louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01687010: Diagnostic and Prognostic Value of Combination Biomarkers in the Critically Ill Patient With Sepsis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diagnostic and Predictive Value
Keywords: CRP, PCT, IL-6, Diagnosis, Prediction
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Southeast University, China
First posted: 2012-09-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients

Brief summary: Sepsis is a common cause for morbidity and mortality in critically ill patients. With the development of medical skills, the mortality is still remain very high. Inappropriateness of initial antibiotic treatment is an important risk factor for mortality and effective antimicrobial administration within the first hour of documented hypotension was associated with increased survival to hospital discharge in adult patients with septic shock. However, the early treatment based on early diagnosis.But it is very difficult to diagnosis because of lack of specific clinic symptom and sign.When severe sepsis occur, biomarker could be helpful to diagnosis. Unfortunately, the diagnostic value of single biomarker is limited. Therefore, combine several biomarkers could enhance the diagnostic value.


Eligibility criteria: Inclusion Criteria:

* Critically ill patients admitted into ICU

Exclusion Criteria:

* Age younger than 18 years
* Refuse to participate in this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Critical Care Medicine Nanjing Zhong-da Hospital Southeast University School of Medicine
state: Jiangsu
Study officials:
References:
Clinical trial NCT02078310: Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Oral Dose Escalation for Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alzheimer's Disease
Keywords: Dementia,
Healthy
geriatric
volunteers
patients
Lead sponsor: Intra-Cellular Therapies, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 35
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia


Eligibility criteria: Inclusion Criteria:

Part 1

* Healthy geriatric volunteers
* MMSE score of \>= 26 at screening
* BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening

Part 2

* Geriatric patients with a clinical diagnosis of dementia
* MMSE score of \< 26 at screening
* BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening

Exclusion Criteria:

* Any clinically significant illness within 6 months before screening
* Any history of cancer within last 5 years
* History of Hepatitis B or C infection and elevated ALT, AST or bilirubin above the upper limit of normal level
* Any subject considered to be an imminent danger to themselves or others

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: up to 7 days
Secondary outcomes:
measure: Area under the concentration-time curve (AUC)
timeFrame: pre-dose and multiple collection points up to 72 h after the last dose
Other outcomes:
measure: Exploratory measures of cognitive function
timeFrame: Baseline and up to 7 days
measure: Exploratory measures of agitation
timeFrame: Baseline and up to 7 days
measure: Exploratory measures of subjective sleep
timeFrame: Baseline and up to 7 days
Locations:
city: Glendale
country: United States
state: California
Study officials:
References:
Clinical trial NCT01389310: Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
Official title: Post-marketing Safety Surveillance Program in HIV-infected Children Exposed to Atazanavir in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: PENTA Foundation
First posted: 2011-07-08
Enrollment: 249
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of this study is to monitor adverse events in HIV-infected children \<18 years old who are exposed to Atazanavir in a real-world setting in Europe.


Eligibility criteria: Inclusion Criteria:

* HIV-infected children participating in individual prospective paediatric HIV cohorts
* Receive Atazanavir treatment during 01JAN2011 to 30DEC2013
* Age \<18 years old on the date starting an Atazanavir-containing regimen
* Have a minimum of 3 months of follow-up

Primary outcomes:
measure: Number of Adverse events reported during Atazanavir drug exposure
timeFrame: 36 months
Secondary outcomes:
measure: Pattern of use of Atazanavir
timeFrame: 12-months
measure: Pattern of use of Atazanavir
timeFrame: 24-months
measure: Pattern of use of Atazanavir
timeFrame: 36-months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hospital St Pierre
city: Frankfurt
country: Germany
facility: German Competence Network
city: Florence
country: Italy
facility: Italian Register for HIV-infection in Children
city: Bucharest
country: Romania
facility: Victor Babes Hospital
city: Barcelona
country: Spain
facility: Spanish Perinatal Cohort
city: Madrid
country: Spain
facility: Madrid Paediatric HIV Cohort
city: Basel
country: Switzerland
facility: Swiss Mother and Child HIV Cohort
city: London
country: United Kingdom
facility: Collaborative HIV Paediatric Study
city: London
country: United Kingdom
facility: European Collaborative Study
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04528810: A Study of Child Injury Based on Data Mining
Official title: A Prospective Observational Study of Child Injury Based on Data Mining
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Injuries
Child
Keywords: Injuries
Child
Epidemiology
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 10762
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients between the ages of 0-18 years newly diagnosed with injuries

Brief summary: A comprehensive pediatric injury burden assessment is an essential foundation for formulating injury prevention strategies and improving emergency care for injured children. Although the hospital-based passive surveillance of national injury surveillance system of medical and health institutions has been well-established in China, the monitoring points of hospitals were not stratified according to children's hospital. Aim of the project is to collect epidemiological and clinical data to describe causes, clinical features and outcomes of pediatric injuries at a Children's Hospital in Shanghai, China. The project intends to establish a method for collecting and analyzing high quality data of child injury using data mining based on the hospital information system.

Detailed description: Injuries are a leading cause of death for infants and children around the world. According to the Haddon Injury Control Model, 90 percent of injuries are both predictable and preventable. Injuries are preventable, not "accidents". All unintentionally and intentionally injured children first visit to the emergency department are recruited in the study. Children's Hospital of Fudan University with a Regional Pediatric Trauma Centre is also the first Pediatric Injury Prevention Center established in China. We conduct a prospective cohort study to investigate the epidemiology, clinical course, and outcomes of the injured child first visit to the emergency department, which expected to serve as evidence of injury prevention and promising practices. In the study, we collect and analyze high quality data of child injury based on data mining.

Eligibility criteria: Inclusion Criteria:

All pediatric patients between the ages of 0-18 years newly diagnosed with injuries in the emergency department，and recorded ICD-10 diagnosis codes from V01 to X39

Exclusion Criteria:

Patients who were dead on arrival to the emergency department are not included.

Primary outcomes:
measure: Distribution of injury categories
timeFrame: At baseline
Secondary outcomes:
measure: 28 days mortality
timeFrame: Within 28 days from ED admission
measure: 180 days mortality
timeFrame: Within 180 days from ED admission
measure: Short-term disability
timeFrame: At 180 days from ED admission
measure: Percentage of ICU admission
timeFrame: From ED admission to 72 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06819410: Efficacy and Safety of Amphotericin B and Azoles in the Treatment of Invasive Fungal Disease
Official title: A Retrospective Clinical Study on the Efficacy and Safety of Amphotericin B Compared With Azoles in the Treatment of Invasive Fungal Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Fungal Disease
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with invasive fungal disease who are treated with polyene antifungals or azole antifungals should be treated for ≥ 7 days.

Brief summary: Efficacy and safety of amphotericin B and azoles in the treatment of invasive fungal disease

Detailed description: The medical records, demographic characteristics and clinical data of patients with invasive fungal disease treated with amphotericin B or azoles were collected through the electronic medical record system of Sichuan Provincial People's Hospital from 2021 to 2024. To evaluate the efficacy and safety of these two types of drugs.

Eligibility criteria: Inclusion Criteria:

* There is no age limit, gender is not limited
* Patients with invasive fungal disease who are treated with polyene antifungals or azole antifungals should be treated for ≥ 7 days.

Exclusion Criteria:

* Patients with incomplete data or other factors affecting the clinical outcome judgement
* Patients who are judged by the investigator to be unsuitable to participate in this study.

Primary outcomes:
measure: Clinical success rate
timeFrame: The end of treatment, up to 1 year
Secondary outcomes:
measure: Safety of amphotericin B and azoles
timeFrame: During the treatment (1-14 days); the end of treatment (Day 14);Day 28 after the start of treatment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: lingai PP Pan, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01659710: Effects of Medical Complexity Using GMA on Lurie Children's In- and Outpatients
Official title: Effects of Medical Complexity on the Development of Fidgety Movements and Feasibility of Screening Utilizing the General Movement Assessment for Lurie Children's ICU Patients and Graduates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medically Complex Infants
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 208
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children's Memorial ICU Patients and Graduates

Brief summary: The purpose of this study is to research a new type of test for cerebral palsy that can be performed earlier, at 10-15 weeks of age (after the due date for premature infants). The test involves a standardized video recording of a baby's natural movements for about 10 minutes. The video recorded movements are evaluated by a special trained observer and also by a computer program. There are some small studies from Europe that suggest that this type of evaluation may be accurate in early diagnosis of cerebral palsy. However, the investigators do not know if this type of evaluation is reliable in large groups of infants, including infants from Children's Memorial Hospital, who tend to be sicker and have more complicated illnesses than many of the European infants. The investigators would therefore like to evaluate whether this type of video recording could be used in the future for early diagnosis of cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Admitted to the NICU/CICU and remain hospitalized at 10-15 weeks postmenstrual age
* Birth at \<28 weeks gestation
* Birth weight \<1000 grams
* Neurologic risk factors (HIE, abnormal imaging, neonatal seizures, microcephaly)
* Cardiac surgery during first 3 months of life
* Severe chronic lung discharge defined as the need for mechanical ventilation at 36 weeks post-menstrual age
* Discharged home on supplemental oxygen (or if still hospitalized, requiring oxygen at 44 weeks post-menstrual age)

Exclusion Criteria:

* Significant malformations/amputations of the extremities
* Recovering from a surgical procedure within 4 weeks of the assessment
* Physiologic instability precluding movement of the hospital bed or peripheral IV lines that might affect movement of an extremity medication for the purpose of ongoing sedation

Primary outcomes:
measure: Presence of cerebral palsy
timeFrame: 24 months (+/- 6 months) and 4 years (+/- 1 year) of age
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Lurie Children's Hospital
name: RayeAnn deRegnier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03184610: Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution OCT
Official title: Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution Optical Coherence Tomography (UHR-OCT) Based Corneal Epithelium Thickness Mapping
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Keywords: Keratoconus
Optical Coherence Tomography
Corneal Epithelium Thickness Maps
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eyes with Keratoconus Healthy eyes

Brief summary: The OCT used in this trial offers the advantage of both a non-contact method and a very high axial resolution. Determined parameters with the highest potential of diagnostic discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this trial is to investigate differences of specific parameters of epithelium thickness maps at healthy eyes and eyes with Keratoconus.


Eligibility criteria: Inclusion Criteria:

* Age\>18
* Existence of Keratoconus
* written informed consent obtained

Exclusion Criteria:

* Earlier surgery such as PK, CXL, relaxing incisions
* Systemic diseases

Primary outcomes:
measure: Corneal Epithelium Thickness
timeFrame: One visit
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Ophthalmology
Study officials:
References:
Clinical trial NCT06507410: Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy
Official title: Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clonidine
Propofol
Sedation
Colonoscopy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 62
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: The objective of this study was to compare safety, satisfaction, and efficiency outcomes of propofol versus propofol with clonidine in patients undergoing colonoscopy.

Detailed description: Colonoscopy is one of the most common procedures in the world, Colonoscopy is a procedure often performed for prevention, diagnosis, and treatment of a variety of symptoms and diseases of the lower digestive tract, and sedation or anesthesia should be considered as an important tool to increase its effectiveness.

Sedation and analgesia are considered key components, as they reduce anxiety and discomfort and therefore improve the procedure tolerability and patient satisfaction, minimize risk of complications and provide better conditions for the examination.

Propofol may be used alone or in combination with opioids and/or benzodiazepines.

The use of propofol alone requires higher doses, which may lead to increased incidence of side effects. However, the risks and benefits of adding analgesic and sedative to propofol are controversial, and the selection of drugs is a crucial factor in determining the outcomes.

Clonidine apparently produces its sedative and anaesthetic-sparing effects by stimulation of centrally located alpha2 adrenoceptors. Analgesia seems to be mediated mainly by activation of alpha2 adrenoceptors in the dorsal horn of the spinal cord.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Patients undergoing colonoscopy.

Exclusion Criteria:

* Patients had recent history of colonoscopy.
* Previous colonic resection.
* Severe heart failure (ejection fraction \< 30%).
* Known history of hypersensitivity to propofol or clonidine and any need for anesthetic drug administration other than the study protocol.

Primary outcomes:
measure: Patient satisfaction
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Heart rate
timeFrame: Till the end of surgery
measure: Mean arterial blood pressure
timeFrame: Till the end of surgery
measure: Side effects
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT00845910: A Study of Circulating Endothelial Cell as Marker for Avastin (Bevacizumab) in Combination With Docetaxel Plus Xeloda (Capecitabine) as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer
Official title: A Phase II Trial of Evaluating Circulating Endothelial Cell as A Surrogate Marker for Monitoring Treatment Efficacy of Docetaxel Plus Capecitabine With Bevacizumab as First Line Treatment for Patients With Locally Recurrent and Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the correlation between circulating endothelial cell levels and treatment efficacy in patients with locally recurrent and metastatic breast cancer given first line treatment with Avastin in combination with docetaxel + Xeloda.Patients will be treated with docetaxel 60mg/m2 iv on day 1, and Xeloda 900mg/m2 po on days 1-14, of each 3 week cycle, plus Avastin 7.5 mg/kg iv on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* female patients, 18-65 years of age;
* locally recurrent and metastatic breast cancer;
* measurable or evaluable disease;
* ECOG performance status of 0-2;
* LVEF \>=50% without clinical symptoms or signs of heart failure.

Exclusion Criteria:

* unknown HER2 status, or known HER2-positive status;
* prior chemotherapy for locally recurrent or metastatic disease;
* prior adjuvant or neoadjuvant taxane therapy within 12 months prior to start of treatment;
* clinical or radiological evidence of CNS metastases;
* clinically significant cardiovascular disease.

Primary outcomes:
measure: Overall response rate
timeFrame: Every 12 weeks
Secondary outcomes:
measure: Time to disease progression
timeFrame: Event driven
measure: Serious adverse events
timeFrame: At planned visits, till disease progression
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05405010: Individually Timed Stair Climbing and Descending to Lower Postprandial Glucose
Official title: Individually Timed Stair Climbing and Descending to Lower Postprandial Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Postprandial Insulin
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Effect of individually timed exercise to attenuate postprandial glucose excursions

Detailed description: Participants will perform 1 and 3 minutes stair climbing and descending at a self-selected pace after a mixed meal on separate visits. The timing of these exercise bouts will be determined from an initial control condition where the participant remains seated. Timing of exercise will coincide with the peak glucose from the control condition. Glucose will be measured every 10 minutes.

Eligibility criteria: Inclusion Criteria:

* between 18 and 65 years

Exclusion Criteria:

* high-risk from PAR-Q

Primary outcomes:
measure: Postprandial Glucose
timeFrame: 1 hour
Secondary outcomes:
measure: Postprandial insulin
timeFrame: 1 hour
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References: