louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03259906: Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate
Official title: Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Distal Intra-articular Radius Fracture With a Dorsal Tilt
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 12
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite the absence of consensus, in recent years, the use of open reduction associated with internal plate fixation has considerably developed. Indeed, this therapeutic option allows a more anatomical reduction and stable fixation.

First-generation posterior plates presented complications related to the size of the plate, notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates has reduced these complications.

In the literature, few studies have compared these two techniques in terms of functional and radiological outcomes. The hypothesis of this research is that osteosynthesis using a posterior plate is more effective than that with an anterior plate in terms of functional recovery in patients older than 45 years.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided written informed consent
* Patients older than 45 years
* Patients presenting a closed intra-articular fracture of the distal radius with a dorsal tilt (stages B2, C1, C2 and C3)

Exclusion Criteria:

* Adults under guardianship
* Patients without national health insurance cover
* Pregnant or breast-feeding women
* Patients presenting other injuries in the same upper limb
* Patients presenting injuries of the wrist or hand (scapholunate injury, fracture of the carpal bone or fingers)
* Pre-trauma paralysis of the limb
* Open fracture
* Fracture with palmer tilt or extra-articular

Primary outcomes:
measure: Evaluation of functional recovery using the DASH questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05540106: Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department
Official title: Impact of Art Therapy on Self-Reported Pain and Anxiety Scores of Patients Waiting to Be Seen in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Pain
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, four-armed prospective interventional study that will test the effect of nature-based coloring activities on patients' pain and anxiety scores during their ED visit. The study will consist of three intervention groups and one active control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research is to assess the effects of engaging in coloring activities on patients' self-reported pain and anxiety scores while they wait to be seen by a physician in an emergency department (ED). The current literature on patient visits in the ED highlights the significance of anxiety, stress, and frustration in patient experiences, especially when accounting for long wait times before the physician-patient encounter. The study will address this common problem by looking at the potential impact of nature-themed or geometric shape coloring activities on the ED patient experience as it relates to self-reported anxiety and pain scores. Given that long wait times are increasingly being reported across the country, this study may offer a possible meaningful low-budget, low-resource intervention which could be offered to patients.


Eligibility criteria: Inclusion Criteria:

* Triage Pain Score \> 3
* Age \>18
* Able to provide informed consent
* English-speaking
* without concern for aggressive behavior
* Glasgow Coma Scale (GCS) of 15
* Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score \> 6

Exclusion Criteria:

* Concern for aggression risk, including active concern for suicidal or homicidal ideations
* Glasgow Coma Scale (GCS) \<15
* triage acuity requiring critical care evaluation

Primary outcomes:
measure: Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Score
timeFrame: 8 hours
measure: Numerical Pain Score
timeFrame: 8 hours
Secondary outcomes:
measure: Color Selection
timeFrame: 8 hours
measure: Patient impression of activities
timeFrame: 8 hours
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
References:
Clinical trial NCT02414906: Goal Directed Therapy for Acute Kidney Injury in Critical Ill Patients
Official title: Goal Directed Therapy in the Early Phase of Acute Kidney Injury in Critical Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Kidney Injury
Keywords: Goal Directed Therapy
Acute Kidney Injury
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Hospital de Base
name: Hospital do Servidor Publico Estadual
name: University of Sao Paulo
First posted: 2015-04-13
Enrollment: 99
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: Acute kidney injury (AKI) is a frequent complication in critically ill patients admitted to intensive care unit (ICU) and it is associated with increased morbimortality.

There is evidence that perioperative hemodynamic optimization decreases the incidence of AKI in the post operative phase in high-risk patients. We aimed to evaluate if the use of a goal-directed therapy to increase oxygen delivery in the early phase of acute kidney injury can decrease the prevalence of patients with acute renal failure.

Detailed description: Randomized, controlled, multicenter study.The intervention group was monitored with Flo Trac/Vigileo and optimized with fluid challenges, dobutamine and blood transfusion, if necessary, to maintain a IDO² ≥600ml/min/m² during 8h. The control group was treated according to the discretion of the attending physician.

Eligibility criteria: Inclusion Criteria:

* Patients admitted in the Intensive Care Unit with Acute Kidney Injury (AKI) classified as AKIN 1 (increase in serum creatinine ≥0.3 mg/dL and/or urine output less than 0.5 ml/kg/h over 6 hours) for less than 12 hours.

Exclusion Criteria:

* ICU length of stay \>10 days, nefrectomy, chronic kidney disease undergoing hemodialysis, baseline creatinine ≥4 mg/dL, life expectance ≤ than 1 month, pregnancy, severe arrhythmia, severe heart failure (≤ III, NYHA), acute myocardial infarction (AMI)

Primary outcomes:
measure: acute kidney injury
timeFrame: 2 months
Secondary outcomes:
measure: death
timeFrame: 2 months
Other outcomes:
measure: lenght of stay
timeFrame: 2 months
Locations:
Study officials:
References:
citation: Amendola CP, Silva-Jr JM, Carvalho T, Sanches LC, Silva UVAE, Almeida R, Burdmann E, Lima E, Barbosa FF, Ferreira RS, Carmona MJC, Malbouisson LMS, Nogueira FAM, Auler-Junior JOC, Lobo SM. Goal-directed therapy in patients with early acute kidney injury: a multicenter randomized controlled trial. Clinics (Sao Paulo). 2018 Oct 29;73:e327. doi: 10.6061/clinics/2018/e327.
Clinical trial NCT05533606: Risk Factors and Machine Learning Model for Beta-Lactam Drugs Related Acute Kidney Injury
Official title: Analysis of Risk Factors of Beta-Lactam Drugs Related Acute Kidney Injury in Hospitalized Patients and Developments of Machine Learning Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Beta-Lactam Antibiotic Toxicity (Diagnosis)
Keywords: Beta-Lactam drugs
Acute kidney injury
Pharmacoepidemiology
Miss diagnosis
Risk factors
Logic regression
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 19000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients were included if received treatment with β-lactam drugs and discharged from the hospital between January 1, 2018 and December 31, 2020

Brief summary: Acute kidney injury (AKI), also known as acute kidney failure (ARF), is a common and complex kidney disease in clinic and an important factor related to poor prognosis of patients in clinic. In the present study, a single-center retrospective study was conducted in our center. The clinical data of hospitalized patients received β-Lactam drugs from January 2018 to December 2020 was retrospectively analyzed. The multiple logistic regression analysis suggested that complicated with hypertension, anemia, pneumonia, shock, sepsis, heart failure, combined use of proton pump inhibitors (PPI), angiotensin-converting enzyme inhibitor (ACEI), angiotensin Ⅱ receptor antagonist (ARB) were independent risk factors for AKI related to β-Lactam drugs. In clinical practice, patients with acute kidney injury risk factors should be closely monitored for changes in their blood creatinine and urine output to avoid acute kidney injury. For patients who have suffered from acute kidney injury, the cause should be removed in time and corresponding symptomatic treatment should be given.


Eligibility criteria: Inclusion Criteria:

* All inpatients who used β-lactam drugs during hospitalization
* Hospital stay ≥ 48h
* Age ≥18 years
* There are two or more blood creatinine tests during hospitalization

Exclusion Criteria:

* Hospital stay \< 48h
* Age \<18 years
* Glomerular filtration rate (GFR)\< 30ml/min/1.73m2 within 48 hours after admission
* AKI was diagnosed on admission
* Less than two Scr test results during hospitalization
* The Scr values were always lower than 40 μmol/L during hospitalization
* Cases with incomplete medical history information

Primary outcomes:
measure: The incidence of acute kidney injury in hospitalized patients treated with β-lactam drugs
timeFrame: Through study completion，up to half a year.
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Xiao Li，MD
state: Shandong
Study officials:
References:
Clinical trial NCT03317106: the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients
Official title: the Prospective Study on the Incidence and the Association Between Motor Subtypes and Outcome of Delirium in Ischemic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Cerebral Infarction
Lead sponsor: Chungnam National University Hospital
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 943
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cerebral infarction patients who admit to stroke unit Chungnam National University Hospital.

Brief summary: this study examines the incidence of newly developed delirium in patients who admit to university hospital stroke unit for cerebral infarction, and analyze the association between delirium motor subtypes and short-term outcome in post-stroke delirium patients.


Eligibility criteria: Inclusion Criteria:

* All cerebral infarction patients who admit to stroke unit Chungnam National University Hospital.

Exclusion Criteria:

* Any patients who refuse to enroll the study.
* Any patients who admit to Intensive Care Unit(ICU), because ICU is well-known for precipitating delirium.

Primary outcomes:
measure: mean K-DRS-R98 score
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Munhwa-ro 282, Jung-gu
Study officials:
affiliation: Professor
name: Jeonglan Kim
role: STUDY_CHAIR
References:
Clinical trial NCT02496806: The Absorption and Metabolism of Seaweed Polyphenols in Humans
Official title: Seaweed Derived Anti-inflammatory Agents and Antioxidants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Polyphenols
Absorption
Metabolism
Phlorotannins
Seaweeds
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: University of Ulster
First posted: 2015-07-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Brown seaweeds are a rich source of phlorotannins, a characteristic class of polyphenols which are unique to seaweeds of this type and can comprise 5 to 15 % of the dried weight. Unlike other classes of polyphenols, there is a lack of knowledge regarding phlorotannins and their bioavailability and bioactivity. The purpose of this study is to investigate the absorption and metabolism of seaweed polyphenols in humans. As part of an EC project (SWAFAX), an acute clinical intervention will be conducted to investigate the metabolism/ bioavailability of brown seaweed phlorotannins. Urine and plasma samples from 24 healthy volunteers that consumed a seaweed capsule containing polyphenols will be collected before and after the intervention. Data emanating from this project will provide strong scientific evidence for bioavailability and health promoting activity of a seaweed polyphenol extract in human volunteers.


Eligibility criteria: Inclusion Criteria:

* Good general health
* Body Mass Index of 18-30 Kg/m2

Exclusion Criteria:

* Inability to swallow capsules
* Smoking
* Alcohol intake of \>21 units/wk
* Blood pressure \> 150/90 mmHg
* Any dietary restrictions or weight reducing diet
* Vegetarian
* Heamoglobin levels\< 125 g/l for male, \< 110 g/l for female,
* Gamma GT levels \> 80 IU/l
* Cholesterol levels \> 6.5 mmol/l
* Myocardial infarction or stroke in the previous 12 months
* Gastrointestinal disease or chronic gastrointestinal disorders
* Reproductive disorder
* Blood-clotting disorder
* Metabolic disorders
* Lipid-modifying medication
* Blood clotting mdication
* Antibiotic medication in previous 3 months before study
* Lactation
* Pregnancy
* Females of childbearing potential and not using effective contraceptive precautions

Primary outcomes:
measure: Seaweed polyphenol metabolites in urine
timeFrame: 24 hours
measure: Seaweed polyphenol metabolites in plasma
timeFrame: 24 hours
Secondary outcomes:
measure: Citokine levels in plasma
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05105906: Post-operative Delirium (POD) in Patients Undergoing Hip Fracture Surgery
Official title: Post-operative Delirium (POD) Assessment in Patients Undergoing Hip Fracture Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Cognitive Dysfunction
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 270
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All men and women over the age of 65 with clinical-radiological hip fracture presence will be enrolled

Brief summary: The primary endpoint of the study is the appearance of Post Operative Delirium within the first 3 months.

The secondary endpoints are the development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time (including rehabilitation performed within the Polyclinic).. The analysis of the risk factors of POD and their correlation with the development of POCD/Dementia in the post-surgery period will provide important information for the optimization of the management path of these patients at an individual level , with inevitable repercussions on the possibility of reintegration into social and family life


Eligibility criteria: Inclusion Criteria:

* Age \> 65
* Clinical - radiological presence of hip fracture

Exclusion Criteria:

* Age \<65

Primary outcomes:
measure: Appearance of POD within the first 3 months
timeFrame: 3 months assessment
Secondary outcomes:
measure: Development of POCD, dementia of any type of new onset at 12 months, mortality at 30 days, postoperative hospitalization time
timeFrame: 12 months assessment
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Giuliano Ferrone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01764906: The Clinical Study of Novosis in Posterolateral Fusion
Official title: The Clinical Study to Evaluate the Efficacy and Safety of Novosis in Posterolateral Fusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posterolateral Fusion
Lead sponsor: BioAlpha Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 evaluate the efficacy and safety of Novosis in posterolateral fusion


Eligibility criteria: Inclusion Criteria:

* 18\~80 aged patients needed single-level posterolateral fusion at L1\~S1
* A subject who provided written informed consent to participate in this study

Exclusion Criteria:

* Patients with BMD T-score \< -3.0
* Women who are pregnant or plan to be pregnant within study period

Primary outcomes:
measure: Fusion grade by CT assessments after surgery
timeFrame: 24 weeks
Secondary outcomes:
measure: Fusion grade by Radiographic assessments after surgery
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References:
Clinical trial NCT05802706: The Biomechanical Study of Diseased Human Carotid, Femoral and Abdominal Aortic Tissue
Official title: The Biomechanical Study of Diseased Human Carotid, Femoral and Abdominal Aortic Tissue
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Diseases
Lead sponsor: University Hospital of Limerick
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 300
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 eligible for peripheral endarterectomy of the carotid/femoral artery or abdominal aortic aneurysm surgery to remove artery blockage will be invited to take part in this study with no restrictions on patient type.

Brief summary: This cross-sectional study aims to ascertain the mechanical properties of human carotid/femoral atherosclerotic plaque and abdominal aortic aneurysm tissue and correlate tissue mechanics with novel blood-based biomarkers of cardiovascular calcification.

Detailed description: The study is a non-randomised, controlled, cross-sectional study of diseased human carotid, femoral and abdominal aortic tissue.

Eligibility criteria: Inclusion Criteria:

* Patients with arterial plaque undergoing treatment where the plaque tissue will be surgically removed as per the usual peripheral endarterectomy procedure.
* Able to provide informed consent.

Exclusion Criteria:

* Patients that are unable to give informed consent.
* Seriously ill/unconscious patients.

Primary outcomes:
measure: Calcification feature classification
timeFrame: 10 years
measure: Biomarker Analysis
timeFrame: 10 years
Secondary outcomes:
measure: Cardiovascular Health Critical Mass
timeFrame: 10 years
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University Hospital Limerick
Study officials:
References:
Clinical trial NCT00526006: PPI-Rebound-Trial. A Study of the Clinical Relevance of the Acid Rebound Phenomena
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy
Keywords: Clinical significance of the acid rebound phenomenon after withdrawal of treatment with a PPI
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2007-09-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The acid secretion in the stomach seems to increase after withdrawal of min. 8 wks of treatment with a PPI (protonpump inhibitor) It is unknown if this acid rebound phenomenon is of clinical significance. In a doubleblinded and placebocontrolled study healthy volunteers are randomized to treatment with placebo or PPI + placebo. Gastrointestinal symptoms are scored once a week and.


Eligibility criteria: Inclusion Criteria:

* 18 years +

Exclusion Criteria:

* Dyspepsia, heartburn og acid regurgitation within the preceeding 4 weeks
* Previous treatment with PPI og H2RA
* Previous contact to doctor or hospital because of dyspepsia or reflux
* Pregnancy or breast feeding

Primary outcomes:
measure: Symptom scores in the reflux part of the GSRS after withdrawal of active treatment in the actively treated group versus the placebo group
Secondary outcomes:
Other outcomes:
Locations:
city: Koge
country: Denmark
facility: University Hospital Køgw
Study officials:
affiliation: University Hospital Køge
name: Christina Reimer, MD
role: PRINCIPAL_INVESTIGATOR
References: