louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06513728: Pilot Study of Methadone Patient Access to Collaborative Treatment: a HEAL Initiative
Official title: Methadone Patient Access to Collaborative Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Substitution Treatment Clinics
Patients
Staff
Keywords: Implementation Science
Methadone treatment
Opioid Use Disorder
Opioid Use Disorder Treatment
Workforce Development
Vicarious trauma
Posttraumatic stress
Treatment retention
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot implementation and preliminary effectiveness study of MPACT.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation.

Detailed description: Specific AIMS:

AIM 1: Develop MPACT through multilevel, iterative planning with OTP staff and people with recent MMT experience.

AIM 2: Conduct a 4-month MPACT pilot test in two AZ OTPs: Mesa (urban) with 50 patients and 22 staff, and Sierra Vista (rural-serving) with 50 patients and 8 staff to:

1. Determine MPACT implementation feasibility, acceptability, and preliminary effect on MMT practice change and culture.
2. Determine MPACT preliminary effect on MMT retention, in-MMT overdose, and patient PTSS.
3. Characterize staff trauma history, PTSS and vicarious trauma, and explore their relationship with MPACT acceptability and implementation fidelity.

AIM 3: Characterize MPACT acceptability, likely adoption, and recruitment feasibility among directors, case managers and counselors from a national random sample of 500 OTPs.

Eligibility criteria: Inclusion Criteria:

* Staff of enrolled opioid treatment programs (methadone clinics) who are involved with methadone treatment
* Patients receiving methadone at these locations

Exclusion Criteria:

* Patients not receiving methadone at these locations
* Staff not involved in methadone treatment at these locations

Primary outcomes:
measure: methadone treatment retention
timeFrame: 4 months (pilot study period)
measure: In treatment overdose
timeFrame: 4 months (pilot study period)
Secondary outcomes:
measure: Trauma symptoms among patients and staff
timeFrame: pilot period of 4 months
measure: Vicarious Trauma symptoms among staff
timeFrame: pilot period of 4 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona College of Medicine
state: Arizona
Study officials:
affiliation: Professor
name: Beth Meyerson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04208828: IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy
Official title: IVIG for Drug and Device Refractory Gastrointestinal Auto-Immune Neuropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Motility Disorder
Gastroparesis
Neuropathy
Keywords: Gastroparesis
Nausea
Vomiting
Abdominal Pain
Neuropathy
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with GI motor disorders, including symptoms of gastroparesis, who are refractory to available dietary, drug, device, and endoscopic/surgical diversion therapies.

Brief summary: Patients with the symptoms of generalized GI dysmotility, including gastroparesis, are sometimes refractory to available medications, devices and other interventions/ Some of these patients have serologic and/or endo organ abnormalities and findings consistent with autoimmune neuropathies, primarily involving the GI tract. These disorders have been known as autoimmune gastrointestinal neuropathies (GAIN) or also as autoimmune gastrointestinal dysmotility (AGID), among other terms. Some patients respond to intravenous immunoglobulin (IVIG) and this study, which is an observational clinical series, documents the patients, their findings and standardized responses to therapy with IVIG.

Detailed description: Gastrointestinal dysmotility disorders encompass a large group of patients including a subset with autoimmune findings, either on serologic testing and/or end organ anatomic and physiologic effects.

The identification of patients with autoimmune gastrointestinal neuropathies (GAIN) or also as autoimmune gastrointestinal dysmotility (AGID), has led to trial with autoimmune therapies. Most promising therapy has been intravenous immunoglobulin (IVIG) and this, usually given in 12-week courses with standard dosing, has helped a number of patient's refractory to other available therapies including diet, drugs, devices and enteral diversions/disruptions.This observational study documents clinical observations in consecutive patients meeting entry criteria who received IVIG.

Patients will have their gastrointestinal (GI) symptoms documented by a standardized patient reported outcome (PRO) survey at baseline and use the same assessment tools after at least one course of IVIG therapy.

Eligibility criteria: Inclusion Criteria: Patient with otherwise refractory symptoms of gastrointestinal (GI) motor disorders.

-

Exclusion Criteria: Inability to receive intravenous immunoglobulin.

-

Primary outcomes:
measure: Gastrointestinal (GI) total symptoms score (TSS)
timeFrame: Baseline to latest, up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References:
Clinical trial NCT02267928: Information Presentation Formats
Official title: Information Presentation Formats and Pursuit of Diagnostic Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meningioma
Keywords: Symptom Assessment
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: Prevention and early detection of medical problems can greatly reduce health care costs, yet time and again, people avoid or ignore services that could help detect medical problems early enough to prevent or reduce the severity of potential problems. The investigators seek to understand whether the elicitation of symptom admission by patients can predict people's perceived risk of the medical condition and voluntary pursuit of medical information.

Detailed description: We will present individuals with medically accurate information about a medical condition and measure people's perceptions of their own likelihood to having that medical condition. This will include an opportunity for people to pursue more information by directing them to a website that features more information about the condition. The initial information provision will vary slightly in presentation (method of eliciting symptoms will vary), and the rate at which individuals visit the subsequent medical website to receive more information will be recorded as a measure of information seeking behavior. Rates will be compared across symptom elicitation conditions to determine which formats are most effective at encouraging information seeking about health issues. No personally identifying information will be collected, and all results will be reported in aggregate. Critically, no deception will be used: Participants will only be provided with information that is as accurate as possible (given existing knowledge in the health/medical fields).

Eligibility criteria: Inclusion Criteria:

* 18 or older
* American

Exclusion Criteria:

* Mechanical Turk approval rate below 95%

Primary outcomes:
measure: Number of symptoms
timeFrame: 1 day
measure: Risk of meningioma
timeFrame: 1 day
measure: Information pursuit
timeFrame: 1 day
Secondary outcomes:
measure: Funding allocation
timeFrame: 1 day
measure: Risk of serious disease
timeFrame: 1 day
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Eric M VanEpps, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00289328: Glucocorticoid-induced Osteopenia in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Nephrotic Syndrome
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2006-02-09
Enrollment: 550
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to characterize the skeletal deficits and risk factors for impaired skeletal development in children requiring glucocorticoid therapy.

We will compare the bone health of children treated with prednisone for nephrotic syndrome (NS with those treated with prednisone for Crohn's Disease (CD). Childhood NS usually responds to prednisone and is not characterized by pathologies that can impact on bone. In contrast, CD is treated with prednisone, but is independently associated with poor growth and maturation, nutritional deficiencies and inflammation. Due to the differences in the diseases, this comparison will allow us to distinguish between the prednisone-related and disease-related effects on bone in the two disease states.

Detailed description: Prednisone, a glucocorticoid medication, is widely used for many pediatric disorders. Studies have shown that this drug decreases bone formation, decreasing bone density and bone thickness in children. Prednisone induced osteopenia, or low bone density, can be worsened by the effects of the underlying disease, such as delayed growth and maturation, malnutrition, and increased bone resorption (removal) by inflammatory compounds. The combined effects of decreased bone formation and increased resorption may be particularly detrimental to the growing skeleton.

Subjects will include 15 newly diagnosed NS patients, 60 patients with pre-existing NS, 90 patients with newly diagnosed CD, 45 patients diagnosed within the last two years and 200 healthy controls of similar age, gender and ethnicity. Participants will visit the Children's Hospital of Philadelphia (CHOP) three times over a 12-month period for assessment of bone mineralization and turnover, fracture history, dietary calcium intake, physical activity, growth, body composition, muscle strength and glucocorticoid exposure.

Eligibility criteria: Inclusion Criteria:

* ages 5-21
* clinical and pathological diagnosis of Crohn's Disease within the last 2 years
* clinical diagnosis of nephrotic syndrome and taking corticosteroids within the last year
* normal renal function GFR\>75 ml/min/1.73m2
* healthy controls

Exclusion Criteria:

* other major medical conditions affecting growth and/or bone health
* significant cognitive or developmental disorders (if child is unable to cooperate sufficiently)
* nonambulatory

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Mary B Leonard, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04815928: Registry of Patients That Have Undergone ICA or PCI
Official title: Registry of Patients That Have Undergone an Invasive Coronary Angiography and/or Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Quantiative Flow Ratio
QFR
Fractional Flow Reserve
FFR
Instantaneous wave-free ratio
iFR
Invasive Coronary Angiography
Percutaneous Coronary Intervention
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 10000
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: All patients that have undergone an invasive coronary angiography and or/percutaneous coronary intervention

Brief summary: In Invasive Coronary Angiography there are multiple invasively obtained measurements to determine the funcitonal significance of Cornary Artery Disease. In this Registry, patients who have undergone Invasive Coronary Angiography or Percutaneous Coronary Intervention are included to investigate diagnostic and prognostic implications of the invasive measurements.


Eligibility criteria: Inclusion Criteria:

* 18 years
* Has undergone or will undergo a clinically indicated invasive coronary angiography.
* Has undergone or will undergo a clinically indicated percutaneous coronary intervention.

Exclusion Criteria:

* Not willing / unable to provide informed consent.

Primary outcomes:
measure: Fractional Flow Reserve (FFR)
timeFrame: Upon inclusion at index procedure
measure: Instantaneous wave-free ratio (iFR)
timeFrame: Upon inclusion at index procedure
measure: Quantitative Flow Ratio (QFR)
timeFrame: Upon inclusion at index procedure
measure: Stenosis percentage
timeFrame: Upon inclusion at index procedure
Secondary outcomes:
measure: Major adverse cardiac events, cardiac death or repeat revascularization
timeFrame: 5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam Univeristy Medical centers, location VUmc
Study officials:
References:
Clinical trial NCT02356328: NovaTears® Eye Drops Observational Study NT-003
Official title: NovaTears® Observational Study NT-003
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 25
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 with dry eye disease due to chronic ocular GvHD

Brief summary: This observational study is intended to collect outcome data from a cohort of 30 patients suffering from dry eye disease due to chronic ocular Graft-versus-Host Disease (GvHD) who are treated with the medical device NovaTears® eye drops for a duration of 11 to 13 weeks.


Eligibility criteria: Inclusion Criteria:

* According to NovaTears® instruction for use
* ≥ 18 years
* Patients after an allogeneic hematopoietic stem cell transplantation with dry eye disease due to chronic ocular Graft-versus-Host Disease
* Ability and willingness to provide written Informed Consent
* Ability and willingness to participate in all examinations
* Willingness and ability to return for follow up visit

Exclusion Criteria:

* Patients with known hypersensitivity to any of the components of NovaTears®
* Patients with contact lenses, pregnancies, or who are breast feeding
* Patients with dry eye disease caused by any other known underlying systemic disease
* Patients planning an ophthalmologic surgical procedure during the course of this PMCF study
* Patients using lipid-containing or tear-film stabilizing eye drops/sprays except cyclosporin formulations

Primary outcomes:
measure: Subjective symptom severity
timeFrame: 11-13 weeks
Secondary outcomes:
measure: Tear-Film Break-up Time
timeFrame: 11 to 13 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Ophthalmology, University of Cologne
city: Freiburg
country: Germany
facility: University Eye Hospital Freiburg
Study officials:
affiliation: Novaliq GmbH
name: Novaliq GmbH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01243528: Observational Study at the Influence of Malnutrition on Infections
Official title: Prospective, Non-interventional Observational Study at the Influence of Malnutrition on Nosocomial Infections in Patients During Early Neurological Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: Malnutrition
Infection
Neurological
Lead sponsor: Schoen Clinic Bad Aibling
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in neurological rehabilitation facility

Brief summary: The purpose of this trial is to determine whether nutritional status has an impact on nosocomial infections. Study population are patients undergoing early neurological rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Patients in early neurological rehabilitation
* informed consent given

Exclusion Criteria:

* none

Primary outcomes:
measure: Nutritional status
timeFrame: 8 weeks
Secondary outcomes:
measure: Nosocomial infections
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bad Aibling
country: Germany
facility: Schoen Clinic Bad Aibling
state: Bavaria
Study officials:
affiliation: Schoen Clinic Bad Aibling
name: Marion Mertl-Rötzer, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01211028: Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine
Official title: Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Vascular Diseases
Cardiovascular Diseases
Keywords: Critical leg ischemia
Adipose derived Stroma/Stem Cells
Autologous
Angiogenesis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: French Blood Establishment
name: Clinical Research Center, Toulouse
name: Centre National de la Recherche Scientifique, France
First posted: 2010-09-29
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.


Eligibility criteria: Inclusion Criteria:

* Severe peripheral vascular disease not amenable to bypass or angioplasty
* Age \>40 years old
* Normal renal function (creatinine \< 1.6)
* Non pregnant female
* Lifespan \> 6 months

Exclusion Criteria:

* Age \<40 years old
* Refusal to give informed consent and/orCognitively disabled
* Congestive heart failure or stroke in the last 3 months
* History of cancer or myeloproliferative disorders
* Proliferative retinopathy
* Pregnancy
* Positive screening test for HIV, Hepatitis B or Hepatitis C
* Buerger patient
* Cachexia or predicted impossibility for a biopsy of at least 30 grams of fat tissue
* Pregnancy or lactation
* Having been non controlled severe pathology

Primary outcomes:
measure: Number and Nature of Adverse Events : safety and tolerability
timeFrame: 15 days, 1, 2, 3, 4,5, 6 months for adverse events record
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse, Rangueil
Study officials:
affiliation: University Hospital of Toulouse, Rangueil
name: Alessandra BURA-RIVIERE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Planat-Benard V, Silvestre JS, Cousin B, Andre M, Nibbelink M, Tamarat R, Clergue M, Manneville C, Saillan-Barreau C, Duriez M, Tedgui A, Levy B, Penicaud L, Casteilla L. Plasticity of human adipose lineage cells toward endothelial cells: physiological and therapeutic perspectives. Circulation. 2004 Feb 10;109(5):656-63. doi: 10.1161/01.CIR.0000114522.38265.61. Epub 2004 Jan 20.
Clinical trial NCT00949728: Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia
Official title: Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium
Primary
Keywords: Pterygium
Autologous Transplantation
Conjunctiva
Fibrin Tissue Adhesive
Recurrence
Lead sponsor: Hospital de Olhos Sadalla Amin Ghanem
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 151
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary pterygium
* Symptomatic pterygium
* Limbal invasion

Exclusion Criteria:

* Secondary pterygium

Primary outcomes:
measure: Recurrence of pterygium after its excision with the conjunctival autograft technique.
timeFrame: One, three and five months after surgery.
Secondary outcomes:
measure: Postoperative complications following the pterygium excision, such as partial graft detachment, dellen, granuloma or sutures failure.
timeFrame: One day, one week and one month after surgery.
Other outcomes:
Locations:
city: Joinville
country: Brazil
facility: Sadalla Amin Ghanem Eye Hospital
state: SC
Study officials:
name: Renan F Oliveira
role: PRINCIPAL_INVESTIGATOR
affiliation: Sadalla Amin Ghanem Eye Hospital
name: Ramon C Ghanem, M.D.
role: STUDY_DIRECTOR
References:
citation: Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4. doi: 10.1136/bjo.2003.032854.
citation: Bahar I, Weinberger D, Gaton DD, Avisar R. Fibrin glue versus vicryl sutures for primary conjunctival closure in pterygium surgery: long-term results. Curr Eye Res. 2007 May;32(5):399-405. doi: 10.1080/02713680701294723.
citation: Marticorena J, Rodriguez-Ares MT, Tourino R, Mera P, Valladares MJ, Martinez-de-la-Casa JM, Benitez-del-Castillo JM. Pterygium surgery: conjunctival autograft using a fibrin adhesive. Cornea. 2006 Jan;25(1):34-6. doi: 10.1097/01.ico.0000164780.25914.0a.