louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05229445: A Continuous Glucose Monitor Based Insulin Bolus Calculator
Official title: Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The "CGM-IBC" Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Keywords: continuous glucose monitor
insulin calculator
Lead sponsor: Welldoc
Sponsor class: INDUSTRY
First posted: 2022-02-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group open label
Primary purpose: TREATMENT

Brief summary: This study examines the safety of an app-based insulin bolus calculator that utilizes glucose values from a continuous glucose monitor

Detailed description: Individuals with type 1 diabetes and those with type 2 diabetes who are prescribed bolus insulin must decide on an insulin dose for any given meal. This dose is often based on what they are eating and their glucose value. Insulin bolus calculators may be helpful in recommending an insulin dose. This study examines the safety of an app-based insulin calculator manufactured by Welloc (Columbia, MD). This app uses the glucose value and trend arrow, in certain circumstances, to recommend a bolus insulin dose. This study is a single arm trial where continuous glucose monitoring metrics such as time in range will be measured before and after the study participants are given the app.

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes
* type 2 diabetes
* using Dexcom G6 CGM system
* injecting bolus insulin

Exclusion Criteria:

* pregnancy,
* insulin pump use

Primary outcomes:
measure: time in range
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Grazia Aleppo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992445: Suicidal Thought and Biological Markers
Official title: Suicidal Thought and Biological Markers: A Prospective Multicenter Study Validating Verbal, Non-verbal and Genetic Methods to Assess Suicidal Intent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicidal Intention
Keywords: suicide
suicidal intent
thought markers
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 375
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency Department and inpatients

Brief summary: Thought Markers (Tm) and Biomarkers(Bm) to accurately predict the likelihood of a repeated suicide attempt.

Detailed description: The purpose of this study is to develop a predictive model that includes Thought Markers (Tm) and Biomarkers(Bm) to accurately predict the likelihood of a repeated suicide attempt.

Eligibility criteria: Inclusion Criteria:

oBe able to understand the requirements of the study and provide written informed consent to participate in this study. Signed and dated informed consent will be obtained from each patient before participation in the study, oHave provided written authorization for the use and disclosure of their protected health information, oBe 13 years of age or older, oBe diagnosed with: oSuicide ideation/attempts/gestures, or oNon-suicidal and having other mental disorders, oNon-mentally ill, and non-suicidal controls, oSpeak English as the primary language in the home, oAgree to abide by the study protocol and its restrictions and be able to complete all aspects of the study.

Exclusion Criteria:

oSignificant unstable medical condition that may obscure the scientific interpretability of the study or unduly increase the risks of the protocol, oAnticipated inability to attend follow-up phone interview, oPatients whose level of consciousness precludes consent and research assessments, oPatients unable to assent because of severe mental retardation, oPatients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol, oFor control patients a diagnosis of depression or another non-mental illness, or a history of suicidal behavior or suicidal attempt, oPatients who are unwilling to provide the DNA sample.

Primary outcomes:
measure: Columbia Suicide Severity Rating Scale
timeFrame: 1 month
Secondary outcomes:
measure: Acoustic analysis of voice
timeFrame: 1 month
measure: Video analysis
timeFrame: Baseline
measure: DNA analysis
timeFrame: Baseline
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: CCHMC
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Princeton
country: United States
facility: Princeton Community Hospital
state: West Virginia
Study officials:
affiliation: CCHMC
name: John Pestian, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00513045: A Self-Help Method for Nightmares
Official title: A Self-Help Method for Nightmares
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nightmares
Keywords: Nightmares
treatment
self-help
Lead sponsor: Utrecht University
Sponsor class: OTHER
Collaborators: name: Fonds Psychische Gezondheid
First posted: 2007-08-08
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to validate a newly designed self-help treatment for nightmares. This self-help treatment is based on Imagery Rehearsal Therapy. This treatment will be validated in comparison to an exposure treatment a diary condition and a waiting list condition.


Eligibility criteria: Inclusion Criteria:

* Suffering from Nightmares
* Access to internet
* A valid e-mail address
* Be able to understand Dutch

Exclusion Criteria:

* Severe posttraumatic complaints
* Severe depression
* High anxiety ratings
* In therapy for post traumatic stress disorder
* Being suicidal
* Schizophrenic or having a psychosis episode

Primary outcomes:
measure: Nightmare frequency
timeFrame: 1 year
measure: Nightmare distress
timeFrame: 1 year
Secondary outcomes:
measure: Sleep quality
timeFrame: 1 year
measure: Sleep complaints
timeFrame: 1 year
measure: Anxiety ratings
timeFrame: 1 year
measure: Posttraumatic complaints (low - moderate - high)
timeFrame: 1 year
measure: Depression ratings
timeFrame: 1 year
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht University
Study officials:
affiliation: Utrecht University
name: Jan Van den Bout, Prof. dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01187745: Study to Look for Artifact on Computed Tomography (CT) Representing Kidney Stones
Official title: Evaluation of Twinkling Artifact Compared to Computed Tomography for Evaluation of Kidney Stones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Stones
Keywords: renal calculi
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2010-08-24
Enrollment: 52
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: Adults with flank pain in the emergency department, suspected to have kidney stones.

Brief summary: Patients suspected of having a kidney stone are usually evaluated by computed tomography (CT) scan. The investigators hypothesize that ultrasound (U/S) should be sufficient to evaluate kidneys for suspected renal stones.

Detailed description: All patients aged 18 years of age and over who are undergoing a renal stone protocol for evaluation of flank pain will be included.

Pregnant patients will not be included.

Eligibility criteria: Inclusion Criteria:

* Adult, able to consent, flank pain

Exclusion Criteria:

* Pregnant, unable to consent

Primary outcomes:
measure: The detection of kidney stones on ultrasound compared to CT.
timeFrame: One year
Secondary outcomes:
measure: Presence of hydronephrosis, a sign of obstruction of the urinary tract, will also be detected.
timeFrame: one year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Civic and General Campuses
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Ania Kielar, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199745: Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
Official title: Investigations on Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscular Diseases
Keywords: statin
statins
statin therapy
adverse events
side effect
Myotoxicity
atorvastatin
Atorvastatin Therapy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo School of Pharmacy
First posted: 2005-09-20
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of the study is to investigate whether differences in atorvastatin metabolite ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.

Detailed description: The primary objective of the study is to investigate whether differences in atorvastatin metabolites ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.

Eligibility criteria: Inclusion Criteria:

* Suspected atorvastatin induced muscle adverse events
* Signed informed consent
* 18 years of age or older
* Able to donate blood samples
* Ongoing treatment with atorvastatin (not necessary if patients only donate a muscle biopsy)

Primary outcomes:
measure: To compare ratios atorvastatin metabolites to atorvastatin in patients with confirmed atorvastatin-induced myopathy compared to healthy volunteers
Secondary outcomes:
measure: Phenotypic differences in isolated muscle cells of patients experiencing muscle toxicity compared to a control group
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
Study officials:
affiliation: Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
name: Kjetil Retterstøl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo
name: Anders Åsberg, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06470945: Color Stability of Sectional and Full Glass Ceramic Laminate Veneer
Official title: Clinical Assessment of the Color Stability of Sectional and Full Glass Ceramic Laminate Veneer by Using Digital Shade Matching Device. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spacing of Anterior Teeth
Keywords: porcelain fragments
miniveneers
sectional veneers
laminate veneers
partial veneers
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the color stability of full and sectional glass ceramic laminate veneer as esthetic failure is reported to be common failure in laminate following clinical service.

The null hypothesis is that there will be no apparent change in color stability between full and sectional veneer over one year of clinical service

Detailed description: The success of any esthetic restorative material depends primarily on the color match and then on the color stability of the material. color changes by time reduce the longevity and quality of restorations.

This in vivo study planned to evaluate the color stability of full and sectional glass ceramic laminate veneer using a digital shade device The primary objective of the study to evaluate the color stability of sectional glass ceramic veneer compared to full laminate veneer

Eligibility criteria: Inclusion Criteria:

Patients seeking for esthetics with the following criteria:

1. Male or female patients age range above 18 years old
2. Minor esthetic defects in anterior region
3. Multiple spacing, diastemas
4. Incisal fracture
5. Initial proximal caries
6. Patients able physically and psychologically to tolerate restorative procedures
7. Patients willing to return for follow-up examinations and evaluation
8. Class I occlusion

Exclusion Criteria:

* Patients free of

  1. Tempromandibular disorders
  2. Para-functional habits
  3. Cracked teeth
  4. Moderate or deep caries
  5. Heavily discolored teeth
  6. Heavy smokers
  7. Enamel defects compromising bonding
  8. Active periodontal disease
  9. Pulpal disease
  10. Mobility
  11. Occlusal disturbances
  12. Class II and III occlusion

Primary outcomes:
measure: Color change
timeFrame: Baseline,3,6,9,12 months
Secondary outcomes:
measure: shade match
timeFrame: Baseline,3,6,9,12 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October University for Modern Sciences & Arts
state: Giza,6th October City
Study officials:
affiliation: October University for Modern Sciences & Arts
name: Aya M Ali, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01421745: Construct Validity, Responsiveness, and Demographic Predictors of the IAPCC-SV
Official title: Construct Validity, Responsiveness, and Demographic Predictors of the Inventory for Assessing the Process of Cultural Competence Among Healthcare Professionals - Student Version (IAPCC-SV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cultural Competence
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: Texas State University, San Marcos
name: Texas Physical Therapy Association
First posted: 2011-08-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There are three purposes for this study:

I. to establish the construct validity (via factor analysis) of the Inventory for Assessing the Process of Cultural Competence Among Healthcare Professionals - Student Version (IAPCC-SV) II. to determine the responsiveness of the IAPCC-SV III. to investigate demographic predictor variables of the IAPCC-SV

It is hypothesized that:

I. the variables will load on only one component, with each component being represented by a number of strongly loaded variables II. the IAPCC-SV will demonstrate responsiveness, evidenced by significantly higher post-module IAPCC-SV scores of the experimental group when compared to the control group III. the cultural composite score and race will be significant predictors of IAPCC-SV score


Eligibility criteria: Inclusion Criteria:

* First semester PT students at Texas State will be eligible to participate in the study

Exclusion Criteria:

* Students previously enrolled in a PT education program will be excluded from this study.

Primary outcomes:
measure: Inventory for Assessing the Process of Cultural Competence Among Healthcare Professionals - Student Version (IAPCC-SV) Score
timeFrame: pre and post module
Secondary outcomes:
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: Texas State University-San Marcos
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Suzanna D Okere, MPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05741645: Effect of Elastic Taping on Stiffness of Lumbar Stabilizer Muscles
Official title: The Effect of Elastic Banding on the Elasticity of the Lumbar Stabilizer Muscles in Individuals With Non-specific Low Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime.

Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain. Chronic low back pain ranks second among the most common pain complaints under the age of 45 in the industrial age of limited activity. Organic pathology is not encountered in most musculoskeletal system pains. There are usually many underlying causes. The current literature offers a variety of treatment options, depending on the duration and severity of the symptoms of non-specific low back pain. These treatments include behavioral cognitive therapy, medication, electrophysical agents, manual therapy, and general exercises. Looking at the literature, it has been observed that there are not many objective studies investigating the effect of elastic bandage application on muscle elasticity.

'Shear Wave Elastography' is a method that quantitatively reveals the elasticity of tissues by measuring the speed of shear waves formed in the tissues through non-invasive high-frequency ultrasound waves. In recent studies, Shear Wave Elastography has shown promising results in demonstrating the elasticity of peripheral nerves.


Eligibility criteria: Inclusion Criteria:

* patients who diagnosed with non-specific low back pain
* between the ages of 18-24
* patients who able to perform at least 40° of trunk flexion

Exclusion Criteria:

* patients who obese, pregnant, had specific low back pain
* indication for surgery in the past 1 year
* the trauma of lumbar region, and systemic inflammatory disease affecting this area
* exercise and conventional physiotherapy in the last 6 months

Primary outcomes:
measure: muscle stiffness
timeFrame: 4 weeks
Secondary outcomes:
measure: The sit and reach test
timeFrame: 4 weeks
measure: The functional reach test
timeFrame: 4 weeks
measure: Lateral bridge test
timeFrame: 4 weeks
measure: The Flamingo Test
timeFrame: 4 weeks
measure: Back isometric endurance test
timeFrame: 4 weeks
measure: Oswestry Disability Index
timeFrame: 4 weeks
measure: Visual Analogue Scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University
Study officials:
References:
Clinical trial NCT04426045: Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Official title: Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Postoperative Pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. The supra-inguinal fascia iliaca compartment block has been described as a promising technique for primary total hip arthroplasty. However, one of the concerns with supra-inguinal fascia iliaca compartment block is still the potential for quadriceps weakness that might delay ambulation. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block is possible to provide sufficient analgesia and preserve lower limb muscle strength. The investigators will compare ultrasound-guided supra-inguinal fascia iliaca compartment block with PENG block in patients undergoing total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3
* scheduled for elective unilateral total hip arthroplasty

Exclusion Criteria:

* Allergy or intolerance to any of the drugs used in the study
* Hepatic or renal insufficiency
* Opioid dependency
* Coagulopathy
* Pre-existing neurologic or anatomic deficits in the lower extremities
* Severe psychiatric illness

Primary outcomes:
measure: Numeric rating scale pain score
timeFrame: 1 hour after the surgery
measure: Numeric rating scale pain score
timeFrame: 6 hours after the surgery
measure: Numeric rating scale pain score
timeFrame: 24 hours after the surgery
measure: Numeric rating scale pain score
timeFrame: 36 hours after the surgery
measure: Numeric rating scale pain score
timeFrame: 48 hours after the surgery
Secondary outcomes:
measure: Quadriceps muscle strength
timeFrame: baseline
measure: Quadriceps muscle strength
timeFrame: at 6 hours postoperatively
measure: Quadriceps muscle strength
timeFrame: at 24 hours postoperatively
measure: Quadriceps muscle strength
timeFrame: at 36 hours postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT05115045: Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients
Official title: Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients (pRNA-COVID-ICU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pneumonia
ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2
Lead sponsor: Hopital of Melun
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in the 34 bed ICU of the Melun-Senart Hospital between march 2021 4th and june 2021 24th meeting eligibility criteria

Brief summary: Retrospective, observationnal study. Evaluation of the association between plasmatic SARS-CoV-2 RNA and day 60 mortality in ICU adult COVID-19 patients.


Eligibility criteria: Inclusion Criteria:

* age above 18 years
* in ICU hospitalization
* COVID-19 related pneumonia confirmed by PCR

Exclusion Criteria:

* plasmatic SARS-COV-2 RNA quantification not available
* patient's refusal to participate

Primary outcomes:
measure: Day 60 mortality
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Melun
country: France
facility: Groupe Hospitalier Sud Ile de France, Hôpital de Melun-Sénart
Study officials:
affiliation: GHSIF MELUN
name: SEBASTIEN JOCHMANS
role: STUDY_DIRECTOR
References:
citation: Veyer D, Kerneis S, Poulet G, Wack M, Robillard N, Taly V, L'Honneur AS, Rozenberg F, Laurent-Puig P, Belec L, Hadjadj J, Terrier B, Pere H. Highly Sensitive Quantification of Plasma Severe Acute Respiratory Syndrome Coronavirus 2 RNA Sheds Light on its Potential Clinical Value. Clin Infect Dis. 2021 Nov 2;73(9):e2890-e2897. doi: 10.1093/cid/ciaa1196.