louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01827189: Staffing Patterns of Comprehensive Primary Care Practices
Official title: Evaluation of the Comprehensive Primary Care Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medicare Expenditures and Hospital Use, All Conditions
Keywords: primary care, Medicare costs, hospitalizations
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medicare patients enrolled in traditional Medicare who receive the majority of their Evaluation and Management visits from one of the study practices.

Brief summary: Examines staff size and composition of the 496 advanced primary care practices participating in CMS's comprehensive primary care initiative, in 7 regions (states or local areas) that were selected for the demonstration.

Detailed description: Participating practices all have electronic health records, submitted applications to participate in this demonstration program designed to improve primary care practices, and were selected as the most advanced of the applicants in terms of use of health information technology and certification as a medical home or possessing features similar to those of a medical home. Participating practices will receive monthly payments from Centers for Medicare \& Medicaid (CMS) for Medicare patients attributed to the practice, and from other payers in the market taht are participating in the initiative. The demonstration began in October 2012 and will continue for 4 years. This early paper focuses on describing these practices at the outset of the demonstration.

Eligibility criteria: Inclusion Criteria:

* All Medicare fee-for-service patients who receive the majority of their Evaluation and Management visits from one of the study practices.

Exclusion Criteria:

* none.

Primary outcomes:
measure: Medicare expenditures per year for patients attributed to the practice
timeFrame: Four years
Secondary outcomes:
measure: number of preventable hospitalizations
timeFrame: four years
Other outcomes:
measure: number of emergency room admissions
timeFrame: four years
Locations:
Study officials:
affiliation: Mathematica Policy Research
name: Randall S Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04486989: Treatment for Teachers With Vocal Fatigue
Official title: Cardiovascular Conditioning in the Treatment of Vocal Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Fatigue
Treatment
Lead sponsor: East Tennessee State University
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 31
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Teachers are a population at high risk for voice disorders given their occupational demands. In a teaching career, a common debilitating symptom among all vocal symptoms experienced is - vocal fatigue, impacting teachers' occupational performance and increasing health care costs. It is therefore essential to identify potential treatment options to alleviate the symptom of vocal fatigue. The purpose of this study is to utilize a body-system level cardiovascular training protocol in comparison to traditional voice production training to alleviate the symptoms of vocal fatigue.


Eligibility criteria: Inclusion Criteria:

* Female teachers between the ages of 21-60 years Female instructors and college professors between the ages of 21-60 years
* A score of ≥ 15 on factor 1 of the VFI (tiredness and avoidance of voice use) or a score of ≤ 5 on factor 3 of the VFI (improvement of symptoms or lack thereof with rest)
* Sedentary- wherein participants will need to be completing mild intensity cardiovascular exercise less than 150 minutes in less than 5 days per week

Exclusion Criteria:

* Trained athletes
* Trained singers
* Smoking in the past 6months
* Prior history of a vocal fold pathology and current vocal fold pathology

Primary outcomes:
measure: Changes in Physiologic Cost of Speaking
timeFrame: At baseline, at 4 weeks after treatment
measure: Changes in Oxygen Uptake Kinetics
timeFrame: At baseline, at 4 weeks after treatment
measure: Changes in Post Task Physiological Recovery
timeFrame: At baseline, at 4 weeks after treatment
measure: Changes in Excess Post Exercise Consumption (EPOC)
timeFrame: At baseline, at 4 weeks after treatment
measure: Changes in Ratings of Perceived Exertion (RPE)
timeFrame: At baseline, at 4 weeks after treatment
measure: Changes in Vocal Fatigue Index (VFI)
timeFrame: At baseline, at 4 weeks after treatment
measure: Changes in Global Rating of Vocal Fatigue (VAS 100mm)
timeFrame: At baseline, at 4 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
Study officials:
References:
Clinical trial NCT04579289: Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions
Official title: Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions_COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid19
Elderly
Long term care
Crisis Management
France
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long Term Care Institution (EHPAD) director

Brief summary: REMPAR EHPAD study addresses environmental and managerial factors associated with an outbreak of COVID 19 in French Long Term Care Institutions in the spring of 2020. The survey used a mixed methodology, combining qualitative and quantitative approaches, with a questionnaire send to all identified institutions (n=501) and qualitative interviews with facility directors (n=21).

Detailed description: 1. Declarative retrospective survey :

   A questionnaire was e-mailed to all identified institutions, with 3 reminders in one month. It included 39 questions concerning :
   * morbidity and mortality linked with COVID-19
   * structural features of the facility (location, architecture, residents characteristics)
   * human resources
   * crisis management (visits and circulation restrictions, personal protective equipment) A statistical analysis by logistic regression will be made, to identify explanatory variables for the occurrence of at least one COVID 19 infection among the residents.
2. Qualitative survey :

The investigators conducted semi-directed face-to-face interviews with facility directors. The investigators realized a purposive sample to assure maximal variability of the facilities (location, size, status, severity of the outbreak). The interview guide focused on structural, organizational, and human factors at stake in outbreak management, to identify incentives and obstacles associated with an easier crisis management.

Eligibility criteria: Inclusion Criteria:

* Long Term Care Institution (EHPAD) in Britain, France,

Exclusion Criteria:

-

Primary outcomes:
measure: case of COVID 19
timeFrame: 01 september 2020, survey closing date
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Aline MD CORVOL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06708689: Overview of Botriomycoma in Children with a Central Line: Epidemiology, Risk Factors, Treatments
Official title: Retrospective Case-control Study of Central Line Botriomycoma in Children on Home Parenteral Nutrition: Epidemiology, Risk Factors, Treatments
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Home Parenteral Nutrition
Intestinal Failure
Central Line
Botriomycoma
Infection
Sepsis
Antibiotics
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 240
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with intestinal failures requiring a long-term central line for home parenteral nutrition in France

Brief summary: Botriomycomas are frequent benign tumors in children. Their appearance on the central catheter orifice is a known event in clinical practice, but one that has been little studied. This lesion could lead to changes in pathways and an increase in the number of sepsis events, which would promote thrombosis and thus depletion of venous capital in patients who have been dependent on a central line for many years.

This study is a pilot study which will enable us to better identify the risk factors for the development of such a tumour, and to take stock of the different treatments used and their respective efficacy.


Eligibility criteria: Inclusion Criteria:

* home parenteral nutrition patients
* never diagnosed with an episode of botriomycoma on their central line
* 0 to 18 years of age at diagnosis

Exclusion Criteria:

* Botriomycoma more than 10 years old at time of data collection (or lack of data)
* Patient over 18 years of age
* Not on home parenteral nutrition patients

Primary outcomes:
measure: Appearance of Botryomycoma
timeFrame: From first diagnosis through a follow-up period of 2 years.
measure: Recurrence of Botryomycoma
timeFrame: From first diagnosis through a follow-up period of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Mère-Enfant
Study officials:
References:
Clinical trial NCT02237989: Effects Of Native Collagen Type 2 Treatment
Official title: Effects Of Native Collagen Type 2 Treatment In Knee Osteoarthritis : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis, native collagen type 2, paracetamol
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 39
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate symptomatic efficacy of native collagen type 2 on joint pain and function and its effects on urinary biological markers related to cartilage degeneration in patients with knee osteoarthritis.

Detailed description: 39 patients diagnosed with knee osteoarthritis were separated into two groups. The 1st group includes 19 patients given 1500mg/day paracetamol, the 2nd group consists of 20 patients given 1500mg/day paracetamol and 10mg/day native collagen type 2 for three months.Pretreatment and posttreatment Visual Analog Scale, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 20-m walking time and Short Form-36 (SF-36), Coll2-1, Coll2-1NO2 and Fibulin-3 levels in urine were compared.

Eligibility criteria: Inclusion Criteria:Patients aged 45-70 years with the diagnosis of primary knee OA according to the American College of Rheumatology (ACR) criteria, Kellgren Lawrence radiological stage II or III and knee pain -

Exclusion Criteria:Patients with intraarticular injections or physical therapy within the last year, a previous lower extremity surgery, oral treatment with glucosamine chondroitin or other natural health products within the last month, serious concomitant systemic diseases, peripheral or central neurological disorder, hypersensitivity to paracetamol or se¬vere cardiac, renal, hepatic, hematologic disease

-

Primary outcomes:
measure: the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)
timeFrame: 3 months
Secondary outcomes:
measure: the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
timeFrame: 3 months
measure: the Change From Baseline in 20 Meters Walking Time
timeFrame: 3 months
measure: the Change From Baseline in Short Form 36 / Bodily Pain Subgroup
timeFrame: 3 months
measure: the Change From Baseline in Coll2-1 Levels
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Yerkoy State Hospital
name: Fulya Bakilan, Specialist
role: STUDY_DIRECTOR
References:
citation: Bakilan F, Armagan O, Ozgen M, Tascioglu F, Bolluk O, Alatas O. Effects of Native Type II Collagen Treatment on Knee Osteoarthritis: A Randomized Controlled Trial. Eurasian J Med. 2016 Jun;48(2):95-101. doi: 10.5152/eurasianjmed.2015.15030.
Clinical trial NCT01181089: Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF)and Safety in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)
Official title: A Multicenter, Randomized, Blinded, Placebo-Controlled, Dose Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the Cerebrospinal Fluid (CSF) and Safety in Subjects With Secondary Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Secondary Progressive Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, multicenter, dose escalation study to determine subject safety, pharmacokinetic, and pharmacodynamic responses in patients with SPMS

Detailed description: This study is a prospective, randomized, placebo-controlled, blinded, dose escalation study of 3 to 4 cohorts with defined number of patients per cohort receiving active drug or placebo for a period of 4 months followed by safety monitoring for an additional 4 months after the last dose

Eligibility criteria: Inclusion Criteria:

* A diagnosis of Secondary Progressive Multiple Sclerosis
* Aged 18 to 57 years old, at the time of informed consent

Exclusion Criteria:

* History of clinically important (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, immune, psychiatric, hepatic, renal or hematologic insufficiency or any other major disease other than MS ( Multiple Sclerosis)
* Inability in the opinion of the Investigator to comply with study requirements
* Other protocol-defined criteria may apply

Primary outcomes:
measure: Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo
timeFrame: after 4 months of treatment
Secondary outcomes:
measure: Number of subjects experiencing Serious Adverse Event (SAE) and Adverse Event (AE) with baminercept relative to placebo
timeFrame: 8 months (4 months on drug, 4 months post-drug)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01456689: A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
Official title: A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Myeloma
Multiple Myeloma
MM
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-10-21
Enrollment: 79
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: The primary purpose of this dose escalation study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of LGH447 as a single agent when administered orally once daily to adult patients with Multiple Myeloma (MM).


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma that is relapsed and/or refractory for which no curative option exists.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
* During the dose expansion part of the study patients must have measurable disease defined by at least 1 of the following 2 measurements:

  * Serum M-protein ≥ 0.5 g/dL
  * Urine M-protein ≥ 200 mg/24 hours
  * Serum free light chain (FLC) \> 100 mg/L of involved FLC

Exclusion Criteria:

* Patients who are currently receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with LGH447:

  * Strong inhibitors or inducers of CYP3A4
  * CYP3A4 substrates with narrow therapeutic index

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Estimate the MTD and/or RDE
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with adverse events and serious adverse events.
timeFrame: 18 months
measure: Pharmacokinetic (PK) effects of LGH447
timeFrame: 18 months
measure: Pharmacodynamic (PD) effects of LGH447
timeFrame: 18 months
measure: Anti-Myeloma activity associated with LGH447
timeFrame: 18 months
measure: Effect of multiple-doses of LGH447 on the PK of midazolam
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Ann Arbor
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Rochester
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Salamanca
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06850389: PMCF Investigation of Medical Device ChitoCare® Medical
Official title: PMCF Investigation of Medical Device ChitoCare® Medical
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dermatitis
Acne
Conditions After Dematosurgical Procedures
Scars
Lead sponsor: Primex ehf
Sponsor class: INDUSTRY
Collaborators: name: Porta Medica
First posted: 2025-02-27
Enrollment: 214
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The device is intended for use in all age groups, including children and the elderly. All participants who fulfill the inclusion and exclusion criteria will be considered for enrollment.

Brief summary: This is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of ChitoCare® Medical, aimed to confirm safety and efficacy according to the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, for the following indications:

Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne

Spray - conditions after dermatosurgical procedures, dermatitis, acne


Eligibility criteria: The inclusion criteria are fully according to indications:

* Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
* Spray - conditions after dermatosurgical procedures, dermatitis, acne

The criteria for exclusion are fully according to contraindications:

* Allergy to any of the ingredients of the product

Primary outcomes:
measure: Significant improvement in Vancouver Scar Scale (VSS)
timeFrame: 3 months
measure: Significant improvement in Comprehensive Acne Severity Scale (CASS)
timeFrame: 2 months
measure: Significant improvement in dermatitis severity scale
timeFrame: 2 months
Secondary outcomes:
measure: Confirmation of safety (adverse events)
timeFrame: 2-3 months
measure: Confirmation of safety (serious adverse events)
timeFrame: 2-3 months
measure: Quality of life assessment (adults)
timeFrame: 2-3 months
measure: Quality of life assessment (children)
timeFrame: 2-3 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Dermatovenerology department, FN Motol
city: Prague
country: Czechia
facility: Dermatology of Prof. Hercogova
Study officials:
References:
Clinical trial NCT00154089: A Pilot Study of EM-1421 for the Treatment of Cervical Intraepithelial Neoplasia
Official title: A Pilot Translational Study of Tetra-O-Methyl Nordihydroguaiaretic Acid (EM-1421) for the Treatment of Cervical Intraepithelial Neoplasia Induced by Human Papilloma Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Keywords: cervical intraepithelial neoplasia
CIN
HPV
Lead sponsor: Erimos Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: University of Maryland, Baltimore County
name: Planned Parenthood Delaware (Wilmington, DE)
First posted: 2005-09-12
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine pilot safety and efficacy data for a topical formulation of EM-1421 applied to the cervix of patients with CIN 1, 2, or 3.

Detailed description: This was an open-label, pilot Phase I/II dose evaluation and pharmacokinetic evaluation study to compare the safety and efficacy of terameprocol (45mg or 90mg/application)administered once per week for 3 weeks to the cervix uteri in patients with biopsy-proven CIN. Patients who met eligibility criteria visited the clinic weekly for terameprocol application. Patients kept a daily diary card record of genitourinary symptoms.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Negative pregnancy test
* Biopsy confirmed CIN 1, 2, or 3

Exclusion Criteria:

* Pregnancy or breast feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Dept. of Family Medicine
state: Maryland
Study officials:
References: