louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04492202: Knowledge, Attitudes, and Practices Towards COVID-19 Among Health Care Professionals Among Healthcare Professionals
Official title: Comparison of the Knowledge, Attitudes, and Practices Towards COVID-19 Between Different Healthcare Professionals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Knowledge, Attitudes, Practice
Keywords: Health Care Professionals
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Our planned study is physician, nurse, physiotherapist, etc. It is designed to measure the knowledge, attitudes and practices of all professionals working in the field of health.

The study designed to measure the knowledge, attitudes and practices of all professionals such as physician, nurse, physiotherapist and nutritionist working in the field of medical and health sciences.

Brief summary: The aim of this study is to evaluate the knowledge level of healthcare professionals such as physicians, nurses, physiotherapists and nutritionist about published COVID-19 guidelines.

The listed healthcare workers are take part in the primary treatment of the Corona virus infected patients in hospitals. Therefore the knowledge of the world wide spreading Corona Virus and its effects for the human being is should be known for the effective treatment and for raising public awareness.


Eligibility criteria: Inclusion Criteria:

* Physicians, nurses, physiotherapists and other healthcare professionals with clinical practical experience
* Actively working in the hospitals and in any health institution

Exclusion Criteria:

* Employees outside the health area
* Health professionals who do not work in any health institution
* Employees who do not have a bachelor's degree

Primary outcomes:
measure: Questionnaire for the Evaluation of Knowledge, Attitude and Practise Levels of Healthcare Professionals for COVID-19
timeFrame: 4 weeks
Secondary outcomes:
measure: Support Approach Survey for Patients in Recovery Stage after COVID-19 Diagnosis
timeFrame: 4 weeks
Other outcomes:
measure: Fear of COVID-19 Scale
timeFrame: 4 weeks
Locations:
Study officials:
References:
Clinical trial NCT01404221: Biochemical Markers and 2 and 3D Ultrasound to ID Maternal & Fetal Complications
Official title: The Combination of Biochemical Markers and Two and Three Dimensional Ultrasound Using Geometric Morphometrics in the Identification of Congenital Anomalies and Maternal or Fetal Complications
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Fetal Aneuploidy
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women presenting for a comprehensive ultrasound at approximately 20 weeks

Brief summary: Can a combination of prenatal screening blood tests, early ultrasound, and a 3D ultrasound of the fetal face at approximately 20 weeks gestation identify fetuses with congenital anomalies and predict maternal and fetal complications?

Detailed description: Pts will be consented upon presenting to the department for a comprehensive ultrasound.The 3D picture is the only part of the study that is not part of standard obstetrical care.

Eligibility criteria: Inclusion Criteria:

* Pregnant women at approximately 20 weeks
* ages 18-50
* singleton pregnancy
* plans to deliver at North Shore University Hosp
* completed step-wise sequential screening

Exclusion Criteria:

* multifetal gestation
* minors
* patients who have undergone diagnostic genetic testing
* incarcerated patients
* intention to deliver at a hospital other than North Shore University hosp

Primary outcomes:
measure: Correlation of geometric morphometric analysis of fetal brow to 10 soft markers
timeFrame: completion of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwell Health
name: Burton Rochelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04914221: The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers
Official title: A Randomized, Open-label, Single-dose, Replicate Crossover Study to Compare the Pharmacokinetics and Safety in Healthy Adult Volunteers Following Oral Administration of JLP-2002
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overactive Bladder(OAB)
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-04
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002

Detailed description: A randomized, open-label, single-dose, replicate crossover study

Eligibility criteria: Inclusion Criteria:

* Those who are 19 years of age or older and 55 years of age
* BMI 18.5 \~ 27.5 kg/m2
* Those who voluntarily agrees in writing after hearing a sufficient explanation of the purpose and procedure of the clinical trial

Exclusion Criteria:

* Those with clinically significant diseases or a history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, respiratory system, neuropsychiatric system, blood/oncology system, etc.
* Those with a history of gastrointestinal diseases or surgery that may affect the absorption of drugs
* Those who donated whole blood within 60 days from the date of eligibility assessment, or who donated component blood within 30 days
* Those who do not have a medically recognized contraceptive intention or plan to provide sperm from the screening date to 4 weeks from the last administration of the investigational drug
* Those whose blood AST, ALT, or GGT levels in the screening test exceeded 3 times the upper limit of the reference range
* Those who showed clinically significant results in the hepatitis B test, hepatitis C test, HIV test, and syphilis test
* In the case of women, those who do not show a negative response on the pregnancy test
* Those who judged that the investigator is not suitable for participation in clinical trials, such as showing clinically significant results in other screening tests

Primary outcomes:
measure: AUClast of JLP-2002
timeFrame: Time Frame: 192 hours
measure: Cmax of JLP-2002
timeFrame: Time Frame: 192 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT06627621: E-Polycaprolactone-Containing Membrane in Alveolar Bone Regeneration
Official title: EVALUATION of the EFFICACY of E-POLYCAPROLACTONE-CONTAINING MEMBRANE in ALVEOLAR BONE REGENERATION: a RETROSPECTIVE STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alveolar Bone Grafting
Keywords: alveolar ridge augmentation, alveolar bone loss, dental implant, guided tissue regeneration, polycaprolactone
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effectiveness of synthetic polycaprolactone (PCL) bioscaffold membranes used for alveolar augmentation in maxillofacial surgery for increasing the amount of newly formed bone after three-dimensional application.


Eligibility criteria: Inclusion Criteria:

* (1) patients aged \>18 years without any systemic disease or with an established systemic disease that precluded the surgical procedure; (2) patients whose bone deficiency was augmented with PCL scaffolds; (3) patients with an indication for dental implant-supported prosthesis who lacked sufficient bone for dental implants according to cone beam computed tomography (CBCT) evaluation and, therefore, needed bone augmentation; and (4) patients with preoperative and postoperative images.

Exclusion Criteria:

* patients (1) with uncontrolled systemic diseases, (2) who had undergone radiation therapy, (3) who were female and pregnant, (4) who had previously undergone any surgical procedure related to augmentation in the area of the defect, (5) who had incomplete files or lacked pre- and post-treatment radiologic records, or (6) who had psychological problems.

Primary outcomes:
measure: Shapiro-Wilk test
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Study officials:
References:
Clinical trial NCT00892021: Study Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder
Official title: An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Subjects With Schizophrenia or Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will evaluate the safety of multiple doses of NSA-789 in subjects with schizophrenia or schizoaffective disorder. This study will also assess how NSA-789 is absorbed and eliminated, and its effect, if any, on the brain.


Eligibility criteria: Inclusion:

* Men or women of non childbearing potential (WONCBP) aged 18 to 50 years, inclusive.
* Currently under the care of a physician for psychiatric illness.
* Clinical diagnosis of schizophrenia or schizo affective disorder in the opinion of the study psychiatrist based on review of all available clinical data.

Exclusion:

* Any unstable medical or psychiatric condition, which may prevent the successful and safe completion of the study.

Primary outcomes:
measure: Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results)
timeFrame: 6 months
Secondary outcomes:
measure: Tolerability as measured through the reporting of adverse events; Pharmacokinetic as measured by the concentrations of NSA-789 in blood; Pharmacodynamics as measured by the results of psychiatric ratings and neurologic evaluations.
timeFrame: 6 months
Other outcomes:
Locations:
city: Rockville
country: United States
state: Maryland
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06592521: OPTI-FREE Family STUDY
Official title: OPTI-FREE Family (OPTI-FREE EXPRESS™, OPTI-FREE PureMoist™, OPTI-FREE REPLENISH™) PMCF STUDY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Contact Lens Care
Keywords: Contact Lens Solution
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 3 commercially available contact lens cleaning and disinfecting solutions in a pediatric population. This study will be conducted in Canada and the US.

Detailed description: Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.

Eligibility criteria: Key Inclusion Criteria:

* Subject and parent/legally authorized representative able to understand and sign an IRB approved informed consent/assent form.
* Subject willing to follow and be able to attend all scheduled study visits as required per protocol.
* Successful wear of daily wear, reusable, soft (including hydrogel and silicone hydrogel) contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular disease or condition that would contraindicate contact lens wear.
* Use of systemic or ocular medication that would contraindicate contact lens wear.
* Any known sensitivity to any ingredients in the study products.
* Current or history of pathological dry eye in either eye that would in the opinion of the Investigator preclude contact lens wear.
* Any use of habitual/prescribed topical ocular medication or artificial tear or rewetting drop (habitual) that would require instillation during the study.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Front surface deposits at Day 90
timeFrame: Day 90
measure: Back surface deposits at Day 90
timeFrame: Day 90
measure: Incidence of corneal infiltrative events
timeFrame: Up to Day 90
measure: Incidence of microbial keratitis
timeFrame: Up to Day 90
measure: Incidence of solution induced corneal staining (SICS)
timeFrame: Up to Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT05306821: Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study
Official title: Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Thromboembolism
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to evaluate and compare the short-term and medicum-term effectiveness of 2 types of interventions in 2 different hospitals to improve the adequacy of hospital thromboprophylaxis among acute medical inpatients.


Eligibility criteria: Inclusion Criteria:

* acute medical inpatients hospitalized at the Geneva University Hospitals or the Lugano Regional Hospitals

Exclusion Criteria:

* patients already on therapeutic anticoagulation
* patients with an estimated life expectancy of \<3 months
* pregnancy
* patients hospitalized for COVID-19

Primary outcomes:
measure: Proportion of patients with an adequate thromboprophylaxis
timeFrame: 90 days
Secondary outcomes:
measure: Incidence of venous thromboembolism
timeFrame: 90 days
measure: Incidence of major bleeding
timeFrame: 90 days
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
Study officials:
References:
Clinical trial NCT00320021: Effect of Pyridorin in Patients With Diabetic Nephropathy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Escalating Dose, Pilot Study to Evaluate the Safety, Tolerability and Biologic Activity of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Keywords: Diabetic nephropathy
Advanced Glycation Endproduct Inhibitor
Pyridorin
Pyridoxamine
Lead sponsor: BioStratum
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the safety, tolerability and efficacy of Pyridorin (pyridoxamine dihydrochloride) up to 250 mg given orally twice daily in patients with diabetic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes
* Sitting blood pressure of \<=170/100 mm Hg at weeks -2 and -1
* Hemoglobin A1C \<=12% at week -2
* Patients with diagnosis of diabetic nephropathy as defined by

  1. Serum Creatinine \<=2.0 mg/dL at weeks -2 and -1 (PYR-205) Serum Creatinine \>2.0 mg/dL but \<=3.5 mg/dL at weeks -2 and -1 (PYR-207)
  2. Urinary albumin excretion \>=300 mg/24 hours at week -2
  3. No other known or suspected etiology for nephropathy
* Voluntary written consent to participate in this study

Exclusion Criteria:

* History of allergic or adverse response to any B vitamin
* History of major cardiovascular or cerebrovascular events
* History of cancer except adequately treated basal or squamous cell carcinoma of the skin
* History of diabetic ketoacidosis
* Autoimmune diseases
* History of significant peripheral neuropathy

Primary outcomes:
measure: Change in Serum Creatinine from baseline to week 26
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: BioStratum, Inc.
name: Thorsten P Degenhardt, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01678521: Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients
Official title: Effect of LDL-apheresis on Pentraxin3 Plasma Levels in Hypercholesterolemic Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
LDL-apheresis
Coronary artery disease
PTX3
CRP
IL6
IL10
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypercholesterolemic patients with documented CAD, on cronic fortnightly HELP-apheresis treatment.

Brief summary: Inflammation plays a major role in atherosclerosis. Pentraxin 3 (PTX3) a multifunctional pattern-recognition protein, is expressed in many tissues/cells, including innate immunity cells, endothelium and atherosclerotic plaques. Its role is controversial: it may exert protective cardiovascular effects and/or it may be an indicator of plaque vulnerability and future cardiovascular risk.

LDL-Apheresis removes apoB100-containing lipoproteins and it can prevent progression of coronary artery disease (CAD). LDL-Apheresis exerts non-lipidic beneficial effects on the procoagulatory state and on hemorheology. No data exist about the effects of LDL-Apheresis on plasma PTX3 levels.

Detailed description: Hypercholesterolemic patients with documented CAD, on chronic fortnightly LDL-apheresis treatment will be enrolled in this study.

Blood samples will be collected before and after a single LDL-Apheresis treatment to asses PTX3, HsCRP, IL6, IL10, Fibrinogen and lipid plasma levels.

Eligibility criteria: Inclusion Criteria:

* Hypercholesterolemia
* documented CAD
* chronic LDL-apheresis treatment

Exclusion Criteria:

* mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Primary outcomes:
measure: acute change in PTX3 plasma values
timeFrame: before and at the end of one LDL-apheresis treatment (about 6 hours)
Secondary outcomes:
measure: acute change in hsCRP
timeFrame: before and at the end of one LDL-apheresis treatment (about 6 hours)
measure: acute change in IL6 and IL10
timeFrame: before and at the end of one LDL-apheresis treatment (about 6 hours)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Endocrinologia e Malattie Metaboliche, Azienda Ospedaliera Universitaria Integrata Verona
state: piazzale Stefani1
Study officials:
affiliation: Universita di Verona
name: Enzo Bonora, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00983021: Safety and Tolerability of NN9068 in Healthy Male Volunteers
Official title: A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-09-23
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068.

The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.


Eligibility criteria: Inclusion Criteria:

* Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator.
* Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive)
* Body weight between 60 kg and 90 kg (both inclusive)

Exclusion Criteria:

* Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the Investigator

Primary outcomes:
measure: Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes
timeFrame: assessed 0-96 hours after trial product administration
Secondary outcomes:
measure: The area under the NN2211 concentration-time curve after single-dose
timeFrame: assessed 0-72 hours after trial product administration
measure: The area under the NN1250 concentration-time curve after single-dose
timeFrame: assessed 0-96 hours after trial product administration
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 10.1002/jcph.549. Epub 2015 Jul 14.