louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06451874: Personalized Exercise Treatments for Older Veterans With Motoric Cognitive Risk Syndrome
Official title: Motoric Cognitive Risk Syndrome: Refining Treatment Strategies and Testing Feasibility to Personalize Treatment for Older Veterans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Motoric Cognitive Risk Syndrome
Keywords: Veterans
Mobility
Cognition
Sequential Multiple Assignment Randomized Trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-06-11
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Multiple Assignment Randomized Trial (SMART)
Primary purpose: PREVENTION

Brief summary: This study will begin to evaluate personalized preventative dementia treatments for Veterans at risk for developing dementia. The investigators will target Veterans with Motoric Cognitive Risk syndrome (MCR), which is characterized by slow gait speed and cognitive concerns (e.g., problems with memory or concentrations).

Detailed description: This study will involve therapeutic exercise treatments for Veterans with pre-clinical dementia syndrome. Participants will either participate in functional power training, music-based walking training, or a combination of both. The study will use a sequential multiple assignment, randomized trial (SMART) design. Successful completion of this study will lay the foundation for subsequent research trials, contributing to valuable evidence for personalized rehabilitation medicine for older Veterans.

Eligibility criteria: Inclusion Criteria:

1. Age 65
2. Receiving VA primary care
3. Community-dwelling
4. Motoric Cognitive Risky Syndrome i. Slow gait speed ii. Subjective cognitive concerns/complaints

Exclusion Criteria:

1. Non-English speaking
2. Presence of a terminal disease
3. Major medical problem
4. Myocardial infarction or major surgery in the previous 3 months
5. Use of a walker
6. Dementia diagnostic
7. Mobility disability

Primary outcomes:
measure: Enrollment/Baseline
timeFrame: Enrollment
measure: Retention
timeFrame: Baseline to end of 12-week treatment
measure: Compliance
timeFrame: Baseline to end of 12-week treatment
measure: Acceptability
timeFrame: End of 12-week treatment
Secondary outcomes:
measure: Gait Speed
timeFrame: Baseline to end of 12-week treatment
Other outcomes:
measure: Cognition - Executive Function
timeFrame: Baseline to end of 12-week treatment
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Elisa Ogawa, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05294874: Gait Rehabilitation in Diplegic Children
Official title: Gait Rehabilitation in Ambulant Diplegic Children Using BOTOX and Ankle Weights
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Spastic Diplegia
Keywords: gait
diplegia
ankle weight
botox injection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 45
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Standing and walking serve an individual's basic need to move from place to place, and both are the most common activities that people do on a daily basis.

Aim: to investigate the combined effect of botulinum toxin A (BoNT-A) injection and ankle weight on the gait of diplegic children who are using Ankle foot orthoses.

Detailed description: Methods: Sixty children with spastic diplegia were included in this prospective, controlled trial. Children were divided into three groups, each with 20 patients: Group 1 received classical gait rehabilitation; Group 2 received the same gait training while adding ankle weight ; and Group 3 received the same as group 2 plus botulinum toxin injection. The Modified Ashworth Scale (MAS),knee range-of-motion measures, and Hoffman /Myogenic reflex ratio were used to examine patients before the commencement of treatment and post-treatment.

Eligibility criteria: Inclusion Criteria:

* diagnosed as spastic diplegia.
* They were able to follow simple verbal instructions.
* The use of Ankle Foot Orthoses.
* Spasticity grade of 1+ or 2 in both calf and hamstring muscles according to modified Ashworth's scale (MAS).
* level I or II on the Gross Motor Function Classification System (GMFCS).

Exclusion Criteria:

* fixed contractures or deformities in the lower limbs.
* surgical orthopedic intervention.
* Botulinum A injection or use of neuromuscular blockers in the previous 6 months before the start of study.

Primary outcomes:
measure: measurement of knee excursion during gait
timeFrame: after 3 months of the treatment program.
measure: evaluation of spasticity: modified ashowrth scale scores
timeFrame: after 3 months of the treatment program.
Secondary outcomes:
measure: electromyography to asses spasticity in hamstring and calf muscles
timeFrame: after 3 months of the treatment program.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy,Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Nahla mohamed, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04257474: Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk
Official title: Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk (B-SUPER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Pathogenic BRCA 1/2 Mutation
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 265
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women will be recruited from mammography and primary care clinics, community-based outreach events, or via Facebook

Brief summary: This study seeks to develop an explanatory framework for breast MRI utilization to inform future interventions. The Health Services Utilization Model (HSUM) will guide the selection of specific participant-level factors for examination, including predisposing characteristics (knowledge, health/cultural beliefs), enabling resources (social support, cost/insurance coverage), and perceived need (perceived susceptibility, provider recommendation).


Eligibility criteria: Inclusion Criteria:

* Ability to speak/read English
* Within 2 years of last screening mammogram
* Pathogenic BRCA1/2 mutations OR estimated lifetime risk ≥20% per the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool (BCRAT)

Exclusion Criteria:

* Women who have received a prior diagnosis of breast cancer

Primary outcomes:
measure: Reporting Receipt of MRI Breast Screening at Any Time
timeFrame: Baseline
measure: Reporting Receipt of MRI Breast Screening in the Last 24 Months
timeFrame: Baseline
Secondary outcomes:
measure: Reporting Receipt of Mammogram
timeFrame: Baseline
measure: Reporting Receipt of Ultrasound
timeFrame: Baseline
measure: Reporting Receipt of Chemoprevention
timeFrame: Baseline
measure: Reporting Receipt of Genetic Testing
timeFrame: Baseline
measure: Reporting Receipt of Genetic Counseling
timeFrame: Baseline
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Susan Vadaparampil, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00863174: A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma
Official title: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of SPARC_147709- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Bio-equivalence
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Safety and bioequivalence of SPARC_147709


Eligibility criteria: Inclusion Criteria:

* Availability for the entire study period and willingness to adhere to protocol requirements.
* Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome
* 18 years of age or older
* No evidence of underlying disease (except multiple myeloma)

Exclusion Criteria:

* History or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride
* History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease.
* History of smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
* Positive result to HIV, HCV, RPR and HBsAg.

Primary outcomes:
measure: 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference
timeFrame: 2 cycles
Secondary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: 2 cycles
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02618174: Enhanced Broccoli Consumption After a Liking Norm and Vegetable Variety Message: Effects After a 24 Hour Delay.
Official title: Enhanced Broccoli Consumption After a Liking Norm and Vegetable Variety Message: Effects After a 24 Hour Delay.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behaviour
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Economic and Social Research Council, United Kingdom
First posted: 2015-12-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Encouraging individuals to eat vegetables is difficult. However, recent evidence suggests that using social-based information might help. For instance, it has been shown that if people think that others are eating lots of fruit and vegetables, that they will consume more of these foods to match the 'norm'. The purpose of this study was to determine whether a liking social norm (information about how much others like vegetables) would be effective at encouraging people to eat more vegetables and to examine whether these effects are sustained beyond initial exposure (i.e. whether the effect of the norm persists on food selection 24 hours alter).

Detailed description: Using a 2 x 5 x 2 experimental design we investigated the effects of exposure to various messages on later food intake and whether any effects were sustained 24 hours after exposure in both low and high consumers of vegetables. There were three factors of delay (immediate food selection versus food selection 24 hours after exposure), message type (liking norm, descriptive norm, health message, food-based control, and neutral control message) and habitual consumption (low versus high). The buffet consisted of three raw vegetables, three energy-dense foods and two dips.

In this study the investigators hypothesised that a liking norm would increase the consumption of vegetables (compared to a neutral control condition) and that the effect would persist on vegetable consumption 24 hours after intital exposure to the liking norm.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Sufficiently fluent in English

Exclusion Criteria:

* Smokers
* Diabetes
* Food allergies
* Past / present depression or anxiety
* Past / present eating disorder.

Primary outcomes:
measure: Grams of vegetables consumed
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Birmingham
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Jason M Thomas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas JM, Liu J, Robinson EL, Aveyard P, Herman CP, Higgs S. The Effects of Liking Norms and Descriptive Norms on Vegetable Consumption: A Randomized Experiment. Front Psychol. 2016 Mar 30;7:442. doi: 10.3389/fpsyg.2016.00442. eCollection 2016.
Clinical trial NCT01585974: Duration of Treatment With Tyrosine Kinase Inhibitors in the Treatment of Metastatic Renal Cell Carcinoma
Official title: Duration of Treatment With TKIs in the Treatment of Metastatic Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma
TKI
Turkey
Observational
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-04-26
Enrollment: 151
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 diagnosed as metastatic renal cell carcinoma and could not tolerate previous cytokine therapy within the first month of treatment

Brief summary: This study is a prospective, non-interventional, non-controlled, multi-center, observational cohort study. The medication is prescribed within the regular practice of the physician. Duration and dosage of treatment is solely at the discretion of the attending physician. The primary objective of this study is to assess duration of treatment in Turkish renal cell carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate prior cytokine treatment within the first month of treatment.


Eligibility criteria: Inclusion Criteria:

* To be diagnosed as metastatic renal cell carcinoma
* Previous cytokine therapy
* To sign informed consent form (ICF)

Exclusion Criteria:

* Patients not willing to sign informed consent form or who withdraw their consent

Primary outcomes:
measure: Duration of treatment: from start of tyrosine kinase inhibitor treatment to permanent discontinuation of the product
timeFrame: After 2 years
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAE)
timeFrame: After 2 years
measure: Change of Tumor status
timeFrame: Baseline and 2 years
Other outcomes:
Locations:
city: Many Locations
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Benekli M, Gumus M, Ozkan M, Dane F, Elkiran ET, Cicin I, Sevinc A, Aliustaoglu M, Isikdogan A, Meydan N, Oksuzoglu B, Ozyilkan O, Artac M, Ozdemir F, Kilickap S. Tyrosine kinase inhibitors in the treatment of metastatic renal cell cancer patients with early cytokine intolerance: TURCOS, a Turkish national, prospective observational study. J Oncol Pharm Pract. 2021 Oct;27(7):1623-1630. doi: 10.1177/1078155220963535. Epub 2020 Oct 13.
Clinical trial NCT01840774: Modifying Virtual Reality Analgesia With Low-Dose Pain Medication
Official title: Modifying Virtual Reality Analgesia With Low-Dose Pain Medication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Virtual Reality Therapy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine how pain relief is modified when the investigators combine the Virtual Reality based Snow World game with certain pain medications.

Detailed description: This is a randomized, double-blind, placebo-controlled, within subject 2x2 factorial, repeated measures study. Research participants will play two versions of the Virtual Reality based video game "Snow World" and be given thermal and electrical stimulus. Each of two study visits will be identical with the exception of whether or not the participant will receive an iv infusion of a low dose pain medication or a saline placebo.

Eligibility criteria: Inclusion Criteria:

* Healthy male and females between the age of 18 and 60 years
* Ability to communicate orally
* Ability to read and understand English
* Body Mass Index between 20-35

Exclusion Criteria:

* Women who are pregnant, trying to become pregnant, or who are breastfeeding
* History of alcohol or substance abuse
* Major medical illness; including history of migraine headaches, seizures, brain injury, or peripheral neuropathy
* Current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids
* Predisposition to severe motion sickness
* Unusual sensitivity or lack of sensitivity to pain
* Urine toxicology positive for opioids or benzodiazepines

Primary outcomes:
measure: Pain responses between placebo and the low-dose pain medication while playing Snow World. We will assess pain responses with subjective questionnaires concerning the participant's experience while playing Snow World.
timeFrame: Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us.
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Samuel Sharar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03249974: Comparison Between Enlite and Flash Glucose Monitoring
Official title: A Comparative Study on the Accuracy, Ease of Use and Skin Reactions Between the Enlite Sensor With Guardian 2 Link Transmitter and the FreeStyle Libre Flash Glucose Sensor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1 Diabetes Mellitus
Keywords: Enlite glucose monitoring
accuracy
usability
skin reactions
type 1 diabetes mellitus
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor

Brief summary: 1. The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with a standardized breakfast test. Patients receive a standardized breakfast. The usual insulin bolus will be administered at breakfast. After breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time, the glucose value shown by the sensors will be noted. A comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose.
2. Patient satisfaction will be evaluated using a questionnaire that will be completed after the Enlite sensor has been worn for 1 month.
3. The development of skin reactions will be checked by a short questionnaire, supplemented with a picture of possible skin phenomena.
4. The data recorded by the FreeStyle sensor (average glucose,% above target,% within target,% under target, amount of hypoglycemia) in the month prior to sensor switching will be compared to the same data recorded by the Enlite sensor during the first month of use.


Eligibility criteria: Inclusion Criteria:

* Children (5 to 18 years)
* Diagnosis of type 1 diabetes mellitus
* Treatment is an insulin pump and wearing a FreeStyle Flash Libre glucosesensor

Exclusion Criteria:

-

Primary outcomes:
measure: Accuracy of Enlite sensor
timeFrame: 2 hours
Secondary outcomes:
measure: Usability of Enlite sensor
timeFrame: 1 month
measure: skin reactions wih Enlite sensor
timeFrame: 1 month
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
affiliation: Jessa Hospital, hasselt, Belgium
name: Guy Massa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00480974: Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea
Official title: Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea.Observational Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Anemia
Sickle Cell Thalassemia
Keywords: Sickle cell anemia
Sickle cell thalassemia
Hydroxyurea
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Sickle Cell Anemia treated at the Pediatric Hematology Unit and receiving Hydroxyurea

Brief summary: Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.

Detailed description: Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.

A long term follow up will be recorded in a cohort of twenty SCA patients treated by Hydroxyurea for a period between 5 to 12 years. The frequency of vaso-occlusive crises, acute chest syndrome, blood transfusions, and hospitalization will be recorded retrospectively. Also the mean hgb level and hgb F percentage will be summarized.

Eligibility criteria: Inclusion Criteria:

* All patients treated by Hydroxyurea in the Pediatric Hematology Unit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - HaEmek Medical Center
Study officials:
affiliation: Pediatric Hematology Unit, Ha'Emek Medical Center
name: Ariel Koren, MD
role: STUDY_DIRECTOR
affiliation: Pediatric Hematology Unit - Ha'Emek Medical Center
name: Carina Levin, MD
role: STUDY_CHAIR
affiliation: Pediatric Hematology Unit - HaEmek Medical Center
name: Miri Golan, Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Hematology Laboratory - HaEmek Medical Center
name: Luci Zalman, PhD
role: STUDY_CHAIR
References: