screening, joint or combined with insulin, oral medications to treat more than 3 months.
* Who signed the informed consent form.

Exclusion Criteria:

* Type 1 diabetes.
* Chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, etc.
* According to the medical doctor's judgement, may endanger the safety of the subjects

Primary outcomes:
measure: Insulin dose
timeFrame: up to the 12-month period following treatment
measure: Adverse events
timeFrame: up to the 12-month period following treatment
Secondary outcomes:
measure: Hemoglobin A1c (HbA1c) level
timeFrame: up to the 12-month period following treatment
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
References:
citation: Nguyen LT, Hoang DM, Nguyen KT, Bui DM, Nguyen HT, Le HTA, Hoang VT, Bui HTH, Dam PTM, Hoang XTA, Ngo ATL, Le HM, Phung NY, Vu DM, Duong TT, Nguyen TD, Ha LT, Bui HTP, Nguyen HK, Heke M, Bui AV. Type 2 diabetes mellitus duration and obesity alter the efficacy of autologously transplanted bone marrow-derived mesenchymal stem/stromal cells. Stem Cells Transl Med. 2021 Sep;10(9):1266-1278. doi: 10.1002/sctm.20-0506. Epub 2021 Jun 3.
Clinical trial NCT00626782: Lucentis Versus Mitomycin C During Glaucoma Surgery
Official title: Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Glaucoma
Keywords: glaucoma
glucoma filtering surgery
ranibizumab
mitomycin C
patients requiring first time glaucoma filtering surgery
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Novartis Pharmaceuticals
First posted: 2008-02-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.
Primary purpose: TREATMENT

Brief summary: Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include late bleb leaks, hypotony and infection.

Detailed description: This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab 0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the surgery. No mitomycin C will be applied.

Post operative follow-up will consist of a minimum of 6 visits during a one year period.

Eligibility criteria: Inclusion Criteria:

* 18 yrs or older
* patients requiring first time glaucoma filtering surgery
* phakic or pseudophakic
* must provide written informed consent and comply with study assignments

Exclusion Criteria:

* Pregnant, lactation or premenopausal women not using adequate contraception.
* Previous glaucoma surgery, tube shunt surgery, pars plana vitrectomy, scleral buckle, penetrating keratoplasty.
* Abnormality preventing reliable applanation tonometry in each eye.
* Current infection or inflammation in either eye.
* Enrolled in another investigational study.

Primary outcomes:
measure: Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Post-Operative Requirement for Glaucoma Medication
timeFrame: 1 day, 2 wks, 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital, Glaucoma Service
state: Pennsylvania
Study officials:
affiliation: Wills Eye Institute
name: Michael J Pro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pro MJ, Freidl KB, Neylan CJ, Sawchyn AK, Wizov SS, Moster MR. Ranibizumab versus mitomycin C in primary trabeculectomy--a pilot study. Curr Eye Res. 2015 May;40(5):510-5. doi: 10.3109/02713683.2014.935441. Epub 2014 Jul 14.
Clinical trial NCT05640882: Is Olfaction the Key to PTSD
Official title: Is Olfaction the Key to PTSD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PTSD
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants arriving to the ED following a potentially traumatic event such as a motor vehicle accident will be recruited into the study. Inclusion criteria: aged 18-65, Hebrew as a first language, no current psychiatric disorder. Exclusion criteria: loss of consciousness, unable to understand study procedure. Participants will answer self report questionnaires in the ED. They will be invited for a follow up interview 2 weeks and six months post trauma. Between 2 weeks and 6 months they will be folllowed up via online questionnaires. At the interviews, they will encounter 20 different olfactory stimuli, answer self-report questionnaires, and a clinical interview assessing Axis 1 disorders and PTSD will be completed. At six month, participants with PTSD will be offered therapy in the embedded RCT. Patients will receive VRET (Virtual reality exposure therapy) with or without olfaction.

Detailed description: The goal of this project is to carry out a systematic longitudinal study with an embedded RCT examining olfactory memories in PTSD, in order to test the following hypotheses. Firstly, olfactory memories occur after all traumatic events; secondly, olfactory memories are predictors of PTSD development and thirdly, adding olfaction to PTSD treatment will enhance treatment outcome. The project comprises of a longitudinal study recruiting participants in the Emergency Room within hours of a traumatic event, assessing them at two weeks post trauma for olfactory memories, and at six months for PTSD. This will allow the first two hypotheses to be examined. Participants with PTSD and olfactory memories will be offered treatment and will be randomized to a Virtual Reality Exposure Therapy with and without added odors. Post treatment assessments will examine the third hypothesis.

Eligibility criteria: Inclusion Criteria:

* hebrew native speaker
* understand study requirements

Exclusion Criteria:

* current psychiatric disorder
* suicidality
* vertigo
* epilepsy

Primary outcomes:
measure: PTSD Status
timeFrame: 3 months after end of treatment
measure: PTSD Levels
timeFrame: 3 months after end of treatment
Secondary outcomes:
Other outcomes:
measure: PTSD Symptoms Levels Before Treatment
timeFrame: 6 months post traumatic event
Locations:
Study officials:
References: