louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06429787: Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
Official title: Post Marketing Observational Study on Safety of BALFAXAR® vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vitamin K-Dependent Coagulation Defect
Significant Bleeding Risk
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 3574
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: Patients at least 18 years of age who are currently on Vitamin K Antagonist treatments and received BALFAXAR or Kcentra for urgent reversal of VKA therapy within 48 hours prior to urgent surgery or invasive procedure. Octapharma will not actively enroll any of the 3,574 projected subjects into the study. Subjects meeting the minimum inclusion and exclusion criteria during the course of routine practice will be added to the study on a monthly basis until the sample size required for the analysis is achieved in each group.

Brief summary: Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure


Eligibility criteria: Inclusion Criteria:

1. Subjects at least 18 years of age.
2. Subjects on VKA treatment.
3. Received 4F-PCC agent, BALFAXAR or Kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure.

Exclusion Criteria:

1. History of TEE within 90 days before receipt of VKA reversal therapy.
2. Subjects treated with VKA reversal therapy and not undergoing urgent invasive procedure.

Primary outcomes:
measure: TEEs within 45 days following VKA reversal treatment
timeFrame: 45 days
Secondary outcomes:
measure: TEEs within 7 and 14 days following VKA reversal treatment
timeFrame: 14 days
measure: Median Time to TEEs
timeFrame: 45 days
measure: All Cause Mortality
timeFrame: 45 days
measure: Median Time to All Cause Mortality
timeFrame: 45 days
measure: Rate of Fatal TEEs
timeFrame: 45 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Octapharma Research Site
state: Massachusetts
Study officials:
References:
Clinical trial NCT03164187: Evaluation of Type 2 Diabetes Treatment
Official title: Evaluation of Type 2 Diabetes Treatment in AZERbaijan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2017-05-23
Enrollment: 105
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The aim of this study is to analyze the efficacy of Diabeton 60 MR as intensive sugar-lowering therapy into routine clinical practice, in patients for whom the treating physician has already decided to prescribe this medication. This concerns untreated newly diagnosed patients uncontrolled by diet, and patients uncontrolled by metformin.


Eligibility criteria: Inclusion Criteria:

- Type 2 diabetes patients:

* Males and females, aged over 35
* Currently treated: with diet only, or with metformin therapy for at least 3 months prior to inclusion
* Who have not been able to achieve target level of glycaemia, with glycated hemoglobin (HbA1c) level exceeding 7%.

Exclusion Criteria:

Patients with at least one of the following criteria are not included in the study:

* Type 1 diabetes
* Severe liver (ALT and AST levels 2.5 times as high as upper level of normal range) or renal insufficiency (creatinin plasma level above 140 µmole/L)
* Patients who are on insulin therapy, or at risk to receive an insulin treatment in the next 4 months, according to physician judgment.
* Intolerance to Gliclazide if such prescription was done in the past
* Pregnancy and breast-feeding
* Night workers or patients able to skip meals
* Presence of any contraindication listed in the SmPC.

Primary outcomes:
measure: Decrease in HbA1c
timeFrame: over 4 months
measure: Percentage of patients achieving HbA1c level ≤ 7 %
timeFrame: week 16.
Secondary outcomes:
measure: number of hypoglycemia episodes
timeFrame: Week 0, 2, 4, 6, 8 and week 16.
measure: Mean daily dosage of Diabeton MR
timeFrame: Week 2, 4, 6, 8 and 16
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: Azerbaijan Republic Ministry of Health Republic Endocrinology Center
city: Baku
country: Azerbaijan
facility: Azer-Turk Med clinic
city: Baku
country: Azerbaijan
facility: Hospital of oil workers, polyclinics and private clinics
city: Baku
country: Azerbaijan
facility: Medical Clinic of Azerbaijan Medical University
Study officials:
References:
citation: Mirzazada VA, Huseynova RA, Mustafayeva SA, Gasimova FN, Ahmadova U, Ismayilova N, Kerimova V, Mehdiyeva H, Suleymanova R, Maharramova Z, Iskandarli G, Gurbanova O, Aghayeva S, Malikova S, Ismayilova K, Salimkhanova K. Evaluation of Type 2 Diabetes Treatment with Gliclazide Modified Release in Azerbaijan (the EdiAzer study): Results from a 16-Week Observational Clinical Study. J Diabetol. 2020 Sep-Dec;11(3):175-182. doi: 10.4103/JOD.JOD_5_20
Clinical trial NCT04527887: Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
Official title: Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2020-08-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Dry Eye Disease
* Objective Signs (Schirmer's II test \<10 mm at 5 min; Tear Break-Up time (TBUT) of \<10 seconds in 1 eye; corneal fluorescein staining of .=4 in at least 1 eye; conjunctival lissamine green staining of the nasal and temporal conjunctive \>=4 in at least 1 eye)
* Ocular inflammation presence confirmed by In-Vivo Confocal Microscopy

Exclusion Criteria:

* History of Diabetes
* History of ocular surgery, corneal infection, or corneal injury within the last 3 months
* Active ocular allergies
* Active ocular infection
* Allergic to benzalkonium chloride

Primary outcomes:
measure: Change in ocular inflammation
timeFrame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Secondary outcomes:
measure: Clinical Parameter: Ocular Surface Disease Index (OSDI)
timeFrame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
measure: Clinical Parameter: Ocular Pain Assessment Survey (OPAS)
timeFrame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
measure: Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE)
timeFrame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
measure: Clinical Parameter: Tear Break Up Time (TBUT)
timeFrame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
measure: Clinical Parameter: Conjunctival staining
timeFrame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
measure: Clinical Parameter: Corneal staining with fluorescein
timeFrame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
measure: Clinical Parameter: Schirmer II test
timeFrame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Pedram Hamrah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06887387: Wearable Devices for Patient Monitoring in Long QT Syndrome
Official title: Application of Wearable Devices for Remote QT Interval Monitoring and Symptom Investigation for Patients With Long QT Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Long QT Syndrome
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of long QT syndrome

Brief summary: The main research question of this study is whether wearable devices have utility in monitoring patients with Long QT syndrome.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Long QT Syndrome
* Aged 18 years or over
* Phone with iOS version 15 or Android OS 9.0 or higher
* Able and willing to provide informed consent

Exclusion Criteria:

* Unwilling or unable to give consent
* Ventricular pacing at recruitment
* Bundle branch block or pre-excitation at baseline

Primary outcomes:
measure: 1. Determine the accuracy of repeated QT interval measurements using Fitbit-derived ECGs in patients with Long QT syndrome compared with the current standard (12-lead ECG and ambulatory monitors)
timeFrame: From enrollment to 3 months
measure: 2. Establish intra-patient QT variability from weekly Fitbit-ECGs and frequency of measurements over 500ms.
timeFrame: From enrollment to 3 months
Secondary outcomes:
measure: 1. Establish the utility of wearable devices for determining symptom aetiology in LQTS.
timeFrame: From enrollment to 3 months
measure: 2. Develop pipelines for the analysis of ECG data collected remotely including use of in-house QT automated algorithms for future machine learning applications.
timeFrame: From enrollment to 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts and London Hospital NHS Trust
Study officials:
affiliation: Queen Mary University of London and St Bartholomew's Hospital
name: William J Young, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06566287: Immediate and Delayed Implant Placement Using Socket Shield Technique and Autogenous Dentin Graft
Official title: Immediate And Delayed Implant Placement Using Socket Shield Technique And Autogenous Dentin Graft (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Tooth Loss
Socket Shield
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the techniques that have been proposed to reduce the amount of bone resorption in anterior maxilla is the "socket shield (SS) ". This technique includes preservation of the facial segment of a root to be extracted and immediate implant placement. A technique of socket shield with delayed implantation using autogenous dentin graft for socket preservation, as an alternative to autogenous bone grafts, has shown predictable clinical and histological outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients with badly destructed or non-restorable maxillary anterior teeth when the Labial cortical plate is still intact, and the thickness was found to be \<2mm in CBCT.
* Patients with health status according to American Society of Anesthesiology (ASA) I and II.
* Patients who agree to participate in the study.

Exclusion Criteria:

* Patients presenting with any systemic pathology or health condition that would inhibit the osseointegration process of the implants.
* Perforated labial cortical plate seen in CBCT.
* Patients undergoing radiation therapy or history of radiation within the last two years.
* Drug or alcohol abuse

Primary outcomes:
measure: Change in implant stability
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: change in thickness of the facial cortical plate
timeFrame: Baseline and 3 months
measure: Change in bone density
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT06467487: Electronic Health Record Strategies to Promote Diverse Participation in Research AIM 2
Official title: Leveraging Community Engagement and Electronic Health Record Strategies to Promote Diverse Participation in COVID-19 Clinical Trials -2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Participation
Keywords: Online Patient Portal
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2024-06-21
Enrollment: 214526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Based on the outcomes of the initial study (NCT05348603), this optimization study will employ the most effective interventions (letters and messages) and distribute these communications to underrepresented minorities to further promote interest in research. Optimized language will be distributed in English, Spanish, Portuguese, Chinese, Arabic, or Haitian Creole, based on preferred language identified in the patient profile in an electronic medical records system.

Detailed description: The primary objective of the optimization study is to examine the effectiveness on increasing interest in research of an optimized letter versus a generic letter; an optimized message versus a generic message; and an optimized letter and an optimized message versus a generic letter and a generic message.

The secondary objective of the optimization study is to examine the effectiveness on increasing participation in research of an optimized letter versus a generic letter, an optimized message versus a generic message, an optimized letter and an optimized message versus a generic letter and a generic message.

Eligibility criteria: Inclusion Criteria:

* Has an account with the online patient portal
* Has logged into the online patient portal at least once in the past year
* Has not set up a research profile

Exclusion Criteria:

* Currently enrolled in a clinical trial
* Opted out of research
* On active cancer treatment
* Active member of the study team

Primary outcomes:
measure: Number of patients who create a research profile
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients who enroll in a research study
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Brian Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00254787: Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients
Official title: Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in the Treatment of Patients With Acute Schizophrenia - a Multicentre, Double-Blind, Parallel Group, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.


Eligibility criteria: Inclusion Criteria:

* Men and women age ≥18 to ≤65 years with acute schizophrenia
* Provision of written informed consent prior to enrolment

Exclusion Criteria:

* Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation
* Patients with substance dependence
* Female patients who are pregnant, lactating or at risk of pregnancy

Primary outcomes:
measure: Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment
Secondary outcomes:
measure: Safety and Tolerability
measure: Number and type of adverse events
measure: Changes in vital signs and weight
measure: Clinically significant changes in ECG (reported as AE)
measure: Change of Simpson-Angus Scale (SAS) score
measure: Change of Barnes Akathisia Rating Scale (BARS) score
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
city: Cologne
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Werneck
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Germany Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04929587: Analysis of Influencing Factors of Preoperative Frailty in Elderly Patients With Gastric Cancer Based on the Health Ecology Theory
Official title: Analysis of Influencing Factors of Preoperative Frailty in Elderly Patients With Gastric Cancer Based on the Health Ecology Theory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Frailty
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 406
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged over 60 years old and who have gastric cancer with clear surgical indications

Brief summary: Frailty is common in patients with gastric cancer undergoing surgical treatment. Preoperative frailty can lead to many adverse outcomes in patients after surgery. This study aims to comprehensively and systematically analyze the influencing factors of preoperative frailty in patients with gastric cancer based on the health ecology theory , to change some critical variable factors in the future, improving the overall prognosis of patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of gastric cancer
* Age over 60 years old
* With clear surgical indication

Exclusion Criteria:

* Malignant tumors in other parts of the body
* Severe cardiopulmonary complications
* Receive palliative surgery
* Have received preoperative radiotherapy and chemotherapy

Primary outcomes:
measure: Frailty assessed by Frailty Phenotype (FP)
timeFrame: preoperative period
Secondary outcomes:
measure: Nutrition assessed by Nutrition Risk Screening 2002 (NRS2002)
timeFrame: preoperative period
measure: Anxiety and depression assessed by Hospital Anxiety Depression Scale (HADS)
timeFrame: preoperative period
measure: Social support assessed by Social Support Rate Scale (SSRS)
timeFrame: preoperative period
measure: Familial caring degree assessed by Family Concern Index Questionnaire (APGAR)
timeFrame: preoperative period
measure: Sleep assessed by Pittsburgh Sleep Quality Index (PSQI)
timeFrame: preoperative period
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
Study officials:
References:
Clinical trial NCT02646787: Virtual Reality Water Friendly Wound Care
Official title: Water Friendly Virtual Reality for Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
name: University of Texas
First posted: 2016-01-06
Enrollment: 56
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.

Detailed description: Using virtual reality as a form of distraction during a painful burn wound care procedure in addition to pain medication.The aim of this study is to conduct a randomized controlled trial of Virtual Reality as a means to reduce pain during wound care in patients hospitalized for their burn injuries at Harborview Medical Center Burn Center, and Shriners Hospitals for Children in Galveston, Texas.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 8 years
* Compliant and able to complete questionnaires
* No history of psychiatric disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* English-speaking

Exclusion Criteria:

* Age less than 8 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Evidence of traumatic brain injury
* History of psychiatric disorder
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
* Unable to communicate orally
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history

Primary outcomes:
measure: Pain. Pain is measured one time prior a painful burn wound care session, by asking the subjects about their pain level, using a questionnaire called graphic rating scale.
timeFrame: one time for the duration of one minute before the wound care
measure: Pain. Pain is measured one time after a painful burn wound, by asking the subjects about their pain level, using a questionnaire called graphic rating scale.
timeFrame: one time for the duration of one minute after the wound care
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington; Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: David R Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: David R Patterson, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: