louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06451250: Providing Evidence-Based Approaches for Caregiver Stress Study
Official title: Providing Evidence-Based Approaches for Caregiver Stress (PEACE) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiving Stress
Dementia
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this preliminary study is to examine the effects of adult day service use on subjective and physiological measures of stress in 50 Black informal caregivers for individuals with dementia (IWD). The PI of the proposed study has substantial training in primary data collection and complex-survey secondary data analysis, she also has the fundamental knowledge to investigate how sociocultural and behavioral factors can influence psychosocial stress. The proposed study will enroll participants from adult day service (ADS) nationally, to examine the effects of adult day service use on subjective and physiological measures of stress in 50 Black informal caregivers. The proposed study extends the current science on the use of ADS on subjective and physiological stress by 1) examining differential impacts of ADS specifically on subjective measures of stress for Black caregivers, 2) evaluating the impact of ADS use on physiological measures of stress among Black caregivers; and 3) examining the relationship between subjective indicators and physiological processes for Black caregivers.


Eligibility criteria: Inclusion Criteria:

* 18 years or older (male or female)
* Self-identify as Black and/or African American,
* Lives with a family member with a physician diagnosis of Alzheimer's disease or related dementia
* Primary responsibility for care of the family member who has been diagnosed with Alzheimer's disease or related dementia
* Utilize Adult Day Services at least two times a week for family member with Alzheimer's disease or related dementia

Exclusion Criteria:

* Either caregiver of client is in active treatment for a terminal illness or are in hospice.

Primary outcomes:
measure: Caregiver stress as assessed by the Perceived Stress Scale
timeFrame: Baseline
Secondary outcomes:
measure: Salivary cortisol levels
timeFrame: Over a five day period
measure: Salivary alpha-amylase
timeFrame: Over a five day period
measure: Salivary Telomere length
timeFrame: Over a five day period
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lauren Parker, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06309550: Provocative Tests for HFpEF
Official title: Provocative Tests for Diagnosing and Phenotyping Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients referred to the Dyspnea and Pulmonary Hypertension Center for suspicion of HF, PH or unexplained dyspnea

Brief summary: Diagnosing heart failure with preserved ejection fraction (HFpEF) in patients complaining exertional breathlessness can be challenging: diagnostic algorithms and scores have low sensitivity, and ageing-associated comorbidities can complicate the interpretation of symptoms. Thus, exercise right heart catheterization (RHC) or invasive cardiopulmonary exercise test (iCPET) have been advocated as gold-standard methods for HFpEF diagnosis. However, exercise RHC and iCPET are still not widely standardized methods, with results mainly coming from US cohorts (that may differ from Italian cohorts), and other provocative tests (e.g. non-invasive CPET, passive leg raising) may offer complementary diagnostic information.


Eligibility criteria: Inclusion Criteria:

* dyspnea

Exclusion Criteria:

* known HFpEF

Primary outcomes:
measure: Mortality
timeFrame: 5 years
measure: Hospitalization for heart failure
timeFrame: 5 years
measure: Atrial fibrillation
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano
Study officials:
References:
Clinical trial NCT01535508: Open Label Clinical Trial of Vitamin D in Children With Autism
Official title: Open Label Clinical Trial of Vitamin D Dosage Tolerability, and Effect on Behavioral Measures in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Autism
Vitamin D Deficiency
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation, titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients.

The study will determine if initial safety and effect estimates predict that a double blind randomized control trial (RCT) with a larger set of patients will be worthwhile in the localization of this treatment aimed at improving the symptoms of ASDs.

Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior, and sleep, as determined by parental and clinical evaluation scales.

Detailed description: data is still being collected

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Autism from DSM-IV TR and ADOS
* Moderate but less than severe on CGI-Severity scale
* IQ \> 40
* ZRT 25(OH)D blood spot test \< 30 ng/ml
* Age 3-8 years old

Exclusion Criteria:

* Developmental delays prior to 12 months of age
* history of head trauma
* seizure in the past year
* bleeding disorder
* history of kidney or liver disease
* clinically significant low white blood cell count
* PDD-NOS, Rett's syndrome, Childhood Disintegrative Disorder or Fragile X syndrome
* current supplementation with Vitamin D, Vitamin A or cod-liver oil

Primary outcomes:
measure: Clinical Global Impression Scale - Improvement (CGI-I)
timeFrame: Baseline and 12 weeks from Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Robert L Hendren, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02346708: Cognitive Dysfunction in Parkinson's Disease
Official title: Cortical Physiology as a Therapeutic Target in Parkinson's Disease Related Dementia and Cognitive Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's
TMS
Kluger
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2015-01-27
Enrollment: 49
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study plans to learn more about the brain function related to thinking problems in individuals with Parkinson's disease.

Detailed description: Dementia is the leading cause of nursing home placement in Parkinson's disease (PD) yet little is known about the cause(s) of cognitive dysfunction in PD and there are no effective treatments. The investigators preliminary data and other published studies suggest that abnormalities in brain activity involving networks important for normal thinking and memory may contribute to cognitive dysfunction in PD and may represent a target for treatment. This proposal will identify abnormalities in cortical activity related to cognitive dysfunction in PD using magnetoencephalography and will perform a randomized control trial of bifrontal repetitive transcranial magnetic stimulation to determine the therapeutic potential of modulating this brain activity.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable PD (using United Kingdom Brain Bank criteria)
* Diagnosis of mild cognitive impairment
* No unstable medical condition

Exclusion Criteria:

* Features suggestive of other causes of Parkinsonism or other neurological disorders
* Prior deep brain stimulation (DBS) or ablation surgery
* Evidence for active depression or Hospital Anxiety and Depression Scale (HADS) score greater than or equal to 11
* Motor symptoms expected to interfere with scanning (e.g. sever tremor)
* Contraindications to TMS, MEG, or MRI such as pregnancy, pacemaker, unstable cardiac disease, skull lesion, claustrophobia, history of epilepsy, or on medications known to lower seizure threshold
* Implanted electronic devices or metal

Primary outcomes:
measure: Change in Magnetoencephalography (MEG) Connectivity Measures
timeFrame: 2 weeks
Secondary outcomes:
measure: Post-TMS Change From Baseline in Cognitive Scores
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Benzi M Kluger, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00164008: Comparison of Pamidronate With Zoledronic Acid for Transplant Related Bone Loss Prevention
Official title: Comparison Between Pamidronate and Zoledronic Acid for the Treatment of Heart and Lung Transplant Related Osteopaenia and Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteopenia
Complications of Heart-lung Transplant
Other Complications of Lung Transplant
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Novartis
First posted: 2005-09-14
Enrollment: 56
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 purpose of this trial is to see whether zoledronic acid is better than pamidronate to treat low bone density in heart and lung transplant patients.


Eligibility criteria: Inclusion Criteria:

* reduced bone density as indicated by a bone density T score \<-1.in either the lumbar spine or femoral neck
* have undergone or are on the waiting list for heart or lung transplantation
* are receiving adequate calcium and vitamin D therapy
* have provided written informed consent prior to participation in the trial

Exclusion Criteria:

* untreated hypogonadism, hypothyroidism or hyperthyroidism
* acute or major organ rejection or intercurrent illness
* pregnancy or breastfeeding

Primary outcomes:
measure: Bone mineral density of lumbar spine at 12 months as measured by DEXA.
Secondary outcomes:
measure: Bone mineral density of femoral neck at 12 months as measured by DEXA.
Other outcomes:
Locations:
Study officials:
affiliation: The Alfred
name: Duncan J Topliss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02297308: A Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications
Official title: A Single Center, Retrospective Study Evaluating the Use of the SoloPath® Sheath in Reducing Vascular and Bleeding Complications After Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Access Complication
Lead sponsor: Terumo Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Montreal Heart Institute
First posted: 2014-11-21
Enrollment: 90
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: The study population will consist of subjects with severe aortic stenosis who underwent TAVI utilizing the SoloPath sheath for vascular access since 2011.

Brief summary: This study is a retrospective, single center data collection to assess bleeding and vascular complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral Introducer is used for vascular access.

Detailed description: This study is intended to collect data on the rate of vascular complications in subjects having transfemoral TAVI when the SoloPath® Balloon Expandable TransFemoral Introducer is used as a guide for introduction and delivery of TAVI devices. The use of a small profile sheath could possibly reduce the incidence of post procedure vascular complications associated with TAVI and further enhance the safety of accessing the femoral delivery route.

In addition, this study will examine the impact of arterial morphology and other subject risk factors as a predictor of clinical outcomes within 30 days following TAVI.

Eligibility criteria: Inclusion Criteria:

1. Subject must have undergone a TAVI procedure with femoral access achieved with a 19Fr (ID) SoloPath (STFI) sheath.
2. Male or female ≥ 18 years old.

Exclusion Criteria:

1. Subjects with Femoral or Iliac vessels less than 6mm on side of TAVI access will be excluded.
2. Subjects treated before January 1, 2011, are excluded from this analysis.

Primary outcomes:
measure: Vascular Access Site Complications
timeFrame: withn 30 days of TAVI procedure
Secondary outcomes:
measure: Bleeding Complications at the Access Site
timeFrame: within 30 days of TAVI procedure
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Ontario
Study officials:
affiliation: Montreal Heart Institute
name: Anita Asagr, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00876408: Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer
Official title: Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer: Role in Clinical Management and Primary Site Prediction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unknown Primary Cancer
Keywords: RT-PCR molecular profiling assay
Molecular Profiling-Real Time Polymerase Chain Reaction
Unknown Primary
UPC
CUP
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Biotheranostics, Inc.
First posted: 2009-04-06
Enrollment: 30
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: Approximately 30 patients at Tennessee Oncology with unknown primary cancer have had commercially available RT-PCR assays done on their tissue biopsy since the assay became available in 2007. These patients are the subjects of this review.

Brief summary: This will be a retrospective review of 30 patients with unknown primary cancer who have had commercially available RT-PCR assays performed on biopsied tumors, in order to determine if the assay results are consistent with clinical features and useful for planning initial therapy or changing therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with RT-PCR testing completed since commercialization of the RT-PCR assay in 2007.

Primary outcomes:
measure: To correlate the tissue of origin predicted by the RT-PCR assay with clinical and pathologic features of patients with carcinoma of unknown primary site.
timeFrame: 6 months
Secondary outcomes:
measure: To correlate the tissue of origin predicted by the RT-PCR with actual primary sites found subsequently in a subset of patients.
timeFrame: 6 months
measure: To evaluate the utility of RT-PCR assay results in guiding treatment selection in patients with carcinoma of unknown primary site.
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Frank A Greco, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00530608: Electrophysiological Properties of the Pulmonary Veins
Official title: Electrophysiological Properties of the Pulmonary Veins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electrophysiology of Pulmonary Veins
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2007-09-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: First review of the data base with respect to study outcome was performed after 35 enrolled patients. As a result, the results were already significant and the study was stopped prematurely.

Brief summary: The pulmonary veins are the predominant sources of AF induction and maintenance. This study aims to assess the electrophysiological properties of the pulmonary veins and their relation to AF in humans.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* No antiarrhythmic drug treatment
* Indication for an electrophysiological study

Exclusion Criteria:

* Structural heart diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Eppendorf, Heart Center, Department of Cardiology
Study officials:
affiliation: University Hospital Eppendorf, Heart Center, Department of Cardiology
name: Thomas Rostock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rostock T, Steven D, Lutomsky B, Servatius H, Drewitz I, Klemm H, Mullerleile K, Ventura R, Meinertz T, Willems S. Atrial fibrillation begets atrial fibrillation in the pulmonary veins on the impact of atrial fibrillation on the electrophysiological properties of the pulmonary veins in humans. J Am Coll Cardiol. 2008 Jun 3;51(22):2153-60. doi: 10.1016/j.jacc.2008.02.059.
Clinical trial NCT04383808: Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR
Official title: Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary goal of this project is to study the feasibility of a brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of human brains. The study will also allow us to compare the imaging performance of the investigator's brain-dedicated PET insert against a commercial whole-body permanently integrated PET/MRI system using a common radiopharmaceutical.

Detailed description: This study will enroll up to 40 participants.

1. 20 participants at Stanford injected with an FDA-approved PET tracer (e.g. amyloid, FDG, etc.), and
2. 20 participants from Stanford who have been pre-injected with a radiopharmaceutical for a study on another PET imaging system

Eligibility criteria: Inclusion Criteria:

1. Whole body radiation dose within the last year of less than 5000 mrem
2. Subjects intended for injected tracer studies (not associated with another study) must be willing/able to undergo injection of 6-12 mCi of either FDG or Neuraceq radiotracer. Both tracers are FDA approved
3. Subjects will be at least 21 years of age
4. Subject provides written informed consent
5. Subject is deemed healthy by the PI by via self-reported questionnaire

Exclusion Criteria:

1. For patients who will be receiving a tracer injection, no known allergy to the imaging agents
2. Participant has a history of or current diagnosis of cancer
3. Participant is pregnant or nursing
4. Metallic implants (contraindicated for MRI)

Primary outcomes:
measure: PETMR image
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT00881608: Study to Evaluate Menses Induction in Women Administered Proellex
Official title: An Open-Label, Escalating Dose, Single Center, Cross-over Design, Phase I Study to Evaluate Menses Induction in Women Administered Proellex
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Amenorrhea
Keywords: Menstruation
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.

Detailed description: The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cycle and inducing menstruation as happens naturally

Eligibility criteria: Inclusion Criteria:

* Clinical laboratory tests within normal ranges
* A normal menstrual period of 26-30 days
* Desiring not to become pregnant
* Agreeing to use a double barrier method of birth control for the duration of the trial

Exclusion Criteria:

* Post-menopausal status
* Aamenorrhea or dysfunctional uterine bleeding
* Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
* Subjects with a Body Mass Index (BMI) below 18 or over 39

Primary outcomes:
measure: Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.
timeFrame: An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses
Secondary outcomes:
measure: Duration of Vaginal Bleeding Following Treatment With Proellex.
timeFrame: At least 2 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Advances in Health Inc.
state: Texas
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre van As, M.D., Ph.D
role: STUDY_DIRECTOR
References: