louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03226860: Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
Official title: Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Lead sponsor: MultiCare Health System Research Institute
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study will see if electrical stimulation increases heel strike (heel hits the floor first when walking), decreases limp, helps muscle contraction, and improves balance in children with a hemiplegic leg. An experimental electrical stimulation device called the Gait MyoElectric Stimulator (GMES) will be used to stimulate the shin and calf muscles.

Detailed description: Physical therapists focus on improving gait and balance in children with hemiplegic cerebral palsy (HCP). Functional electrical stimulation (FES) has the potential to improve strength and functional gait for children with HCP. The investigators hypothesize that a new FES system stimulating the dorsiflexor (DF) and plantarflexor (PF) muscles alternately at the correct time during gait, would lead to a significant improvement (p\<.05) in foot contact, gait symmetry and balance, compared to 12 weeks of a healthy lifestyle program called 5210.

Eligibility criteria: Inclusion Criteria:

* Children who are:

  1. Are age 5-18 years
  2. Have been walking independently (no walker or cane) for at least 18 months.
  3. Use co-contraction of DF and PF during walking based upon surface electromyography.
  4. Have a diagnosis of spastic hemiplegic CP, Gross Motor Function Classification System (GMFCS) Levels I-II

Exclusion Criteria:

* Children who:

  1. Have passive ankle range \<5 DF or \< 10 PF with hip and knee extended.
  2. Report uncontrolled seizures.
  3. Had orthopedic surgery (for example heel cord or hamstring lengthening)
  4. Have used tone reducing medications (Botox, Baclofen) in the last 6 months.
  5. Wear ankle foot orthoses that limit DF/PF motion.
  6. Have low motivation/tolerance for electrical stimulation.
  7. Have parents/caregivers who are not able or willing to assist with the protocol for 6 months.
  8. Have low tolerance to electrical stimulation in screening process.

Primary outcomes:
measure: Aim 1 - Improve initial contact during gait, as measured by Noraxon video software
timeFrame: 12 weeks
Secondary outcomes:
measure: Aim 2 - Improve walking symmetry, as measured by Noraxon video software
timeFrame: 12 weeks
measure: Aim 3 - Improve balance, as measured by the Balance Subtest of the Bruininks-Oseretsky Test of Motor Proficiency (BOT2).
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Physical Therapist for Mary Bridge Children's Therapy at Good Samaritan
name: Brenna Brandsma, PT, DPT, PCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651560: Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)
Official title: Vytorin As Strategy To Reduce Dislipidemia In Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to allow physicians to check the superior clinical efficacy of Vytorin compared to atorvastatin, as the most adequate therapy using the ATP-III goals achievement and cardiovascular risk reduction in adult patients with dislipidemia.


Eligibility criteria: Inclusion Criteria:

* Patients Who Voluntary Accept To Participate In The Study After Been Informed By The Doctor And Signed The Informed Consent Form.

Exclusion Criteria:

* Any Another Kind Of Contraindication For Use Of Statins
* Hypersensitivity To Any Of The Active Ingredients
* Increased Serum Hepatic Enzymes (Over 3 Times Only)
* Patients With Severe Hepatic Insufficiency
* Women who are Pregnant or Potentially Pregnant

Primary outcomes:
measure: Evaluate the hypolipidemic effect of Vytorin after 4 weeks treatment in adult patients with mix dislipidemia to reduce the cardiovascular risk and achieve the ATP-III goals.
timeFrame: After 4 weeks treatment
Secondary outcomes:
measure: To determine the capability of Vytorin to allow adults patients with dislipidemia and previously treated with atorvastatin to get further reduction of the cardiovascular risk and to achieve the ATP-III goals.
timeFrame: After 4 weeks treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03484260: Association Between the Prevalence of Cardiovascular Risk Factors and New Use of Testosterone
Official title: Association Between the Prevalence of Cardiovascular Risk Factors and New Use of Testosterone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism
Keywords: Risk factors predicting the initiation of testosterone use
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-03-30
Enrollment: 27778
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source population is the subset of male patients in the Clinical Practice Research Datalink (CPRD) that has been linked to the Hospital Episodes Statistics (HES) database (CPRD-HES).

Cases will be defined by first testosterone use between 1st January 2001 and 31st March 2016 (study period). The date of the GP consultation associated with the first testosterone prescription will be designated as the index day. All cases will be required to be over 18 years on the index day, to have contributed for at least 2 years to the CPRD-HES link and to have no history of testosterone before the index day.

Brief summary: We will investigate if testosterone is preferentially given to patients at higher risk of cardiovascular events. If this is the case, then observational studies may be prone to selection bias resulting in overestimation of the cardiovascular risk associated with testosterone when compared to a healthier population not taking testosterone


Eligibility criteria: Inclusion Criteria:

- All male individuals in the source population with a first testosterone use during the study period will be included as cases. The date of the GP consultation associated with the first testosterone prescription will be designated as the index day.

Exclusion Criteria:

- Patients of less than 18 years on the index day, with less than 2-year contribution to the CPRD-HES link before the index day, or with use of testosterone before the study period will be excluded from the group of cases.

Primary outcomes:
measure: Estimation of the association between cardiovascular risk factors and initiation of testosterone therapy
timeFrame: Retrospectively from 01 January 2001 to 31 March 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Many Locations
Study officials:
References:
Clinical trial NCT03963960: Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis
Official title: Evaluation of Daily Hemodialysis With Low Dialysate Flux in Unscheduled Patients With Kidney Injury Admitted to Hemodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Kidney Injury
Kidney Failure, Chronic
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the EQUODIA study is to evaluate the hemodynamic stability of hemodialysis with low dialysate flow in patients requiring emergency hemodialysis in the context of acute kidney injury or unscheduled end-stage renal disease, not in intensive care, compared to conventional triweekly high-flow hemodialysis.

Short daily hemodialysis has excellent hemodynamic tolerance, which has already been confirmed by clinical experience. This modality, commonly used in the patient's home through new machines allowing a low dialysate flow purification technique, can prove to be an innovative, effective and safe alternative for patients admitted for hemodialysis in an unscheduled situation (acute kidney injury, unscheduled end-stage renal disease not followed).

Up to now, no studies have evaluated the use of short daily hemodialysis with low dialysate flow in patients with acute kidney injury or unscheduled end-stage renal disease, requiring the initiation of emergency extra-renal purification.


Eligibility criteria: Inclusion Criteria:

* Male or Female 18 years of age or older
* Patient requiring unscheduled hemodialysis for end-stage renal disease or acute kidney injury
* Patient able to understand the protocol
* Patient who has agreed to participate in the study and has given express oral consent
* Patient affiliated to a social security system

Exclusion Criteria:

* Patient with more than one dialysis session
* Intensive care patient (need for vasoactive amine infusion, non-invasive ventilation, assisted ventilation)
* Patient participating in interventional clinical research involving a drug/medical device
* Patient under guardianship, curator, deprived of liberty
* Pregnant or breastfeeding patient, or with the ability to procreate without effective contraception
* Patient refusing to participate
* Patient unable to understand the protocol and/or give express oral consent

Primary outcomes:
measure: Number of hypotension episodes
timeFrame: During the first two weeks of dialysis
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental Vendée
Study officials:
affiliation: CHD Vendée de la Roche sur Yon
name: Natalia TARGET, PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01792960: Registry and Prevalence of Gene Mutation in Korean Patients With Familial Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Familial Hypertrophic Cardiomyopathy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 99
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: familial hypertrophic cardiomyopathy patients and their relatives

Brief summary: Set the Korean Familial Hypertrophic Cardiomyopathy (KFHC) registry to study the prevalence of gene mutations in Korean patients with familial hypertrophic cardiomyopathy


Eligibility criteria: Inclusion Criteria:

1. left ventricular maximal wall thickness ≥ 15mm on echocardiography
2. hypertrophic cardiomyopathy patients' relatives

Exclusion Criteria:

1. other cardiomyopathy or systemic disease (e.g. fabry disease, danon disease, glycogen storage disease)
2. who deny the study entrance, especially in patients' relatives

Primary outcomes:
measure: 1) DNA analysis
timeFrame: 1 year
Secondary outcomes:
measure: 2) Prognosis of familial hypertrophic cariomyopathy
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04963660: Primary Immunodeficiencies in Costa Rican Adults
Official title: CASE SERIES OF PRIMARY IMMUNODEFICIENCIES IN ADULTS DIAGNOSED IN TWO HOSPITALS OF THE TERTIARY LEVEL OF CARE OF THE COSTA RICAN SOCIAL SECURITY Fund, 2017-2018
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immune Deficiency in Adults
Lead sponsor: Caja Costarricense de Seguro Social
Sponsor class: OTHER_GOV
First posted: 2021-07-15
Enrollment: 137
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases of primary immunodeficiency and idiopathic defects of immunity detected in the primary immunodeficiency clinics of the Hospitals Mexico and Dr. Rafael Ángel Calderón Guardia between November 2017 and May 2018.

Brief summary: Primary immunodeficiencies represent a underdiagnosed group of rare diseases which if diagnosed well and in time can be treated in an efficient manner and prevent complications that may affect the quality of patients life in an severe manner. Neither in Costa Rica nor in Central America studies or national registries regarding the prevalence and characterization of primary immunodeficiencies in adult patients exist up to now. This study reflects for the first time the epidemiologic situation of primary immunodeficiencies in a Central American country, characterizing adult patients diagnosed with primary and idiopathic immune disorders treated in two specialized immunodeficiency clinics in Costa Rica.


Eligibility criteria: Inclusion Criteria:

* All patients from adult primary immunodeficiency clinics will be included.

Exclusion Criteria:

* Patients with HIV
* Proven secondary immunodeficiencies.

Primary outcomes:
measure: Clinical manifestations of all adult patients diagnosed with primary and idiopathic immune defects
timeFrame: 1 year
Secondary outcomes:
measure: characterization of immunodeficient patients
timeFrame: 1 year
measure: Concordances between clinical manifestations and literature
timeFrame: 1 year
measure: organic complications
timeFrame: 1 year
measure: type and degree of immunodeficiency
timeFrame: 1 year
measure: pathonges that cause infectious
timeFrame: 1 year
measure: bacteria present in upper airways
timeFrame: 1 year
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Hospital Calderon Guardia
Study officials:
References:
Clinical trial NCT02969460: Neurotrack Virtual Cognitive Health Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Cognitive Decline
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: Neurotrack
First posted: 2016-11-21
Enrollment: 85
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Neurotrack Virtual Cognitive Health Study is a 12-month long, prospective study that aims to evaluate the impact of the Neurotrack Virtual Cognitive Health Coaching Program on cognitive ability, anxiety and depression, and lifestyle behaviors for individuals who show signs of subjective cognitive decline.


Eligibility criteria: Inclusion Criteria:

* Ages 60-75
* Individuals who show signs of subjective cognitive decline (assessed by scoring ≥ 1 on the Subjective Cognitive Decline \[Short Form\] Questionnaire and endorsing the Personal Worry Item on the questionnaire)
* Have the ability to make and receive phone calls
* Have the ability to send and receive text messages
* Access to a desktop computer, video-teleconferencing and reliable internet connection
* Motivated to use a daily coaching program

Exclusion Criteria:

* Significant history of mental illness, substance abuse, learning disability, or neurologic conditions
* History of dementia
* Ophthalmologic/visual problems that prevent individual from viewing a computer screen at a normal distance (e.g., legal blindness, detached retinas, occlusive cataracts)
* Currently participating in a formal cognitive-training coaching program
* Currently pregnant

Primary outcomes:
measure: RBANS score
timeFrame: week 24
measure: RBANS score
timeFrame: week 52
Secondary outcomes:
measure: PHQ-9
timeFrame: week 24
measure: PHQ-9
timeFrame: week 52
measure: GAD-7
timeFrame: week 24
measure: GAD-7
timeFrame: week 52
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
References:
citation: Kumar S, Tran J, Moseson H, Tai C, Glenn JM, Madero EN, Krebs C, Bott N, Juusola JL. The Impact of the Virtual Cognitive Health Program on the Cognition and Mental Health of Older Adults: Pre-Post 12-Month Pilot Study. JMIR Aging. 2018 Nov 9;1(2):e12031. doi: 10.2196/12031.
citation: Bott N, Kumar S, Krebs C, Glenn JM, Madero EN, Juusola JL. A Remote Intervention to Prevent or Delay Cognitive Impairment in Older Adults: Design, Recruitment, and Baseline Characteristics of the Virtual Cognitive Health (VC Health) Study. JMIR Res Protoc. 2018 Aug 13;7(8):e11368. doi: 10.2196/11368.
Clinical trial NCT02729376: Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone
Official title: An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone in Healthy Male Subjects After Oral Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: LTN PHARMACEUTICALS, INC.
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 6
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open label, single dose, 1 period study of \[14C\] galeterone.

Detailed description: This is an open label, 1 period study under fed conditions. Six (6), healthy, adult, non tobacco using, male subjects will be enrolled. Screening of subjects will occur within 28 days prior to dosing. On Day 1, a single dose of radio-labeled galeterone will be administered orally. Blood, urine, and fecal samples will be collected until release criteria are met to measure total radioactivity, for analysis of galeterone concentrations, and for potential metabolic profiling.

Eligibility criteria: Inclusion Criteria:

1. Healthy, adult, male, 19 to 55 years of age, inclusive, at screening.
2. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to dosing.
3. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
2. History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

Primary outcomes:
measure: Radioactivity concentration equivalents in plasma
timeFrame: 168 hours
measure: Single dose galeterone concentrations in plasma
timeFrame: 168 hours
measure: Route(s) of elimination of a single [14C]galeterone dose
timeFrame: 8 days
measure: Mass balance of a single [14C]galeterone dose
timeFrame: 8 days
measure: Ratio of whole blood to plasma 14C radioactivity
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Tokai Pharmaceuticals, Inc.
name: Karen J Ferrante, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06213376: MIT Intensive Treatment Study
Official title: Intensive MIT Paired With Video Feedback for Motor Speech Disorders and Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aphasia
Motor Speech
Lead sponsor: Nevada State University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-subject experimental design
Primary purpose: TREATMENT

Brief summary: This study is examining the use of intensive melodic intonation therapy and video feedback as a means of aiding individuals with nonfluent aphasia and co-occurring motor speech impairments. Individuals with nonfluent aphasia have difficulty with language, particularly with word retrieval.


Eligibility criteria: Inclusion Criteria:

* Fluent English speakers
* Sustained a left-hemisphere stroke
* Presents with language and motor speech impairments

Exclusion Criteria:

* • History of learning disability prior to accident (per patient report)

  * Uncorrected auditory or visual impairments
  * Not meeting the criteria of stroke
  * Failure to provide evidence of stroke diagnosis (medical record history)
  * History of psychiatric disorder

Primary outcomes:
measure: Intelligibility
timeFrame: From enrollment to 4 weeks post treatment
Secondary outcomes:
measure: Apraxia Battery for Adults
timeFrame: Baseline and one week following the end of treatment
measure: Assessment of Intelligibility of Dysarthria Speech
timeFrame: Baseline and one week following the end of treatment
measure: Longer Connected Speech Assessment
timeFrame: Baseline and one and four weeks following the end of treatment
measure: Quality of Life with Dysarthria (QOLdys)
timeFrame: Baseline and four weeks following treatments.
Other outcomes:
Locations:
city: Henderson
country: United States
facility: Nevada State University
state: Nevada
Study officials:
affiliation: Nevada State University
name: Andre Lindsey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albert ML, Sparks RW, Helm NA. Melodic intonation therapy for aphasia. Arch Neurol. 1973 Aug;29(2):130-1. doi: 10.1001/archneur.1973.00490260074018. No abstract available.
citation: Helm-Estabrooks, N., Albert, M. L., & Nicholas, M. (2014). Manual of aphasia and aphasia therapy (3rd ed.). Austin, TX: Pro-Ed
citation: Zumbansen A, Peretz I, Hebert S. Melodic intonation therapy: back to basics for future research. Front Neurol. 2014 Jan 28;5:7. doi: 10.3389/fneur.2014.00007. eCollection 2014.