louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01381042: The Incidence and Factors of Brown Adipose Tissue in Chinese
Official title: Retrospective Study on the Incidence and Factors of Brown Adipose Tissue in Adult Chinese
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Brown Adipose Tissue
Incidence
Factor
Human
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who underwent scanning for either cancer surveillance (CS) or medical check-up (MC) from July 2006 to June 2010 in Huashan Hospital.

Brief summary: Previous studies have shown active brown adipose tissue (BAT) is present in adults and may play important roles in regulating energy homeostasis. However, the majorities of these studies were done in patients undergoing scanning for cancer surveillance, and may not reflect BAT behavior in healthy individuals. In addition, little is known about the ethnic variation in BAT activity, particularly in Chinese adults. Due to the large amount in our cohort, we are able to look at the difference between subjects for cancer surveillance (CS) and subjects for medical check-up (MC), and to clarify the impact of clinical and lifestyle parameters.

Detailed description: We will study scanning database including data from July 2006 to June 2010 in Shanghai. BAT activity will be measured via 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT). Age, imaging date, sex, and outdoor temperature will be collected for all patients. To evaluate the effects of multiple metabolic parameters on BAT activity, we will collect height, body weight, fasting plasma glucose (FPG), medical history, diagnosis, smoking, alcohol consumption, exercise, liver triglyceride content, and thyroid metabolic activity for all patients with detectable BAT and their negative controls, consisting of two patients who underwent PET/CT scans at the same day but without detectable BAT.

Eligibility criteria: Inclusion Criteria:

* Subjects with detectable brown adipose tissue
* Negative controls, consisting of two subjects who underwent PET/CT scans at the same day but without detectable BAT

Exclusion Criteria:

* Younger than 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Yiming Li, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT01223742: Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy
Official title: ORAL ACETYL-L-CARNITINE THERAPY REDUCES FATIGUE IN HEPATIC ENCEPHALOPATHY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2010-10-19
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT

Brief summary: The aim of this study was to evaluate the effect of exogenous ALC on the both physical and mental fatigue in mild and moderate encephalopatic patients.


Eligibility criteria: Inclusion Criteria:

* 1) Chronic hepatitis with spontaneous manifest HE (mental state grade 1 or 2 according to the West Haven criteria) and an NCT-A performance time \>30 seconds;
* 2) Hyperammonemia (venous ammonia concentration \>50 mmol/L);
* 3) Cooperative, hospitalised, adult patients with liver cirrhosis diagnosed by clinical, histological and ultrasonographic findings (reduced dimensions of the liver as well as splenomegaly) and oesophageal varices at stage II and III observed by endoscopy.

Exclusion Criteria:

* 1) Major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis;
* 2) Acute superimposed liver injury;
* 3) Patient with other neurological disease and metabolic disorders, diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease;
* 4) Alcoholic -toxic cirrhosis because toxic brain damage may interfere with the assessment of HE;
* 5) Severe HE;
* 6) Administration of anti-HE medications such as neomycin, branched-chain amino acids;
* 7) Any additional precipitating factors such as high protein intake (additional high-protein meals), constipation or intake of psycho stimulants, sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil), beta-adrenergic blockers, neuromuscular blocking agents, certain antibiotics;
* 8) Patients with fever, sepsis or shock were also excluded to avoid variations caused by body temperature;
* 9) Illiteracy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Cannizzaro Hospital
Study officials:
References:
citation: Malaguarnera M, Vacante M, Giordano M, Pennisi G, Bella R, Rampello L, Malaguarnera M, Li Volti G, Galvano F. Oral acetyl-L-carnitine therapy reduces fatigue in overt hepatic encephalopathy: a randomized, double-blind, placebo-controlled study. Am J Clin Nutr. 2011 Apr;93(4):799-808. doi: 10.3945/ajcn.110.007393. Epub 2011 Feb 10.
Clinical trial NCT00131742: Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
Official title: A Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2005-08-19
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.


Eligibility criteria: Inclusion Criteria:

* Documented clinical history compatible with chronic hepatitis B infection

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV
* Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog

Other protocol-defined exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
References:
citation: Hou J, Yin YK, Xu D, Tan D, Niu J, Zhou X, Wang Y, Zhu L, He Y, Ren H, Wan M, Chen C, Wu S, Chen Y, Xu J, Wang Q, Wei L, Chao G, Constance BF, Harb G, Brown NA, Jia J. Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: Results at 1 year of a randomized, double-blind trial. Hepatology. 2008 Feb;47(2):447-54. doi: 10.1002/hep.22075.
Clinical trial NCT04377542: RCT on LIFT Versus Modified Parks Technique Versus Two-Stage Seton
Official title: Randomized Controlled Trial on Ligation of Intersphincteric Fistula Tract (LIFT) Versus Modified Parks Technique Versus Two-Stage Seton In Treatment of Complex Anal Fistula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 66
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: LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Modified Parks technique involves adequate drainage of the intersphincteric space by extending the internal anal sphincterotomy. Placement of seton in the fistula track has been used for a long time and is still being currently used. Drainage two-stage seton is used to promote adequate drainage of infection and can be employed as a definitive treatment of anal fistula.

This present randomized study aimed to compare LIFT, modified Parks technique, and two-stage seton in treatment of complex anal fistula in terms of success of treatment and complication rates.


Eligibility criteria: Inclusion Criteria:

* Adult Patients of either sex aged less than 65 years presenting with complex anal fistula were included. Complex anal fistulas were defined as high trans-sphincteric (involving more than 30% of the external anal sphincter), extra-sphincteric, supra-sphincteric, horse-shoe fistulas and anterior fistulas in females

Exclusion Criteria:

* Patients with simple anal fistula (intersphincteric and low trans-sphincteric anal fistula)
* Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.
* Patients on long-acting steroids or immunosuppressive drugs.
* Patients with fecal incontinence (FI)
* Patients with previous anorectal operations including surgery for previous anal fistula.
* Patients with ASA score (American society of anesthesiologists) of III and higher

Primary outcomes:
measure: Healing of anal fistula
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01700842: Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia
Official title: Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Skin Diseases
Keywords: ceftaroline, infection, CAPB, CAP, ABSSSI, cSSTI
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: clinical material form patients in geographically distinct Russian cities

Brief summary: Approximately 3,000 of clinically significant isolates of different species from respective respective sources in geographically distinct Russian cities will be collected and tested on ceftaroline and other antimicrobials.


Eligibility criteria: Inclusion Criteria:

* Isolates derived from patients' clinical material will be included in the study
* Isolates collected retro- and prospectively will be included in the study (from 01.01.2008 till 31.12.2012)
* Isolates, allocated of a clinical material of adult patients (\> 18 years), should make not less than 70 % from total number of included isolates)
* All included isolates should be unique: only one isolate can be included in the study of each biological type from each patient
* All isolates should correspond to clinic-laboratory criteria of the etiologic importance, i.e. should be derived from patients with infection symptoms from the corresponding clinical material
* Case report form (CRF) (Appendix 1) should be correctly completed for each isolate

Exclusion Criteria:

* ESBL-producing representatives of Enterobacteriaceae (ESBL-Extended-spectrum beta-lactamase)
* Isolates, arrived in the central laboratory contaminated or unviable

Primary outcomes:
measure: Percentage(numerical) MIC distribution of microorganisms for ceftaroline and other tested antimicrobials, including MIC50 and MIC90, percent(quantity)of susceptible and resistant strains in accordance with EUCAST or CLSI recommended breakpoints.
timeFrame: up to 3 months
Secondary outcomes:
measure: Percentage(numerical)MIC distribution of microorganisms,including MIC50 and MIC90, percent(quantity) of susceptible and resistant strains, to tested antibiotics depend on: infection localization, medical condition, ward/unit profile,patient profile(age)
timeFrame: up to 3 months
measure: Percentage(numerical)MIC distribution of microorganisms,including MIC50 and MIC90, percent(quantity) of susceptible and resistant strains,to ceftaroline and other antimicrobials by years from 2008 to 2012
timeFrame: upto 3 months
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
Study officials:
References:
Clinical trial NCT00175942: Risk Indicators in Patients With Ventricular Fibrillation During Acute Myocardial Infarction
Official title: Indicators of Coagulation Activation and Inflammation Contributing to Ventricular Fibrillation Complicating Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Sudden Cardiac Death
Keywords: acute myocardial infarction
ventricular fibrillation
coagulation
inflammation
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Sudden cardiac death is in most cases triggered by ischemia-related ventricular tachyarrhythmias and accounts for 50% of deaths from cardiovascular disease in developed countries. Chronic elevation of indicators of coagulation activation has been found in patients with coronary heart disease , but a role of coagulation activation and proinflammatory state as a potential risk factor for ventricular fibrillation (VF) during acute myocardial infarction has not been investigated.

Detailed description: Sudden cardiac death (SCD) is in most cases triggered by ischemia-related ventricular arrhythmias and is responsible for 50% of the mortality from cardiovascular disease in developed countries (1). Chronic elevation of indicators of coagulation activation and inflammation has been found in patients with coronary heart disease and may contribute to vasculatory disorders probably contributing to the development of arrhythmogenesis. However, the role of coagulation activation as a potential risk factor for ventricular fibrillation during acute myocardial infarction has not been investigated yet.

Eligibility criteria: Inclusion Criteria:

ST-elevation myocardial infarction ventricular fibrillation during acute MI

Exclusion Criteria:

NSTEMI coagulation disorders, e.g.intake of coumadin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Hospital of Mannheim, University of Heidelberg
Study officials:
affiliation: University Hospital of Mannheim, University of Heidelberg
name: Carl E. Dempfle, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00688142: Sleepiness and Brain Function: The Effect of Armodafinil in Shift Work Sleep Disorder
Official title: Magnetoencephalographic Imaging of Sleepiness: The Effect of Armodafinil in Shift Work Sleep Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shift Work Sleep Disorder
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Cephalon
First posted: 2008-06-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population must be healthy night shift workers with a diagnosis of shift work sleep disorder.

Brief summary: The investigators hypothesize that in patients with shift work sleep disorder, armodafinil will specifically increase brain activity in the frontal cortex parallel with improvements in deficits of fundamental mechanisms of attention.

Detailed description: The current protocol will utilize a paradigm which is well suited to examine frontal attentional neuronal mechanisms by eliciting event related potential components known to reflect automatic stimulus detection as well as involuntary and voluntary attentional processes. The that end the proposed research has two specific aims. 1) Identify what areas of the frontal lobe and corresponding cognitive functions are impacted by excessive sleepiness in shift work sleep disorder and 2) identify specific brain areas affected by armodafinil and their role in improvement of fundamental attentional processes using a complex cognitive task targeting attentional control.

Eligibility criteria: Inclusion Criteria:

* Night shift workers with and without shift work sleep disorder.

Exclusion Criteria:

* Secondary condition to shift work sleep disorder.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital Sleep Disorders & Research Center
state: Michigan
Study officials:
affiliation: Henry Ford Hospital Sleep Disorders & Research Center
name: Christopher Drake, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03533842: Validation of a Computerized Triage Algorithm for Ophthalmic Emergencies
Official title: Interactive Care Assessment of Risk Factors and Emergency Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Keywords: Triage
Algorithms
Emergencies
Eyes emergencies
Ophtalmology
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-05-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seeking an emergency consultation at the Ophthalmologic emergency unit

Brief summary: The investigators conceived a computerized interactive tool for Emergency Triage, based on a patient's symptoms, medical history and background. Using this tool, the patient (alone or helped by a nurse / supporting person) presenting to an ophthalmologic ER, should be able to detect and prioritize his most urgent symptoms (A,B), in opposition to less urgent (C) or non urgent symptoms (D). To test the validity of this tool, each patient presenting at the Rothschild Foundation ER (Paris, France) with an ophthalmological problem should be included and sorted by the algorithm before the medical consultation. Neither the patient nor the practitioner are aware of the scoring (A,B,C,D) defined by the algorithm. The practitioner should then give his own emergency scoring (A,B,C,D) after patient examination. A total of 1000 patients is expected.


Eligibility criteria: Inclusion Criteria:

* Patients attending the Emergency Room for Ophthalmologic concerns

Exclusion Criteria:

-

Primary outcomes:
measure: Comparison between the emergency level defined by iCare and the emergency level decided by the physician at the end of his consultation (gold standard).
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Paris
country: France
facility: Instutut Arthur Vernes
Study officials:
affiliation: Institut Arthur Vernes
name: Mikael Guedj
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560742: Efficacy Study of Intramuscular or Intracoronary Injection of Autologous Bone Marrow Cells to Treat Scarred Myocardium
Official title: Efficacy of the Mode of Delivery of Autologous Bone Marrow Cells Into Heart Scar Muscle for the Recovery of Contractile Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarct
Bone Marrow Cells
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2007-11-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the administration of patient's own bone marrow cells into scar areas of the heart, can improve the contractile function of these areas.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective CABG
* chronic irreversible myocardial scar
* coronary vessel supplying the scar must be amenable to bypass grafting

Exclusion Criteria:

* significant valvular heart diseases
* major organ failures, eg. heart, liver, renal etc
* pre-existing bone marrow conditions

Primary outcomes:
measure: Contractile function of treated scar areas
timeFrame: 6 months
Secondary outcomes:
measure: Global left ventricular functions
timeFrame: 6 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals Leicester
state: Leicestershire
Study officials:
affiliation: University Hospitals, Leicester
name: Manuel Galiñanes, MD PhD FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04900142: Micropulsed Laser Trabeculoplasty Using Different Parameters
Official title: Micropulsed Laser Trabeculoplasty: a Randomized Double Blinded Clinical Trial Using Different Parameters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double blinded, clinical trial compares two different parameters setting of micropulsed laser trabeculoplasty for open angle glaucoma. Group one is treated with 1500 mW of Power, Group two with 1000 mW. The other settings (300 micron of diameter, 300 ms of duration, 15% duty cycle) are the same for both groups, and the laser is applied for 360°.

The main outcome is to evaluate the IOP (IntraOcular Pressure) lowering effects of both treatments and the safety on the corneal endothelium.

Detailed description: This study is a randomized, double blinded, clinical trial. Eligibility criteria are: primary open angle glaucoma, pigmentary glaucoma and pseudoexfoliation glaucoma.

Exclusion criteria are: secondary glaucoma, previous glaucoma surgery (not including cataract surgery as a glaucoma surgery), uncooperative patients, corneal endothelial diseases (such as Fuchs dystrophy or cornea guttata) and severely decompensated glaucoma.

Both eyes of the patient are treated: each eye is allocated in a group using the closed envelopes method. Both the patient and the surgeon who performs the post laser examinations are not aware of the group allocation.

The exams required before the trabeculoplasty are: best corrected visual acuity, IOP measurement, specular microscopy with corneal central thickness.

The IOP is measured an hour after MLT (micropulsed laser trabeculoplasty), then on day one, at one month, at three months and six months. Best corrected visual acuity and specular microscopy are repeated at three months.

Expected outcomes: to compare the IOP lowering effects between group one and two and to assess the safety of the procedure on the corneal endothelium.

Secondary outcomes: decrease the number of glaucoma medications applied by the patients.

Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma
* Pigmentary glaucoma
* Pseudoexfoliative glaucoma

Exclusion Criteria:

* Secondary glaucoma
* Previous glaucoma surgery
* Severely decompensated glaucoma
* Corneal endothelial disease

Primary outcomes:
measure: IOP lowering effect
timeFrame: Up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Policlinico di Modena
city: Modena
country: Italy
facility: Policlinico di Modena
Study officials:
affiliation: Policlinico di Modena
name: Mastropasqua Rodolfo, MD, Professor
role: STUDY_DIRECTOR
References: