louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02840695: Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)
Official title: Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Spinal Fractures
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 9858
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AS as registered in the Swedish Patient Registry with ICD-9-code 720 or ICD-10 code M45.9.

Brief summary: Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been successfully introduced to reduce the disease activity. It is unclear whether bDMARD treatment had an effect on spinal fracture risk related to AS. This national registry study will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort of patients with AS.


Eligibility criteria: Inclusion Criteria:

* age 30-60 years
* registered diagnosis of ankylosing spondylitis

Exclusion Criteria:

* age \<30 or \>60 years

Primary outcomes:
measure: Spinal fracture
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Robinson Y, Olerud C, Willander J. Do biological disease-modifying antirheumatic drugs reduce the spinal fracture risk related to ankylosing spondylitis? A longitudinal multiregistry matched cohort study. BMJ Open. 2017 Dec 28;7(12):e016548. doi: 10.1136/bmjopen-2017-016548.
citation: Badar F, Mahmood S. Epidemiology of cancers in Lahore, Pakistan, among children, adolescents and adults, 2010-2012: a cross-sectional study part 2. BMJ Open. 2017 Dec 21;7(12):e016559. doi: 10.1136/bmjopen-2017-016559.
Clinical trial NCT01939795: Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
Official title: Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: cardiac resynchronization therapy (CRT)
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.


Eligibility criteria: Inclusion Criteria:

* QRS\> 150 ms or 120-150ms associated dyssynchrony
* The etiology can be idiopathic, ischemic, hypertensive and Chagas' disease
* Ejection fraction \<35%
* The optimal pharmacological treatment for heart failureExclusion Criteria:

Exclusion Criteria:

* Patients with pulmonary diseases, neurological diseases, renal, skeletal muscle diseases
* Patients with contraindications to implant a cardiac pacemaker
* Pregnancy
* New York Heart Association functional class IV
* Atrial fibrillation

Primary outcomes:
measure: Sympathetic nerve activity
timeFrame: 4 months
Secondary outcomes:
measure: Peak oxygen consumption
timeFrame: 4 months
measure: Quality of life
timeFrame: 4 months
measure: Blood inflammatory markers
timeFrame: 4 months
measure: skeletal muscle strength
timeFrame: 4 months
measure: Muscle Blood Flow
timeFrame: 4 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Thais Simoes Nobre Pires Santos
state: SP
Study officials:
affiliation: InCor, HCFMUSP
name: Carlos E Negrao, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04938895: Willingness to Participate in Clinical Trials Among Black and African Americans
Official title: Willingness to Participate in Clinical Trials Among Black and African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Researcher-Subject Relations
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 323
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite significant racial disparities in health outcomes, racial minority groups in the United States are not adequately represented in clinical trials, and clinical trial results published in major medical journals often underreport racial demographic data of participants. Lack of diversity in clinical trials threatens the generalizability of study results and reduces the ability of minority groups to benefit from medical advancement and innovation. Prior studies show that Black men are more likely to engage in preventive services when there is racial concordance with their healthcare provider. There is minimal literature about how racial concordance or diversity in clinical trial leadership impacts study enrollment. This project examines whether patients' willingness to participate in randomized clinical trials differs based on the characteristics of the investigator.

Detailed description: We plan to recruit subjects and randomly assign them to one of four treatments. In each treatment arm, the subject will view a photograph of a real NIH investigator. We experimentally vary treatment along two dimensions: whether the sender is Black or white and whether the sender is male or female.

Our primary aim is to assess whether the subject's stated willingness to participate in a clinical trial led by the investigator. Our secondary aim is to assess whether the subject is a more objective measure of interest in signing up for information on other clinical trials. To assess mechanisms, we will ask the respondent to rate the subject's perceived trustworthiness and quality of the investigator. In addition, we will also assess the subject's perceived attractiveness and age of the investigator as well as the subject's risk aversion, altruism, time preference, and general trust.

Eligibility criteria: Inclusion Criteria:

* participant identifies as Black or White

Exclusion Criteria:

* participant doesn't identify as Black or White
* younger than 25 years old, older than 64

Primary outcomes:
measure: Willingness to Participate in a Clinical Trial
timeFrame: February 17, 2022 - February 19, 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Marcella Alsan, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01502995: Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
Official title: Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Keywords: Assistive devices
Freezing of gait
Gait disorders
Gait hesitation
Gait ignition failure
Laser light
Parkinson's disease
Rolling walker
Visual Cue
Walker
Lead sponsor: Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
Sponsor class: FED
First posted: 2012-01-02
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's disease.

Detailed description: Freezing of gait is a debilitating feature of Parkinson's disease. This study aims to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes. Patients will perform two trials of 3 timed walking tasks: once with the laser beam and once without. For each trial, the time to complete, number of steps, and number of freezing episodes will be recorded. Patients will be randomized to perform the first trial either with the light or without the light, to control for fatigue.

Eligibility criteria: Inclusion Criteria:

* idiopathic PD confirmed by a movement disorders neurologist
* a Mini-Mental Status Examination (MMSE)\[13\] score ≥ 24 to ensure competence to participate in informed consent and an ability to learn procedurally the use of the rolling walker with laser beam
* functional visual acuity for recognizing the laser beam on the rolling walker
* FOG in both on and off medication states, as indicated by a score of ≥ 2 on Item 14 of the Unified Parkinson's Disease Rating Scale (UPDRS) and/or ≥1 on Item 3 of the Freezing of Gait Questionnaire (FOGQ)
* ability to ambulate for at least household distances with or without an assistive device as indicated by scoring 0, 1, or 2 on Items 15 and 29 of the UPDRS.

Exclusion Criteria:

* diagnosis of a gait disorder other than Parkinson's disease

Primary outcomes:
measure: Time to complete walking task
timeFrame: Two hours
Secondary outcomes:
measure: Number of steps
timeFrame: Two hours
measure: Number of freezing episodes
timeFrame: Two hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center PADRECC
state: Pennsylvania
Study officials:
affiliation: Philadelphia VAMC PADRECC
name: Lisette Bunting-Perry, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04420195: Envarsus XR in Lung Transplant
Official title: Pilot Study Comparing Early Conversion to Extended-Release Tacrolimus (ENVARSUS XR) to Immediate-Release Tacrolimus in Lung Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Transplant
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing a lung transplant will be enrolled. All patients will undergo lung transplantation with standard post-operative management, including triple immunosuppression. As soon as the patient is deemed appropriate to take medications via the oral route, they will be converted from IR tacrolimus to Envarsus XR. Patients will be followed per site's standard of care.

Detailed description: Lung transplantation will be performed per standard-of-care techniques. All post-transplant management, including initial triple immunosuppression, will be carried out per standard of care. Once the patient is able to take medications via the oral route, they will be converted to Envarsus XR, which will be maintained for the first year post-lung transplant.

Eligibility criteria: Inclusion Criteria:

Prospective arm:

* Age ≥ 18 years
* Received a lung transplant at NYU Langone Health
* Be able to convert to Envarsus XR within the first month post-transplant
* Able and willing to provide informed consent

Historical control:

* Age ≥ 18 years
* Received a lung transplant at NYU Langone Health
* Completed one year from transplant on IR tacrolimus

Exclusion Criteria:

Prospective arm:

* Contraindication to tacrolimus due to allergic or adverse reactions
* Pregnant or nursing women
* Multi-organ transplant recipient

Historical control:

* Contraindication to tacrolimus due to allergic or adverse reactions (not including chronic kidney disease)

Primary outcomes:
measure: Percentage of Patients Remaining on Envarsus XR at 1 Year
timeFrame: 1 Year Post-Transplant
Secondary outcomes:
measure: Freedom From Acute Cellular Rejection (ACR) at 1 Year
timeFrame: Up to 1 Year Post-Transplant
measure: Composite Rejection Standardized Score (CRSS)
timeFrame: 1 Year Post-Transplant
measure: Number of Treated Episodes of ACR
timeFrame: Up to 1 Year Post-Transplant
measure: Number of Participants With of Chronic Lung Allograft Dysfunction (CLAD)
timeFrame: Up to 1 Year Post-Transplant
measure: Number of Participants With De Novo Donor-Specific Antibody (DSA)
timeFrame: Up to 1 Year Post-Transplant
measure: Change in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, 1 Year Post-Transplant
measure: Overall Survival at 1 Year
timeFrame: 1 Year Post-Transplant
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Luis Angel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00600795: Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus
Official title: Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Pressure Hydrocephalus
Keywords: NPH
TGF-beta
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic and neurology clinic

Brief summary: Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus

Detailed description: The goal of this research is to investigate a potential CSF biomarker of NPH as a new tool for both the diagnosis of NPH and prognosis of VPS placement. Transforming growth factor-b1 (TGF-b1) is a signaling molecule involved in three fundamental activities; suppression of cell proliferation, immunosuppression, and deposition of extracellular matrix through promotion of synthesis and inhibition of degradation.8 Previously, TGF-b1 had been implicated in the development of communicating hydrocephalus secondary to pre-term infant intraventricular hemorrhage9 and adult aneurysmal sub-arachnoid hemorrhage.10, 11 Recently, an investigation demonstrated elevated levels of TGF-b1 in patients with shunt-responsive NPH compared to non-NPH patients.12

The specific aims of this research proposal are to:

1. Correlate CSF levels of TGF-b1 with the clinical response of patients diagnosed with NPH to VPS placement.
2. Correlate CSF levels of TGF-b1 with optimal VPS pressure settings.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Normal Pressure Hydrocephalus

Exclusion Criteria:

* Patients not diagnosed with Normal Pressure Hydrocephalus

Primary outcomes:
measure: TGF beta-1 levels
timeFrame: Time of Surgery
measure: Mini-mental status exam
timeFrame: Pre-operative, 3 and 12 months post-operatively
measure: Modified barthel index
timeFrame: Pre-operative, 3 and 12 months post-operatively
measure: Tinetti mobility assessment
timeFrame: Pre-operative, 3 and 12 months post-operatively
Secondary outcomes:
measure: Programmable shunt setting
timeFrame: Pre-operative, 3 and 12 months post-operatively
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Noel Tulipan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05149495: Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery
Official title: Maintenance of Remission After Discontinuation of Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acromegaly
Keywords: Acromegaly
Pituitary microadenoma
Pituitary macroadenoma
Somatostatin analogues
Hormonal control
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 100
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: Subject operated for a pituitary adenoma at the HUS between 01/01/2000 to 09/01/2021

Brief summary: At present there are no recommendations regarding the possibility of discontinuing treatment in cases of recurrent acromegaly with good hormonal control. Discontinuation of treatment is therefore most often decided by the practitioner, on the basis of his experience and knowledge of the patient, the long-term course with somatostatin analogues being very little described.

Thus, although hormonal control is achieved in a majority of cases under medical treatment, we do not know if it is possible to stop treatment and in this case how the pathology evolves. It would appear that approximately 40% of patients defined as very good responders to somatostatin analogues may gradually space their injections.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Having been seen at least once in consultation in the Internal Medicine, Endocrinology and Nutrition department of Hautepierre Hospital
* Subject operated for a pituitary adenoma at the HUS between 01/01/2000 to 09/01/2021
* In whom biological confirmation of recurrence has been demonstrated
* Patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Treatment pre and / or post surgery by radiotherapy
* No recurrence
* No treatment with a somatostatin analogue for recurrence
* Subject under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Study of the clinical and biological evolution, after discontinuation of treatment with somatostatin analogues, of acromegalic patients with recurrence after surgery.
timeFrame: Files analysed retrospectively from January 01, 2000 to September 01, 2021 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg
name: Philippe BALTZINGER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05556395: Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline
Official title: Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: blood-brain barrier
post-stroke cognitive impairment and dementia
vascular cognitive impairment and dementia
Alzheimer's disease and related dementias
stroke
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-09-27
Enrollment: 150
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 who are admitted to the hospital and diagnosed with an ischemic stroke based on an MRI scan that also includes perfusion imaging with an exogenous contrast agent and are will/able to be contacted for serial phone-based cognitive evaluations.

Brief summary: The goal of this study is to gain a better understanding of why some individuals who have suffered a stroke experience post-stroke cognitive decline. Specifically this study is testing whether global disruption of the blood-brain barrier detected at the time of the stroke is informative about the risk of post-stroke cognitive decline over the next 3 years.

Detailed description: It is well known that ischemic stroke is a risk factor for developing dementia. Prior studies have shown that after a stroke, there can be a change in the trajectory of cognitive performance with acceleration of decline. The mechanism of this phenomenon has not been established. It is known that vascular changes in the brain, referred to as cerebral small vessel disease, are associated with cognitive decline and dementia. Cerebral small vessel disease is readily seen on MRI scans of the brain, and the larger the burden of these findings, the higher the risk of cognitive deficits. Disruption of the blood-brain barrier has been implicated in the development of the changes seen on MRI. Acute stroke has been shown to disrupt the blood-brain barrier, even in parts of the brain not directly affect by the stroke. The investigators hypothesize that when there is diffuse blood-brain barrier disruption in response to an acute stroke it sets off a cascade of changes in the brain that lead to post-stroke cognitive decline.

Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke demonstrated on an MRI scan that includes perfusion imaging with an exogenous contrast agent

Exclusion Criteria:

* Inability to perform telephone-based cognitive assessments

Primary outcomes:
measure: Change in Cognition (Cognitive Decline)
timeFrame: Assessments occur every 6 months for 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Richard Leigh, MD
role: PRINCIPAL_INVESTIGATOR
References: