louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02010658: Effect of Cognitive Aid on Adherence to Perioperative Guidelines
Official title: Effect of Cognitive Aid on Adherence to Perioperative Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Decision Making
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Brigham and Women's Hospital
name: University of Kentucky
name: Vanderbilt University
First posted: 2013-12-13
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this prospective randomized trial is to ascertain whether the use of a cognitive aid improves adherence to best published practices for the management of simulated patients regarding perioperative cardiac evaluation and management.


Eligibility criteria: Inclusion Criteria:

Any active resident or faculty member will be allowed to volunteer.

Exclusion Criteria:

There are no exclusion criteria (notably we will include residents on academic probation)

Primary outcomes:
measure: Adherence of ACC/AHA Guideline
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Scott T Reeves, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00825058: Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine
Official title: A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorders
Keywords: Depression
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-01-19
Enrollment: 317
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: Primary objective :

* To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode.

Secondary objectives:

* To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.


Eligibility criteria: Inclusion Criteria:

* patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
* patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
* the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration

Primary outcomes:
measure: change from baseline of the total score of the HAM-D 17 items.
timeFrame: 6 weeks
Secondary outcomes:
measure: HAM-D subscores
timeFrame: 6 weeks
measure: HAM-D responders and remitters
timeFrame: 6 weeks
measure: HAM-A total score and subscores
timeFrame: 6 weeks
measure: MADRS total score
timeFrame: 6 weeks
measure: clinical global impression (CGI) severity and improvement scores
timeFrame: 6 weeks
measure: patient global impression (PGI) improvement score
timeFrame: 6 weeks
measure: social and occupational functioning assessment scale (SOFAS) score
timeFrame: 6 weeks
measure: clinical monitoring of adverse events (AEs)
timeFrame: 6 weeks
measure: laboratory parameters
timeFrame: 6 weeks
measure: electrocardiogram (ECG) parameters, change in vital signs and body weight
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Sanofi-Aventis Administrative Office
city: Zagreb
country: Croatia
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Montenegro
country: Montenegro
facility: Sanofi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Belgrade
country: Serbia
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00745758: The Factors Cause Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Official title: The Factors Cause Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage
Vasospasm, Intracranial
Keywords: SAH, vasospasm, ADMA
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient of spontaneous SAH

Brief summary: Extensive research has shown that the big event that leads to the initiation of vasospasm is the release of oxyhemoglobin (blood breakdown product).Depletion of NO synthase (19,20,21) was also noted after SAH.CSF is produced from choroid plexus in the ventricle. If the SAH is too dense, the blood in the subarachnoid space will not easy to be washed out.

Detailed description: Cerebral vasospasm remains a significant source of morbidity and mortality in patients with subarachnoid hemorrhage (SAH) after an aneurysmal rupture. Despite being a significant source of morbidity and mortality, death and disability from vasospasm have declined from approximately 35% in the early 1970's, to between 15% and 20% in the 1980's to \<10% in the 1990's(1,2,3,4).Extensive research has shown that the big event that leads to the initiation of vasospasm is the release of oxyhemoglobin (blood breakdown product)(1,12,13). This mechanism appears to be a multifactorial process that involves the generation of free radicals, lipid peroxidation and activation of protein kinase C as well as phospholipase C and A2 with resultant accumulation of diacylglycerol and the release of endothelin-1(14,15,16,17,18). On the other hand, depletion of NO synthase (19,20,21) was also noted after SAH. Previous reports showed that shunting of CSF through a lumbar drain after an SAH markedly reduces the risk of clinically evident vasospasm and its sequelae, shortens hospital stay, and improves outcome. Its beneficial effects are probably mediated through the removal of spasmogens that exist in the CSF(22). In our preliminary data, we have demonstrated a case with severe vasospasm, CSF was collected both from EVD and lumbar drain. The ADMA level and amount of Nitrate was well correlate with vasospasm and the level was much higher in lumbar drain then EVD. So, we will compared the CSF from EVD and lumbar puncture to see which factor is correlate with vasospasm.

Eligibility criteria: Inclusion Criteria:

* Aneurysmal rupture with SAH

Exclusion Criteria:

* Bleeding tendency,
* Large ICH with impending herniation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: devision of neurosurgery, National taiwan university hospital
Study officials:
affiliation: NTUH
name: Kuo-Chuan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01581658: Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
Official title: A Phase I, Open-label, Parallel-group Study to Investigate Pharmacokinetics, Pharmacodynamics and Safety of a Single 25 mg Dose of Empagliflozin in Japanese Type 2 Diabetes Patients With Different Degrees of Renal Impairment in Comparison to Type 2 Diabetes Patients With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2012-04-20
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion criteria:

* Type 2 diabetes patients
* Glycosylated haemoglobin\>= 6.1% (Japan Diabetes Society)
* Estimated glomerular filtration rate based on the modification of diet in renal disease-formula at screening , of \>= 15 mL/min/1.73m2

Exclusion criteria:

* Any evidence of significant disease (other than renal impairment)
* Moderate and severe concurrent liver function impairment
* Gastrointestinal tract surgery, that might affect absorption and elimination of drugs
* Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders
* Chronic or relevant acute infections
* Participation in another trial with investigational drug administration within 30 days prior to study drug administration or during the trial

Primary outcomes:
measure: Change From Baseline in Total Urinary Glucose Excretion (UGE)
timeFrame: baseline and 24 hours
measure: Area Under the Concentration Time Curve of the Analyte in Plasma
timeFrame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
measure: Maximum Concentration
timeFrame: Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Kurume, Fukuoka
country: Japan
facility: 1245.53.001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Sarashina A, Ueki K, Sasaki T, Tanaka Y, Koiwai K, Sakamoto W, Woerle HJ, Salsali A, Broedl UC, Macha S. Effect of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus. Clin Ther. 2014 Nov 1;36(11):1606-15. doi: 10.1016/j.clinthera.2014.08.001. Epub 2014 Sep 5.
Clinical trial NCT06645158: TCB Self-Monitoring in Healthy Term and Near-Term Neonates
Official title: Self-Monitoring of Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates: a Multi-center Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperbilirubinemia, Neonatal
Keywords: Hyperbilirubinemia
transcutaneous bilirubin
neonate
Lead sponsor: Neonatal-Infant Brain and Behavior Development Network
Sponsor class: NETWORK
Collaborators: name: Guangzhou Women and Children's Medical Center
First posted: 2024-10-16
Enrollment: 160000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy neonates from participating hospitals from 26 provinces in China

Brief summary: The goal of this observational study is to monitor the transcutaneous bilirubin (TCB) level in healthy near-term and full-term neonates from birth to 30 days of age across China. The main question it aims to answer is:

Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants Compare the changing trend of TCB among different areas in China Compare the changing trend of TCB among different gestational groups in China


Eligibility criteria: Inclusion Criteria:

Gestational age \>=35wk; did not admitted to hospital for any reason Less than 30 days of age

Exclusion Criteria:

Accept phototherapy within 60h of age

Primary outcomes:
measure: Development of TcB Nomogram in Term and Late-preterm Infants from birth to 30 days of age
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children&#39;s Medical Center,
state: Guangdong
Study officials:
References:
Clinical trial NCT00385658: Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome
Official title: A 16-week Multicenter, 2-period Study to Investigate the Effect of the Combination of Fluvastatin ER 80mg and Fenofibrate 200mg on HDL-C in Comparison to the Combination of Simvastatin 20mg and Ezetimibe 10mg in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: Dyslipidemia
metabolic syndrome
fluvastatin
fenofibrate
simvastatin
ezetimibe
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.


Eligibility criteria: Inclusion Criteria:

* Written informed consent to participate in the study prior to any study procedures.
* Male or female subjects, age between 18-75 years inclusive.
* All women of child bearing potential must have a negative pregnancy test
* Metabolic Syndrome according to the International Diabetes Federation definition:

  * Low plasma HDL-C (Men \< 40 mg/dl ; Women \< 50 mg/dl ).
  * Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)
  * And one or more of the following criteria:

    * Triglycerides ≥ 150 mg/d.l
    * Raised blood pressure (DBP ≥ 85 mmHg and/or SBP ≥ 130mmHg ) or treated hypertension.
    * Fasting plasma glucose≥ 100mg/dl.
    * Previously diagnosed type 2 diabetes.

Exclusion Criteria:

* Dyslipidemia secondary to other causes such as nephrotic syndrome, autoimmune disease.
* Type 1 diabetes.
* HbA1c \> 9.5%.
* Unexplained serum creatine phosphokinase \> 2 x Upper limit of normal.
* History of myocardial infarction and/or cerebral stroke and/or unstable angina pectoris.
* Known or suspected contraindications and warnings according to the country specific label for the investigational drugs.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: High density lipoprotein cholesterol (HDL-C) measured at the end of each study period.
Secondary outcomes:
measure: Compared at the end of each treatment period:
measure: patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl
measure: patients reaching target levels of non-HDL-C <130mg/
measure: LDL-C/HDL-C
measure: Triglycerides
measure: LDL subfractions in a subgroup of patients
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharma AG
Study officials:
affiliation: Novartis
name: Novartis Pharma AG
role: STUDY_DIRECTOR
References:
Clinical trial NCT04899258: Evaluation of the Effect of Myopic Femtosecond Laser Assisted-LASIK on Anterior Chamber Flare Values and Corneal Endothelial Cells: A Prospective Before-and-After Study
Official title: Effect of Myopic Femtosecond Laser Asssisted-LASIK on Anaterior Chamber Flare Values and Corneal Endothelial Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cornea
Refractive Surgery
Anterior Chamber Inflammation
Keywords: Excimer laser Corneal Endothelium
Laser in situ keratomileusis (LASIK);
femtosecond assisted-LASIK
Anterior chamber flare
Endothelial cell densit
Corneal Endothelium
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, before-after study
Primary purpose: PREVENTION

Brief summary: This study aimed to investigate whether femtosecond laser-assisted LASIK (FS-LASIK) surgery causes inflammation in the anterior chamber and to analyze its effect on endothelial cells.

Detailed description: Since FS-LASIK surgery is applied using both an FS laser and an excimer laser, we aimed to determine the direct and indirect effects of these applications on the corneal endothelium, the intensity of the inflammation, and the blood-aqueous barrier in the anterior chamber. To the best of our knowledge, the effects of FS-LASIK on anterior chamber inflammation have not been previously investigated. Therefore, we evaluated these effects using objective measurement methods, such as specular microscopy and laser flare photometry.

Eligibility criteria: Inclusion Criteria:

* The patients who performed Femtosecond laser assisted LASIK for myopia or myopic astigmatism.
* Uncomplicated surgery

Exclusion Criteria:

* Complicated surgery,
* Hyperopic or hyperopic astigmatism
* Lack of follow-up measurements

Primary outcomes:
measure: Change of Flare Values
timeFrame: The change of flare values on first day, seventh day, 1. month and 3. months according to preoperative values
Secondary outcomes:
measure: Change of Corneal endothelium features-1
timeFrame: the changes of the parameters of preoperative and 3. months' values
Other outcomes:
measure: Change of Corneal endothelium features-2
timeFrame: the changes of the parameters of preoperative and 3. months' values
measure: Change of Corneal endothelium features-3
timeFrame: the changes of the parameters of preoperative and 3. months' values
Locations:
city: Fatih
country: Turkey
facility: Istanbul Faculty of Medicine
state: Istanbul
Study officials:
affiliation: Istanbul University
name: Kemal Turgay Ozbilen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozbilen KT, Altinkurt E, Ceylan NA, Bilgin GS, Gozum N. Effect of Myopic Femtosecond Laser-Assisted LASIK on Anterior Chamber Inflammation (Flare Values) and Corneal Endothelium: A Prospective before and after Study. J Ophthalmol. 2021 Nov 26;2021:2395028. doi: 10.1155/2021/2395028. eCollection 2021.
Clinical trial NCT04652258: Pyrexia Management Using an IL-6 Antibody in BRAF+ Melanoma Patients Treated with Dabrafenib/ Trametinib +/- Immunotherapy
Official title: A Phase II, Open Label, Single Arm, Single Center Study to Evaluate Pyrexia Management (with or Without Any Other Cytokine Release Symptoms) Using Tocilizumab, an Humanized Monoclonal Antibody Against the Interleukin - 6 Receptor in BRAF+ Melanoma Patients Treated with Dabrafenib/ Trametinib +/- Immunotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pyrexia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 20
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 study examines the development of fever after administration of Actemra (tocilizumab) in patients who have fever and other cytokine release symptoms (headache, nausea, palpitations, low blood pressure) due to cancer therapy (Tafinlar (dabrafenib) / Mekinist (trametinib) +/- immunotherapy) . The goal of the study is to better understand the side effects and to find an effective therapy against them.


Eligibility criteria: Inclusion Criteria:

1. Informed Consent as documented by signature
2. Subjects (males and females) age ≥ 18 years
3. ECOG \< 3
4. Subjects with pyrexia grade 1\*- 4 and elevated CRP with persistent fever after one day of antipyretic therapy with or without at least one other additional symptom of cytokine release syndrome such as nausea, headache, tachycardia, hypotension, maculopapular rash, shortness of breath, transaminitis, renal failure, dehydration
5. Elevated CRP serum levels further than normal baseline levels (\> 3.0 mg/L)
6. Subjects with resected, non-resectable, adjuvant or metastatic BRAF+ melanoma treated with :

   * BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib)
   * BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib) preceded by therapy with anti-PD-1/PD-L1 and/or anti CTLA-4 inhibitor
   * BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib) plus anti-PD- 1/PD-L1 inhibitor

Primary outcomes:
measure: Pyrexia management
timeFrame: 1 hour to up to 72 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich, Clinic of Dermatology
Study officials:
References:
Clinical trial NCT02297958: Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma
Official title: Impact of Fas/FasL in Chemotherapy Response in Epithelial Ovarian Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Carcinoma
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with ovarian carcinoma

Brief summary: Ovarian carcinoma has poor prognosis and new therapeutic strategies are required. Many patients with ovarian carcinoma showed resistance to chemotherapy. Cleaved FasL is known for induced atypical response when is binding to Fas such as avoiding apoptosis and inducing cell motility.


Eligibility criteria: Pre-Inclusion Criteria:

- Patient with suspicious ovarian carcinoma using clinical data, biological data (ca125) and radiological data (CT)

Inclusion Criteria:

* Pathological ovarian carcinoma diagnosed at pathological analysis after surgery.
* Neo adjuvant chemotherapy

Exclusion Criteria:

* no neo-adjuvant chemotherapy
* no ovarian carcinoma at final pathological analysis
* less than 18 years old.

Primary outcomes:
measure: Correlation between cleaved FasL level ans neoadjuvant chemotherapy tumor response
timeFrame: surgery
Secondary outcomes:
measure: Identification of tumoral T cells
timeFrame: surgery
measure: Disease Free Survival rate
timeFrame: 18 months after surgery
measure: Overall survival rate
timeFrame: 18 months after surgery
Other outcomes:
Locations:
city: Rennes
country: France
facility: Service de Gynécologie
Study officials:
affiliation: Rennes University Hospital
name: Vincent Lavoue, PH
role: PRINCIPAL_INVESTIGATOR
References: