louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01159470: The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children
Official title: CRP Velocity as a Marker for Bacterial Infections in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacterial Infections
Viral Infection
Keywords: CRP velocity
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 200
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children \< 5 years of age presenting to the Emergency Department with fever

Brief summary: Fever is one of the most common problems in pediatrics. Differentiating between bacterial infections, that require antibiotic therapy, and viral infections that resolve on their own is an important challenge for physicians.

C-reactive protein (CRP) is a protein that increases in response to inflammation and its level is generally higher in bacterial infections compared to viral infections. it can be measured by a simple blood test, however its utility as a sole marker for bacterial infection is limited.

The hypothesis of the study is that measuring CRP velocity, e.g the value of CRP divided by the hours since the fever started will improve the utility of CRP for the diagnosis of bacterial infections in children.


Eligibility criteria: Inclusion Criteria:

* children less than 5 years of age,
* children with no comorbidities and fever \> 38 for at least 24 hours, and
* children with no previous antibiotic therapy.

Exclusion Criteria:

* HIV,
* immunosuppressive conditions,
* antibiotic therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01372670: Does Hydroxyzine Decrease Anxiety in Underweight Patients Diagnosed With an Eating Disorder
Official title: Hydroxyzine Effects on Meal-Related Anxiety in Underweight Adolescents and Young Adults Diagnosed With an Eating Disorder - A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Anxiety in Those Patients With Anorexia Nervosa
Eating Disorder Not Otherwise Specified, BMI (<=18)
Keywords: Treating meal related anxiety
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Park Nicollet Eating Disorder Institute
First posted: 2011-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment of meal-related anxiety in adolescents and young adults 8 to 25 years of age diagnosed with an eating disorder who are underweight. The investigators want to find out if hydroxyzine given before meals will improve meal-related anxiety compared to no hydroxyzine.

Detailed description: This study is a practiced-based pilot study in follow-up to clinical observations made by our treatment team that hydroxyzine attenuates meal-related anxiety and improves treatment adherence in patients with a diagnosis of Anorexia Nervosa (AN) (excluding the amenorrhea criterion) or Eating Disorder Not Otherwise Specified (EDNOS) specifically with low BMI (≤ 18). To our knowledge, hydroxyzine has never been formally investigated in treating meal-related anxiety and improving outcomes in patients with AN or EDNOS specifically with low BMI (≤ 18).

Eligibility criteria: Inclusion Criteria:

* Admitted to the Intensive Structured Living Unit (ISL) at Melrose Institute for treatment of an eating disorder that meets DSM-IV criteria for Anorexia Nervosa (excluding the amenorrhea criterion), or Eating Disorder Not Otherwise Specified, specifically with BMI (≤ 18)
* Age 8-25 years old at admission to ISL.
* Weight ≥ 15 kg at admission to ISL.
* Stable psychotropic and/or sedative medications for at least (≥) 6 weeks

Exclusion Criteria:

* Age \< 8 years
* Age ≥ 25 years
* Weight \< 15 kg at admission to ISL
* Prolonged QT interval on ECG at admission to ISL
* Current substance or alcohol abuse or dependence
* Malabsorption syndrome or inability to take oral medications
* History of hydroxyzine intolerance or hypersensitivity
* History of Type 1 Diabetes Mellitus
* History of angle closure glaucoma
* Currently on another clinical trial
* Pregnancy

Primary outcomes:
measure: Self-reported anxiety
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Melrose Institute
state: Minnesota
Study officials:
affiliation: Park Nicollet Melrose Institute
name: Marcus Westerman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04109170: Dry Eye Evaluation System Based on Bioinformatics
Official title: Dry Eye Evaluation System Based on Bioinformatics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye
Keywords: Dry Eye
Bioinformatics
Data mining
Lead sponsor: Huaxia Eye Hospital Group
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 500
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People who meet the experimental conditions among the outpatients in our hospital will be selected into the group

Brief summary: Dry eye is a common ocular surface disease of multifactorial etiology characterized by elevated tear osmolality and inflammation leading to a disrupted ocular surface. The latter is a risk factor for ocular surface infection, yet overt infection is not commonly seen clinically in the typical dry eye patient. This suggests that important innate mechanisms operate to protect the dry eye from invading pathogens. Understand the pathogenesis of dry eye will be the measure to prevention and treatment of dry eye.

In this essay, the investigators use the data of experiment in the patients with dry eye and normal, acquire their tear production, tear film stability, and surface damage. The investigators use weka to calculate the prediction accuracy of the 6 algorithm and select the best one, optimize the parameters to get the final prediction accuracy.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Dye Eye

Exclusion Criteria:

* systemic disease (such as diabetes, glaucoma, or systemic collagen vascular disease), ocular disease, a history of tear supplement usage or contact lens wear during the past year,and pregnancy

Primary outcomes:
measure: OSDI
timeFrame: up to 2 months
measure: Schirmer I test
timeFrame: up to 2 months
measure: Fluorescein staining
timeFrame: up to 2 months
measure: Noninvasive Tear Breakup Time
timeFrame: up to 2 months
Secondary outcomes:
measure: Tear meniscus height
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Foshan
country: China
facility: Huaxia Eye Hosptial of Foshan
state: Guangdong
Study officials:
affiliation: Huaxia Eye Hospital of Foshan
name: Chi Zhang, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02562170: Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
Official title: Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Hereditary Breast and Ovarian Cancer Syndrome
Keywords: breast
reconstruction
mesh
acellular dermal matrix
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.


Eligibility criteria: Inclusion Criteria:

* breast cancer patients with indication for skin or nipple sparing mastectomy
* BRCA1/2 mutation carriers with indication for skin or nipple sparing mastectomy

Exclusion Criteria:

* prior local radiotherapy
* inflammatory breast cancer

Primary outcomes:
measure: complications
timeFrame: up to two weeks after surgery
measure: change of baseline patient quality of life after 3 and 6 months
timeFrame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
measure: change of baseline cosmetic outcome after 3 and 6 months
timeFrame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
measure: change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months
timeFrame: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
measure: complications
timeFrame: 3 months after surgery
measure: complications
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University Vienna
name: Daphne Gschwantler-Kaulich, Ass.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gschwantler-Kaulich D, Schrenk P, Bjelic-Radisic V, Unterrieder K, Leser C, Fink-Retter A, Salama M, Singer C. Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial. Eur J Surg Oncol. 2016 May;42(5):665-71. doi: 10.1016/j.ejso.2016.02.007. Epub 2016 Feb 23.
Clinical trial NCT05418270: Anorexia and Personality Traits in Elderly Individuals
Official title: Anorexia and Personality Traits in Elderly Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia
Personality
Aging
Chronic Disease
Keywords: anorexia
personality
aging
Chronic Disease
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 310
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 65 years of age and older with chronic illness

Brief summary: The aim of this study is to evaluate the relationship between age-related anorexia and personality traits in elderly individuals with comorbidities.

Detailed description: There is no study in the literature investigating the relationship between personality traits and age-related anorexia. The aim of this study is to evaluate the relationship between age-related anorexia and personality traits in elderly individuals with comorbidities.

Eligibility criteria: Inclusion Criteria:

* Being 65 years or older,
* Volunteering to participate in the study,
* Being conscious and not having communication problems,
* Having a Charlson comorbidity index of 1 or higher and/or a diagnosis of hypertension,
* Being fed orally.

Exclusion Criteria:

* oropharyngeal dysphagia,
* Presence of neurological or muscular disease that prevents swallowing,
* Being fed by nasogastric tube, percutaneous endoscopic gastrostomy or intravenous nutrition,
* Using drugs that affect appetite (corticosteroid, cancer chemotherapy digoxin, opioids, serotonin reuptake inhibitors, topiramate),
* Using appetizers (megestrol acetate, dronabinol, mirtazapine, growth hormone analogue),
* Having an active cancer disease,
* Major neuro-psychiatric disease (Alzheimer's, dementia, major depression, mania, psychosis, etc.),
* Presence of acute infection,
* Not having sufficient communication skills (Mini Mental Test score below 24 points).

Primary outcomes:
measure: relationship between anorexia and personality traits
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: Sultan Abdülhamid Training and Research Hospital
state: İstanbul
Study officials:
affiliation: Sultan Abdülhamid Training And Research Hospital
name: Elif Yıldırım Ayaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02371070: Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2
Official title: Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation With Direct Oral Anticoagulants
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Heart and Diabetes Center North Rhine-Westphalia
First posted: 2015-02-25
Enrollment: 60
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: Consecutive stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events.

Brief summary: The investigators study aims to test the correlation between the Hemochron Signature point-of-care testing (POCT) device (ITC, USA) and low plasma levels of all three currently approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients.


Eligibility criteria: Inclusion Criteria:

* Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events
* Age ≥ 18 years

Exclusion Criteria:

* Vitamin K antagonists or direct oral anticoagulants ≤ 14 days prior to study participation
* Low-molecular weight heparin ≤ 24 hours
* Unfractionated heparin ≤ 12 hours
* Abnormal coagulation values at baseline (Quick \< 70% or activated thromboplastin time (aPTT) \> 40sec.)
* History of coagulopathy

Primary outcomes:
measure: Effect/Correlation of direct oral anticoagulants (DOAC) on Hemochron Signature point-of-care testing (POCT) result
timeFrame: 24 hours
Secondary outcomes:
measure: Diagnostic accuracy of the Hemochron Signature POCT to rule out or detect relevant DOAC levels
timeFrame: 24h
measure: Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay
timeFrame: 24h
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Tuebingen
name: Sven Poli, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ebner M, Birschmann I, Peter A, Hartig F, Spencer C, Kuhn J, Blumenstock G, Zuern CS, Ziemann U, Poli S. Emergency Coagulation Assessment During Treatment With Direct Oral Anticoagulants: Limitations and Solutions. Stroke. 2017 Sep;48(9):2457-2463. doi: 10.1161/STROKEAHA.117.017981. Epub 2017 Aug 3.
citation: Ebner M, Birschmann I, Peter A, Spencer C, Hartig F, Kuhn J, Blumenstock G, Zuern CS, Ziemann U, Poli S. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants. Crit Care. 2017 Feb 15;21(1):32. doi: 10.1186/s13054-017-1619-z.
Clinical trial NCT00314470: Image and Dosimetry Related Research of Department of Medical Physics, Cross Cancer Institute
Official title: Image and Dosimetry Related Research of Department of Medical Physics, Cross Cancer Institute
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2006-04-14
Enrollment: 40
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: Representative selection from the database (images) of clinical research patients approved for other protocols.

Brief summary: The purpose of this study is to retrospectively have access to image files of patients.


Eligibility criteria: Inclusion Criteria:

* Subject 18 years of age and over

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Gino Fallone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04813770: The Impact of Theory-based Messaging on Covid-19 Vaccination Intentions
Official title: The Impact of Theory-based Messaging on Covid-19 Vaccination Intentions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Covid19
Keywords: vaccine hesitancy
vaccination uptake
messaging
illness beliefs
treatment beliefs
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 1113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Uptake of vaccination against COVID-19 is key to controlling the pandemic. However, a significant proportion of people report that they do not intend to have a vaccine, often because of concerns they have about its side effects or safety. It is important to identify ways to communicate information about the vaccines that facilitate informed decisions rather than promoting uptake through coercion. This study will assess whether theory-based messages can change beliefs and increase intentions to receive a COVID-19 vaccine in Scotland. The messages will be based on publicly available information about the need for COVID-19 vaccination and the safety of the vaccines, and structured to address specific types of treatment beliefs. Participants will be randomised to either a group shown the messages or a control group shown general information messages about the COVID-19 virus and vaccination programme. By comparing the two groups we aim to test what impact the theory-based messages have on intentions and beliefs about COVID-19 vaccination.


Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent for participation in the trial
* Aged 18 years or above
* Resident in Scotland

Exclusion Criteria:

* Received at least one COVID-19 vaccination dose

Primary outcomes:
measure: Covid-19 vaccination intention measured by a single item and aggregated as the proportion of intenders.
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Mean COVID-19 illness coherence score as assessed by the IPQ-R
timeFrame: Immediately post-intervention
measure: Mean perceived necessity score as assessed by the BMQ
timeFrame: Immediately post-intervention
measure: Mean perceived concerns score as assessed by the BMQ
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
Study officials:
affiliation: University of Glasgow
name: Katie Robb
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young B, Kotzur M, Gatting L, Bonner C, Ayre J, McConnachie A, Batcup C, McCaffery K, O'Carroll R, Robb KA. The impact of theory-based messages on COVID-19 vaccination intentions: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Apr 29;22(1):311. doi: 10.1186/s13063-021-05277-7.
Clinical trial NCT00311870: Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Nephropathy
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2006-04-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare the renoprotective effect of a long acting calcium antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type 1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and urinary excretion of albumin were measured every 6 months


Eligibility criteria: Inclusion Criteria:

* diabetic nephropathy, type 1 diabetes, hypertension

Exclusion Criteria:

* child bearing potential, non-diabetic kidney disease, malignancy

Primary outcomes:
measure: change in glomerular filtration rate from study start to study end
Secondary outcomes:
measure: blood pressure response
measure: change in urinary albumin excretion rate
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Peter Rossing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Steno Diabetes Center Copenhagen
name: Hans-Henrik Parving, MD
role: STUDY_CHAIR
References:
citation: Tarnow L, Rossing P, Jensen C, Hansen BV, Parving HH. Long-term renoprotective effect of nisoldipine and lisinopril in type 1 diabetic patients with diabetic nephropathy. Diabetes Care. 2000 Dec;23(12):1725-30. doi: 10.2337/diacare.23.12.1725.
Clinical trial NCT04441970: The Influence of Head and Neck Position on the Cuff Pressure Using Nasotracheal Tube
Official title: The Influence of Head and Neck Position on the Cuff Pressure Using Nasotracheal Tube
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adult Patients Over 20 Years of Age Who Require Intubation of the Nasotracheal Tube to Undergo Oral and Maxillofacial Surgery Under General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Nasotracheal tube is a commonly used for securing airways when performing general anesthesia in various oral and maxillofacial surgery such as tooth extraction, maxillary and mandibular fractures. After the nasotracheal tube is placed in the patient's trachea, the process of inflating the cuff at the end of the tube with air is required. If the cuff is inflated with excess air, the cuff may press the mucous membrane on the inner wall of the trachea, causing ischemia. Previous studies have shown that if the pressure in the cuff exceeds 30 cmH2O, it is highly likely to cause ischemia. In addition, it was found that the pressure in the excessively inflated cuff was associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Moreover, the pressure in the cuff may vary according to the patient's head and neck posture. The pressure changes in the cuff may vary depending on the material and shape of the cuff. Therefore, we will investigate to evaluate the effect of head and neck posture on the pressure in the cuff of nasotracheal tube.


Eligibility criteria: Inclusion Criteria:

* Adult patients over 20 years of age
* patients who require intubation of the nasotracheal tube to undergo oral and maxillofacial surgery under general anesthesia

Exclusion Criteria:

* Patients whose neck cannot be rotated due to cervical diseases, cervical fractures, and previous cervical surgery
* Patients undergoing emergency surgery
* Pregnant women

Primary outcomes:
measure: cuff pressure of the nasotracheal tube
timeFrame: for 10 minutes after intubating the nasotracheal tube. At Day 0.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Hyun Joo Kim
role: PRINCIPAL_INVESTIGATOR
References: