louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04858555: Staging System in Amyotrophic Lateral Sclerosis
Official title: Staging System in Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
ALS
Staging
Biomarker
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 50
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: patients with ALS, followed-up in the ALS expert center of Limoges university Hospital (France).

Brief summary: Recently two staging systems have been proposed for amyotrophic lateral sclerosis (ALS), based on clinical milestones The King's college clinical staging system (1) and ALS Milano-Torino Staging (ALS-MITOS) (2). Further research to validate and develop an accurate staging system in different populations will improve our understanding of its pathogenesis, disease activity and progression.

General objective : To validate the two previously proposed staging system and to test the interest of considering Neurofilament biomarkers in these systems.

Specific objectives: 1) To validate the two classification systems in an independent cohort of patients with ALS followed-up in the ALS expert center of Limoges (France) 2) To assess the interest of Nf biomarkers to predict neurological decline

Detailed description: Amyotrophic lateral sclerosis (ALS) is a rare, fatal neurodegenerative disease of the human motor system. Recently two new staging systems have been proposed for ALS, based on clinical milestones related also to the spreading pattern of the disease (1,2). Furthermore, biomarker development is still an essential component of future therapeutic development in ALS. Thus, it is also important to acknowledge the value of biomarker research in supporting or revealing fundamental pathophysiological mechanisms in ALS.

The proposed staging systems: have been recently tested in two independent cohorts (3,4) with results that were not fully consistent (ii) did not considered the potential value of biomarkers.

Eligibility criteria: Inclusion Criteria:

* ALS cases recruited for retrospectively (between) 2007 to 2016 for the retrospective cohort
* ALS cases recruited for prospectively by the ALS expert center of Limoges for one year.

Exclusion Criteria:

* Previous neurosurgical operations
* A recent history of neurotrauma
* Peripheral neuropathies
* ALS/frontotemporal dementia (ALS/FTD)

Primary outcomes:
measure: To validate the two previously proposed staging system and to develop an accurate staging system in ALS considering Neurofilament (Nf) biomarkers.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
References:
Clinical trial NCT02055755: WEMR With Clinical Decision Support for Diabetic Foot Ulcers
Official title: Wound Research Database With Clinical Decision Support for Patients With Diabetic Foot Ulcers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetic Foot Ulcers
Keywords: Diabetes
Wounds
Wound Healing
Diabetic Foot Ulcer
DFU
Clinical Decision Support
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients at Winthrop University Hospital diagnosed with a Diabetic Foot Ulcer.

Brief summary: The goal of this project to begin using a wound research database with clinical decision support features at Winthrop University Hospital. A research database is an electronic computer system that is used to collect patient information. Clinical decision support is the ability for a computer system to provide medical assistance to the doctor through alerts and recommendations based on the information entered. The investigators believe that use of a wound clinical decision support tool, much like a drug, will improve healing in patients diagnosed with Diabetic Foot Ulcers and ultimately lower the risk of death and illness caused by these wounds. In order to develop a useful clinical decision support tool, investigators first need to develop a large research database to determine the data points important for wound healing. The investigators will be using the data collected in this study for future research and publication. Data will be reviewed to answer questions important to diabetic foot ulcer healing and for the purpose of developing the clinical decision support alert system.

After providing informed consent, participants will be asked a series of questions related to their past medical history, and relevant wound data will be collected. Study staff will photograph the wound at baseline, and once per week until the wound is completely healed, or for a duration of six months.

Participants will be expected to return to Winthrop University Hospital for wound follow-up on a regular basis, or as determined by the Principal Investigator.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 21
* Diabetes Type I, or Type II
* Must have a break in the skin on the plantar aspect of foot, \> 0.5cm2
* Willing and able to provide written Informed Consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Questionnaire relevant to wound healing
timeFrame: up to 6 months
Secondary outcomes:
measure: Develop new parameters for clinical decision support based on data collected in this study.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Harold Brem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04040855: Medication Reviews in Elderly in Primary Care
Official title: The Impact of Medication Reviews Conducted in Primary Care on Hospital Admissions and Mortality - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Utilization Review
Keywords: medication reviews, elderly, primary care
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 369
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were blindly randomized to intervention or control group in 2011. This study is a follow-up with additional data collection for the included patient, a total of 369.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is a follow-up of a randomized controlled study performed in 2011-2012 with medication reviews in elderly patients in Sweden. Additional data about mortality and hospital admissions have been collected.

Detailed description: Background Drug-related problems among the elderly population are common and increasing. Multi-professional medication reviews (MR) have arisen as a method to optimize drug therapy for frail elderly patients. Research has not yet been able to show conclusive evidence of the effect of MRs on mortality or hospital admissions. Aim The aim of this study was to assess the impact of MRs' on hospital admissions and mortality after six and 12 months in a frail population of 369 patients in primary care in a randomized controlled study. Methods Patients were blindly randomized to an intervention group (receiving MRs) and a control group (receiving usual care). Descriptive data on mortality and hospital admissions at six and 12 months were collected. Survival analysis was performed for time to death and time to the first hospital admission within 12 months.

Eligibility criteria: Inclusion Criteria:

* age\>75 years, living in nursing homes or community-dwelling with municipality-provided care, with multi-dose drug dispensing

Exclusion Criteria:

* lack of multi-dose drug dispensing, living at home with no municipality-provided care, \<75 years old

Primary outcomes:
measure: hospital admission
timeFrame: six months
measure: hospital admission
timeFrame: twelve months
measure: Survival analysis
timeFrame: six months
measure: Survival analysis
timeFrame: twelve months
Secondary outcomes:
measure: number of hospital admissions
timeFrame: six months
measure: number of hospital admissions
timeFrame: twelve months
measure: mortality
timeFrame: six months
measure: mortality
timeFrame: twelve months
Other outcomes:
measure: number of drugs
timeFrame: base-line
Locations:
Study officials:
References:
citation: Milos Nymberg V, Lenander C, Borgstrom Bolmsjo B. The Impact of Medication Reviews Conducted in Primary Care on Hospital Admissions and Mortality: An Observational Follow-Up of a Randomized Controlled Trial. Drug Healthc Patient Saf. 2021 Jan 27;13:1-9. doi: 10.2147/DHPS.S283708. eCollection 2021.
Clinical trial NCT00732355: Syph-Check Syphilis Antibody Point of Care (POC) Test
Official title: One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Screening for Syphilis Infections
Keywords: syphilis
Lead sponsor: Healthcare Providers Direct, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Point of Care clinics and doctor's office that test routine patients (both male and female), i.e. STD clinics, planned parenthood, pre-marital, blood donors, pre-employment, and general populations from different geographic locations having varying prevalence populations.

Brief summary: The study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory based tests.

Detailed description: The overall objectives of this study are to determine the performance characteristics of a candidate rapid point-of-care test (Syph-Check cassette format) for Treponema pallidum antibodies in serum, plasma and finger stick whole blood obtained from females and males attending sexually transmitted diseases (STD) clinics, family planning / reproductive health clinics, and physician's office; and to compare the performance of this new, rapid test to currently licensed laboratory based tests, the non-treponemal RPR and a Treponemal ELISA or TPPA test.

Eligibility criteria: Inclusion Criteria:

* Men and Women will be eligible who:

  1. are 18 years of age or older;
  2. Routine "presumed uninfected" for screening visit, or show symptomatic signs of infection or are asymptomatic but are suspected of infection, and either/or have other STD disease conditions and infections, will be identified.
  3. Pregnant women in the first and third trimester

Exclusion Criteria:

* are under 18 years of age
* unwillingness to give consent

Primary outcomes:
measure: Identify the sensitivity and specificity of the POC test versus accepted laboratory tests
timeFrame: end of study
Secondary outcomes:
measure: Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible
timeFrame: end of study
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Lehnus & Associates Consulting
name: Gary L Lehnus, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01966055: Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents
Official title: A Phase 1, Open-label, Multi-center Study to Determine the PK and Safety of Solithromycin as Add-on Therapy in Adolescents With Suspected or Confirmed Bacterial Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2013-10-21
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study of the safety and pharmacokinetics of solithromycin capsules in adolescents


Eligibility criteria: Inclusion Criteria:

* 12 to 17 yo male or female with suspected or confirmed bacterial infection

Exclusion Criteria:

* Bacterial meningitis
* Clinical significant concomitant medical condition

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: San Diego
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Ann Arbor
country: United States
state: Michigan
city: Hackensack
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Duke Clinical Research Institute
name: Michael Cohen-Wolkowiez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beechinor RJ, Cohen-Wolkowiez M, Jasion T, Hornik CP, Lang JE, Hernandez R, Gonzalez D. A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication. Ther Drug Monit. 2019 Dec;41(6):761-765. doi: 10.1097/FTD.0000000000000670.
citation: Gonzalez D, James LP, Al-Uzri A, Bosheva M, Adler-Shohet FC, Mendley SR, Bradley JS, Espinosa C, Tsonkova E, Moffett K, Marquez L, Simonsen KA, Stoilov S, Boakye-Agyeman F, Jasion T, Hornik CP, Hernandez R, Benjamin DK Jr, Cohen-Wolkowiez M. Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00692-18. doi: 10.1128/AAC.00692-18. Print 2018 Aug.
citation: Gonzalez D, Palazzi DL, Bhattacharya-Mithal L, Al-Uzri A, James LP, Bradley J, Neu N, Jasion T, Hornik CP, Smith PB, Benjamin DK Jr, Keedy K, Fernandes P, Cohen-Wolkowiez M. Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2572-6. doi: 10.1128/AAC.02561-15. Print 2016 Apr.
Clinical trial NCT04857255: Technology-assisted Language Intervention (TALI)
Official title: Technology-assisted Language Intervention for Children Who Are Deaf/Hard-of-hearing (TALI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Bilateral
Language Development
Keywords: hearing loss
randomized clinical trial
intervention
language development
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 114
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is testing the effectiveness of augmentative and alternative communication technology among deaf or hard of hearing children for improving language development. Children will be randomized to receive either the technology intervention or treatment as usual


Eligibility criteria: Inclusion Criteria:

* Age 3-10 years
* Documented permanent bilateral hearing loss with severity levels clinically defined moderate to profound).
* Identified with a language deficit, defined by either the ratio of language standard scores to nonverbal intelligence quotient \<.85 or a differences in nonverbal IQ and language standard scores of 10 points. Language scores may either be receptive or expressive.
* Currently receiving speech-language therapy.

Exclusion Criteria:

Mild hearing loss and unilateral hearing loss

* primary language other than English
* significant motor impairments
* nonverbal IQ \<80
* children with severe communication disorders (i.e. autism spectrum disorders).

Primary outcomes:
measure: Mean Length of Utterance in morphemes
timeFrame: 24 weeks
measure: Mean Turn Length
timeFrame: 24 weeks
measure: Number of different vocabulary words spoken
timeFrame: 24 weeks
measure: Clinical Evaluation of Language Fundamentals-5th edition
timeFrame: 24 weeks
Secondary outcomes:
measure: Expressive Vocabulary Test 2nd edition
timeFrame: 24 weeks
measure: Clinical Evaluation of Language Fundamentals-5th edition-pragmatics profile
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital of Colorado
state: Colorado
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jareen Meinzen-Derr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01244555: Muscle Treatment for Management of Pain & Disability in Tension-type Headache
Official title: Muscle Treatment for Management of Pain & Disability in Tension-type Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tension-type Headache
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-11-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of treatments (massage therapy or ultrasound) directed at skeletal muscle for alleviating pain associated wtih tension headache.

Detailed description: Chronic or episodic forms of tension-type headache affect a high percentage of the population. Pain from tension-type headache (TTH) not only impacts personal well-being, but also poses a significant socioeconomic burden in terms of workdays lost and decreased worker productivity. Although TTH is the most prevalent of the headache disorders, there is a distinct lack of research with regards to specific treatments for this ailment in comparison to all other headache classifications, such as migraine. A muscular involvement is associated with TTH and is reported in the research literature as elevation in skeletal muscle tenderness, increased presence of active myofascial trigger point's, and physical abnormalities in cervical and cranial muscles. Thus, a treatment approach that addresses the skeletal musculature could be an important component in the management of TTH. The purpose of this randomized trial is to determine the effectiveness of two muscle oriented treatments on reducing pain and disability associated with TTH: massage therapy and ultrasound.

Eligibility criteria: Inclusion Criteria:

* 2 or more tension-type headache episodes per week
* Headache episodes of 2 hours or longer
* Experiencing tension-type headache for 6 months or longer

Exclusion Criteria:

* Migraine \>1/month
* Presence of alternate forms of headache (e.g. cluster headache, medication-induced headache, headache caused by injury)
* The diagnosis of fibromyalgia, major depression, other neurological or cardiovascular disease
* Pregnancy
* Prior massage or ultrasound treatment for headaches

Primary outcomes:
measure: Headache frequency
timeFrame: Measure is assessed daily for 14 weeks
Secondary outcomes:
measure: Headache Disability Index
timeFrame: Assessed at 4 time points over 14 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Albert Moraska, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00589355: C-reactive Protein and Endothelial Dysfunction in Women With Glucose Intolerance
Official title: C-reactive Protein and Endothelial Dysfunction in Women With Glucose Intolerance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glucose Intolerance
Keywords: c-reactive protein
endothelial dysfunction
glucose intolerance
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-01-09
Enrollment: 46
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups of healthy postmenopausal women who do not smoke. One group includes women with either pre-diabetes or diet-controlled diabetes. The control group includes women with normal glucose tolerance

Brief summary: The goal of this study is to determine whether markers of vascular inflammation (such as c-reactive protein) can predict endothelial dysfunction (as measured by flow-mediated dilation) in postmenopausal women with glucose intolerance compared to normal controls.


Eligibility criteria: Inclusion Criteria:

* healthy postmenopausal women
* ages 40-65

Exclusion Criteria:

* smokers
* diabetes requiring medication

Primary outcomes:
measure: c-reactive protein
timeFrame: performed after screening evaluation
Secondary outcomes:
measure: flow-mediated dilation of brachial artery
timeFrame: performed twice after screening visit
measure: sex steroids
timeFrame: performed after screening visit
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
Study officials:
affiliation: Yale University
name: Barbara I Gulanski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: