louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03490721: Effects of Clustering Care on the Physiological Stability of Preterm Infants.
Official title: Effects of Clustering Care on the Physiological Stability of Preterm Infants in a Neonatal Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Baby 26 to 32 Weeks
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 10
Sex: ALL
Minimum age (years): 26
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This crossover design experimental study aims to compare the physiological stability of premature newborns during and after a cluster of care compared to a period when they receive standard non clustered care at the neonatal unit.

Detailed description: The cluster care will take place at the time of feeding of the premature infants. The intervention will start with a calm period of 20 minutes before the start of care (no manipulations will be allowed), the baby will then received the cluster care for 20 minutes and a quiet period of 30 minutes will follow after the cluster care.

Eligibility criteria: Inclusion Criteria:

* between 26 to 31 6/7 weeks of gestation at birth
* more than 72 hours of life,
* receive a respiratory aid such as endotracheal tube, NIPPV (non invasive positive pressures ventilation), CPAP (continuous positive airway pressure) or nasal prongs with oxygen,
* are fed intravenously (IV) or by central venous catheter (CVC),
* one of the parents speaks and reads English or French,
* one of the parents is at least 18 years old to sign the consent.

Exclusion Criteria:

* severely ill (necrotizing enterocolitis, septicemia),
* under respiratory assistance or on a high frequency mode,
* having a congenital or cardiac abnormality,
* requiring surgery,
* sedatives or opioids,
* diagnosed with grade II, III or IV intraventricular hemorrhage and / or hydrocephalus,
* have a device for invasive blood pressure,
* having an oxygen requirement of more than 30% to maintain oxygen saturation within the limits indicated by the NICU (neonatal intensive care unit).
* one of the parents is at least 18 years old to sign the consent.

Primary outcomes:
measure: Physiological stability (heart rate, respiratory rate and oxygen saturation)
timeFrame: The physiological stability will be measured for 70 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Marilyn Aita, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01024621: Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial
Official title: Comparison of Confocal Laser Endomicroscopy With Standard Endoscopy for the Detection and Evaluation of Gastric Intestinal Metaplasia in a High Risk Population: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Metaplasia
Keywords: gastric intestinal metaplasia
Confocal laser endomicroscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 168
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Detailed description: Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.

Eligibility criteria: Inclusion Criteria:

* 40 years old ≤ age \< 80 years old
* Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia
* Able to give informed consent.

Exclusion Criteria:

* Esophageal, gastric or duodenal cancer or other malignancy
* Known GIM or intraepithelial neoplasia in upper GI tract
* Scheduled for endoscopic therapy
* History of upper GI tract surgery
* Reflux esophagitis or acute gastritis or peptic ulcers
* Acute upper gastrointestinal bleeding
* Coagulopathy or bleeding disorders
* Allergy to fluorescein sodium
* Pregnant or breast-feeding (for females)
* Impaired renal function

Primary outcomes:
measure: the diagnostic yield of gastric intestinal metaplasia
timeFrame: Seven months
Secondary outcomes:
measure: the biopsy number needed in each group
timeFrame: Seven months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03433521: Observational Study of Spatio-Temporal Patterns of New Cases of Acute Myeloid Leukemia
Official title: Observational Study of Spatio-Temporal Patterns of New Cases of Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Keywords: Spatio-Temporal Diagnostic Pattern
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2018-02-14
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spanish population

Brief summary: Published data regarding the temporal pattern of AML are scarce and old. The greater knowledge of these neoplasias has made that their classification has been remarkable modified. Therefore, we consider relevant to carry out the present study as it would allow us to analyze the potential existence of a spatio-temporal pattern in the incidence of AML in Spain.


Eligibility criteria: Inclusion Criteria Patients with a first diagnostic of AML between 2004 and 2014.

.

Primary outcomes:
measure: AML diagnosis
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Investigacion Sanitaria Fundacion Jimenez Diaz
Study officials:
References:
Clinical trial NCT04597021: Wireless US-guided CVC Placement in Infants
Official title: Performing Central Venous Catheters in Neonates and Small Infants Undergoing Cardiac Surgery Using a Wireless Transducer for Ultrasound Guidance: a Prospective, Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wireless Ultrasound
Central Venous Catheter
Congenital Heart Disease in Children
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 30
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: neonates and small infants with a maximum body weight of 10 kg and need for insertion of a CVC before cardiac surgery at our institution

Brief summary: Background: Neonates and small infants with congenital cardiac disease undergoing cardiac surgery represent major challenges facing pediatric anesthesia and perioperative medicine. Aims: We here aimed to investigate the success rates in performing ultrasound guided central venous catheter insertion (CVC) in neonates and small infants undergoing cardiac surgery, and to evaluate the practicability and feasibility of thereby using a novel wireless ultrasound transducer (WUST).

Methods: Thirty neonates and small infants with a maximum body weight of 10 kg and need for CVC before cardiac surgery were included in this observational trial and were subdivided into two groups according to their weight: \< 5 kg and ≥5 kg. Cannulation success, failure rate, essential procedure related time periods, and complications were recorded and the clinical utility of the WUST was assessed by a 5-point Likert scale.


Eligibility criteria: Inclusion Criteria:

neonates and small infants with a maximum body weight of 10 kg and need for insertion of a CVC before cardiac surgery at our institution

Exclusion Criteria:

* missing consent for study participation \>10 kg body weight
* emergency surgery
* central venous catheter in situ

Primary outcomes:
measure: Rate of success using a wireless US for pediatric CVC
timeFrame: during cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Judith Schiefer, MD, Ph
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiefer J, Lichtenegger P, Zimpfer D, Hutschala D, Kuessel L, Felli A, Hornykewycz S, Faybik P, Base E. Performing central venous catheters in neonates and small infants undergoing cardiac surgery using a wireless transducer for ultrasound guidance: a prospective, observational pilot study. BMC Pediatr. 2021 Aug 13;21(1):341. doi: 10.1186/s12887-021-02822-w.
Clinical trial NCT04413721: Effects of Packed Red Blood Cell Storage Duration on Pediatric Living Donor Liver Transplantation
Official title: Effects of Packed Red Blood Cell Storage Duration on Pediatric Living Donor Liver
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transfusion Related Complication
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The patients assigned to either short-storage leukoreduced RBCs group (stored for ≤ 14 days) or longer-term storage leukoreduced RBCs group(stored for ≥21 days).When the hemoglobin concentration fell below 7.0 g per deciliter, PRBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0/dL. The primary outcome : Death from all causes in1-year after randomization. Secondary outcomes included: Intraoperative blood transfusion, Postoperative blood transfusion, Postoperative inflammatory reaction, Mechanical ventilation time in the intensive care unit, Lengths of stay in the intensive care unit and the hospital were also recorded.


Eligibility criteria: Inclusion Criteria:

* Our study included pediatric patients (6 months\< the moon's age \<36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.

Exclusion Criteria:

* The exclu¬sion criteria of the study were a congenital sufferer from heart, lung, kidney, nervous system or blood disease,active Lung infection，a history of liver transplantation，Multivisceral transplantation , refused to participate the study.

Primary outcomes:
measure: Mortality in in1-year after randomization
timeFrame: 1-year after randomization.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06890221: Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) In Breast Cancer Patients
Official title: Impact of PErioperative Nutrition Intervention on Bioimpedance Phase Angle (IPENIPA) In Breast Cancer Patients: A Double-Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Mastectomy Patient
Keywords: bioimpedance phase angle
nutritional intervention
oral nutritional supplement
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: B-Crobes Laboratory (M) Sdn Bhd
First posted: 2025-03-21
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to measure the mean difference of phase angle after nutritional intervention in breast cancer patients. The main question it aims to answer is:

1. Can perioperative nutrition interventions improve phase angle in relation to other bioimpedance parameters, handgrip strength and surgical outcomes in breast cancer population?

Researchers will compare oral nutritional supplement to a placebo to see if oral nutritional supplement can improve phase angle.

Participants will:

1. Be randomized into either arm
2. Take oral nutritional supplement or placebo according to the result of randomization for 7 days preoperatively and 30 days postoperatively
3. Have their measurements (weight, height, phase angle, handgrip strength) done at least 7 days preoperative, 1 day preoperative and 30 days postoperative


Eligibility criteria: Inclusion Criteria:

* Female
* Histopathologically confirmed operable breast cancer
* Aged 18 of years and above
* Consented and scheduled for mastectomy

Exclusion Criteria:

* On enteral supplementation prior to the study
* Lactose intolerance
* Pregnant or lactating
* Previous history of gastrectomy or small bowel resection surgery
* Advanced breast cancer staging, presence of pacemaker, decompensated liver disease, end stage renal failure, uncontrolled diabetes, on steroid therapy or complementary traditional medications

Primary outcomes:
measure: Mean difference of phase angle after nutritional intervention
timeFrame: From enrollment to 30 days post operation
Secondary outcomes:
measure: Changes in handgrip strength
timeFrame: From enrollment to 30 days post operation
measure: Correlation of phase angle with bioimpedance analysis parameters
timeFrame: From enrollment to 30 days post operation
measure: Potential factors associated with postoperative complications
timeFrame: From enrollment to 30 days post operation
measure: Cutoff value of phase angle
timeFrame: From enrollment to 30 days post operation
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Universiti Malaya Medical Centre
state: Kuala Lumpur
Study officials:
References:
Clinical trial NCT00780221: C-Reactive Protein (CRP) Gene Variants and Coronary Artery Disease in a Chinese Han Population
Official title: CRP Gene Variants and Coronary Artery Disease in a Chinese Han Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: CRP
coronary artery disease
polymorphisms
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: in-hospital patients and community healthy individual

Brief summary: The recognition of the association between circulating C-reactive protein (CRP) levels and risk of coronary heart disease (CHD) has led to an increased emphasis on CRP genetic effects on CRP level and CHD. However, the causality of CRP variants remains uncertain.The objective of this study is to evaluate the association of CRP gene variants and CRP levels in CHD in Chinese Han population. We conduct case-control study in CRP-Han study participants. The common single-nucleotide polymorphisms (SNPs) in the CRP gene, haplotypes, and plasma CRP levels are detected. A Mendelian randomization analysis will be used to help test the likelihood of causal association of gene-CRP levels, CRP levels-CHD and gene-CHD. The investigators hypothesize that CRP gene variants influence the protein level and may participate in CHD progress.

Detailed description: CHD patients and non-CHD population are recruited. CRP level and CHD severity by coronary angiograph will be examined. Mendelian randomization analysis are taken to analyze statically.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of coronary artery disease

Exclusion Criteria:

* with major organ disfunction or acute inflammatory disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Junbo Ge
role: STUDY_DIRECTOR
References:
Clinical trial NCT00489021: Feasibility and Outcomes of Older Patients Hospitalization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Community-Acquired Pneumonia
Exacerbation of Chronic Heart Failure
Exacerbation of Chronic Obstructive Pulmonary Disease
Cellulitis
Keywords: Subacute care
Activities of Daily Living
Cognition assessment
Mood assessment
Incontinence control
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-06-21
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hospitalization is a traumatic event for the patient and his family at any age nevertheless in the older age. One of its consequences is the difficulty to resume previous activity of daily living especially in older (over 75 years) patients. Sub acute completes the acute phase of the hospitalization and its main purpose is to improve the patient's functional status and quality of life. There are not enough clinical trails to proof this assumption. The purpose of our study is to compare the outcome of acute and sub-acute hospitalization programs by a randomized controlled prospective intervention study. Outcome measures will comprise activity of daily living, functional status, re-hospitalization and utilization of medical services following the hospitalization.Study hypothesis is that sub-acute hospitalization will improve outcomes and will cost less.


Eligibility criteria: Inclusion Criteria:

* Age over 65
* Hemodynamic, nutritional and respiratory stability
* eligibility for sub- acute hospitalization

Exclusion Criteria:

* Oncological active disease
* uncorrectable hypoxemia (oxygen saturation 90%),
* suspected myocardial ischemia
* presence of an acute illness, other than the target illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clalit Health Services, Israel
name: Doron Nezer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00275821: Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Official title: A Randomized, Double-masked, Active-controlled, Multi-center Study Comparing the Efficacy and Safety of Ranibizumab Administered as Two Dosing Regimens in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Age Related Macular Degeneration
Keywords: Age-related macular degeneration, ranibizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-01-12
Enrollment: 353
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.


Eligibility criteria: Inclusion Criteria:

* Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
* Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)

Exclusion Criteria:

* Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
* History of submacular surgery or other surgical intervention for AMD in the study eye, glaucoma filtration surgery, corneal transplant surgery.
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Primary outcomes:
measure: Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12
timeFrame: Baseline to Month 12
measure: Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12
timeFrame: Baseline to Month 12
measure: Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis - Including Sites in Germany
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT06315621: Deviation Parameters of Intraorfal Scanning in Capturing Different Intraoral Defects
Official title: Deviation Parameters of Intraoral Scanning with and Without Artificial Markers Versus Conventional Impression of Total, Partial and Congenital Nasal Defects: a Pilot Non-Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Defect
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: For all participants, a conventional facial impression will be done using silicone material then poured and scanned using a desktop scanner which represented the control group (Group 1).

Group 2, involves nasal defects which will be optically scanned using IOS(medit 700 wireless) without facial markers Group 3 involves nasal defects which will be optically scanned using IOS(medit 700 wireless) with facial markers.

STL files of the facial scans and scanned cast obtained from the impression will be exported and saved to be used later for outcome assessment.


Eligibility criteria: Inclusion Criteria:

* isolated nasal defects either, total or subtotal.
* congenitally missing external nose with healthy and intact remaining facial structures.

Exclusion Criteria:

* Any debilitating medical condition.

Primary outcomes:
measure: Dimensional accuracy of intraoral scanners
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: