louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00738504: Intensive Insulin Therapy and Acute Kidney Injury. Analysis Using RIFLE Criteria.
Official title: INTENSIVE INSULIN THERAPY REALLY REDUCES THE INCIDENCE OF ACUTE KIDNEY INJURY IN CRITICALLY ILL PATIENTS? An Analysis Using the RIFLE Criteria for Definition of Acute Kidney Injury.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney
Injury
Keywords: Intensive insulin therapy
Carbohydrate restrictive strategy
RIFLE Criteria
Acute Kidney Injury
Critically ill patients
Acute
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We are going to evaluate retrospectively the occurrence of acute kidney injury defined by the RIFLE criteria in a population of patients submitted to two different strategies for glycemic control: a carbohydrate restrictive strategy or intensive insulin therapy. The protocol of the original trial that we are going to summarize below, was approved by the Research Ethical Committee of the Federal University of Maranhão. We included 337 adult patients, non pregnant, admitted from July 1, 2004 to December 31, 2006, to a 20-bed multidisciplinary ICU of a general hospital and to an 11-bed trauma center ICU that had at least two blood glucose levels above 150 mg/dl from three measurements obtained in the first 12 hours after admission.

Brief summary: The purpose of this study is to determine if intensive insulin therapy really reduces the incidence of acute kidney injury in critically ill patients, using for analysis the RIFLE criteria for definition of AKI.


Eligibility criteria: Inclusion Criteria:

* We included 337 adult patients, non pregnant, admitted from July 1, 2004 to December 31, 2006, to a 20-bed multidisciplinary ICU of a general hospital and to an 11-bed trauma center ICU that had at least two blood glucose levels above 150 mg/dl from three measurements obtained in the first 12 hours after admission.

Exclusion Criteria:

* pregnant patients

Primary outcomes:
measure: To compare the renal function outcome, defined by the RIFLE criteria in patients submitted to two different regimens of glycemic control: a carbohydrate restrictive strategy and intensive insulin therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Luis
country: Brazil
facility: Hospital Sao Domingos
state: MA
Study officials:
affiliation: Director. BRAZILIAN ASSOCIATION OF INTENSIVE CARE MEDICINE
name: JOSE R AZEVEDO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03732404: Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section
Official title: Effects of Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section. A Double-Blind Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Keywords: Enhanced recovery after surgery
Preoperative carbohydrate drink
cesarean section
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, placebo-controlled, study.
Primary purpose: PREVENTION

Brief summary: Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.

Detailed description: Carbohydrate (sugar-containing) nutritional supplements have become a routine part of the package of care for people undergoing planned surgical procedures. the investigator wanted to discover whether carbohydrate supplements are a useful part of care packages used by doctors to improve recovery after planned cesarean section.

Eligibility criteria: Inclusion Criteria:

* Pregnant women undergoing elective caesarean section
* Term gestational age (37+0 to 41+6 weeks)
* Singleton gestation

Exclusion Criteria:

* Women with gestational diabetes and diabetes mellitus
* Fetal intrauterine growth restriction
* Ante-natally detected congenital anomaly which will require admission to the neonatal nursery
* Women who received steroids within the past 7 days prior to delivery
* Women who did not complete a gestational diabetes screening test

Primary outcomes:
measure: Length of hospital stay
timeFrame: 3 weeks
Secondary outcomes:
measure: number of participants experienced nausea
timeFrame: 24 hours postoperative
measure: Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale
timeFrame: ist 24 hours postoperative
measure: neonatal blood glucose concentration at four and ten hours of age
timeFrame: 24 hours post operative
measure: Neonates with plasma glucose level of less than 45 mg/dL between the groups
timeFrame: ist 24 hours postoperative
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04664504: A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Official title: A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: Rectal Cancer
Neoadjuvant Chemoradiotherapy
Recurrence Risk
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2020-12-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

Detailed description: For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.

Eligibility criteria: Inclusion Criteria:

1. Rectal adenocarcinoma confirmed by histopathology
2. MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)
3. The age is 18-75 years old, no gender limit

3) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1

Exclusion Criteria:

1. History of other malignant tumors;
2. They were allergic to 5-FU, platinum, etc;
3. The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;
4. After the previous renal history, proteinuria or clinical renal function were found to be abnormal;
5. History of gastrointestinal fistula, perforation or severe ulcer;
6. At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.

Primary outcomes:
measure: R0 resection rate
timeFrame: 1 year
Secondary outcomes:
measure: 3y OS
timeFrame: 3 years
measure: 3yDMFS
timeFrame: 3 years
measure: 3yLRRFS
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Sciences and Peking Union Medical College
name: Yuan Tang, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03495804: Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography
Official title: Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography (CTE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CTE
Keywords: CT enterography
oral contrast agent
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to group A or B. Participants of group A are given isotonic mannitol as oral contrast agent, while participants of group B are given isotonic polyethylene glycol as oral contrast agent.
Primary purpose: DIAGNOSTIC

Brief summary: CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. There are several shortcomings of commonly used isotonic mannitol as an oral contrast agent, such as incident adverse reactions and gases in the gut. However, polyethylene glycol can avoid these drawbacks with a good performance in some pilot experiments.


Eligibility criteria: Inclusion Criteria:

* patients aged from 18 to 75
* patients undergoing CT enterography

Exclusion Criteria:

* patients with a history of colorectal surgery
* patients with severe colonic stricture or obstructing tumor
* patients with significant gastroparesis or gastric outlet obstruction
* patients with known or suspected bowel obstruction or perforation
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* patients with severe inflammatory bowel disease or megacolon
* patients with documented allergy to intravascular contrast agent
* patients with dehydration
* patients with pregnancy or lactation
* patients hemodynamically unstable
* patients with dysphagia
* patients with severe constipation.
* patients unable to give informed consent.

Primary outcomes:
measure: Performance of two neutral oral contrast agents in CT enterography.
timeFrame: 12 months
Secondary outcomes:
measure: Side effects of the two oral contrast agents.
timeFrame: 12 months
measure: The flavor, volume and participants' willing for the second use of the two oral contrast agents in CT enterography.
timeFrame: 12 months
measure: Dizziness and debilitation of patients.
timeFrame: 12 months
measure: Temperature of patients.
timeFrame: 12 months
measure: Blood pressure of patients.
timeFrame: 12 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03234504: Development and Validation of a Novel Stereoacuity Test Using Head-mounted Display
Official title: Development and Validation of a Novel Stereoacuity Test Using Head-mounted Display
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Normal Healthy Volunteers
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal healthy volunteers

Brief summary: This prospective study investigated the validity and test-retest reliability of stereopsis test using head-mount display (HMD). Contour-based circles (crossed disparity: 1,960 to 195 arc of seconds(arc secs)) were generated as separate images on a high resolution phone display (Galaxy S7; Samsung, Suwon, Korea) using a HMD (Galaxy Gear VR; Samsung, Suwon, Korea). Two images were independently projected to each eye as graded circles with random dot background. While the position of the stimulus changed from among 3 possible locations, the subjects were instructed to select the circle with disparity by pressing the corresponding position on a keypad. The results of the new HMD stereotest were compared to those from standard Randot and TNO stereotests.


Eligibility criteria: Inclusion Criteria:

1. The subjects who want or need to visual acuity test or to test for a prescription for glasses visited the hospital. 2. The Subjects' ages ranged from 19 to 60 years in the study.

Exclusion Criteria:

1. Ocular alignment was assessed with cover-uncover and alternate prism cover testing at distance and near. Significant exodeviation included exophoria was considered to be ≥6 prism diopters were excluded.
2. Subjects with a history of ocular surgery within 3 months of the study were excluded.
3. Foreigners or subjects who are unable to understand informed consent were excluded.
4. Subjects with a history of eye problems, including infection, inflammation, cataract, vitreous opacity or retinal diseases were excluded.
5. Subjects with corrected visual acuity of 20/32 in bad eye were excluded.
6. Subjects with significant refractive error considered to be ≥2.00 diopters of anisometropia were excluded.
7. A female who is pregnant, may be pregnant, or is lactating was excluded.

Primary outcomes:
measure: Correlation between stereopsis with head mount display and stereopsis with Randot or TNO test
timeFrame: one visit
Secondary outcomes:
measure: Test-retest variability of stereopsis using head mount display
timeFrame: one visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Institute of Vision Research, Department of Ophthalmology
Study officials:
References:
Clinical trial NCT06346704: Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis
Official title: Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis (NHS-MS-EGYPT)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Keywords: Digital Health Technology
Lead sponsor: SYSNAV
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects followed for multiple sclerosis care at the investigational site.

Brief summary: The study aims to assess the validity of real-world activity monitoring by the Syde® wearable device in subjects with multiple slclerosis. The Syde® collected data will be compared to on-site conventional clinical endpoints for MS pathology (EDSS, FSS and T25FWT). Subjects with multiple sclerosis will be assessed every 6 months for 2 years.


Eligibility criteria: Inclusion Criteria:

1. Male or female subject aged from 18 to 65 years old.
2. Signed informed consent and ability to comply with study and follow-up.
3. Diagnosed with MS base on 2017 McDonald criterion
4. EDSS ≤ 5.5
5. No clinical or radiological relapse within the last 3 months
6. For patient under treatment, the molecule and its dose should be stable about 2 months before inclusion
7. Subject willing and able to comply to all study procedures including the Syde® related ones

Exclusion Criteria:

1. Patient with a cognitive or communicational disorder disturbing the understanding of the tasks or data collection
2. Previous or current disorder with an impact on current ambulation or motor function
3. Patient who have had surgery or traumatic injury in upper or lower limb within the last 6 months before the inclusion or patients who have had major surgery or trauma within the last 6 months before the inclusion

Primary outcomes:
measure: Longitudinal change of 95th centile of stride velocity
timeFrame: 2 years
Secondary outcomes:
measure: Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Air Force Specialized Hospital
Study officials:
affiliation: Air Force Specialized Hospital Cairo
name: Ahmed Elnemr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02077504: Glial Tumors Electromagnetic Signature Study by MagnetoEncephaloGraphy (MEG) "CONDUCTOME"
Official title: Magnetoencephalographic Study of Glial Tumors Electromagnetic Signature
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cerebral Primitive Tumor With Chirurgical Indication
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the correlation between functional MEG analysis of the tumor and its periphery and the tumor stage and treatment response.

Detailed description: A better tumor grade definition would provide an optimized surgical care, prognosis and therapeutical response evaluation.

Eligibility criteria: Inclusion Criteria:

* more or equal than 18 years old
* patient affiliated to social security or similarly regime
* informed consent form signed
* supra-tentorial primitive cerebral tumor

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Magnetic Resonance Imaging (MRI) contraindication (implanted material non MRI-compatible, ferro-magnetic foreign body, claustrophobia)
* Patients needed emergency medical care for other pathology
* severely altered general health (Performance Status 3 or 4)

Primary outcomes:
measure: Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) data in tumor grade prediction
timeFrame: 1 week before exeresis
measure: anatomopathologic and clinical data in tumor grade prediction
timeFrame: 1 week after exeresis
Secondary outcomes:
measure: Measurement of molecules involved in glial cells neuralisation expression in tumor samples
timeFrame: Up to 1 month after surgery
measure: Tumoral growth modelisation from patient MEG and MRI data
timeFrame: Up to 1 month after surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CLINATEC
Study officials:
affiliation: University Grenoble Hospital
name: François BERGER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01371604: Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
Official title: A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C
HCV
treatment-naive
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-06-13
Enrollment: 68
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 purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.


Eligibility criteria: Inclusion Criteria:

* Males and females with documented genotype 1, chronic hepatitis C infection.
* Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.
* Has not received prior antiviral treatment for HCV.
* Written informed consent by participant.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen \[HBsAg\] positive) and/or human immunodeficiency virus (HIV).

Primary outcomes:
measure: Percentage of participants who experience a serious adverse event
timeFrame: Up to Week 16 and end of treatment (Weeks 24 or 48)
measure: Percentage of participants who experience an adverse event
timeFrame: 16 weeks
measure: Percentage of participants who experience a grade 1-4 laboratory abnormality
timeFrame: 16 weeks
measure: Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4
timeFrame: Week 4
measure: Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment
timeFrame: Weeks 24 or 48
measure: Percentage of participants who achieve sustained virologic response (SVR)
timeFrame: 24 weeks after the last dose (Weeks 48 or 72)
measure: Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4
timeFrame: Week 4
measure: Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment
timeFrame: Weeks 24 or 48
measure: Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose)
timeFrame: Weeks 48 or 72
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: