louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01283087: Spinal Anesthesia Using Lidocaine and Sufentanil and (Transient Neurological Symptoms) TNS
Official title: Spinal Anesthesia Using Lidocaine and Sufentanil and TNS (=Transient Neurological Symptoms)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transient Neurologic Symptoms
Keywords: TNS
Spinal anesthesia
Lidocaine
Lead sponsor: Vestre Viken Ringerike Sykehus
Sponsor class: OTHER
First posted: 2011-01-25
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are submitted for surgery at a local hospital and where spinal anesthesia is indicated.

Brief summary: The purpose of this study is to find out whether patients receiving spinal anesthesia containing lidocaine and sufentanil get transient neurological symptoms.


Eligibility criteria: Inclusion Criteria:

* adults over the age of seventeen years

Exclusion Criteria:

* patient refuse spinal anesthesia
* spinal anesthesia is contraindicated
* pregnancy
* patient is incapable of giving consent
* diabetes
* neurological disorders
* chronic pain
* chronic use of analgesics
* spinal anesthesia within five days before the actual surgery

Primary outcomes:
measure: Symptoms of transient neurological symptoms
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hønefoss
country: Norway
facility: Ringerike Sykehus
city: Hønefoss
country: Norway
facility: Vestre Viken HF Ringerike Sykehus
Study officials:
affiliation: Vestre Viken HF
name: halfdan Aas, MD, PhD
role: STUDY_CHAIR
affiliation: VestreViken HF
name: halfdan Aas, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01046487: Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate
Official title: Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: dermatofibrosarcoma
cylindroma
choroid melanoma
gastrointestinal stroma tumor
chordoma
ocular melanoma
conjunctival melanoma
malignant melanoma of the anus
gastric melanoma
desmoid tumor
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).


Eligibility criteria: Inclusion Criteria:

* Rare tumor
* metastatic disease or locally advanced disease, inoperable, with no standard treatment
* At least 28 days since the prior treatment
* Measurable disease with at least one measurable lesion

Exclusion Criteria:

* Medullary insufficiency
* Cystitis, haemorrhagic cystitis
* Hepatic porphyria

Primary outcomes:
measure: For safety: NCI-CTCAE scale version 3.0
timeFrame: 42 days
Secondary outcomes:
measure: For anti tumoral efficiency : RECIST criteria
timeFrame: 70 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Oscar Lambret
name: Antoine ADENIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01504087: ICU Venous Thromboembolism Incidence Study in a Chinese Population
Official title: Using Inflammatory Markers to Predict the Development and Outcome of Venous Thromboembolism in an Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Thromboembolism
Keywords: patient in critical care
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to ICU with age over 18 y/o are eligible

Brief summary: Venous thromboembolism (VTE) is one of the major public health problems in Western country. More than 100,000 Americans die each year from VTE. VTE is also a common complication of critical illness,1-2 and probably related to poor outcome in this patient group. Although there are guidelines about VTE prophylaxis in acutely ill medical patients and patients in medical ICU3, they are overlooked in our daily practice frequently in our country. There are many reasons for our common practice, including inadequate knowledge for the ICU physicians, more patients with bleeding tendency in ICU and low prevalence of VTE in our (eastern) country. However, the true prevalence of VTE in ICU and if thromboprophylaxis still needed in certain high risk patients are not unknown. Besides, if there is a difference in the VTE rate between western and eastern patients, what is the underlying mechanism? The major objective of this application is to answer the first part of the problem, i.e. to delineate the scope of this problem.

The specific aims of this application are as follows:

* prevalence of venous thromboembolism in ICU in Taiwan
* specific risk in subgroups of ICU patients
* prevalence and risk factors for silent pulmonary embolism


Eligibility criteria: Inclusion Criteria:

* All patients admitted to medical ICU with age over 18 y/o are eligible

Exclusion Criteria:

* Patients who do not sign the informed consent will be excluded from this study

Primary outcomes:
measure: deep venous thrombosis by ultrasound
timeFrame: day 14 after ICU admission
Secondary outcomes:
measure: any clinical thromboembolic event
timeFrame: day 14
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital Yunlin branch
Study officials:
affiliation: National Taiwan University Hospital Yunlin Branch
name: Yung-Wei Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02209987: Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
Official title: A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will estimate the absolute bioavailability of subcutaneously injected GS-5745, characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation of anti-GS-5745 antibodies after SC and IV administration.


Eligibility criteria: Inclusion Criteria:

* In the opinion of the investigator, individuals must be in good general health based upon medical history and physical examination
* Females, of childbearing potential, and males must agree to utilize protocol specific contraception methods
* Screening laboratory evaluations must be within defined thresholds

Exclusion Criteria:

* Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
* Pregnant and lactating females
* History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual treatment and/or adherence to the protocol

Primary outcomes:
measure: PK profile of GS-5745
timeFrame: Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8
Secondary outcomes:
measure: Incidences of adverse events and laboratory abnormalities
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
Study officials:
affiliation: Gilead Sciences
name: Bittoo Kanwar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03545087: A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants
Official title: Pharmacokinetics of Lanabecestat (LY3314814) in Subjects With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Renal Insufficiency
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2018-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment.

Participants will be on study for up to 6 weeks; this includes a 2-week screening and a follow-up about 10 days after final drug administration.


Eligibility criteria: Inclusion Criteria:

- Have a body mass index (BMI) of 19 to 40 kilograms per meter square (kg/m²)

Exclusion Criteria:

* Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina
* Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation
* Have acute unstable neuropsychiatric disease
* Have active or uncontrolled neurologic disease, or clinically significant head injury

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat
timeFrame: Baseline through 168 hours after the administration of study drug
measure: PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat
timeFrame: Baseline through 168 hours after the administration of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Ctr.
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03519633: Role of Curarization During Anesthesia for Laparoscopic Hysterectomy
Official title: The Role of Deep Neuromuscular Blockade and Sugammadex in Laparoscopic Hysterectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Curarization, Postoperative Residual
Postoperative Pain Of Laparoscopic Surgery
PONV
Keywords: deep neuromuscular blockade
sugammadex
postoperative pain
laparoscopic hysterectomy
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 238
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic hysterectomy, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of CO2, insufflation time, resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient satisfaction.


Eligibility criteria: Inclusion Criteria:

Age 18-75 years BMI between 16 and 40 Kg/m2 ECOG Performance Status tra 0 e 1 American Society Anesthesiologist (ASA) class 1 or 3 Able to provide informed consent to trial procedures

Exclusion Criteria:

* Age \< 18 or \> 75 years
* BMI \<16 o \> 40 Kg/m2
* ECOG Performance Status \>1
* Pregnancy
* Active or recent pelvic inflammation
* Anticipated airway difficulty
* Patients with history of allergy to rocuronium, neostigmine or sugammadex
* Allergy to NSAIDs
* Previous opioids consumption for chronic pain
* Patients receiving drugs for different medical conditions, that may prolong or shorten the duration of rocuronium effect (e.g aminoglycosides, magnesium)
* Hepatic or renal failure
* Persistent coagulopathy
* Neurological or cognitive disorders
* Conversion from laparoscopic to open surgery Onset of intraoperative complications

Primary outcomes:
measure: Overall pain in the first 24 hrs after gynecologic surgical procedures
timeFrame: First 48 hrs after gynecologic surgical procedures
measure: Recovery time (or Reversal time) from NMB (TOF≥0.9)
timeFrame: Recovery time (or Reversal time) from NMB (TOF≥0.9) will be measured after the administration of reversal agent at the end of the surgical procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Campus Bio-medico
state: RM
Study officials:
References:
Clinical trial NCT06663033: Anastomotic Leak in Covid-19
Official title: COVID-19 Specific Risk Factor for Anastomotic Leak After Colorectal Cancer Surgery. a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomosis, Leaking
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-10-29
Enrollment: 390
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 with colorectal cancer

Brief summary: evaluate the incidence of anastomotic leak after colorectal surgery


Eligibility criteria: Inclusion Criteria:

* colorectal cancer

Exclusion Criteria:

* stage 4

Primary outcomes:
measure: anastomotic leak
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine Zagazig University
state: Sharkia
Study officials:
References:
Clinical trial NCT04529733: Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting
Official title: Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Lead sponsor: Nexus DX
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical laboratory using a comparative assay, with respect to the same subset of human EDTA plasma specimens.


Eligibility criteria: Inclusion Criteria:

* Subject is able and willing to provide written informed consent
* Subject is 18 years of age or older
* Subject is presenting with symptoms suggestive of bacterial infection
* Subject is presenting with two or more of the following symptoms suggestive of systemic inflammatory response syndrome (SIRS):

  * Body temperature less than 36°C (96.8°F) or greater than 38°C (100.4°F);
  * Heart rate greater than 90 beats per minute;
  * Respiratory rate greater than 20 breaths per minute, or an arterial partial pressure of carbon dioxide (pCO2) less than 4.3 kPa (32 mmHg);
  * White blood cell count less than 4,000 cells/mm3 (4 x 109 cells/L) or greater than 12,000 cells/mm3 (12 x 109 cells/L);
  * A normal white blood cell count with the presence of greater
  * than 10% immature neutrophils.

Exclusion Criteria:

* Subjects less than 18 years of age;
* Subjects who do not present with a minimum of two symptoms suggestive of SIRS, as defined above
* Subjects unable or unwilling to provide written informed consent

Primary outcomes:
measure: To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings, with corresponding procalcitonin measurements obtained in a ref or clinical laboratory using a comparative assay, with respect to the same EDTA plasma specimens
timeFrame: 1 day
measure: To establish the equivalence of IB10 sphingotest PCT+ measurements in EDTA whole blood and plasma specimens, as obtained in point-of-care settings as defined above
timeFrame: 1 day
measure: To establish equivalence of IB10 sphingotest PCT+ measurements in fresh EDTA plasma specimens and frozen EDTA plasma specimens
timeFrame: 24 hours
measure: To establish the precision of IB10 sphingotest PCT+ measurements in point-of-care setting with respect to frozen EDTA plasma specimens
timeFrame: 1 day
measure: To establish the in vitro stability of EDTA whole blood and plasma speciments with respect to procalitonin concentrations as measured by the of IB10 sphingotest PCT+ test.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06331533: Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea
Official title: Effects of Botulinum Toxin Type a Treatment on Clinical and Biophysical Parameters in Patients With Erythematotelangiectatic Rosacea: A Prospective, Randomized, Placebo-controlled, Double-masked Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erythematotelangiectatic Rosacea
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized, split face, efficacy study
Primary purpose: TREATMENT

Brief summary: Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy.

Detailed description: There is no gold standard treatment for erythematotelangiectatic rosacea (ETR). In recent years, some studies have been conducted to demonstrate the efficacy of intradermal botulinum toxin A (BoNT-A) treatment in ETR and facial erythema. Studies including objective and quantitative measurements are limited.

This study aims to investigate the efficacy and safety of intradermal BoNT-A treatment in ETR patients.

This randomised, double-blind, split-face study included 30 participants with erythematotelangiectatic rosacea (ETR). They were randomly randomised to intradermal BoNT-A on one side of the face and placebo on the other side. Clinician's erythema assessment (CEA) score, patient self-assessment (PSA) score, erythema index (EI), melanin index (MI), dermatoscopic and capillaroscopic analyses of background erythema and vascular structure were assessed at baseline and one month after treatment.

Eligibility criteria: Inclusion Criteria:

* 18-60 years old
* Erythematotelangiectatic rosacea subtype
* Willingness to participate in the research and providing informed consent

Exclusion Criteria:

* Patients under 18 years of age, over 60 years of age
* A rosacea subtype other than ETR
* History of using topical or systemic medications within the past two weeks due to rosacea or other dermatoses
* Known history of autoimmune disease
* History of neuromuscular disease
* History of facial botulinum toxin injection within the last six months
* Reporting allergy to the active ingredient
* Pregnant or breastfeeding patients
* Patients who do not accept treatment and follow-up

Primary outcomes:
measure: Assessment of erythema with Clinician's Erythema Assessment scale
timeFrame: One month
measure: Evaluation of erythema using mexameter
timeFrame: One month
measure: Evaluation of erythema by dermatoscopy
timeFrame: One month
Secondary outcomes:
measure: Evaluation of the change in vascular structure using videocapillaroscopy
timeFrame: One month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
References:
Clinical trial NCT05240833: VExUS-guided Fluid Management in Patients With Acute Kidney Injury in the Intensive Care Unit
Official title: VExUS-guided Fluid Management in Patients With Acute Kidney Injury in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury
Renal Insufficiency, Acute
Kidney; Disease, Acute
Critical Illness
Volume Overload
Fluid Overload
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 55
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: A quasi experimental study that aims to verify whether the incorporation of VExUS in patients with AKI in the Intensive Care Unit (ICU) may prompt tailored interventions to increases the number of days free from Renal Replacement Therapy (RRT) during the first 28 days.

Detailed description: Fluid overload is associated with organ dysfunction, such as Acute Kidney Injury (AKI), and increased mortality. It remains unclear if fluid overload is merely an epiphenomenon in critically ill patients or if organ congestion is a mediator of complications. Considering AKI related to fluid overload, diuretic therapy would reduce venous congestion and improve renal blood flow. The Venous Excess Ultrasound score (VExUS) identifies clinically significant venous congestion and indicates a high risk of post-operative AKI. This quasi-experimental study aims to verify whether the incorporation of VExUS in patients with AKI in the Intensive Care Unit (ICU) may prompt tailored interventions to increases the number of days free from Renal Replacement Therapy (RRT) during the first 28 days.

Eligibility criteria: Inclusion Criteria:

* Non-elective ICU admission
* Severe acute kidney injury (AKI) defined either: A ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization OR Urine output \< 6.0 mL/kg over the preceding 12 hours

Exclusion Criteria:

* Life-threatening indication of RRT (defined as intractable hyperkalaemia, acidosis, uraemic symptoms) at Day 0
* RRT before recruitment
* Use of Extracorporeal membrane oxygenation (ECMO)
* Hepatic cirrhosis or other condition with portal hypertension
* Lack of commitment to provide RRT as part of limitation of ongoing life support
* Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate \< 30 mL/min/1.73 m2 or chronic RRT
* Refusal to sign the informed consent form

Primary outcomes:
measure: Renal replacement therapy
timeFrame: Day 28
Secondary outcomes:
measure: Mortality
timeFrame: Day 28
measure: KDIGO category for AKI
timeFrame: 48 hours
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: MARCIO M BONIATTI, PhD
role: PRINCIPAL_INVESTIGATOR
References: