louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01887405: Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext
Official title: Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext; the HEJ-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Handling of Auto-injectors
Keywords: Adrenaline
Auto-injector
Jext
Epipen
Lead sponsor: ALK Nordic A/S, Danmark Filial
Sponsor class: INDUSTRY
First posted: 2013-06-26
Enrollment: 91
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to demonstrate non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection. And to evaluate and compare the handling characteristics of two auto-injectors (Jext and EpiPen).


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained before entering the study 1
* Prescription of EpiPen or AnaPen for at least 2 months
* Age ≥16 years
* Body weight \>50 kg
* Subject willing and able to comply with study protocol

Exclusion Criteria:

* Any of the following concomitant diseases: cardiovascular disease, e.g. arrhythmias or signs of coronary atherosclerosis, heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, cancer, hyperthyroidism, severe renal impairment
* Known blood-born infection, e.g. hepatitis and/or HIV
* Concomitant treatment with medication which may potentiate the effect of adrenaline, e.g. catechol-O-methyl transferase (COMT) inhibitors, monoamine oxidase (MAO) inhibitors and tricyclic antidepressants
* Pregnancy
* Being immediate family of the investigator or study staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild

Primary outcomes:
measure: Non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection.
timeFrame: 1 day
Secondary outcomes:
measure: To evaluate and compare the handling characteristics of two auto-injectors (Jext and EpiPen) regarding subject preference for one of the two auto-injectors over the other, the time to perform the injection and any hesitance to perform the injection
timeFrame: 1 day
Other outcomes:
measure: Evaluation of instructions and AEs
timeFrame: 1 day
Locations:
city: Stockholm
country: Sweden
facility: Asthma and Allergy Clinic at St Göran's Hospital
Study officials:
affiliation: Asthma and Allergy Clinic at St Göran's Hospital, Stockholm, Sweden
name: Victoria Strand, MD Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01492205: NovoLet® Acceptance Study Within the Hospital Practise in Indonesia
Official title: A Doctor and Nurse Survey on Using NovoLet® Within the Hospital Practice in Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 203
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: Individuals with either type 1 or type 2 diabetes, who were likely to be hospitalised and require insulin therapy in Indonesia

Brief summary: This study is conducted in Asia. The aim of this study is to evaluate the overall acceptance of healthcare professionals (nurses and doctors) to the NovoLet® system used in a hospital environment.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Type 2 diabetes
* Likely to be hospitalised and require insulin therapy

Primary outcomes:
measure: Overall acceptance of the NovoLet® system among healthcare professionals (nurses and doctors)
Secondary outcomes:
measure: Time taken for the healthcare professionals (nurses and doctors) to teach the patient
measure: Incidence of adverse drug reactions
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02670005: Fractional Flow Reserve Versus Angiography for Guiding Selective Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fractional Flow Reserve
ST-segment Elevation Myocardial Infarction
Percutaneous Coronary Intervention
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 600
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: patients with ST-segment elevation myocardial infarction received selective percutaneous coronary intervention

Brief summary: To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI) assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous coronary intervention (PCI).

Detailed description: The investigators retrospectively collect STEMI patients received selective PCI from Jan 2012 to Dec 2015. Clinical follow-up is performed from the date of FFR assessment to Dec 2016 or death, which is up to 5 years. The primary endpoint is major adverse cardiac events, composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. The primary endpoints are cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established. Reinfarction is defined as myocardial infarction after the PCI procedure. Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of angina, ventricular arrhythmias and heart failure. All patients were received FFR-guided PCI or angiography-guided PCI before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.

Eligibility criteria: Inclusion Criteria:

* age\>18 years
* documented acute ST-segment elevation myocardial infarction
* onset of symptom \>6 days before percutaneous coronary intervention
* eligible for PCI

Exclusion Criteria:

* cardiogenic shock or hemodynamic instability
* highly tortuous or calcified arteries
* infarct related artery with a diameter \< 2.5mm
* a life expectancy\< 2 years
* intolerance to anti-platelet drugs
* left main disease (≥ 50% stenosis)
* contraindication to adenosine
* hypertrophic cardiomyopathy

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: up to 5 years
Secondary outcomes:
measure: cardiac death
timeFrame: up to 5 years
measure: reinfarction
timeFrame: up to 5 years
measure: unplanned hospitalization due to cardiovascular reasons
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06294405: Intraocular Lens Implant Registry Study
Official title: Development of a Database to Optimize the Results With Intraocular Lens Implants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intraocular Lens Complication
Intraocular Lens Rotation
Intraocular Lens Associated Postoperative Inflammation
Lens Opacities
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive an intraocular lens are offered to participate in the study.

Brief summary: The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.

Detailed description: A variety of intraocular lens implants are available for patients undergoing cataract surgery and new technologies are continuously being developed in this field.

In the planned monocentric retro- and prospective clinical study, a database to optimize outcomes with modern intraocular lens implants will be established to further improve anatomical and functional outcomes.

Patients treated with an intraocular lens implant will be included. The retrospective evaluation of data includes data routinely collected prior to study inclusion (preoperative, intraoperative, postoperative up to the 1st study visit). Prospectively, refraction, visual acuity, examination findings, intraocular pressure and complications are recorded 1-6 months postoperatively. Depending on the type of IOL, results of further non-invasive measurements are also recorded. Optional follow-up visits with the aforementioned examinations are possible up to 10 years postoperatively.

Eligibility criteria: Inclusion Criteria:

Treatment with an intraocular lens implant 18 years of age or older Patient consent Full legal capacity

Exclusion Criteria:

Dementia Pregnancy Breastfeeding

Primary outcomes:
measure: Functional results with different Intraocular lenses
timeFrame: 6 months
measure: Contrast sestivitiy with different Intraocular lenses
timeFrame: 6 months
measure: Anatomical results.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg
Study officials:
References:
Clinical trial NCT00807105: Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: MOOD EVALUATION
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: Brainsway
First posted: 2008-12-11
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective open label study of acute and maintenance treatment of MDD. The acute phase consists of daily treatments for 4 weeks. maintenance will be twice a week for eight weeks followed by 10 weeks of once a week treatments.


Eligibility criteria: Inclusion Criteria:

* MDD patients

Exclusion Criteria:

* risk factors for convulsions

Primary outcomes:
measure: response in HAMDS
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: ShalvataMHC
Study officials:
References:
Clinical trial NCT02775097: Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT
Official title: Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cornea
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2016-05-17
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seeing eye doctor for routine or follow-up care

Brief summary: Evaluate the accuracy of the RTVue-XR and iVue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.


Eligibility criteria: Inclusion Criteria:

Normal

* Able and willing to provide consent.
* Able and willing to complete required exams.

Corneal conditions

* Able and willing to provide consent.
* Able and willing to complete required exams.
* History of refractive surgery, contact lens, dry eye or keratoconus.

Exclusion Criteria:

Normal

* History of refractive surgery, contact lens, dry eye or pathology.
* Blepharitis or meibomitis
* Unable to complete required exams.

Corneal conditions

• Unable to complete required exams.

Primary outcomes:
measure: Epithelial thickness
timeFrame: Day 1
Secondary outcomes:
measure: Corneal thickness
timeFrame: Day 1
Other outcomes:
measure: Stromal thickness
timeFrame: Day 1
Locations:
Study officials:
References:
Clinical trial NCT01910597: Phase I, Dose-Escalation Study of Soluble Beta-Glucan (SBG) in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2013-07-29
Enrollment: 10
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: Soluble Beta-Glucan (SBG) is a compound prepared from commercial active dry Baker's yeast which is then proceeded through a multi-step laboratory processes invented by Prof. Rapepun Wititsuwannakul, Faculty of Science, Prince of Songkla University, Thailand. Based upon pre-clinical data, SBG has been shown to inhibit angiogenesis and probably enhance immune function, leading to shrinkage of tumor size in athymic nude mice injected by hepatocellular carcinoma cells (HepG2) and cervical cancer cells. Therefore, the investigators expect to see the safety and anti-cancer property of SBG in patients with advanced cancer whom no available therapy can be offered.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of histologically or cytologically documented, advanced-stage, primary or metastatic solid tumors that are refractory to standard therapy or for which no available standard therapy exists.
* Evidence of measurable or evaluable disease.
* Age must be at least 18 years.
* ECOG performance status must be 0 or 2.
* Received only best supportive care.
* Patient must meet protocol-specified laboratory values.

Exclusion Criteria:

* Second primary cancer diagnosed within 5 years, except cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma which completed curative treatment.
* Concurrent therapy with any other investigational agent.
* Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study-drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, make the subject inappropriate for this study.
* Allergy to study drug.

Primary outcomes:
measure: Dose limiting toxicity (DLT) to define the maximum tolerated dose (MTD). The DLT is defined as treatment related grade 3 or grade 4 adverse events or abnormal lab test that occurred in the first 28 days after start of study drug.
timeFrame: continuous monitoring for the first 28 days after start of the study medication
Secondary outcomes:
measure: Antitumor activity by comparing baseline and post-treatment changes. Tumor assessment will be performed using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
timeFrame: baseline, month 2, month 4, month 6 and month 8
Other outcomes:
Locations:
city: Hat yai
country: Thailand
facility: Songklanagarind Hospital, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Prince of Songkla University, Thailand
name: Arunee Dechaphunkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05590897: Assessment of Photodynamic Therapy With Annatto and Led for the Treatment of Halitosis in Mouth-Breathing Children
Official title: Assessment of Photodynamic Therapy With Annatto and Led for the Treatment of Halitosis in Mouth-Breathing Children: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Halitosis
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To assess the effectiveness of antimicrobial photodynamic therapy (aPDT) employing an annatto-based (20%) dye combined with blue LED for the treatment of halitosis in mouth-breathing children. Methods: Fifty-two children six to twelve years of age with diagnoses of mouth breathing and halitosis (score of ≥ 3 on Breath Alert® portable breath meter) were randomly allocated to two groups (n = 26). Group 1: brushing, dental floss and aPDT applied to middle third of the dorsum of the tongue. Group 2: brushing, dental floss and tongue scraper. Breath meter results before, immediately after treatment as well as seven and 30 days after treatment were compared. The normality of the data will be determined using the Shapiro-Wilk test. Parametric data will be submitted to analysis of variance and nonparametric data will be compared using the Kruskal-Wallis test. The results of each treatment in the different periods of the study will be compared using the Wilcoxon test.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mouth breathing (performed using the calibrated Glatzel mirror test, water retention test and a questionnaire);
* Halitosis presenting a score equal or greater than 2, in the Breath Alert analysis.

Exclusion Criteria:

* Nasal breathers;
* Dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine);
* Undergoing orthodontic and/or orthopedic treatment;
* Undergoing cancer treatment;
* Systemic alterations (gastrointestinal, renal, hepatic);
* Under antibiotic treatment for up to 1 month before the research;
* Fissured or grooved tongue.

Primary outcomes:
measure: Changes in Halimetry Results
timeFrame: Baseline, immediately after treatment, after 7 days and after 30 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Santos
country: Brazil
facility: Universidade Metropolitana de Santos - UNIMES
state: São Paulo
Study officials:
References:
Clinical trial NCT01525797: Blood Draw Study for Liver Transplant Patients
Official title: Immunomonitoring of Transplant Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant Recipients
Keywords: Liver Transplant
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Liver Clinic

Brief summary: The purpose of this study is to see what a lab test will show and if there is a way to predict which patients will be more likely to have rejection after receiving a liver transplant.

Detailed description: The purpose of this study is simply to see what the new oligonucleotide microarrays will show when comparing the the different patient groups. The results of this study will be one of the first steps In exploring the potential use of this new test.

Eligibility criteria: Inclusion Criteria:

* Received a liver Transplant

Exclusion Criteria:

* Received Multiple Organ Transplant

Primary outcomes:
measure: Identify signatures predictive of graft rejection or tolerance.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Goran Klintmalm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04883697: Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap Technique
Official title: Retrospective Evaluation of Risk Factors for Lower Outcomes After Vitrectomy With ILM Flap
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Holes
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patieints have undergone vitrectomy with ILM peeling and ILM flap technique in the time period form 1.1.2015 to 31.4.2020 for macular hole repair

Brief summary: A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair.

Detailed description: A retrospective review of medical charts of patients having undergone vitrectomy with ILM Peeling and ILM flap technique for macular hole repair. Pre- and postoperative OCT and visual acuity in the time period up to 6 months after surgery are reviewed and possible risk factors for failed macular hole closure or lower visual acuity outcome after surgery are assessed.

Eligibility criteria: Inclusion Criteria:

* Vitrectomy with ILM peeling and ILM flap technique in the time period form 1.1.2015 to 31.4.2020
* Age 18 or older

Exclusion Criteria:

* Age \<18

Primary outcomes:
measure: visual acuity
timeFrame: change between visual acuity 2-6 months postoperative to baseline
measure: macular hole closure
timeFrame: 2-6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04039997: How to Learn Cardiopulmonary Resuscitation
Official title: A Comparison of Two Chest Compression Techniques Among Laypersons. A Prospective, Randomized Simulation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resuscitation
Chest Compression
Quality
Keywords: cardiopulmonary resuscitation
medical simulation
basic life support
chest compression
feedback device
Lead sponsor: Lazarski University
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
name: The Cleveland Clinic
First posted: 2019-07-31
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the aim of the study is to evaluate two methods of teaching cardiopulmonary resuscitation in the context of chest compression quality. We will evaluate the usefulness of the application cpr feedback device (CPRMeter) for quality of chest compression.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* no medical experience

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy

Primary outcomes:
measure: chest compressions effectiveness
timeFrame: 1 day
Secondary outcomes:
measure: depth
timeFrame: 1 day
measure: pressure point
timeFrame: 1 day
measure: Complete pressure release
timeFrame: 1 day
measure: Rate of chest compression
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Lazarski Univerisity
state: Masovia
Study officials:
affiliation: Lazarski University
name: Lukasz Szarpak
role: STUDY_CHAIR
References: