louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03456258: Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy
Official title: Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy,a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia of Pregnancy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy.

Detailed description: The study was done at ainshams university maternity hospital on 100 pregnant women randomized in two groups .

Group one lactoferrin group Group two ferrous sulphate group

Eligibility criteria: Inclusion Criteria:

* pregnant women from 20 to 40 years
* iron deficiency anemia (mild and moderate)
* gestational age 13 to 26 weeks
* singleton viable pregnancy.

Exclusion Criteria:

* history of anemia due to chronic blood loss
* hemolytic anemia
* severe anemia
* history of peptic ulcer

Primary outcomes:
measure: hemoglobin level
timeFrame: 2 months
Secondary outcomes:
measure: Serum ferritin
timeFrame: 2 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams maternity hospital
state: Abbasia
Study officials:
affiliation: Ainshams university maternity hospital
name: Ahmed M Ragab, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01597258: Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
Official title: SPECIAL INVESTIGATION OF XALKORI FOR NSCLC (REGULATORY POST MARKETING COMMITMENT PLAN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Safety
All cases surveillance in Japan
ALK-positive unresectable advanced and/or recurrent non-small cell lung cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-05-14
Enrollment: 2029
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A8081031 prescribes the Crizotinib (XALKORI).

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.

Eligibility criteria: Inclusion Criteria:

* All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.)

Exclusion Criteria:

* Patients not administered XALKORI in spite of enrolled.

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: 52 weeks
Secondary outcomes:
measure: Objective Response Rate (ORR) at 52 Weeks
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ueno N, Banno S, Endo Y, Tamura M, Sugaya K, Hashigaki S, Ohki E, Yoshimura A, Gemma A. Treatment status and safety of crizotinib in 2028 Japanese patients with ALK-positive NSCLC in clinical settings. Jpn J Clin Oncol. 2019 Jul 1;49(7):676-686. doi: 10.1093/jjco/hyz049.
Clinical trial NCT04272658: PET/CT Whole-body Dynamic Acquisition at FDG to Metastatic Melanoma Under Immunotherapy
Official title: Interest in PET/CT Whole-body Dynamic Acquisition at FDG to Differentiate Progression/Pseudo Progression of Metastatic Melanoma Under Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Melanoma
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic melanoma treated with immune checkpoint inhibitors (ICI) and do 4D body-to-whole dynamic acquisition in FDG PET / CT to differentiate progression / pseudo-progression

Brief summary: The value of 4D body-to-whole dynamic acquisition in FDG PET / CT to differentiate progression / pseudo-progression during the first therapeutic assessment (PET1) of metastatic melanoma treated with immune checkpoint inhibitors (ICI)to predict the progression of the disease..


Eligibility criteria: Inclusion Criteria:

* Patient old ≥ 18 years
* With metastatic melanoma
* Treated with anti-PD1 : Nivolumab or Pembrolizumab or Combo IPI-Nivo
* Having formulated a non-opposition

Exclusion Criteria:

* - Minor patient \< 18 years
* Pregnancy or breastfeeding
* Other type of tumor than metastatic melanoma
* Non-eligibility for the examination
* Refusal of participation

Primary outcomes:
measure: Values of the Ki absorption coefficient resulting from a FDG PET / CT full-body 4D dynamic acquisition to differentiate the pseudo-progression / progression of metastatic melanoma treated with ICI
timeFrame: 5 years
Secondary outcomes:
measure: Correlation between the Ki lesion values derived from PET1 and the quantitative parameters resulting from PET0 histological specifications of the tumors (% PD-L1, T-CD8 infiltration, PTEN status) to differentiate pseudo-progression / progression.
timeFrame: 5 years
measure: Correlation between the Ki lesional values resulting from the 4D acquisition of the PET / CT from PET1 and PET0 the biological parameters (LDH, leucocytes, neutrophils) to differentiate pseudo-progression / progression
timeFrame: 5 years
measure: Correlation between the Ki lesion values resulting from the 4D acquisition of FDG PET / CT for PET1 and the quantitative parameters resulting from PET0 to differentiate pseudo-progression / progression
timeFrame: 5 years
measure: Correlation between lesional Ki values resulting from the 4D acquisition of FDG PET / CT for from PET1 and the quantitative parameters resulting from PET0 ICI- related adverse effect to differentiate pseudo-progression / progression
timeFrame: 5 years
Other outcomes:
Locations:
city: Brest
country: France
facility: Hospital University ff Brest
state: Finistere
Study officials:
affiliation: Nuclear Medecine
name: Ronan ABGRAL, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04029558: Effect of a Combination of Plant Extracts (BSL_EP024) on the Immune Response
Official title: Pilot Study of Nutritional Intervention, Randomized, Double Blind and Controlled Parallel Groups to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP024) on the Immune Response in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Response
Keywords: Immune response
Plant extracts
Dietary supplement
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present trial is to study the effect of the combination of plant extracts (BSL_EP024) in the activation of the immune response.

Detailed description: More than 90% of the diseases are related, directly or indirectly, with immune alterations. Traditionally, protection against infections and improvement of the immune response has been addressed by natural means through the use of plant extracts. This activity has been attributed to phenolic compounds.

The aim of the present study is to evaluate the effect of the combination of plant extracts (BSL_EP024) on immunological response parameters.

Eligibility criteria: Inclusion Criteria:

* Healthy adult between 18 and 55 years.
* Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria:

* Be under pharmacological treatments that may affect the immune response (anti-inflammatory drugs of chronic or frequent use, antiallergic treatments).
* Have allergy to some plant extracts
* Suffer from gastric problems or ulcers.
* Receive treatment with anticoagulant activity.
* Have a low expectation of adherence to the study protocol.

Primary outcomes:
measure: IgM
timeFrame: 4 weeks
measure: IgA
timeFrame: 4 weeks
measure: IgG
timeFrame: 4 weeks
Secondary outcomes:
measure: IL-2
timeFrame: 4 weeks
measure: IL-8
timeFrame: 4 weeks
measure: TNF-alpha
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Biosearch Life
state: Andalucia
Study officials:
affiliation: Medical specialist in Endocrinology, Hospital San Cecilio de Granada
name: Miguel Quesada, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03761758: Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
Official title: Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.

Detailed description: This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.

Eligibility criteria: Inclusion Criteria:

* Ages between 6 and 12 years
* Myopia between -1.00 and -4.00 D

Exclusion Criteria:

* Participating in any clinical or other research study
* Contact lens wearer

Primary outcomes:
measure: Distance Visual Acuity
timeFrame: 2 weeks
measure: Contrast Sensitivity
timeFrame: 2 weeks
measure: Subjective Responses
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research & Education
state: Ontario
Study officials:
affiliation: SightGlass Vision
name: Joe Rappon, OD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03163758: Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis
Official title: Study of Cerebral Structural and Functional Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation (rTMS) Using the Method of Neuroimaging Brain Network Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Ischemic stroke
Functional magnetic resonance imaging (fMRI)
Repetitive transcranial magnetic stimulation (rTMS)
Brain Reorganization
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
name: University of Pennsylvania
First posted: 2017-05-23
Enrollment: 52
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to figure out brain structural and functional reorganization evidence after repetitive transcranial magnetic stimulation through the method of neuroimaging brain network analysis, such as resting-state functional magnetic resonance imaging and diffusion tensor imaging.


Eligibility criteria: Inclusion Criteria:

1. stroke patients within 1 week after onset with unilateral cerebral subcortex lesion in the middle cerebral artery territory detected by diffusion weighted image,
2. right-handed,
3. without memory loss or intelligence disorder,
4. never suffered stroke before.

Exclusion Criteria:

1. direct damage to the cerebral cortex,
2. a history of cerebral vessel disease,
3. tendency to hemorrhage or existed brain hemorrhage,
4. epilepsy or other mental disorders,
5. any MRI contraindications.

Primary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Change from Baseline NIHSS at 1 month after real rTMS/sham rTMS
measure: Barthel Index (BI)
timeFrame: Change from Baseline BI at 1 month after real rTMS/sham rTMS
measure: Fugl-Meyer Assessment Upper Limb (FMA-UL)
timeFrame: Change from Baseline FMA at 1 month after real rTMS/sham rTMS
Secondary outcomes:
measure: Functional Connectivity Map (FC Map)
timeFrame: Change from Baseline z-FC maps at 1 month after real rTMS/sham rTMS
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: Li J, Zuo Z, Zhang X, Shao X, Lu J, Xue R, Fan Y, Guan Y, Zhang W. Excitatory Repetitive Transcranial Magnetic Stimulation Induces Contralesional Cortico-Cerebellar Pathways After Acute Ischemic Stroke: A Preliminary DTI Study. Front Behav Neurosci. 2018 Jul 27;12:160. doi: 10.3389/fnbeh.2018.00160. eCollection 2018.
Clinical trial NCT02277158: Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.
Official title: A Phase I Study of Concurrent Radiotherapy and Tegafur, Gimeracil and Oteracil Potassium Capsule(S-1) as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rectal Cancer
Keywords: Rectal cancer
S-1
Chemoradiotherapy
Phase I
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer

Detailed description: This stage I study is designed to evaluate the appropriate dose of S-1 plus radiotherapy for patients with R0 resection of rectal cancer for stage II-III patients(AJCC 7th). To evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.

Eligibility criteria: Inclusion Criteria:

* R0 resection of histologically proved stage II/III rectal cancer;
* 18-75 years old;
* No previous radiotherapy or chemotherapy for rectal cancer;
* Performance status of ECOG 0,1;
* Adequate organ function defined as below:

  i. WBC ≥ 4,000/mm\^3 ii. ANC ≥ 1,500/mm\^3 iii. Hemoglobin ≥ 10g/dL iv. Platelet ≥ 100,000/m\^3 v. Total bilirubin ≤ 1.5ULN vi. AST/ALT ≤ 1.5ULN vii. Serum creatinine ≤ 1.5ULN or creatinine clearance rate ≥ 60ml/min、Urea nitrogen ≤ 1.5ULN viii. Protein in urine dipstick test\<1+; if the test result \>1+ ,total protein in urea must \<500mg within 24 hours
* Able to receive oral administration
* Informed consent

Exclusion Criteria:

* Hypersensitive to S-1 or its excipients
* Pulmonary fibrosis or interstitial pneumonitis found within 28 days prior to registration
* Significant co-morbid medical conditions, including, but not limited to, heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
* Received any investigational drug or anti-cancer agent
* Pregnant or lactating female or pregnancy test positive
* Severe mental disorder
* Judged ineligible by physicians for participation in the study due to safety concern.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: 6weeks (42 days)
Secondary outcomes:
measure: Dose Limiting Toxicities (DLTs)
timeFrame: 6weeks (42 days)
measure: Quality of Life
timeFrame: 6weeks (42 days)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Zhenzhou-Yang
state: Chongqing
Study officials:
References:
Clinical trial NCT03220958: Metoclopramide for Post Traumatic Headache
Official title: A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Traumatic Headache
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.


Eligibility criteria: Inclusion Criteria:

Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows:

* Traumatic injury to the head has occurred
* Headache has developed within 7 days of injury to the head
* Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)

The headache must be rated as moderate or severe in intensity at the time of initial evaluation.

Exclusion Criteria:

Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.

Primary outcomes:
measure: 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable
timeFrame: 1 hour after medication administration
Secondary outcomes:
measure: Sustained Headache Relief
timeFrame: 48 hours after medication administration
measure: Headache Days
timeFrame: 7 days after ED visit
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
citation: Friedman BW, Irizarry E, Cain D, Caradonna A, Minen MT, Solorzano C, Zias E, Zybert D, McGregor M, Bijur PE, Gallagher EJ. Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache. Neurology. 2021 May 4;96(18):e2323-e2331. doi: 10.1212/WNL.0000000000011822. Epub 2021 Mar 24.
Clinical trial NCT05766358: Role Of Metabolic Adaptation In Weight Regain
Official title: Role Of Metabolic Adaptation In Weight Regain: Expend Follow-Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Weight Gain
Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants having completed the NCT04081337 study.

Brief summary: In a previous study (NCT04081337), 55 participants with obesity participated on a 18-week lifestyle intervention to reduce their body weight, targeting 10% body weight loss. The participants received tirzepatide (15mg after titration) or placebo during the weight loss intervention. Before and after the lifestyle intervention, energy expenditure (48-h room indirect calorimetry) and body weight and composition (dual-X-ray absorptiometry) were measured, thus enabling the assessment of metabolic adaptation. In this study, participants having provided their consent to be re-contacted will be invited to attend the research center 12,18 and 24 months after completing the lifestyle intervention. Body weight and composition will be measured, aiming to explore the association between metabolic adaptation and changes in body weight and composition after a weight loss intervention. In addition, we will explore whether weight and fat mass changes are different between groups, and whether these effects are mediated by metabolic adaptation.


Eligibility criteria: Inclusion Criteria:

* Having participated in the study NCT04081337.

Exclusion Criteria:

* Being pregnant.

Primary outcomes:
measure: Body weight
timeFrame: 24 months
Secondary outcomes:
measure: Body weight
timeFrame: 12 months
measure: Body weight
timeFrame: 18 months
measure: Body fat mass (DXA)
timeFrame: 12 months
measure: Body fat mass (DXA)
timeFrame: 18 months
measure: Body fat mass (DXA)
timeFrame: 24 months
measure: Body fat free mass (DXA)
timeFrame: 12 months
measure: Body fat free mass (DXA)
timeFrame: 18 months
measure: Body fat free mass (DXA)
timeFrame: 24 months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT03692858: IPACK Block in Total Knee Arthroplasty
Official title: IPACK Block Efficacy as a Part of Multimodal Analgesia in Total Knee Arthroplasty. A Prospective, Randomized, Controlled, Double Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Total Knee Arthroplasty
Keywords: arthroplasty
replacement
knee
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Aikaterini Kalampokini
name: Chryssoula Staikou
First posted: 2018-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for total knee arthroplasty

Exclusion Criteria:

* Previous operation on same knee
* Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol
* BMI above 32
* Serious psychiatric, mental and cognitive disorders
* Language barrier
* Block failure
* Chronic opioid, gabapentinoid use
* Severe kidney disfunction

Primary outcomes:
measure: NRS scores
timeFrame: 48 hours
measure: Morphine consumption
timeFrame: 24 hours
measure: Chronic pain
timeFrame: 6 months
Secondary outcomes:
measure: Delirium occurence
timeFrame: 48 hours
measure: Range of knee motion
timeFrame: 48 hours
measure: Complications
timeFrame: 48 hours
measure: Patient mobilization
timeFrame: 5 days
measure: Patient satisfaction
timeFrame: 48 hours
measure: Joint function
timeFrame: 6 months
measure: Intestinal function
timeFrame: 5 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Asklepieion Hospital of Voula
Study officials:
References: