louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05889702: Kentucky Access to Recovery Evaluation
Official title: Evaluation of the Kentucky Access to Recovery (KATR) Linkage Strategy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Use Disorders
Treatment Adherence and Compliance
Keywords: Support Services
Recovery
Opioid Overdose
Addiction
Social Services
Appalachia
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 458
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: individuals in underserved areas with incomes at or below the 200% poverty level, individuals with prior criminal-justice involvement, veterans, and pregnant and parenting populations, with illicit SUD

Brief summary: Evaluate the long-term effectiveness of implementing vouchers as a linkage strategy in a population requiring recovery support services (RSS) when no other funding sources are available. A within-subjects study design will be used to test the effectiveness of the Kentucky Access to Recovery (KATR) last resort voucher linkage approach to reduce the risk of nonfatal and fatal overdoses by (a) increasing an individual's recovery capital; (b) reducing resumption of illicit substance use; and (c) promoting relinking to RSSs if illicit substance use is resumed.


Eligibility criteria: Inclusion Criteria:

* be in SUD treatment or have completed within the past year SUD treatment for opioid use disorder or stimulant use disorder or have a history of overdose from opioid use
* be a first-time participant in KATR
* be in early stages of recovery (less than one year in recovery)
* be a resident of a KATR service county
* be at or below the 200% federal poverty level
* not have financial resources available through other funding mechanisms for RSSs
* be 18 years of age and older
* be in need of recovery supports that will enhance their likelihood of staying in recovery

Exclusion Criteria:

* Under 18
* Participated in KATR previously

Primary outcomes:
measure: Change in Recovery Capital per person
timeFrame: Enrollment, Up to 6 months, 3 months post discharge, and 12 months post enrollment
measure: Change in number of drug overdoses per person
timeFrame: Enrollment, Up to 6 months, 3 months post discharge, and 12 months post enrollment
measure: Change in number of days of illicit substance use per person
timeFrame: Enrollment, Up to 6 months, 3 months post discharge, and 12 months post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Berea
country: United States
facility: FAHE
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Terry Bunn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06726902: Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis
Official title: Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis: (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Periodontitis
Keywords: GBT
Periodontitis
SI
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to evaluate and compare the effect of a newly designed air-polishing device (APD) using Erythritol, Glycine, and Trehalose air-polishing powders in nonsurgical periodontal therapy with control (conventional scaling and root planning) following the concept of guided biofilm therapy (GBT) as an adjunctive to subgingival instrumentation (SI) in nonsurgical periodontal therapy for Stage II and III periodontitis patients both clinically and microbiologically.


Eligibility criteria: Inclusion Criteria:

1. Individuals of both sexes with an age between 30 and 65 years, having at least 16 natural teeth in function,
2. Stage II and III (moderate to severe) periodontitis, having at least 16 teeth with the need for SI
3. Interproximal plaque index (API) ≤ 35%; patients with Good oral hygiene.
4. No history of systemic disease that may influence periodontal disease

Exclusion Criteria:

1. Pregnancy or breastfeeding,
2. Smokers with more than seven cigarettes per day
3. Patients that had a treatment with antibiotics within six months before the study
4. Need for periodontal surgery or adjunctive antibiotic treatment to the SI
5. Patients who had any periodontal treatment during the last year before the study.
6. Patients with known systemic or autoimmune disease.

Primary outcomes:
measure: Bleeding on probing
timeFrame: up to six months
measure: Pain Assessment
timeFrame: up to six months
measure: Probing depth
timeFrame: up to six months
measure: Plaque accumulation
timeFrame: up to six months
measure: Clinical attachment level
timeFrame: up to six months
measure: Microbiological Assessment of Aggregatibacter actinomycetemcomitans (Aa)
timeFrame: one month
measure: Microbiological Assessment of Porphyromonas gingivalis (Pg)
timeFrame: one month
measure: Microbiological Assessment of Tannerella forsythia (Tf)
timeFrame: one month
measure: Microbiological Assessment of Treponema denticola (Td)
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Rania Abdelaziz Fahmy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06200402: Antibiotic-Loaded Cement Versus Non-Antibiotic-Loaded Cement in Hip Prosthesis Surgery for Proximal Femur Fractures
Official title: Antibiotic-Loaded Cement Versus Non-Antibiotic-Loaded Cement in Hip Prosthesis Surgery for Proximal Femur Fractures: A Prospective, Randomized, Single-Center, Blinded Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Proximal Femoral Fractures
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 450
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to determine if antibiotic-loaded cement reduces post-surgery infection rates compared to non-antibiotic cement. The trial involves 450 elderly patients with specific hip fractures, assessing infection incidence, implant stability, and associated costs. This randomized, blinded study is conducted by IRCCS Ospedale San Raffaele.


Eligibility criteria: Inclusion Criteria:

* Patients must be older than 65 years
* Fracture Type: The study includes patients with medial femoral neck fractures classified as AO type B1, B2, and B3, indicating specific types of hip fractures.
* Surgical Indication: Patients should have an indication for prosthetic hip surgery.
* Informed Consent: Patients must provide signed informed consent to participate in the study

Exclusion Criteria:

* Fracture Type: Exclusion of patients with trochanteric region fractures and femoral head fractures (AO classification types A and C), periprosthetic fractures, patients with multiple traumas or multiple fractures.
* Blood Test Anomalies: Patients with pre-operative blood test anomalies, such as ionic disorders and hemoglobin levels lower than 8 g/dL.
* Renal Insufficiency: Patients with renal insufficiency.
* Active Infections: Exclusion of patients with active infections or suspected/confirmed hypersensitivity or allergy to gentamicin, history of toxicity or reaction to aminoglycosides.

Primary outcomes:
measure: Incidence of Acute Postoperative Infections
timeFrame: 7 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ircss Ospedale San Raffaele
state: Lombardy
Study officials:
References:
Clinical trial NCT01248702: A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy
Official title: A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Heart Failure
Keywords: Myocardial Infarction
Heart Failure
Sudden Cardiac Death
Critical Pathways
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to develop and implement a critical pathway to identify patients with ischemic cardiomyopathy who are candidates for an implantable cardioverter-defibrillator (ICD). This study will also determine whether the use of the critical pathway for ICDs is associated with a change in the ICD referral and implantation rate.

Detailed description: Despite improvements in both medical management and revascularization strategies, sudden death is still a significant complication in patients with ischemic cardiomyopathy. There is strong evidence to support the role of ICDs for the primary prevention of sudden death in this population. However, in Canada and the United States, ICDs are underutilized.

Critical pathways are algorithms that improve health care delivery and clinical outcomes while reducing practice variability. The use of a critical pathway to assess a patient's eligibility for an ICD may increase the appropriate use of this evidence-based technology.

Eligibility criteria: Inclusion Criteria:

* acute ST segment elevation myocardial infarction (STEMI)
* candidate for percutaneous revascularization
* permanent residents of British Columbia, Canada

Exclusion Criteria:

* patients with heart disease or a comorbid illness who have a documented life expectancy of less than 1 year

Primary outcomes:
measure: Rate of Referral for ICD Assessment
timeFrame: 1 year
Secondary outcomes:
measure: Rate of ICD Implantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital, Vancouver, British Columbia
name: S Cowan, MD, MSc
role: STUDY_DIRECTOR
affiliation: St. Paul's Hospital, Vancouver, British Columbia
name: A Ignaszewski, MD
role: STUDY_DIRECTOR
affiliation: St. Paul's Hospital, Vancouver, British Columbia
name: C Kerr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Paul's Hospital, Vancouver, British Columbia
name: S Tung, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06967779: The Relationship Between Delirium and BDNF in Coronary Artery Bypass Graft Surgery
Official title: Analysis of the Relationship Between the Concentration of the Brain Derived Neurotrophic Factor (BDNF) in Plasma, the Occurrence of BDNF Gene Polymorphism (Val66Met) and White Blood Cell Markers and the Incidence of Postoperative Central Nervous System Disorders in Patients Undergoing General Anesthesia for Cardiac Surgery With Extracorporeal Circulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium - Postoperative
BDNF
CABG
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 107
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: A prospective observational cohort study will recruit 200 patients scheduled for planned coronary artery bypass grafting (CABG), with the use of cardio-pulmonary by-pass who will be operated at the Cardiac Surgery Department of the Pomeranian Medical University in Szczecin. The Cardiac Surgery Department of Pomeranian Medical University has a volume of 900-1100 operations per year, 70% being CABG (approx. 700 CABG operations per year).

Brief summary: This study is aimed at finding a correlation between postoperative delirium occurrence, severity and duration after cardiac surgery and the level of brain-derived neurotrophic factor (BDNF) in plasma as a marker of brain injury induced by cardio-pulmonary by-pass and its association with genetic predisposition in patients undergoing coronary artery bypass grafting (CABG) carrying BDNF gene polymorphism (Val66Met).


Eligibility criteria: Inclusion criteria include:

1. Age \> 18 years.
2. Planned coronary artery bypass grafting (CABG) procedure with the use of cardiopulmonary by-pass (CPB).
3. Ability to understand and sign an informed consent form.

Exclusion criteria include:

1. Emergency surgery.
2. Previous known cognitive disorders: Mini Mental State Examination (MMSE) score \<15.
3. Baseline delirium (positive CAM test prior to surgery).
4. Diagnosis of psychiatric syndromes in the past - i.e. depression, dementia, psychosis or schizophrenia.
5. Inability to understand Polish language.
6. Inability to give and sign informed consent due to auditory or visual dysfunction.

Primary outcomes:
measure: The main aim of the study will be to assess the correlation between brain function disorders, defined as abnormal BDNF levels, and postoperative delirium.
timeFrame: Up to a year after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie
state: Zachodniopomorskie
Study officials:
References:
Clinical trial NCT00779779: Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
Official title: Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 522
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
* A male or female at least 6 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
* Any contraindication as stated in the updated and approved Prescribing Information

Primary outcomes:
measure: Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea
timeFrame: During the 8-day solicited follow-up period
Secondary outcomes:
measure: Number of Subjects Reporting Each Type of Solicited General Symptoms
timeFrame: During the 8-day follow-up period
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day follow-up period
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: Throughout the study period (Day 0 to Month 3 or 4)
Other outcomes:
Locations:
city: Colombo
country: Sri Lanka
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ruberu D et al. Post-marketing surveillance of a live-attenuated human rotavirus vaccine (Rotarix™) in India and Sri Lanka. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand, 18-20 October 2011.
citation: Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, Bernardo R, Mehta S, Balasubramanian S, Karkada N, Htay Han H. Reactogenicity and safety of the human rotavirus vaccine, Rotarix in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280.
Clinical trial NCT00708279: Study of Osteopathic Manipulation in the Management of Angina
Official title: Study of Osteopathic Manipulation in the Management of Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina Pectoris
Keywords: angina pectoris, osteopathic manipulation
Lead sponsor: University of New England
Sponsor class: OTHER
Collaborators: name: Osteopathic Heritage Foundations
First posted: 2008-07-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of osteopathic manipulation in decreasing angina pectoris symptoms.


Eligibility criteria: Inclusion Criteria:

* Canadian Cardiovascular Society Class II, III for a minimum of 6 months
* documented coronary artery disease via previous myocardial infarction, abnormal stress test, or abnormal coronary angiogram of greater than or equal to 50% luminal obstruction of at least one epicardial vessel.

Exclusion Criteria:

* severe left ventricular dysfunction
* symptomatic heart failure
* symptomatic aortic stenosis or any valvular disease
* significant pulmonary disease
* unstable angina
* major surgery or angioplasty in the past three months
* acute myocardial infarction within past three months
* insulin dependent diabetes mellitus
* uncontrolled hypertension
* acute renal or hepatic failure
* currently being treated with osteopathic manipulation

Primary outcomes:
measure: Decrease in angina symptoms
timeFrame: over 4 month period
Secondary outcomes:
measure: Improvement in quality of life
timeFrame: over 4 month period
Other outcomes:
Locations:
city: Saco
country: United States
facility: University Health Care
state: Maine
Study officials:
affiliation: University of New England
name: Joy L. Palmer, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01051479: A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer
Official title: A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Esophageal Cancer
Keywords: PET Positron emission tomography
CT X-ray computed tomography
Patients with Locally Advanced Esophageal Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the investigators ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed or recurrent patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology.
* Ability to tolerate PET imaging
* Prior malignancy is allowed, but the expectation of survival must be that beyond that expected for patients with locally advanced esophageal cancer.

Exclusion Criteria:

* Pregnant or lactating females are not eligible for this pilot study.
* Patients having received chemotherapy in the 3 months prior to registration for any reason
* Patients with metastatic disease requiring chemoradiation for palliation are not allowed.

Primary outcomes:
measure: To evaluate our ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer (pre- and post- chemotherapy).
timeFrame: 2 years
Secondary outcomes:
measure: Perform semi-quantitative analysis of tracer uptake using standard uptake values (SUV) and qualitative analysis using pure visual analysis.
timeFrame: 2 years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
References:
Clinical trial NCT02370979: Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients
Official title: Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV-1 Infection
Keywords: Dolutegravir
Proviral HIV-1 DNA
Reservoir
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.


Eligibility criteria: Inclusion Criteria:

* Male or female aged from de 18 to 80 years
* Patient starting a DTG-regimen
* Patients agreeing to use methods of birthcontrol while on the study and during the 6 weeks after stopping DTG treatment
* Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* HBV or HCV coinfection
* Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
* An active AIDS-defining condition at Screening
* Documented resistance to DTG
* Allergy or intolerance to the study drugs or their components or drugs of their class
* Any acute or verified Grade 4 laboratory abnormality (with the exception of Grade 4 lipids) at Screening.
* Coadministration with Dofelitide

Primary outcomes:
measure: Change from baseline in Proviral HIV-1 DNA at Week 48
timeFrame: baseline (Day 0) and Week 48
Secondary outcomes:
measure: Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels)
timeFrame: Week 4, Week 24 and Week 48
measure: Quantification of biomarkers of immune activation
timeFrame: baseline (Day 0), Week 24 and Week 48
Other outcomes:
Locations:
city: Belfort
country: France
facility: Centre hospitalier de Belfort-Montbéliard
city: Colmar
country: France
facility: Centre hospitalier de Colmar
city: Mulhouse Cedex
country: France
facility: Centre hospitalier de Mulhouse
city: Strasbourg Cedex
country: France
facility: Hôpitaux Universitaire de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: David REY, PhD
role: PRINCIPAL_INVESTIGATOR
References: