louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03146468: Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Stem Cell Transplantation
Official title: Pilot Study of the Tolerability of Nivolumab for Relapsed or Residual Haematological Malignancies After Allogeneic Haematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Haematological Malignancy
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective study of the safety and efficacy of nivolumab for the treatment of relapsed or residual haematological malignancies after allogeneic stem cell transplantation (alloSCT).

Eligible patients will receive nivolumab at a dose of 3mg/kg intravenously every 2 weeks. The primary objective is to evaluate the incidence, severity and treatment responsiveness of GVHD following nivolumab treatment post-alloSCT.


Eligibility criteria: Inclusion Criteria:

* Prior allogeneic stem cell transplant for a haematological malignancy
* Confirmed relapse of haematological malignancy or persistent disease post-alloSCT
* Immunosuppression cessation for minimum of 2 weeks
* Life expectancy \> 2 months
* ECOG performance status 0-2
* Greater than or equal to 30% CD3+ donor chimerism
* Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 40mL/min
* AST and ALT ≤ 3 times upper limit of normal
* Total bilirubin ≤ 1.5 times upper limit of normal (except patients with Gilbert Syndrome)
* Signed written informed consent

Exclusion Criteria:

* Current evidence of any grade of GVHD
* Prior history of grade 2 or higher acute GVHD
* Moderate chronic GVHD within the previous 6 months or any prior history of severe chronic GVHD
* Active, known or suspected autoimmune disease (excluding vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger)
* Positive hepatitis B virus surface antigen
* Positive hepatitis C virus antibody
* Known human immunodeficiency virus infection

Primary outcomes:
measure: Graft versus host disease
timeFrame: 8 weeks
measure: Graft versus host disease
timeFrame: 24 weeks
measure: Graft versus host disease
timeFrame: 48 weeks
Secondary outcomes:
measure: Overall response rate
timeFrame: 8 weeks
measure: Overall response rate
timeFrame: 16 weeks
measure: Overall response rate
timeFrame: 24 weeks
measure: Overall response rate
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: David Ritchie, FRACP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06712368: Effect of Virtual Reality on Pain, Arterial Blood Gases and Functional Capacity in Children After Open Heart Surgery
Official title: Effect of Virtual Reality on Pain, Arterial Blood Gases and Functional Capacity in Children After Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Children After Open Heart Surgery
Keywords: virtual reality, heart surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate:

* The effect of virtual reality on pain in children after open heart surgery,
* The effect of virtual reality on arterial blood gases in children after open heart surgery,
* The effect of virtual reality on functional capacity in children after open heart surgery.


Eligibility criteria: Inclusion Criteria:

* Both genders will be included.
* Their age range from 6 to 12 years.
* Children after open heart surgery ( phase I cardiac rehabilitation).

Exclusion Criteria:

The children have one or more of the following will be excluded:

* Any child Suffering from any other chronic congenital diseases.
* Severe visual or auditory problems.
* Neurological problems.
* Vertigo problems.
* Post surgical hemorrhage.
* Post surgical arrhythmia.

Primary outcomes:
measure: pain
timeFrame: 1 hour /session 1 time / day for 5 consecutive days
measure: arterial blood gases
timeFrame: 1 hour /session 1 time / day for 5 consecutive days
measure: functional capacity
timeFrame: 1 hour /session 1 time / day for 5 consecutive days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National heart institute
Study officials:
References:
Clinical trial NCT02471768: The Association Between Central Aortic Blood Pressure Indices and Severity of Coronary Artery Disease
Official title: The Association Between Central Aortic Blood Pressure Indices and Severity of Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: central pressure
Gensini score
pulsatility
coronary artery disease
Lead sponsor: Government Medical College, Kozhikode
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 623
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ALL CONSECUTIVE SUBJECTS UNDERGOING CORONARY ANGIOGRAM FOR THE DIAGNOSIS OF CAD DURING A 6 MONTH PERIOD

Brief summary: Abstract

Objectives:

Primary: To study the association between central aortic blood pressure indices and coronary artery disease in patients undergoing elective angiography. Secondary: (a) To study whether any association exists between central aortic pressure indices and the incidence of major adverse cardiovascular events (MACE) in the same patients during a 6 month follow up period. (b) To study whether any association exists between the central aortic pressures and peripheral pressures.

Methods: The investigators conducted a prospective observational study in consecutive patients undergoing coronary angiography. Central and peripheral pressures were invasively recorded and coronary artery disease (CAD) classified into obstructive and non-obstructive group. CAD severity was graded using the Gensini score and subjects were divided into tertiles. Patients were followed up and the role of central aortic pressure indices in the prediction of cardiovascular events were analysed.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective angiography for diagnosis of CAD.
* Age \> 18 years

Exclusion Criteria:

* Patients with acute myocardial infarction, unstable angina or thromboembolism in the preceding 3 months.
* More than mild valvular heart disease.
* Renal impairment with serum creatinine \> 1.5 mg%.
* Unable to obtain a full study of the coronary arteries.
* Peripheral vascular occlusive disease.
* Post coronary artery bypass grafting( CABG)
* Heart rate \< 50/min and \> 120/min and other arrhythmias.
* Contraindications for coronary angiography.
* Unable to provide written informed consent

Primary outcomes:
measure: acute coronary syndrome(ACS)
timeFrame: 6 MONTHS
measure: stroke
timeFrame: 6 months
measure: revascularisation
timeFrame: 6 months
measure: death
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Government Medical College, Kozhikode
name: SHREETAL R NAIR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00576368: An Open Therapeutic Project to Confirm the Efficacy Tolerability and Safety Profile of Lantus in Everyday Medical Practice
Official title: An Open Therapeutic Project to Confirm the Efficacy Tolerability and Safety Profile of Lantus in Everyday Medical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 4464
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: The objective of this survey on this registered product is to confirm the efficacy, and safety profile of Lantus in every day medical practice. This program will also help to obtain information about the use of the insulin titration regimen and handling of the Lantus insulin analogue.


Eligibility criteria: Inclusion Criteria:

* All newly diagnosed diabetics and existing diabetics uncontrolled on other anti-diabetic therapy, where treatment with basal insulin is required to control hyperglycaemia, and who the treating investigator considers may benefit from the treatment with Lantus, could enter in this program.

Exclusion Criteria:

-

Primary outcomes:
measure: Glycemic status (Fasting Blood Glucose, Fasting Plasma Glucose, and HbA1C as done in routine medical practice)
timeFrame: at least 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: E Hens
role: STUDY_DIRECTOR
References:
Clinical trial NCT00827268: Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes
Official title: Multimodal Treatment of Phonological Alexia: Behavioral & fMRI Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Dyslexia, Acquired
Keywords: Dyslexia
Reading
Aphasia
Stroke
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-01-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a repeated probe design study.
Primary purpose: TREATMENT

Brief summary: This study offers 90-120 hours of 1:1 training to improve reading skills in adults who have poor reading skills following a stroke. Specifically, this study is designed to improve skill in sounding out words for reading and spelling. The overall time commitment for participation in this study is approximately 11-30 weeks.

Detailed description: The proposed study is a mixed-effects (single-subject ABA repeated-probe and small group elements) design with 90-120 hours of a modified multi-modal treatment of alexia replicated across up to 18 adults with post-stroke phonological alexia. The short-term goals of this research proposal includes the following: 1) determine if a modified multimodal treatment of phonological alexia can improve pseudoword reading skills (providing a basis from which training will also treat real word reading skills), 2) determine if a modified multimodal treatment of phonological alexia can improve real word reading skills, 3) determine how brain lesion extent and location relate to participants' response to treatment, and 4) identify relationships between changes in functional brain activity in specified regions of interest and participants' response to treatment.

Eligibility criteria: Inclusion Criteria:

* Adults with post-stroke reading difficulties (phonological alexia)
* \>3 months post-stroke
* native English speaker
* can go in MRI scanner (3 to 6 scans),
* participate in 90 to 120 free treatment sessions
* return for 3-month post-treatment follow-up assessment \& MRI.

Exclusion Criteria:

* mental illness
* degenerative disease, visual or auditory acuity impairment
* drug abuse
* English is not first language
* claustrophobia
* pregnancy

Primary outcomes:
measure: Change in Real World Reading Skills
timeFrame: Language testing are conducted two weeks prior to treatment, immediately following end of treatment and 3 months after end of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: Timothy W. Conway, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03667768: Atraumatic Restorative Treatment Sealants in First Permanent Molars
Official title: Atraumatic Restorative Treatment Sealants in First Permanent Molars: a Bi-center Split-mouth Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries, Dental
Keywords: Dentition, Permanent
Glass Ionomer Cements
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Academic Centre for Dentistry in Amsterdam
name: Universidade Federal de Pernambuco
First posted: 2018-09-12
Enrollment: 437
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split-mouth design
Primary purpose: TREATMENT

Brief summary: The aim of this bi-center study was to evaluate the retention and caries-preventive effect of Atraumatioc Restorative Treatment (ART) sealants, using two glass ionomer cement (GIC) versus non-sealant on first permanent molars of schoolchildren. The null hypothesis is that there is no difference in the retention rates of the two GIC, as well as in caries prevention between sealants application and non-sealant. Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil. They were randomly divided into two groups, according to the GIC used (Fuji IX or Maxxion). All children had their four first permanent molars included in the research and two molars were sealed with a GIC, while the other two molars remained unsealed. Clinical evaluations were performed up to 36 months by one independent examiner at each city.


Eligibility criteria: Inclusion Criteria:

* patients presenting the four first permanent molars without gingival tissue covering the occlusal surface and without clinically detectable dentine caries lesion, assessed as scores 0, 1 and 2 of ICDAS criteria \[Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178 \].

Exclusion Criteria:

* patients presenting any physical and/or medical health issues and having non-cooperative behavior.

Primary outcomes:
measure: Changes in glass ionomer selants retention
timeFrame: 3, 6, 12, 18, 24 and 36 months
Secondary outcomes:
measure: Changes in caries status of first permanent molars
timeFrame: 3, 6, 12, 18, 24 and 36 months
measure: Comparison between the development of caries in dentine(measured using ICDAS score system) of first permanent molars between the two cities
timeFrame: 3, 6, 12, 18, 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03524768: Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.
Official title: Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas Cardiomyopathy
Keywords: endothelial function, microvascular
laser speckle contrast imaging
capillaroscopy, skin
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2018-05-15
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients presenting with the cardiac form of Chagas disease in the National Institute of Cardiology, Ministry of Health, Rio de Janeiro,, Brazil

Brief summary: The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients with the cardiac form of Chagas disease, and to search for associations with clinical and laboratory variables.

Detailed description: Chagas disease is an endemic anthropozoonosis in South America, caused by the protozoaTrypamosoma cruzi. Between 15 and 17 million people are estimated to be infected by the parasite in South America. During the chronic phase, 30 to 40% of patients develop the cardiac or intestinal forms of the disease. The myocardial involvement is divided in two subtypes, according to the presence or absence of systolic ventricular dysfunction. The first type is characterized by heart failure symptoms. The second is acknowledged by the development of various degrees of atrioventricular blockade and by tachyarrhythmias.

Microcirculation function is recognized as a fundamental aspect in the pathophysiology of cardiovascular diseases. The identification of endothelial dysfunction by techniques that assess the microvasculature is considered as both a progression and prognostic marker in various conditions, including hypertension, coronary heart disease, and heart failure.

The effects of T. cruzi infection in vascular function were evaluated in previous studies, performed in animals with acute infection. Previous studies in humans observed medium size vessels (brachial artery), in small groups of patients, most without cardiac dysfunction. There are no studies evaluating the microcirculation of patients with the cardiac form of Chagas disease.

Eligibility criteria: Inclusion Criteria:

* patients presenting with Chagas cardiomyopathy

Exclusion Criteria:

* diabetes

Primary outcomes:
measure: Endothelium-dependent skin microvascular function
timeFrame: 2 hours
Secondary outcomes:
measure: Endothelium-dependent skin capillary density
timeFrame: 1 hour
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National Institute of Cardiology, Ministry of Health, Brazil
Study officials:
References:
Clinical trial NCT02994368: "Natural History" Study of Choroideremia
Official title: A Multicenter Prospective Observational "Natural History" Study in Patients With Choroideremia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Choroideremia
Keywords: retinal degeneration
eye
REP-1 gene
Lead sponsor: 4D Molecular Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 57
Sex: MALE
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: Individuals with a clinical diagnosis of choroideremia

Brief summary: The purpose of this study is to understand the rate of progression of all stages of choroideremia using a variety of assessments performed in the clinic including visual field measures, specialized photography of the eye and participant-reported visual problems


Eligibility criteria: Inclusion Criteria (Primary Cohort):

* Healthy individuals (at least 14 years) with choroideremia (20/200 or better vision) willing to participate in an observational study and meeting the eligibility criteria.

Inclusion Criteria (Expansion Cohort):

* Healthy individuals (at least 18 years) with choroideremia (20/200 or better vision in both eyes) willing to participate in an observational study and meeting the eligibility criteria.

Exclusion Criteria (Primary and Expansion Cohort):

1. Prior therapy with an AAV vector-based treatment
2. Pre-existing eye conditions that would: (1) preclude future planned treatment in a therapeutic intent clinical trial (i.e. intravitreal injection), (2) interfere with the interpretation of study endpoints, and/ or put patient at risk for surgical complications
3. Complicating systemic diseases that would preclude future enrollment in a therapeutic intent clinical trial
4. Any other condition that would not allow the potential subject to complete follow-up examinations during the course of the study and, in the opinion of the investigator, makes the potential subject unsuitable for the study.

Primary outcomes:
measure: Rate of progression of disease
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Ophthalmology-Cullen Eye Center
state: Texas
city: Salt Lake City
country: United States
facility: Moran Eye Center, University of Utah
state: Utah
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: 4D Molecular Therapeutics
name: Schonmei Lee, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00311168: Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
Official title: Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-04-05
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV delay.


Eligibility criteria: Inclusion Criteria:

* Patient has been implanted with dual chamber SJM Victory® device with VIP™ for 1 month (± 2 weeks).
* At the time of pacemaker implant, VIP™ is programmed "OFF".
* At the time of enrollment, patient is paced in the RV ≤ 60% of the time.
* Patient is medically stable.

Exclusion Criteria:

* Patient has evidence of complete AV block, such that ventricular pacing would be required as part of the patient's routine management.
* Patient is indicated for AF Suppression.
* Patient has persistent or chronic atrial fibrillation.
* Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
* Patient is currently participating in another device research study.
* Patient is younger than 18 years of age.
* Patient is pregnant.
* Patients life expectancy is less than 12 months.

Primary outcomes:
measure: Percentage of Intrinsic Ventricular Events
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Incidence of Arrhythmias
timeFrame: 6 months after randomization
measure: Percentage of Atrial Sensing to Ventricular Sensing (%PR)
timeFrame: 6 months after randomization
measure: Percentage of Atrial Sensing to Ventricular Pacing (%PV)
timeFrame: 6 months after randomization
measure: Percentage of Atrial Pacing to Ventricular Sensing (%AR)
timeFrame: 6 months after randomization
measure: Percentage of Atrial Pacing to Ventricular Pacing (%AV)
timeFrame: 6 months after randomization
measure: Percentage of Patients Experiencing a Study-Related Adverse Event
timeFrame: 6 months after randomization
measure: Number of Auto Mode Switch Events
timeFrame: 6 months after randomization
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Abbott
state: California
Study officials:
affiliation: Abbott
name: Clay Cohorn
role: STUDY_DIRECTOR
References: