louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03138174: OneTouch Verio Flex System Accuracy Evaluation
Official title: OneTouch Verio Flex System Accuracy Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Blood Glucose Monitor System Accuracy
Lead sponsor: LifeScan
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will consist of subjects diagnosed with diabetes

Brief summary: Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197

Detailed description: Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015.

Eligibility criteria: Summary of Inclusion Criteria:

* All Subjects must be registered into the LFSS Patient Registry to participate in the study.
* Each Participant must read and sign the approved Informed Consent Form.
* Diabetes Diagnosis - Participants should be diagnosed with some form of diabetes for system accuracy.

Summary of Exclusion Criteria:

\> Subjects not enrolled in the LFSS Patient Registry are not eligible to participate in the study.

Primary outcomes:
measure: To meet the requirements of ISO 15197:2015
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Diabetes Centre, Birmingham Heartlands Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Inverness
country: United Kingdom
facility: Highland Diabetes Institute
Study officials:
affiliation: National Health Service, United Kingdom
name: Alan Patrick
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02373020: Enteropathogenic Escherichia Coli (EPEC): Does it Have a Role in Colorectal Tumourigenesis?
Official title: ROLE OF E COLI IN Colorectal Tumourigenesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enteropathogenic Escherichia Coli .
Colorectal Carcinoma
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who were diagnosed to have colorectal cancer (Group 1) and healthy controls who had colonoscopy for colorectal symptoms in the same study period (Group 2

Brief summary: Despite the characterization of many aetiologic genetic changes. The specific causative factors in the development of sporadic colorectal cancer remain unclear. This study was performed to detect the possible role of Enteropathogenic Escherichia coli (EPEC) in developing colorectal carcinoma.

Detailed description: Fresh biopsy specimens have been obtained from the colonic mucosa overlying the colorectal cancer as well as from the colon of the healthy controls. Culture, genotyping and virulence of EPEC were done using (nutrient broth culture, and PCR). Strains biochemically identified as E. coli were selected from the surface of a MacConkey's plate and were serogrouped by slide agglutination tests

Eligibility criteria: Inclusion Criteria:

* patients with colorectal carcinoma after have been diagnosed

Exclusion Criteria:

* Patients with inflammatory bowel disease (IBD) or macroscopic signs of inflammation were excluded.

Primary outcomes:
measure: virulence genes: eaeA, bfpA and stx. PCR
timeFrame: 1 week
Secondary outcomes:
measure: EPEC serogrouping:
timeFrame: 1 week
measure: Strains: OF E COLI
timeFrame: 1 week
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT04024020: Chronic Insomnia and CSF Markers of Dementia
Official title: Chronic Insomnia and CSF Markers of Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia Chronic
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with chronic insomnia and matched good sleepers

Brief summary: The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. However, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years.The purpose of this study is to examine the relationship between chronic insomnia and dementia biomarkers and orexin levels found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia and age- and gender-matched good sleepers will undergo overnight polysomnography and CSF sampling in the morning.


Eligibility criteria: Inclusion Criteria:

* Age 30-50
* Men and women
* To be included in the insomnia group, subjects must meet the following DSM5 Diagnostic Criteria for insomnia disorder: dissatisfaction with sleep quantity or quality (difficulty initiating or maintaining sleep, or waking up too early) despite adequate opportunity for sleep; sleep disturbance causes clinical significant distress or impairment in functioning; present at least 3 times per week for at least 3 months; sleep disturbance is not better explained by a medical or psychiatric condition or based on the effects of a substance

Exclusion Criteria:

* Diagnosis or evidence of sleep disorders other than insomnia as determined by the screening questionnaires and clinical history
* Women who have been pregnant or lactating within the past six months
* Non-fluency in spoken or written English
* Current or past month shiftwork defined as working during the evening or night shift
* Current use of medications or OTC products that impact sleep
* Evidence of neurological abnormalities that could include the risks associated with lumbar puncture (e.g.papilledema, mass lesion, Chiari malformation).

Primary outcomes:
measure: CSF Markers Related to Dementia
timeFrame: one morning
Secondary outcomes:
measure: CSF Levels of Orexin
timeFrame: one morning
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Philip Gehrman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04399720: Root Canal Treatment Outcome in Patients Under Bisphosphonate Therapy
Official title: Root Canal Treatment of Compromised Teeth as Alternative Treatment in Patients Under Bisphosphonate Therapy: 60-month Results of a Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Root Canal Infection
Bisphosphonate-Associated Osteonecrosis
Periapical Abscess
Endodontically Treated Teeth
Keywords: success rate
survival rate
endodontic treatment
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 111
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Similar geographic provenience

Brief summary: The aim of this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . Clinical complications, success and survival rate was reported. Mean clinical parameters, clinical symptoms and presence of periapical radilucency were recorded.

Detailed description: The study was conducted in one University Endodontic Clinical Department - Dental School between January 2009 and December 2017.

Root canal treatment was performed according previously reported operative protocols.

Eligibility criteria: Inclusion Criteria:

* Patients affected by endodontic disease and able to attend a hygiene recall program

Exclusion Criteria:

* inability to attend a recall hygien program

Primary outcomes:
measure: health patients
timeFrame: 5 years
Secondary outcomes:
measure: Complications
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
citation: Pirani C, Chersoni S, Montebugnoli L, Prati C. Long-term outcome of non-surgical root canal treatment: a retrospective analysis. Odontology. 2015 May;103(2):185-93. doi: 10.1007/s10266-014-0159-0. Epub 2014 Jun 8.
citation: Prati C, Pirani C, Zamparini F, Gatto MR, Gandolfi MG. A 20-year historical prospective cohort study of root canal treatments. A Multilevel analysis. Int Endod J. 2018 Sep;51(9):955-968. doi: 10.1111/iej.12908. Epub 2018 Mar 7.
Clinical trial NCT05873920: Atrial Fibrillation and Diabetes Mellitus
Official title: Impact of Individual Atrial Arrhythmia Substrate on the Outcome Following Radiofrequency-Guided Catheter Ablation for Atrial Fibrillation in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 50
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: A total of 50 consecutive patients with diabetes mellitus and symptomatic atrial fibrillation will be included in this prospective observational analysis. All patients will be treated for atrial fibrillation at the Heart and Diabetes Center NRW, Bad Oeynhausen, Germany. Written informed will be obtained from each patient, the study concept complies with the Declaration of Helsinki and the institutional review board already approved the study design. Catheter ablation will be performed under deep sedation. In all patients preprocedural magnetic resonance imaging (MRI) will be performed prior to the intervention to visualize the individual amount and distribution of fibrosis and to visualize the anatomical location and course of the esophagus.

Brief summary: Single center prospective study to analyze the impact of diabetes mellitus on patients' outcome following radiofrequency-guided catheter ablation for atrial fibrillation.

Detailed description: A total number of 50 patients with diabetes mellitus will undergo radiofrequency-guided catheter ablation for atrial fibrillation. Pre-procedural cardiac MRI will be performed with late-gadolinium enhancement to visualize the individual amount and distribution of fibrosis in the right and left atrium. The relationship between diabetes mellitus and individual atrial arrhythmia substrates as well as patients' outcome following catheter ablation will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing their 1st radiofrequency-guided catheter ablation for atrial fibrillation
* Diabetes mellitus
* Able to understand and willing to sign the Informed Consent Form.
* Age ≥18 years.

Exclusion Criteria:

* Contraindication for DE-MRI with a full dose of gadolinium-based contrast agent.
* Previous left atrial ablation or surgical procedure
* Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception
* Mental or physical inability to take part in the study
* Morbid obesity (BMI \> 35), or inability to be placed in MRI due to body mass.

Primary outcomes:
measure: atrial fibrillation recurrence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
Study officials:
References:
Clinical trial NCT03973320: Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty
Official title: Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Arthroplasty
Primary Total Hip Arthroplasty
Hypotension
Database
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 11292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Primary Total Hip Arthroplasty

Brief summary: This is a retrospective chart review to determine if neuraxial anesthesia is associated with worse outcomes after Primary Total Hip Arthroplasty.

Detailed description: The goal of this study is to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty. The plan to analyze the outcomes is listed below:

Primary outcomes:

Multiple logistic regression will be used to compute the adjusted odds ratios of any postoperative complications (MI, CVA, death) , adjusting for covariates including duration of intraoperative mean arterial pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure.

Sensitivity analyses will also consider the effects of intra-operative hypotension (IOH) defined as mean blood pressure of less than 40, 45, 50, 55, 60, and 65 mm Hg.

Secondary outcomes:

Multiple logistic regression will be to compute the adjusted odds ratios of individual postoperative complications, (such as MI, CVA, stroke) , adjusting for covariates including duration of intraoperative mean blood pressure of less than pre-defined threshold, such as 55, or 60 mmHg mean blood pressure. Sensitivity analyses will also be conducted to test the effects of extend of IOH on complications.

Eligibility criteria: Inclusion Criteria:

* All primary total hip arthroplasty patient data with sufficiently complete intraoperative vital signs

Exclusion Criteria:

* Revision primary total hip arthroplasty
* Incomplete intraoperative vital signs
* Anterior total hip arthroplasty

Primary outcomes:
measure: Number of Participants Who Experience Myocardial Infarction, Cerebrovascular Accident, or Mortality
timeFrame: Day of Surgery (Day 0) through discharge (days til discharge is an average of 2 days), follow-ups up to 30 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgey
name: Jiabin Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02939274: An Open Label, Phase II Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin (Visudyne®) for the Treatment of Cutaneous Metastases of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Rogers Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-20
Enrollment: 15
Sex: ALL
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 purpose of this Phase II study is to evaluate the efficacy and safety of Continuous Low- Irradiance Photodynamic Therapy (CLIPT) when used with Verteporfin in the treatment of cutaneous metastases of breast cancer for which no curative or significantly palliative therapy exists, including chest wall therapy.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed Stage IIIb or IV breast cancer with cutaneous metastases.

Exclusion Criteria:

* Participants receiving any medications or substances that are known to cause photosensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones, St. Johns' wort, amiodarone) are ineligible.
* Participants who have received prior systemic therapy (chemotherapy or targeted therapy) within 7 days of Study Day 1 or those who have not recovered from clinically significant adverse events due to agents administered more than 7 days earlier. (continuation of the same regimen of HER-2 antibody targeted therapy agents, hormonal therapy and treatment with bisphosphonates or denosumab are permitted)
* Participants who are receiving any other investigational agents during the proposed treatment cycle.

Primary outcomes:
measure: Objective Response Rate
timeFrame: Day 23
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven J Isakoff, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03847974: Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003
Official title: Open-Label Extension, Phase 2b Study to Evaluate the Longer Term Efficacy and Safety of LIB003 in Patients on Stable Lipid Lowering Therapy Requiring Additional LDL-C Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Lead sponsor: LIB Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2019-02-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label
Primary purpose: TREATMENT

Brief summary: To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)

Detailed description: To assess the longer term safety, tolerability, immunogenicity, PK, PD and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W) in patients on stable maximally tolerated statins with or without ezetimibe who completed the phase 2 dose ranging trial LIB003-002

Eligibility criteria: Inclusion Criteria:

1. men and women 18 years or older
2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (CVD) event or evidence of CVD or without CVD but at high risk for CVD based on American Heart Association/American College of Cardiology (AHA/ACC) CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH)
3. patients who met original entry criteria in, and completed, the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)

Exclusion Criteria:

1. patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)
2. \<18 years of age
3. pregnant or women of childbearing potential not using acceptable birth control

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 52 weeks
Secondary outcomes:
measure: Percent Change in LDL-C at 52 Weeks
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Metabolic & Atherosclerosis Research Center (MARC)
state: Ohio
Study officials:
affiliation: LIB Therapeutics
name: Evan A Stein, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01969474: Effectiveness of Cannabis in the Treatment of Tinnitus Patients
Official title: Phase 1 Study to Study the Efficacy and Safety of Cannabis in the Treatment of Tinnitus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Tinnitus
Keywords: Tinnitus Cannabis
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of the study is that the use of Cannabis will attenuate the tinnitus level as experienced by the patients.


Eligibility criteria: Inclusion Criteria:

* Tinnitus lasting more than 3 months
* Tinnitus Handicap Inventory score over 58
* Treated previously for tinnitus (2 modalities)

Exclusion Criteria:

* Prior use of drugs
* Current use of Cannabis
* Neurologic or Psychiatric disease
* Heart Failure
* Ischemic Heart Disease
* Immune Deficiency
* Acoustic Neuroma

Primary outcomes:
measure: Tinnitus handicap inventory score
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Centre
Study officials:
References:
Clinical trial NCT03710174: Evaluation of the Effectiveness of Infrared LED Photobiomodulation in Children With Sleep Bruxism
Official title: Evaluation of the Effectiveness of Infrared LED Photobiomodulation in Children With Sleep Bruxism: Study Protocol for Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bruxism, Sleep
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sleep bruxism is a masticatory muscle activity characterized as rhythmic (phasic) or non-rhythmic (tonic). The literature reports the prevalence rates, diverse etiologies and different types of treatment. In children and adolescents, etiological factors, such as breathing pattern and sleep quality, have recently been addressed in studies investigating sleep bruxism. While studies have also reported psychological factors as a causal factor, this aspect requires further research. There are also divergences in opinion regarding the form of treatment. New therapies for adults, such as botulinum toxin, have been investigated, but such techniques are not applicable for individuals in the growth and development phase. Thus, photobiomodulation therapy has piqued the interest of researchers, as this noninvasive method has demonstrated positive results in problems related to muscle tissues. This document describes the protocol for a proposed study to evaluate morphological and psychosocial aspects in children and adolescents with awake bruxism and their responses to photobiomodulation therapy with infrared LED.


Eligibility criteria: Inclusion Criteria:

* mixed dentition phase (permanent incisors and molars erupted)
* established permanent dentition.

Exclusion Criteria:

* dental caries
* using medications, such as anti-inflammatory agents, muscle relaxants, corticoids, anticonvulsants and antidepressants
* those with chronic diseases that affect muscles or motor coordination
* those who do not cooperate during the evaluation

Primary outcomes:
measure: Change in muscle activity evaluated by electromyography
timeFrame: Before and immediately after treatment
Secondary outcomes:
measure: Change in salivary cortisol and dopamine
timeFrame: Before and immediately after treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Uninove
state: SP
Study officials:
References: