louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06312488: Point of Care Evaluation of Fibrinolysis in Sepsis
Official title: Point of Care Evaluation of Fibrinolysis in Sepsis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibrinolytic Defect
Sepsis
Critical Illness
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Impaired fibrinolysis in septic patients is associated with worse outcome. The present study investigates fibrinolysis shutdown in septic patients, defined as prolonged ClotPro® TPA lysis time at 30 minutes. The TPA lysis time reference range is established in a cohort of healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* sepsis or septic shock
* vasopressors required to maintain a MAP ≥ 65 mmHg despite adequate fluid resuscitation

Exclusion Criteria:

* coagulation disorders
* ECMO therapy
* use of oral anticoagulant drugs

Primary outcomes:
measure: Prevalence of impaired fibrinolysis
timeFrame: Lysis time at 30 minutes at enrollment and on day 1, 2, 3, and 7
Secondary outcomes:
measure: Correlation between impaired fibrinolysis and changes in coagulation standard tests
timeFrame: Measures are performed at enrollment and on day 1, 2, 3, and 7
measure: Correlation between impaired fibrinolysis and inflammation markers
timeFrame: Measures are performed at enrollment and on day 1, 2, 3, and 7
measure: Correlation between impaired fibrinolysis and multiorgan failure
timeFrame: Measures are performed at enrollment and on day 1, 2, 3, and 7
measure: Correlation between impaired fibrinolysis and ICU lenght of stay
timeFrame: Through study completion, an average of 1 year
measure: Correlation between impaired fibrinolysis and ICU mortality
timeFrame: From date of enrollment until date of ICU discharge or date of death from any cause, whichever comes first, assessed up to 1 year
Other outcomes:
measure: Trend of fibrinolysis in the first ICU week with repeated ClotPro® tests
timeFrame: ClotPro® tests are performed at enrollment and on day 1, 2, 3, and 7
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: MI
Study officials:
References:
Clinical trial NCT01992588: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
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 the trial is to compare the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin infusion (CSII).


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index (BMI) 18.5-28.0 kg/m\^2 (both inclusive)
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Primary outcomes:
measure: CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 30 minutes
Secondary outcomes:
measure: CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 1 hour
measure: CSII bolus related baseline corrected area under the glucose infusion rate curve
timeFrame: From 0 to 1 hour
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: Heise T, Zijlstra E, Nosek L, Rikte T, Haahr H. Pharmacological properties of faster-acting insulin aspart vs insulin aspart in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion: A randomized, double-blind, crossover trial. Diabetes Obes Metab. 2017 Feb;19(2):208-215. doi: 10.1111/dom.12803. Epub 2016 Nov 14.
Clinical trial NCT01793688: Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -
Official title: Special Use-result Surveillance Of Unasyn-s (Kit) For Intravenous Use - A Surveillance On High-dose (>6 G Daily) Administration For Pneumonia, Lung Abscess And Peritonitis -
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Lung Abscess
Peritonitis
Keywords: UNASYN-S
High Dose
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 982
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with the following disease who received high doses of UNASYN (exceeding 6 g per day) from the first dosing date or the second dosing date.

1. Pneumonia
2. Lung Abscess
3. Peritonitis

Brief summary: The purpose of the survey is to study the followings under practical use, regarding the safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and UNASYN-S KIT for intravenous use (UNASYN).

1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse Drug Reaction)
2. Incidence status of adverse drug reactions
3. Factors that may affect the safety and effectiveness

Detailed description: Implemented as a Special Investigation by a central registration system. Secondary data collection. Safety and effectiveness of UNASYN-S under Japanese medical practice.

Eligibility criteria: Inclusion Criteria:

* Patients with the following disease who received high doses of UNASYN (exceeding 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis
* Patients aged 15 years or more

Exclusion Criteria:

* Patients with the following disease who received high doses of UNASYN (less than 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis
* Patients aged less than 15 years.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 14 Days
measure: Clinical Effectiveness Rate by Indication
timeFrame: 14 Days
Secondary outcomes:
measure: Number of Participants With Treatment-Related Serious Adverse Events
timeFrame: 14 Days
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: 14 Days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04645888: Articaine and Bupivacaine in Impacted Tooth Surgery
Official title: Evaluation of the Effects of Articaine and Bupivacaine in Impacted Third Molar Tooth Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, split-mouth, triple-blinded study was designed.
Primary purpose: SCREENING

Brief summary: Articaine is a common local anesthetic used in oral surgery and belongs to the amide group of it has fast onset with little side effects. Bupivacaine is preferred in prolonged surgical procedures with its long duration of action and residual analgesic effect.

The aim of this study was to evaluate the anesthetic, analgesic, hemodynamic effects of 4% articaine and 0.5% bupivacaine in extraction of impacted mandibular third molar teeth in intraoperative and postoperative periods. Hemodynamic parameters, onset of anesthetic action, total amount, intraoperative comfort, intraoperative bleeding, duration of postoperative anesthesia and analgesia, rescue analgesic use, maximum incisal opening and postoperative pain at 6th, 12th, 24th, 48th and 72th hours and 7th day using a visual analogue scale be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients above 18 years of age with bilaterally symmetric, impacted or partially impacted mandibular third molar and patients classified in American Society of Anesthesiologists (ASA) 1 group.

Exclusion Criteria:

* Patients with the presence of any systemic diseases, patients allergic to articaine and bupivacaine or any other NSAIDs and patients with analgesic or anti-inflammatory drugs usage in 15 days before to the surgery.

Primary outcomes:
measure: Hemodynamic Changes
timeFrame: 60 minutes
measure: Postoperative pain
timeFrame: 1 week
Secondary outcomes:
measure: Maximum mouth opening
timeFrame: 7days
measure: Duration of Surgery
timeFrame: 60 minutes
measure: Onset of anesthetic action
timeFrame: 10 minutes
measure: Operation time
timeFrame: 60 minutes
measure: Quality of the anesthesia
timeFrame: 60 minutes
measure: Intraoperative bleeding
timeFrame: 60 minutes
measure: Surgical difficulty
timeFrame: 60 minutes
measure: Duration of the postoperative anesthesia
timeFrame: 6 hours
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Faculty of Dentistry
state: Basiskele
Study officials:
affiliation: Kocaeli University
name: Berkay Tokuc, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00494988: Self-control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart
Official title: Self-control Trial to Evaluate the Remission Rate and Safety in Newly Diagnosed Type 2 Diabetes Patients After Short-term Intensive Insulin Aspart and Insulin NPH Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-07-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is evaluate the remission rate in newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with insulin aspart and insulin NPH.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes newly diagnosed within 6-12 months
* FBG: 11.1-17.0 mmol/L
* Body mass index (BMI) larger than 25.0 kg/m2

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Recurrent major hypoglycaemia as judged by the Investigator

Primary outcomes:
measure: Remission rate
timeFrame: after 24 weeks
Secondary outcomes:
measure: blood glucose profiles
measure: HbA1c
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04830488: Body Image After Head and Neck Cancer Treatment
Official title: Pilot Testing of the Body Image After Head and Neck Cancer Treatment (BIHNC) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: body image
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study of the Body Image after Head and Neck Cancer Treatment Program \[BIHNC\]. It is a six-week, psychoeducational, web-based program that includes e-learning didactic modules and personal reflection activities for participants to complete.

Detailed description: Specific Aim 1: To assess the feasibility and acceptability of \[BIHNC\] in patients who have completed treatment for head and neck cancer and who have body image concerns.

H1a: Eighty percent of enrolled study participants who complete baseline self-report measures will complete the BIHNC Program.

H1b: Eighty percent of study participants completing the BIHNC Program will rate it acceptable on the intervention evaluation form.

Specific Aim 2: To assess the preliminary efficacy of BIHNC for reducing body image concerns in patients who have completed treatment for head and neck cancer and who have body image concerns.

H2: Body image scores will improve from pre- to post- intervention

Eligibility criteria: Inclusion Criteria:

* Completion of any form of head and neck cancer treatment between 3 and 24 months previously at study enrollment
* Answer in the affirmative to at least one of two questions concerning dissatisfaction with the way their body looks or function
* Have clinically significant body image concerns as defined by (BIS score \> 10)

Exclusion Criteria:

* Undergoing head and neck cancer treatment at time of study enrollment
* Cognitive impairment that would preclude ability to provide informed consent
* Unable to read text on a computer screen
* Not able to read and understand English

Primary outcomes:
measure: Percentage of participants who complete program
timeFrame: Approximately 6 weeks
measure: Percentage of participants who will rate program as acceptable
timeFrame: Approximately 6 weeks
Secondary outcomes:
measure: Percentage of participants with improvement in body image indicators
timeFrame: Approximately 6 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt Medical Center
name: Bethany Rhoten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04952688: Modifications in Retinal Microvascularization With Targeted Anti-angiogenic Therapy in Colorectal Cancer
Official title: Modifications in Retinal Microvascularization With OCT- Angiography in Patients With First-line Colorectal Cancer, Treated With Targeted Anti-angiogenic Therapy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: retina
OCT-angiography
Anti-VEGF
microvascularization
Targeted therapy
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Retinal microvascularization can provide important informations to systemic vascular phenomena. The non-invasive quantitative description of the retinal vascularization is now possible by performing OCT-angiography and their image analysis software (vascular density and retinal perfusion). Systemic microvacular changes during the establishment of oncological treatment by targeted antiangiogenic therapy are little described in the literature. The objective of this pilot study is to describe the evolution of the retinal vascular density of patients with antiangiogenic drugs. In addition, the evolution of the retinal vascular density of patients on antiangiogenic drugs will study as a function of the response to the treatment and the toxicity of these treatments.

Detailed description: The main objective of this study is to describe the change in retinal vascular density of patients with first-line colorectal cancer treated with Bevacizumab.

Eligibility criteria: Inclusion Criteria:

1. Patient over 18 years old starting first-line treatment for metastatic colorectal cancer including BEVACIZUMAB (AVASTIN®)
2. Systemic or intraocular anti-VEGF treatment naïve
3. ECOG ≤ 2

Exclusion Criteria:

1. Pregnant woman,
2. Minor patient or under legal protection
3. Person deprived of liberty or under guardianship
4. Inability to undergo medical monitoring of the trial
5. Impossibility of carrying out the OCT-A
6. Patient with a contraindication to Tropicamide 0.5% eye drops
7. Patient with a history of degenerative macular pathology, vascular macular pathology or presenting an epiretinal membrane with traction phenomenon.
8. Diabetes
9. Patient for whom it is not possible to schedule an ophthalmology consultation before the start of treatment.

Primary outcomes:
measure: retinal vascular density retinal vascular density
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
affiliation: Centre Georges François Leclerc
name: Audrey HENNEQUIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02337088: Delayed Cord Clamping in Very Low Birth Weight Infants
Official title: Delayed Cord Clamping at 30 vs. 60 Seconds for Very Low Birth Weight Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Very Low Birth Weight Infants
Premature Infants
Intraventricular Hemorrhage
Keywords: delayed cord clamping
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.

Detailed description: Immediately following delivery, up to 40% of the total blood volume available to the infant is in the placenta. Over a period of 30 seconds to 3 minutes, a significant portion of this blood is transferred to the infant through the umbilical cord. Delayed cord clamping following delivery facilitates this transfer of blood.

Preterm infants are very susceptible to the effects of anemia and hypovolemia. A recent meta-analysis showed that a brief delay in umbilical cord clamping (30-60 seconds) decreases the risk of anemia, blood transfusion, intraventricular hemorrhage, necrotizing enterocolitis, and the need for blood pressure support after delivery. The same meta-analysis showed no impact on Apgar scores or hypothermia due to a brief delay in resuscitation efforts to allow delayed cord clamping.

Preterm infants are at significant risk for IVH and as high as 20% of very low birth weight infants will have it. IVH is an important cause of brain injury in these infants. In our study, we would like to determine the optimal timing of delayed cord clamping in order to prevent IVH in these infants.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who are expected to deliver a very low birth weight infant
* Neonates born weighing \>= 500g and \<1500 grams
* Mother 18 years of age or older
* English speaking mother

Exclusion Criteria:

* Placental abruption
* Vasa previa
* Fetal hydrops or other signs of fetal volume overload
* Other major fetal anomalies
* Placenta Accreta
* Mother \< 18 years of age
* Non-English speaking mother
* Infants \>= 1500g (3.3 lbs) or \<500g

Primary outcomes:
measure: Intraventricular hemorrhage
timeFrame: During NICU admission up to 6 months
Secondary outcomes:
measure: Hemoglobin and hematocrit
timeFrame: During NICU admission up to 6 months
measure: Need for blood transfusion
timeFrame: During NICU admission up to 6 months
measure: Bilirubin levels
timeFrame: During NICU admission up to 6 months
measure: Delivery room temperature
timeFrame: Delivery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT02971488: The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID
Official title: The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Drug Users
Harm Reduction
HIV
Keywords: Hepatitis C
PWID
Linkage-to-care
Lead sponsor: Hospital Universitario Infanta Leonor
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Fundacion SEIMC-GESIDA
First posted: 2016-11-23
Enrollment: 529
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: The study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed. It is estimated that between 4000 and 6000 people per day visit the shantytown for their dose. The regional government's Anti-Drug Agency has a mobile HRU operating daily in the area. The unit provides screening tests to anyone who is willing to take them, regardless of whether they are already aware of their serological status or not. Screening includes education on prevention of HCV infection and other transmissible diseases.

Brief summary: Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. More frequent diagnosis, new methods that prevent loss of tracking, and access to antiviral treatment are all strategies that must be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.


Eligibility criteria: Inclusion Criteria:

* PWID
* \>18 years of age
* Signed consent form

Exclusion Criteria:

Primary outcomes:
measure: Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to
timeFrame: 2 years
measure: Percentage of Participants Who Were Evaluated at a HCV Clinic.
timeFrame: 2 years
measure: Percentage of Participants Who Started HCV Antiviral Therapy.
timeFrame: 2 years
measure: Percentage of Participants Who Achieved a Sustained Virological Response (SVR)
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of Participants With Active HCV in Screened Population
timeFrame: 2 years
measure: Prevalence of Other Chronic Viral Infections in the Population Screened
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: