louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03261284: D-dimer to Improve Anticoagulation Outcome During ECMO loNg-term supporteD
Official title: D-dimer to Improve Anticoagulation Management in Adult Patients Supported With Extracorporeal Membrane Oxygenation: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation Complication
Thrombosis
Hemorrhage
Heparin Overdose
Keywords: D-dimer
Extracorporeal Membrane Oxygenation
heparin
anticoagulant
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: D-dimer is mornitored. If D-dimer levels continue to rise (\>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (\<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding).
Primary purpose: TREATMENT

Brief summary: This was a prospective, cohort study.

Detailed description: Adult Patients receiving ECMO surpport in Wuhan Asia Heart Hospital were enrolled by cohort. Unfractionated heparin was used for Anticoagulation therapy, APTT or Anti-Xa activity is monitored for dose adjustment. Meanwhile, D-dimer is mornitored. If D-dimer levels continue to rise (\>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (\<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding). All patients were followed up The occurrence of endpoints during in-hospital and 30 days after discharge, including bleeding events, thrombotic events and all-cause deaths were recorded.

Eligibility criteria: Inclusion Criteria:

* Adult Patients
* Receiving ECMO surpport for any reason

Exclusion Criteria:

* The duration of ECMO surpport was less than 24 hours .
* Those who had difficulty in compliance or were unavailable for follow-up.

Primary outcomes:
measure: Thrombotic events
timeFrame: 24 months
measure: hemorrhagic events
timeFrame: 24 months
Secondary outcomes:
measure: all-cause deaths
timeFrame: 24 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhang litao
state: Hubei
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: Zhenlu ZHANG, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00748384: Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients
Official title: Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: HMP, CNV, AMD, PHP, HPHP, foresee
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed as Intermediate AMD

Brief summary: The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.

Detailed description: Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.

Eligibility criteria: Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study

  * Subjects diagnosed as intermediate AMD in at least one eye (in case a patient will convert during the study period he will be excluded)
  * Age more than 50 years
  * VA with habitual correction better than 20/60 in the study eye
  * Ability to speak, read and understand instructions in English or Hebrew
  * Familiar with computer usage

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye

  * Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
  * Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
  * Never been tested on the PHP device
  * Participation in another study with the exclusion of AREDS study
  * Patients diagnosed with geographic atrophy (GA)

Primary outcomes:
measure: Proportion of subjects who managed to set the device
timeFrame: 6 months
measure: Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training
timeFrame: 6 month
measure: Number of device malfunctions
timeFrame: 6 month
measure: Average use of the device
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
Study officials:
affiliation: Kaplan Medical Center
name: Haya Morori Katz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02515279: An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria
Official title: A Non-Interventional Trial of Pegasys/Copegus in HCV Patients for 12 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-08-04
Enrollment: 463
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll Austrian participants receiving peginterferon alfa-2a and ribavirin for HCV infection according to routine practice.

Brief summary: This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice.


Eligibility criteria: Inclusion Criteria:

* Ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician
* HCV infection

Exclusion Criteria:

* None specified

Primary outcomes:
measure: Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)
timeFrame: Up to 6 years
measure: Percentage of Participants With End of Treatment Response
timeFrame: 12 months
measure: Percentage of Participants With Sustained Virologic Response 24 (SVR24)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ried-innkreis
country: Austria
facility: A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00632879: The Study of Metabolic Syndrome in Hemodialysis Patients
Official title: The Study of Metabolic Syndrome in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodialysis
Metabolic Syndrome X
Insulin Resistance
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2008-03-11
Enrollment: 300
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 who receive maintenance hemodialysis in our HD center

Brief summary: Metabolic syndrome (MS), comprised of central obesity, glucose intolerance, hyperinsulinemia, low HDL-cholesterol (HDL-C), high triglyceride (TG) and hypertension, results in markedly increased risk for cardiovascular disease in the general population. The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) report recommended the use of five variables for the diagnosis of the MS including waist circumference (WC), serum TG concentration, serum HDL-C concentration, blood pressure and fasting glucose concentration. A waist circumference of 80 cm in women and 90 cm in men would better identify those with the MS in Asian populations. However, the studies of modified asian criteria of metabolic syndrome in hemodialysis (HD) patients are scarce.

We will perform prevalence investigation, cross-sectional study, and prospective investigation for metabolic syndrome in our HD patients (around 360 at present). We will enroll all the patients who receive maintenance HD more than three months in our HD center. The patients who are hospitalizing, suffered from active malignancy, active infections, recent cardiovascular events and surgery will be excluded in the beginning of study. Biochemistry and anthropometric parameters including HDL-C, TG, insulin resistance index, high sensitivity C-reactive protein and WC will be collected and analyzed. We will also prospectively establish the mortality and hospitalization indices of these patients, to study the prognosis of HD patient with or without metabolic syndrome.

This study will be helpful to understand whether the application of a modified criteria of metabolic syndrome in HD patients is capable to predict cardiovascular events, hospitalization and mortality rates.


Eligibility criteria: Inclusion Criteria:

* We will enroll all the patients who receive maintenance HD more than three months in our HD center.

Exclusion Criteria:

* The patients who are hospitalizing, suffered from active malignancy, active infections, recent cardiovascular events and surgery will be excluded in the beginning of study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: PanChiao, Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Shao-Yu Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06187779: Induction ATAD Catheter and Lower Segment Thickness
Official title: Influence of Lower Segment Thickness on Induction of Labor With Balloon Insertion (ATAD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A prospective cohort study of pregnant women undergoing induction of labor at term .inculding- Women with a singleton pregnancy at ≥ 37 weeks' gestation, with a live fetus in cephalic presentation. all women will undergo transvaginal ultrasound assessment before induction of labor admission. Maternal and obstetric characteristics and Bishop score will be recorded. The main outcome is the overall rate of Cesarean delivery after induction of labor.


Eligibility criteria: Inclusion Criteria:

* Gestational age above 24 weeks
* Singleton
* Vertex position
* Labor induction based on obstetrics guidelines

Exclusion Criteria:

* C/I for Induction of labor
* C/I for vaginal birth
* Multiple gestation
* Known fetal anatomical or genetic anomalies.

Primary outcomes:
measure: Cesarean section prevalence
timeFrame: during labor
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT02625779: Combined Cytidine and Creatine-containing Drug in the Treatment of the Bipolar Depression
Official title: A Double-Blind, Placebo-Controlled Trial of Combined Cytidine- and Creatine-containing Drug and Dietary Supplement in the Treatment of the Bipolar Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Depression, Bipolar
Keywords: Bipolar depression
Cytidine
Creatine
Magnetic resonance spectroscopy
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is aimed to investigate the efficacy and safety of the creatine and cytidine augmentation in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy.


Eligibility criteria: Inclusion Criteria:

* Aged 19-65 years
* Bipolar disorder I or II (DSM-IV-TR) with current depressive episode
* Informed consent

Exclusion Criteria:

* Use of medication for bipolar depression or other psychotropic drugs
* Current Axis I mental disorders other than bipolar depression based on structured clinical interview
* Current borderline or antisocial personality disorder based on structured clinical interview
* Major medical or neurological illnesses (epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc)
* Hypersensitivity to divalproate or valpromide
* Diagnosis of porphyria
* Current or past liver diseases
* Severe dysfunction in liver or pancreas
* Use of mefloquine
* Alcohol or substance abuse/dependence
* Intelligence quotient of 80 or below
* Contraindications to magnetic resonance imaging
* Pregnancy or breastfeeding
* Allergy or intolerance to the study drugs

Primary outcomes:
measure: Change in symptoms of bipolar depression
timeFrame: Baseline and 8 weeks
measure: Change in depressive symptoms
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in brain Glx (glutamate+glutamine) level
timeFrame: Baseline and 8 weeks
measure: Change in brain phosphocreatine level
timeFrame: Baseline and 8 weeks
measure: Number of participants with adverse events
timeFrame: Baseline through 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
References:
Clinical trial NCT05999279: Patient Preferences With Pharmaceutical Care: In-person Versus Digital Health
Official title: A Cross-sectional Study Addressing Lebanese Patient Preferences With Pharmaceutical Care: Traditional Versus Digital Health?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Preference
Keywords: pharmaceutical care
preference
digital care
Lead sponsor: Lebanese University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult individuals who visited two community pharmacies during the data collection period. No criteria were based on sex, race, nationality, or ethnicity.

Brief summary: Digital pharmaceutical care, also known as e-pharmaceutical care or telepharmacy, refers to using digital technologies to provide remote pharmaceutical care services. It involves the application of digital tools and platforms to deliver medication-related services, patient counseling, medication management, and other pharmaceutical care activities. It allows patients to access pharmaceutical services conveniently from their homes or any location with an internet connection. This is particularly beneficial for individuals with limited mobility, those living in rural or underserved areas, or patients with difficulty visiting a physical pharmacy. However, it is essential to note that while digital pharmaceutical care provides many benefits, it may only suit some patients or situations. Some individuals may still prefer face-to-face interactions or may require hands-on assistance, especially for complex medication management. Healthcare providers should assess the appropriateness of digital solutions on a case-by-case basis and ensure patient privacy and data security when implementing digital pharmaceutical care services.


Eligibility criteria: Inclusion Criteria:

* Patients who took at least one medication in the past month
* Patient visiting two community pharmacies

Exclusion Criteria:

* Those refusing to participate
* Those with severe hearing or mental problems

Primary outcomes:
measure: Patient preference
timeFrame: through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Pharmacy Bouchi
state: Mount Lebanon
city: Beirut
country: Lebanon
facility: Pharmacy du Liban
Study officials:
References:
Clinical trial NCT01298479: Sayana-Uniject Volumetric Delivery
Official title: Quantitative Determination of the Volume of Suspension Delivered Via the Uniject Delivery System Following Simulated Subcutaneous Injection by Healthcare Professionals Into a Synthetic Subcutaneous Injection Training Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Volume Delivery
Keywords: volume delivery
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: nurses

Brief summary: The purpose of this study is to determine the volumetric delivery of the Uniject.

Detailed description: Observe subjects deliver the drug None used

Eligibility criteria: Inclusion Criteria:

* Nurses

Exclusion Criteria:

* Non-nurses

Primary outcomes:
measure: Weight of drug suspension delivered (estimated by change in mass of the Uniject(TM) delivery system).
timeFrame: Visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00063479: Bisphosphonate Treatment of Osteogenesis Imperfecta
Official title: Bisphosphonate Treatment of Osteogenesis Imperfecta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteogenesis Imperfecta
Keywords: Osteogenesis Imperfecta
OI
bone markers
fracture
bone loss
pediatric
bisphosphonate
brittle bone disease
pamidronate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2003-06-30
Enrollment: 158
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.


Eligibility criteria: Inclusion

* Male or Female children between 3 months and 17 years old
* OI type I, III or IV

Exclusion

* Deformity or abnormality which would prevent spine bone density from being done
* Any surgical bone-lengthening procedure
* Any kidney diseases or abnormalities
* Low calcium or vitamin D levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change in lumbar spine bone mineral density at month 12 relative to baseline
Secondary outcomes:
measure: Change in Z score of the lumbar spine at month 12 relative to baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA - Division of Pediatric Nephrology
state: California
city: Wilmington
country: United States
facility: Alfred I. DuPont Hospital for Children
state: Delaware
city: Boise
country: United States
facility: Intermountain Orthopedics
state: Idaho
city: Peoria
country: United States
facility: St. Jude Children's Research Hospital
state: Illinois
city: Omaha
country: United States
facility: Children's Hospital
state: Nebraska
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hosptial
state: Texas
Study officials:
References:
Clinical trial NCT03725579: Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine
Official title: Anesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine for Inferior Alveolar Nerve Blocks in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial PART 6
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Symptomatic Irreversible Pulpitis
Keywords: Anesthetic efficacy
Inferior alveolar nerve blocks
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this prospective randomized clinical trial was compare between 2% Mepivacaine and 4% Articaine for inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis in mandibular molars as regards to their anesthetic efficiency; during access cavity preparation and instrumentation.

Detailed description: Sixty-six patients diagnosed clinically and radiographically with symptomatic irreversible pulpitis in mandibular posterior teeth will received single-visit root canal treatment using ProTaper Universal rotary system for canal preparation, then they will be randomly divided into two groups (n=33) according to the anesthetic solution used, either Group M (3.6 ml Mepivacaine hydrochloride 2% with 1:100000 epinephrine) or Group A (3.4 ml Articaine hydrochloride 4% with 1:100000 epinephrine). The pain will be assessed using numerical rating scale (NRS) during access cavity preparation and instrumentation, then the need for supplemental anesthesia will be also recorded.

Eligibility criteria: Inclusion Criteria:

1. Patients in good health (American Society of Anesthesiologists Class II or higher)
2. Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
3. Age range is between 20 and 50 years.
4. Patients who can understand Visual Analogue Scales VAS.
5. Patients able to sign informed consent

Exclusion Criteria:

1. Patients allergic to articaine and/or mepivacaine and/or sulfur
2. Patients having active sites of pathosis in the area of injection.
3. Patients having active pain in more than one molar.
4. Patients who had taken analgesics in the 12 hours preceding the injection.

Primary outcomes:
measure: Pain intensity: Numerical rating scale (NRS)
timeFrame: Fifteen minutes after injection of the anaesthetic solution
Secondary outcomes:
measure: Pain intensity: Numerical rating scale (NRS)
timeFrame: Twenty-five minutes after injection of the anaesthetic solution
measure: The number of patients who need suplemental anesthesia
timeFrame: Fifteen minutes after injection of the anaesthetic solution
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Cairo university, faculty of dentistry
name: Marwa Bedier, PHD
role: STUDY_DIRECTOR
References: