louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03960203: Effect of a Sepsis Prediction Algorithm on Clinical Outcomes
Official title: Effect of a Sepsis Prediction Algorithm on Patient Mortality, Length of Stay, and Readmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis
Keywords: Dascena
Patient mortality
Length of stay
Readmissions
Algorithm
Diagnostic
Clinical outcomes
Lead sponsor: Dascena
Sponsor class: INDUSTRY
First posted: 2019-05-22
Enrollment: 75147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: DIAGNOSTIC

Brief summary: In this clinical outcomes analysis, the effect of a machine learning algorithm for severe sepsis prediction on in-hospital mortality, hospital length of stay, and 30-day readmission was evaluated.

Detailed description: Materials and Methods: Clinical outcomes evaluation performed on a multiyear, multicenter clinical data set of real-world data containing 75,147 patient encounters from nine hospitals. Mortality, hospital length of stay, and 30-day readmission analysis performed for 17,758 adult patients who met two or more Systemic Inflammatory Response Syndrome (SIRS) criteria at any point during their stay.

Eligibility criteria: Inclusion Criteria:

* All patients over the age of 18 presenting to the emergency department or admitted to an inpatient unit at the participating facilities were automatically included for clinical outcomes analysis

Exclusion Criteria:

* Patients under the age of 18

Primary outcomes:
measure: In-hospital mortality
timeFrame: 1 year
Secondary outcomes:
measure: Hospital length of stay
timeFrame: 1 year
measure: 30-day readmissions
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Dascena
name: Ritankar Das, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burdick H, Pino E, Gabel-Comeau D, McCoy A, Gu C, Roberts J, Le S, Slote J, Pellegrini E, Green-Saxena A, Hoffman J, Das R. Effect of a sepsis prediction algorithm on patient mortality, length of stay and readmission: a prospective multicentre clinical outcomes evaluation of real-world patient data from US hospitals. BMJ Health Care Inform. 2020 Apr;27(1):e100109. doi: 10.1136/bmjhci-2019-100109.
Clinical trial NCT01615003: The Study of MicroRNA Genomics of Blood Stasis Syndrome and of Coronary Heart Disease
Official title: The Analysis of Blood Stasis Syndromeand of Coronary Heart Disease Related MicroRNA Genomics and Target Gene Regulatory Networks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Heart Disease
Unstable Angina
Blood Stasis Syndrome
Keywords: MicroRNA
coronary heart disease
unstable angina
blood stasis syndrome
Xuesaitong soft capsule
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, typical cases of blood stasis syndrome of coronary heart disease are selected, by using microRNA chip, cDNA microarray and other bioinformatics technologies to filter and verify related miRNA and its target gene of Coronary Heart disease. Meanwhile, intervene by Xuesaitong soft capsules to investigate related miRNA and its target gene of Coronary Heart disease.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of coronary angiography unstable angina
* Clinical diagnosis of unstable angina
* Age of 30 to 75 years old
* Not use thrombolysis, dilate coronary drugs within two weeks
* Tongue dark
* Sign the consent

Exclusion Criteria:

* Severe valvular heart disease
* Insulin-dependent diabetes
* mental disease
* Combined with severe liver, kidney, hematopoietic system disorder
* Patients with malignant tumors
* Pregnancy or breast-feeding women
* Recent history of trauma
* Drug allergy

Primary outcomes:
measure: the change of Cycle threshold of relational microRNA in coronary artery disease with unstable angina
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'an men Hispital
state: Beijing
Study officials:
References:
Clinical trial NCT04169503: Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events
Official title: Immune Checkpoint Inhibitors Rechallenge After Immune-related Adverse Events in Patients With Cancer: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 17562
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with immune checkpoint inhibitors and experiencing irAEs

Brief summary: Although immune checkpoint inhibitors (ICIs) have proved effective in treating many cancers, patients receiving ICIs may experience immune-related adverse events (irAEs). Little evidence exists on the safety of resuming these treatments after an irAE.

Our objective was to investigate the safety of ICI rechallenge after an irAE using the WHO pharmacovigilance database


Eligibility criteria: Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
* consecutive individual case safety reports present in VigiBase reporting an irAEs associated to at least one immune checkpoint inhibitor.

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity.

Primary outcomes:
measure: Rate of occurrence of second immune-related adverse events (irAEs)
timeFrame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months).
Secondary outcomes:
measure: Description of cases experiencing an initial irAEs
timeFrame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
measure: Description of the rechallenge cases
timeFrame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
measure: Description of the clinical features of cases experiencing a second irAEs
timeFrame: Number of case reported in the World Health Organization (WHO) of individual safety case reports, through study completion (an average of 2 months)..
Other outcomes:
Locations:
city: Caen
country: France
facility: Alexandre Joachim
state: Basse Normandie
Study officials:
References:
Clinical trial NCT02285803: The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients
Official title: The Effect of Transcranial Direct Current Stimulation (tDCS) in Addition to Tinnitus Retraining Therapy (TRT) for Treatment of Chronic Tinnitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2014-11-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the added effect of tDCS to TRT within patients with chronic, non-pulsatile tinnitus. Patients were randomised in two groups namely, TRT and real tDCS and the second one is TRT with sham tDCS. Evaluations took place at the start of therapy, at the end of the counselling and at last a follow-up visit will be planned after 84 days of the start of the therapy. Subjective outcome measurements such as Tinnitus Functional Index and Visual Analogue Scales of loudness are the primary outcome measurement. Secondary outcome measurements are the Hospital Anxiety and Depression Scale, hyperacusis questionnaire and psychoacoustic measurements.


Eligibility criteria: Inclusion Criteria:

* Duration of tinnitus \> 6 months
* Maximum loudness of tinnitus on the VAS ≥ 4
* TFI score ≥ 25

Exclusion Criteria:

* Pregnancy
* Psychiatric disorders
* Pace maker or defibrillator
* Pulsatile tinnitus
* Acoustic Neurinoma
* CVA

Primary outcomes:
measure: Tinnitus Functional Index (TFI)
timeFrame: 3 months
Secondary outcomes:
measure: Hyperacusis Questionnaire
timeFrame: 3 months
measure: Hospital Anxiety and depression Scale
timeFrame: 3 months
measure: Patient Global Impression of Change
timeFrame: 3 months
measure: Psychoacoustic measurements
timeFrame: 3 months
measure: Late Latency Evoked Potentials
timeFrame: 3 months
measure: Visual Analogue Scale of Loudness
timeFrame: 3 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital of Antwerp
state: Antwerp
Study officials:
References:
citation: Rabau S, Van Rompaey V, Van de Heyning P. The effect of Transcranial Direct Current Stimulation in addition to Tinnitus Retraining Therapy for treatment of chronic tinnitus patients: a study protocol for a double-blind controlled randomised trial. Trials. 2015 Nov 10;16:514. doi: 10.1186/s13063-015-1041-2.
Clinical trial NCT00868803: Aberrant Gene Expression Prostate Carcinoma
Official title: Identification of Aberant Gene Expression in Human Prostatic Carcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 5000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with prostate cancer patients undergoing surgery for suspected prostate cancer but have negative biopsy healthy volunteers - blood sample only

Brief summary: The goal of the study is to gain a better understanding of the molecular changes responsible for causing prostate cancer and that examination of tissue and blood samples will help in the development of improved screening and therapeutic approaches.

Detailed description: The goal of this study is to identify novel genetic elements that are aberantly expressed throughout prostatic neoplastic progression. The approaches proposed exploit the known familial arm of prostatic cancer, using established molecular genetic approaches, and extend these studies to sporadic prostatic cancer using a novel technique of differential display. Application of the latter technique to colon cancer in the American population establishes this tumor type as a high priority for scientific investigation and this study is part of an initiative to address this problem. Presently the studies in the field of prostate are under-represented. The collection of tissue samples from patients diagnosed with prostate cancer. Patients will also provide a blood sample at the time of their surgery and potentially post-op from 6 mos to 5 years. Samples will also be obtained from patients who's biopsy turns out to be non-prostate cancer. These samples will be obtained shortly following the biopsy out to 6 months after the biopsy.

Eligibility criteria: Inclusion Criteria:

* Diagnosed prostate cancer undergoing prostatectomy
* Suspicion of prostate cancer undergoing biopsy - negative biopsy
* Health volunteer (control group) - blood sample for PSA

Exclusion Criteria:

* Patients not fitting the inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Kimberly R Christ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05131503: Evaluation of The Fear of Childbirth
Official title: Evaluation of The Fear of Childbirth in Pregnant Women Who Are In The Antenatal Polyclinic: The Sample of Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fear of Childbirth
Keywords: fear
Parturition
midwifery
Pregnant Women
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: they are healthy pregnant women who are 18-35 years old. they do not have any obstetrical complications. they go to the antenatal polyclinic.

Brief summary: Most pregnant women have fear of labor. The reasons of fear of labor are different according to women. The investigators will examine the relationship between the descriptive features and level of fear of labor of pregnant women by using the Oxford worries about labour scale

Detailed description: The investigators will give a survey to pregnant women who go to the antenatal polyclinic. The survey is consisted by researchers. The survey has a few questions about pregnant women's descriptive features. Next the investigators will evaluate the level of fear of labor of pregnant women. After the investigators will analyze the relationship between pregnant women's fear and their descriptive features.

Eligibility criteria: Inclusion Criteria:

* all of volunteers and pregnant women who are 18-35 years old.

Exclusion Criteria:

* the pregnant women have any obstetrical complications.

Primary outcomes:
measure: The Oxford Worries About Labour Scale
timeFrame: approximately 30 minutes, waiting in the antenatal polyclinic.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital- Maternity Hospital
state: Çankaya
Study officials:
affiliation: Ankara City Hospital- Maternity Hospital
name: Nükhet Kaçar, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05330403: The Moxibustion-Induced Thermal Transport Effect Between The Heart And Lung Meridians
Official title: The Moxibustion-Induced Thermal Transport Effect Between The Heart And Lung Meridians With Infrared Thermography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meridians
Keywords: heart and lung meridians
site specificity
infrared thermography
moxibustion
thermal transport
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
Collaborators: name: The Third Affiliated hospital of Zhejiang Chinese Medical University
First posted: 2022-04-15
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes. Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study was designed to assess the heat transport characteristics of meridian phenomenon for the Heart and Lung meridians by using infrared thermography. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.

Detailed description: 80 eligible subjects were finally included. Among them, 40 participants were assigned to the lung meridian intervention group, and 40 participants were assigned to the heart meridian intervention group. All 80 participants completed the trial.

Eligibility criteria: Inclusion Criteria:

* Had recent medical examination records confirming the absence of cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological diseases
* 20 ≤ age ≤ 40 years, male or female
* Had the ability to communicate with others normally
* An understanding of the entire study protocol
* Signed written informed consent

Exclusion Criteria:

* Had mental illnesses, severe depression, alcohol dependence or a history of drug abuse
* Pregnant or lactating
* Were participating in other trials

Primary outcomes:
measure: Temperature change of relevant sites
timeFrame: Baseline, Moxibustion 5 min, Moxibustion 10 min, Moxibustion 15 min, 5 minutes after stopping moxibustion
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: the Third affiliated hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: Zhejiang Chinese Medical University
name: Jianqiao Fang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li X, Jiang Y, Hu H, Lou J, Zhang Y, He X, Wu Y, Fang J, Shao X, Fang J. The Moxibustion-Induced Thermal Transport Effect Between the Heart and Lung Meridians With Infrared Thermography. Front Cardiovasc Med. 2022 May 13;9:817901. doi: 10.3389/fcvm.2022.817901. eCollection 2022.
Clinical trial NCT02003703: Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .
Official title: Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV : A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
HIV
Keywords: Vaccine
Primary Prevention
Immunogenicity
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: GlaxoSmithKline
name: Aclin Laboratory
First posted: 2013-12-06
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. The purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age.
* Patients infected with Human Immunodeficiency Virus (HIV)
* Failed previous vaccination with a standard dose scheme of recombinant hepatitis B vaccine (20mcg at 0, 1 and 6 months). Nonresponders will be considered as those patients presenting a hepatitis B surface antigen antibody titer lower than 10UI/mL 4 to 8 weeks after the last dose of the vaccine.
* Provision of informed consent.

Exclusion Criteria:

* Proven Hepatitis B virus infection (acute or chronic).
* Proven hypersensitivity to the vaccine or any of its components.

Primary outcomes:
measure: Serologic Response
timeFrame: 4-8 weeks After Exposure
Secondary outcomes:
measure: Local Reactions to Vaccine
timeFrame: One Week after Exposure
measure: Systemic Reactions to the Vaccine
timeFrame: One Week after Exposure
Other outcomes:
Locations:
city: Viña del Mar
country: Chile
facility: Hospital Gustavo Fricke
state: Valparaíso
Study officials:
affiliation: Hospital Gustavo Fricke, Viña del Mar, Chile
name: Francisco Fuster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Escuela de Medicina, Universidad de Valparaíso, Chile
name: Jose I Vargas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Escuela de Medicina, Universidad de Valparaíso
name: Daniela Jensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro de Investigaciones Biomédicas, Escuela de Medicina, Universidad de Valparaíso
name: Felipe T Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vargas JI, Jensen D, Martinez F, Sarmiento V, Peirano F, Acuna P, Provoste F, Bustos V, Cornejo F, Fuster A, Acuna M, Fuster F, Soto S, Estay D, Jensen W, Ahumada R, Arab JP, Soza A, Fuster F. Comparative Efficacy of a High-Dose vs Standard-Dose Hepatitis B Revaccination Schedule Among Patients With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2120929. doi: 10.1001/jamanetworkopen.2021.20929.
Clinical trial NCT01186003: Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy
Official title: Effectiveness of a Subcutaneously Administered Long-Acting Insulin Detemir Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2010-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators anticipate that the use of Detemir will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued.


Eligibility criteria: Inclusion Criteria:

* Diabetic ketoacidosis (DKA) and hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre-and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutritional requiring insulin drip.
* Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
* Patient with both types of diabetes will be among those treated with insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition
* Patients will be of age 19 to 80.

Exclusion Criteria:

* Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drop 2 weeks and longer, pregnancy, Levemir allergy, and concurrent sulfonamide treatment

Primary outcomes:
measure: Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)
timeFrame: within 48 hours of discontinuation
Secondary outcomes:
measure: Reduction in Duration of Insulin Drip Therapy and Reduction in Total and Average Per Hour Insulin Drip Dose
timeFrame: within one week of insulin drip therapy
measure: Reduction in ICU Length of Stay
timeFrame: within two weeks of hospitalization
measure: Equal or Improved Diabetes Control
timeFrame: within two weeks of hospitalization
measure: Reduction in Time to Get Back to Control of Glycemia (140-180 mg/dl) if Rebound Hyperglycemia Occurs
timeFrame: within one week post insulin drip
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Boris Draznin, MD., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: