louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06496802: Prognostic Significance of Preoperative Nutritional Status on Postoperative Acute Kidney Injury
Official title: Prognostic Significance of Preoperative Nutritional Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Lung Resection Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injury
Pneumonectomy
Keywords: Acute Kidney Injury
lung resection surgery
malnutrition
prediction model
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 1880
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older patients (aged ≥ 65 years) who underwent lung resection surgery under general anesthesia at our Hospital between January 2020 and June 2024 were included in our study. Lung resection surgery included pneumonectomy , bilobectomy , lobectomy, segmentectomy, wedge resection/bullectomy.

Brief summary: The incidence of postoperative acute kidney injury (AKI) is high in patients undergoing lung resection surgery, especially in the elderly. Early identification of high-risk postoperative AKI patients can help develop prevention and treatment management strategies.

Detailed description: The goal of this retrospective study is to investigate the predictive value of preoperative nutritional status, as measured by three scoring systems - the geriatric nutritional risk index (GNRI), prognostic nutritional index (PNI), and controlling nutritional status (CONUT) score - on postoperative AKI in elderly patients under lung resection surgery.

Eligibility criteria: Inclusion Criteria:

1. aged ≥ 65 years
2. lung resection surgery including：pneumonectomy , bilobectomy , lobectomy, segmentectomy, wedge resection/bullectomy.

Exclusion Criteria:

1. patients with an American Society of Anesthesiologists (ASA) physical status V.
2. those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis).
3. those did not have sufficient data required for nutritional evaluation or AKI evaluation.

Primary outcomes:
measure: Postoperative acute kidney injury
timeFrame: Within 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00239902: Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
Official title: Two-year Extension of a One-year, Multicenter, Randomized, Partially-blinded Study of the Safety and Efficacy of FTY720 Combined With Corticosteroids and Full or Reduced-dose Cyclosporine, USP [Modified] (Novartis Brand) in de Novo Adult Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Transplantation
Keywords: Transplantation, kidney, and organ transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.


Eligibility criteria: Inclusion Criteria

- Completion of Core study

Exclusion Criteria

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: IA, IB, IIA, IIB or III diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
measure: Permanent resumption of dialysis within 36 months post transplant
measure: Surgical removal of graft within 36 months post transplant
measure: Death within 36 months post transplant
measure: Discontinuation within 36 months post transplant
Secondary outcomes:
measure: FEV1 , FVC, DLCO within 36 months post transplant
measure: Serum creatinine and estimated creatinine clearance within 36 months post transplant
measure: Absolute lymphocyte count within 36 months post transplant
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT02988102: Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma
Official title: Role of Concentration of Biomarkers S100B and NSE in Serum in Mild and Moderate Head Trauma Injury in Acute Phase in Relation to Head CT and Post Concusion Syndrome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biomarkers
Keywords: S100B, NSE
moderate brain trauma
mild brain trauma
Lead sponsor: University Clinical Centre of Kosova
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 2 groups pediatric and adult.

Brief summary: In pediatric age groups communication difficulties very sometimes may present further obstacles in obtaining a detailed injury history and early identification of TBI symptoms.

Most emergency management protocols are focused exclusively on the identification of the relatively small number of patients who may require operative intervention, as early surgery is believed to improve outcome.

Detailed description: However early rehabilitation can also be effective for the much larger number of patients who do not require surgery\[1\] In addition, Hall and others recently reported that low doses of ionizing radiation to the brain in infancy may influence cognitive abilities in adulthood. \[2\] Accordingly, increased serum concentrations of, for example S100B ( a calcium-binding protein present in high concentrations in glial cells) and neurone-specific enolase ( NSE: a cytoplasmatic enzyme occuring predominantly in neurones ) have been demonstrated to reflect the presence and severity of brain tissue damage in acute head injuries. \[3\] In both pediatric age and adults.

Eligibility criteria: Inclusion Criteria:

* Only head trauma without any other body injury

Exclusion Criteria:

* Blood thinner, hydrocephalus , previous brain infarcts, encephalopathy, birth trauma.

Primary outcomes:
measure: Role of concentration of biomarkers S100B and NSE in serum in mild and moderate head trauma injury in acute phase in relation to head CT and post concusion syndrome.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: Fatos Kelmendi
state: Kosovo Prishtina
Study officials:
References:
Clinical trial NCT02101502: Quality Assurance of Obstetrics and Gynecology Department
Official title: Quality Assurance of Obstetrics and Gynecology Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problems With Access to Health Care
Keywords: Healthcare,educational effectiveness, institutional capacity
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 2300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This work aimed to prepare the obstetrics and gynecology department for high education and health care accreditation.

Detailed description: For Institutional Capacity and Educational Effectiveness we have used a special questioner for assessment (Met or Not Met Questioner). For Quality Assurance System in Health-care we used a special questioner which contain several items each of them may be A ,B or C. A= structured standards, and are scored as M= Met or N=Not Met or NA=Not Applicable ,The B \&C standards are implementation standards . these standards are scored either on the number of observations , documentation of deficiencies , or non compliance with the standards.

Eligibility criteria: Inclusion criteria:

* Female patients attending the obstetrics and gynecology department
* Medical and assistant medical staffs
* institutional employees

Exclusion criteria:

* Female patients complaining from disorders not included in the obstetrics and gynecology department activities.
* Male patients.

Primary outcomes:
measure: Quality Assurance
timeFrame: One year and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Al-Azhar University (Assuit)
Study officials:
affiliation: Al-Azhar University
name: Mahmoud Edessy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Abd El-Naser Mohammad, MD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Manal Abd El-Aty, MD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Mahmoud Badawi, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT01772602: The National Amyotrophic Lateral Sclerosis Registry
Official title: The National Amyotrophic Lateral Sclerosis Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Lou Gehrig's Disease
Motor Neuron Disease
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
name: Centers for Medicare and Medicaid Services
First posted: 2013-01-21
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALS cases in the United States

Brief summary: The purpose of this registry is to (A) better describe the incidence and prevalence of Amyotrophic Lateral Sclerosis (ALS) in the United States;(B) examine appropriate factors, such as environmental and occupational, that may be associated with the disease; (C) better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and (D) better examine the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS.

Detailed description: The National ALS Registry's Research Notification System allows person with ALS to participate in clinical trials.

Eligibility criteria: Inclusion Criteria:

- U.S. citizens 18 years of age or older

Exclusion Criteria:

-

Primary outcomes:
measure: The National Amyotrophic Lateral Sclerosis (ALS) Registry
timeFrame: 1 year
Secondary outcomes:
measure: Risk factors of ALS
timeFrame: 1 year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: CDC
state: Georgia
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Paul Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173602: The Burden of Peripheral Artery Occlusion Disease and Associated Factors in Peritoneal Dialysis Patients
Official title: The Burden of Peripheral Artery Occlusion Disease and Associated Factors in Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Vascular Diseases
Keywords: Peritoneal Dialysis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The investigators want to evaluate the burden of peripheral artery occlusion disease in Taiwan peritoneal dialysis (PD) patients by using ankle-brachial pressure index (ABI) and toe-brachial pressure index (TBI). Furthermore, the investigators hope to demonstrate the possible casual factors of peripheral artery occlusion disease (PAOD) in PD patients.


Eligibility criteria: Inclusion Criteria:

* Receive stable peritoneal dialysis patients for more than 3 months

Exclusion Criteria:

* Active infection, malignancy and recent hospitalization

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chih-Kang Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01863602: Special Drug Use Investigation for LAMICTAL® (Long Term)
Official title: Special Drug Use Investigation for LAMICTAL (Long Term)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 850
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult (\>=15 to \<65 years) and pediatric (\>=2 to \<15 years) subjects with epilepsy with the following seizure type who use lamotrigine tablets

* Partial seizures
* Tonic-clonic seizures
* Generalized seizures of Lennox-Gastaut syndrome

Brief summary: The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (AED), and to confirm its efficacy.


Eligibility criteria: Inclusion Criteria:

* Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome
* Subjects who are treated with lamotrigine tablets

Exclusion Criteria:

* None

Primary outcomes:
measure: The incidence of adverse drug reactions
timeFrame: 1 year
measure: Occurrence of skin disorder after the start of treatment
timeFrame: 1 year
Secondary outcomes:
measure: Overall improvement of subjects' symptoms
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01481402: Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Left Ventricular Ejection Fraction (LVEF)
Official title: Liothyronine and Heart Failure. The Long Term Effect of Liothyronine on Heart Function, Body Composition and Metabolic Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Low T3 Syndrome
Keywords: Heart failure
Liothyronine
Low T3 syndrome
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose of the study is to examine if treatment with liothyronine increases left ventricular ejection fraction (LVEF) in patients with stable, chronic heart failure.

Detailed description: The patients are examined 3 times. At baseline, after 3 months and after 6 months.After the examination is performed, they begin the study medication while admitted at Dept. of Cardiology, Herlev Hospital, for cardiac monitoring.

Eligibility criteria: Inclusion Criteria:

* Patients with stable, chronic systolic heart failure
* T3 ≤1.4 nmol/l in two blood samples, TSH is to be normal
* LVEF ≤ 45 % on prior echocardiography

Exclusion Criteria:

* Established thyroid illness
* Atrial fibrillation/flutter
* More than 20% ventricular extrasystoles
* Severe chronic obstructive lung disorder
* Pregnancy. Pregnancy testing will be done for fertile women
* Age \< 18 years

Primary outcomes:
measure: left ventricle ejection fraction
timeFrame: 3 months
Secondary outcomes:
measure: Body composition
timeFrame: 3 months
measure: Quality of Life, questionaire
timeFrame: 3 months
measure: YKL-40, YNF-alpha, hsCRP and IL-6
timeFrame: 3 months
measure: RBP 4, HBA1C, adiponectin (high and low weight), glucose and HOMA-1
timeFrame: 3 months
measure: GDF 8, SHBG, CK and PINP
timeFrame: 3 months
measure: NT-proBNP, EDV and ESV
timeFrame: 3 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital, Dept. of Endocrinology
Study officials:
affiliation: Herlev Hospital, Dept. of Endocrinology
name: Jens Faber, MDSci
role: STUDY_DIRECTOR
References:
Clinical trial NCT01967602: Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support
Official title: Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Multi-organ Failure
Keywords: Acute respiratory distress syndrome (ARDS)
Extracorporeal membrane oxygenation (ECMO)
biomarker
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-10-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are admitted to National Taiwan University Hospital for acute respiratory distress syndrome needing ECMO placement.

Brief summary: The goal of this project is to find a marker expression that the investigators can use to trace symptom progression and develop a more efficient therapy to enhance ARDS patient survival rate and better post-ICU life quality.

Detailed description: The investigators will first identify acute respiratory distress syndrome (ARDS) patients receiving ECMO support in ICU at National Taiwan University Hospital, and then collect blood, urine and bronchioalveolar lavage fluid (BALF) samples at different time points: before setting up ECMO, 2, 6, 12, 24, 72 hours,5 and 14 days after ECMO installment, time to wean ECMO and the day removing ECMO and leaving ICU. From the samples, the free radicals, cytokines (IL-1, IL-6, IL-8, IL-18,tumor necrosis factor-α, transforming growth factor-β), and inflammasome- related markers, immune cell responses and other biochemical markers would be measured. The novel biomarkers to predict the outcome of the patient will be identified.

Eligibility criteria: Inclusion Criteria:

1. \>18 years old
2. ARDS, needing ECMO support

Exclusion Criteria:

1. pre-existing sepsis
2. pre-existing chronic renal failure (dialysis dependent), liver failure other diseases precluding chance of survival.

Primary outcomes:
measure: Mortality or multi-organ failure
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shuenn-Wen Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234102: Eagle AF (Atrial Fibrillation) - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation
Official title: Eagle AF - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Märkische Kliniken GmbH
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 160
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: The study aims to compare the results of pulmonary vein isolation (PVI) with a single technology approach in patients suffering from paroxysmal atrial fibrillation (PAF) with patients who have persistent AF of less than 3 months. Many studies have shown that electrical reconnection of the pulmonary veins following the index procedure can occur in up to 40% of targeted veins leading to a recurrence of PAF. Endoscopically guided laser ablation utilising the HeartLight system (CardioFocus Inc., USA) has been shown to be safe and effective and has also shown promising rates of durable isolation compared to point by point radio frequency techniques. However, the impact of employing this technique for patients with persistent AF has not yet been reported. The study hypothesis is that there will be no statistically significant difference between the results of PVI in the two groups of patients.


Eligibility criteria: Inclusion Criteria:

* failure of at least one specific class I or III antiarrhythmic drug (AAD)
* left atrial size \< 50 mm
* left ventricular ejection fraction \> 45%
* others
* specific for PAF: diagnosed with self-terminating episodes for no longer than 7 days
* specific for persistent AF: diagnosed with episodes of \> 7 days and \< 90 days

Exclusion Criteria:

* AF secondary to a reversible cause of non-cardiac origin
* uncontrollable hypertension
* left atrial thrombus
* others
* specific for PAF: more than 1 electrical cardioversion in the year prior to enrollment
* specific for persistent AF more than 4 electrical cardioversions in the year prior to enrollment

Primary outcomes:
measure: Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds
timeFrame: Between day 90 and 365 after index procedure
Secondary outcomes:
measure: Number of electrical cardioversions needed
timeFrame: 365 days after index procedure
Other outcomes:
Locations:
city: Köln
country: Germany
facility: St.Vinzenz-Hospital GmbH
state: NRW
city: Lüdenscheid
country: Germany
facility: Märkische Kliniken GmbH, Klinik für Innere Medizin III
state: NRW
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
Study officials:
affiliation: Klinikum Lüdenscheid Klinik f. Innere Medizin III
name: Bernd Lemke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02877602: Patient Understanding of LiverMultiScan
Official title: Patient Understanding of LiverMultiScan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Lead sponsor: Perspectum
Sponsor class: INDUSTRY
First posted: 2016-08-24
Enrollment: 101
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with experience of liver disease, either as a sufferer or carer.

Brief summary: This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them.

Detailed description: This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them. Each individual will receive at least an MRI scan (LiverMultiScan), with many also receiving a FibroScan (Transient Elastography). Patients will then undergo a focused qualitative interview, as well as filling out a questionnaire. The interviews will be thematically analysed and trends identified by significance.

Eligibility criteria: Inclusion Criteria:

* Individuals with experience of liver disease.
* Individuals over the age of 16.
* Individuals willing to give informed consent for participation in the study.

Exclusion Criteria:

* Individuals with any contraindication to magnetic resonance imaging.

Primary outcomes:
measure: Factors effecting MRI experience and understanding.
timeFrame: Immediately (within 1 hour) after undergoing the MRI scan, and receiving results feedback.
Secondary outcomes:
measure: Comparison of MRI to ultrasound scan in terms of patient experience.
timeFrame: Immediately (within 1 hour) after undergoing an MRI scan, and ultrasound (FibroScan) scan.
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford Centre for Clinical Magnetic Resonance Research (OCMR)
state: Oxfordshire
Study officials:
affiliation: Perspectum Diagnostics
name: Rajarshi Banerjee, BM BCh MRCP MSc DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: McKay A, Pantoja C, Hall R, Matthews S, Spalding P, Banerjee R. Patient understanding and experience of non-invasive imaging diagnostic techniques and the liver patient pathway. J Patient Rep Outcomes. 2021 Sep 10;5(1):89. doi: 10.1186/s41687-021-00363-5.