louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01837186: Empyema Following Pneumonectomy for Non Small Cell Lung Cancer (NSCLC)
Official title: Incidence, Risk Factors and Outcome of Empyema Following Pneumonectomy for Non Small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lung Cancer
Keywords: Surgery
NSCLC
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive pneumonectomies for Non Small Cell Lung Cancer (NSCLC) from the University Hospital Leuven from 1996 till 2012

Brief summary: Empyema following pneumonectomy for Non Small Cell Lung Cancer (NSCLC) is a known problem that occurs in about 2% of pneumonectomy patients.

Detailed description: The development of an empyema following pneumonectomy is a devastating complication, especially if associated with an underlying fistula. Whilst the perioperative mortality of pneumonectomy overall is now less than 5%, this rises to around 25% when complicated by empyema, and about 50% when associated with fistula. In addition, there is the morbidity and social cost of long-term drainage, chronic sepsis and often multiple operations.

Eligibility criteria: Inclusion Criteria:

* Pneumonectomy for NSCLC

Exclusion Criteria:

* Pneumonectomy for other reasons (infectious pathology, trauma, mesothelioma, ...)

Primary outcomes:
measure: Overall survival
timeFrame: 5 years from surgery
Secondary outcomes:
measure: incidence rate
timeFrame: 1 and 5 years from surgery
Other outcomes:
measure: fast track treatment outcome
timeFrame: 5 years from surgery
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven, Dept. Thoracic Surgery
Study officials:
affiliation: UZ Leuven, Dept. Thoracic Surgery
name: Paul De Leyn, PhD; MD
role: STUDY_DIRECTOR
affiliation: University Leuven
name: Arnaud Colle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06717386: Pelvic Osteotomy in Bladder Exstrophy
Official title: Modified Diagonal Pelvic Osteotomy and External Fixator in the Surgical Treatment of Bladder Exstrophy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bladder Exstrophy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study focuses on the surgical treatment of bladder exstrophy, a congenital condition where the bladder is located outside the body. It examines the use of modified diagonal pelvic osteotomy combined with an external fixator as a treatment approach. This method aims to improve pelvic support and facilitate proper bladder reconstruction. The study likely evaluates the outcomes, complications, and overall effectiveness of this surgical technique in enhancing patient quality of life and functional results. Key findings may include insights into recovery times, rates of successful bladder closure, and potential long-term benefits for patients.


Eligibility criteria: Inclusion Criteria:

1. age: all cases of delayed exstrophy repaior
2. sex : both gender
3. children who received no operative treatment befor

Exclusion Criteria:

1. previous pelvic surgery
2. sever comorbidities

Primary outcomes:
measure: symphyseal diastaisis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT05681286: CRP to Serum Albumin Ratio in Type 2 DM é Diabetic Nephropathy
Official title: C-reactive Protein to Serum Albumin Ratio in Type 2diabetic Patients With Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 DM /Diabetic Nephropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 2 DM patients

Brief summary: we aimed to compare C-reactive protein to serum albumin ( CAR) level of the T2DM patients with DN to those T2DM without DN

Detailed description: Diabetic Nephropathy (DN) is a serious complication of Diabetes Mellitus associated with chronic and low-grade inflammatory burden affects around 30 % of diabetic patients It is the leading cause of end-stage renal failure worldwide and associated with cardio vascular diseases and increases mortality of diabetic patients It characterized by persistent albuminuria, raise in arterial blood pressure ,decrease in glomerular filtration rate (GFR) It associated with chronic low grade inflammation that's leads to increase glucose and activities inflammation Despite of the pathogenesis of DN is multifactorial, but local inflammatory process may result from both the metabolic and hemodynamic affection seen in DN sustained diabetes-related metabolic and haemodynamic perturbations can induce subclinical low-grade renal inflammation and drive kidney from repair response to damage process, eventually to renal fibrosis Chronic inflammatory processes not only play a principle role in the progression of micro vascular but also macro vascular complications in type 2 diabetes mellitus. An association between low -grade inflammation and type 2 diabetes has been described in recent studies .C- reactive protein to serum albumin ratio has attracted great attention recently , and used as biomarker in detection disease severity

, since type 2 Diabetes Mellitus and Diabetic Nephropathy(DN) is associated with low grade inflammation in recent studies. In this study investigator presume that C-reactive protein to serum albumin ratio ( CAR )levels could be associated with the progression of DN in patients with T2DM.

Eligibility criteria: Inclusion Criteria All type 2diabetic patients

Exclusion Criteria:

* Type 1 diabetes is , patient t with liver cirrhosis, patient with active infection ,pregnant women,patients with cancer

Primary outcomes:
measure: C-reactive protein to serum albumin ratio in type 2diabetic patients with diabetic nephropathy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assuit u
name: Salah Argoon
role: STUDY_CHAIR
affiliation: Assiut University
name: Alshaimaa sayed
role: STUDY_CHAIR
References:
Clinical trial NCT01454986: Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Administration, Sequential-Cohort Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of ALXN1007 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy subjects
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-19
Enrollment: 64
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose of ALXN1007 in healthy volunteers.

Detailed description: All subjects will be screened for eligibility after providing signed informed consent. Once a subject is determined to be eligible, the subject will be vaccinated with the quadrivalent meningococcal conjugate vaccine at least two weeks prior to dosing, if applicable. A total of 7 dose cohorts will be enrolled sequentially and randomized to receive ALXN1007 or placebo. Subjects will receive ALXN1007 or placebo at the clinic and be kept at the clinic for a total of 4 days for observation and completion of the required study tests.

The subjects will return for 8 additional clinic visits to complete the required study tests over the next 86 days. The total duration of the study is 90 days from the day of dosing with ALXN1007 or placebo.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals 25 to 55 years of age with documented vaccination with MCV4.

Exclusion Criteria:

* Abnormal renal or liver function.
* History of meningococcal disease.
* History of Guillain-Barre syndrome.
* Known infection with HIV or Hepatitis B or C.

Primary outcomes:
measure: Safety and tolerability of a single dose of ALXN1007.
timeFrame: Up to 90 days
Secondary outcomes:
measure: PK parameters of ALXN1007
timeFrame: Up to 90 days
measure: PD parameters of ALXN1007
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: PAREXEL Baltimore EPCU
state: Maryland
Study officials:
References:
Clinical trial NCT02117986: Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
Official title: Clinical and Microbiological Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gram Negative Bacterial Infections
Keywords: critically ill patients
colistin dosing
multidrug resistant bacteria
Lead sponsor: Hospital Barros Luco Trudeau
Sponsor class: OTHER
Collaborators: name: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
First posted: 2014-04-21
Enrollment: 200
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: The study hypothesis is that the loading dose of intravenous colistin (6 million of international units) is associated with greater clinical and microbiological efficacy, and reduced mortality of critically ill patients infected by multidrug resistant Gram- negative bacilli, compared to a scheme without loading dose.

Detailed description: It is a prospective, multicenter, randomized, controlled study to evaluate a scheme with and without a loading dose of 6 million international units of colistin, followed by a maintenance dose of 3 million international units every 8 hours intravenous. The study should be conducted in 3 hospitals in Chile, in critically patients presenting infection by multidrug Gram-negative bacteria and requiring be treated with colistin for at least 48 hours. The objectives of the study are: to evaluate the clinical and microbiological response, and mortality.

Eligibility criteria: Inclusion Criteria:

* patient hospitalized in critical care units
* patient infected by multi drug resistant Gram negative bacteria susceptibly only to colistin
* source of infection: blood, respiratory, intra abdominal or urinary

Exclusion Criteria:

* pregnant or breastfeeding patients
* patient with a history of hypersensitivity to colistin

Primary outcomes:
measure: Percentage of patients with clinical response to treatment
timeFrame: up to 1 week
measure: percentage of patients with microbiological response
timeFrame: up to 1 week
measure: mortality
timeFrame: during their stay in the intensive care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Barros Luco Trudeau
state: Region Metropolitana
city: Puerto Montt
country: Chile
facility: Hospital de Puerto Montt
Study officials:
affiliation: Hospital Barros Luco Trudeau
name: Loreto Rojas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05598086: Anti-fibrinolytic and Anti-inflammatory Effects of Local Infiltration of Tranexamic Acid in Patients With Calcaneal Fractures
Official title: Anti-fibrinolytic and Anti-inflammatory Effects of Local Infiltration of Tranexamic Acid in the Post-operation of Displaced Intra-articular Calcaneal Fractures: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tranexamic Acid
Fibrinolysis
Inflammatory
Fracture
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background. Consensus is lacking regarding the use of tranexamic acid (TXA) in calcaneal fracture surgery. This study aims to investigate the hypothesis that local infiltration of TXA in the post-operation would maintain hemoglobin (Hb) level, reduce incision drainage volume and risk of infection in patients with displaced intra-articular calcaneal fractures. Methods. A total of 120 patients with displaced intra-articular calcaneal fractures who received extensible lateral L-shaped approach were included in this trial and equally randomized to receive one single dose of 1g TXA or 1g normal saline after closing incision. The demographic data and fracture characteristics, intra-operative indicators, laboratory tests and Visual Analogue Scale (VAS) scores, incision drainage volume, and incision-related complications were collected and compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* adult patients with age of eighteen years or older;
* diagnosis of closed and unilateral displaced intra-articular calcaneal fracture;
* agreement to receive one of the two treatment strategies;
* agreement to participate in regular follow-up after surgery

Exclusion Criteria:

* open calcaneal fractures;
* polytrauma of the ipsilateral lower limb;
* systemic inflammatory or infectious diseases;
* previous history of calcaneal fracture or bone tumor;
* allergies to drugs used, or refused to accept the specified treatment strategy.

Primary outcomes:
measure: Incision drain output (mL)
timeFrame: 2 days
measure: Outcomes of laboratory test
timeFrame: 4 days
measure: Outcomes of laboratory test
timeFrame: 4 days
measure: Outcomes of laboratory test
timeFrame: 4 days
Secondary outcomes:
measure: Incidence of surgical related complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
Study officials:
References:
Clinical trial NCT05887986: Management of Dyspnea: Use of Hand Held Fan
Official title: Management of Pulmonary Toxicity-related Dyspnea: Effect of Hand-held Fan Airflow Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
dyspnea
fan therapy
comfort
oncology nursing
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled experimental study
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research is planned as a randomized controlled experimental study to determine the effect of air stimulation to the face with a hand fan in the management of dyspnea in lung cancer patients. The universe of the research was carried out between December 2022 and February 2024, Izmir Provincial Health Directorate, University of Health Sciences, Suat Seren Chest Diseases and Surgery Training and Research Hospital will consist of cancer patients. Individuals who meet the sampling selection criteria from the specified universe will constitute the sample of the research. The sample number of the research was determined as a result of the power analysis made with the G\*power program. As a result of the power analysis, based on the t-test in independent groups, the minimum number of samples to be taken was 27 people for a group with 1:1 ratio, 0.80 power, effect value 0.80 and 0.05 significance level. Randomization of the sample will be ensured by accepting the first patient who applied to the outpatient chemotherapy unit randomly and with an appointment at the beginning of the study to the experimental group, and the next patient to the control group. Considering the losses, it is planned to work with 60 people, 30 people in the intervention group and 30 people in the control group. Individual Descriptive Information Form, Medical Research Council Scale (mMRC), Cancer Dyspnea Scale, Vital Signs Follow-up Form, Eastern Cooperative Oncology Group (ECOG) Performance Scale and General Comfort Scale Short Form will be used.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Diagnosed with lung cancer
* mMRC dyspnea scale score ≥2
* ECOG Performance Score score ≥3
* Volunteered to participate in the research

Exclusion Criteria:

* Having a fever of 38⁰C and above in the last 24 hours
* Inability to communicate cognitively and verbally
* Having a psychiatric illness

Primary outcomes:
measure: dyspnea level
timeFrame: baseline, day 3, and day 5
Secondary outcomes:
measure: comfort level
timeFrame: baseline, day 3, and day 5
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Provincial Health Directorate Health Sciences University Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
Study officials:
References:
Clinical trial NCT04022486: Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis
Official title: Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis : Description and Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis
Seizures
Hyponatremia
Keywords: Infant
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 805
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children hospitalized in the pediatric intensive care unit

Brief summary: Bronchiolitis is the leading cause of pediatric intensive care unit admission in infants. Seizures during bronchiolitis may be a neurological complication of respiratory viruses but also of the treatments. The investigating team's hypothesis is that the incidence of seizures is not so so uncommon in infants hospitalized in the pediatric intensive care unit for severe bronchiolitis.


Eligibility criteria: Inclusion Criteria:

* age \< 90 days
* hospitalization from January 1st, 2010 to April 30th, 2018 in the Pediatric Intensive Care Unit (PICU) of pediatric hospital in Lyon
* with bronchiolitis (clinical diagnosis according to American Academy of Pediatrics)

Exclusion Criteria:

* neurological history that may explain the occurrence of seizures
* significant congenital heart disease

Primary outcomes:
measure: : Incidence of seizure during bronchiolitis (before or during hospitalization in the pediatric intensive care unit)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Florent BAUDIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01571986: Improving Non-invasive Ventilation
Official title: Improving Non Invasive Ventilation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Failure
Keywords: NIV
acute respiratory failure
hypoxia
hypercapnia
non-invasive ventilation
hospital ward
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with acute respiratory failure treated with non-invasive ventilation who give informed consent about treatment of their clinical data

Brief summary: A single center, observational, prospective study to improve knowledge about non-invasive ventilation, obtaining data about compliance, efficacy, imaging in patients who already receive non-invasive ventilation as standard of care.


Eligibility criteria: Inclusion Criteria:

* treatment with non-invasive ventilation
* informed consent

Exclusion Criteria:

* refusal of informed consent

Primary outcomes:
measure: Number of patients requiring NIV in a large university hospital. Incidence of NIV failure (including patient compliance) and NIV related complications. Imaging (chest ultrasound) in a subgroup of patients before and after receiving NIV.
timeFrame: Outcome measures will be assessed every day and participants will be followed for the duration of hospital stay, an expected average of 1 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele di Milano
Study officials:
References:
citation: Cabrini L, Nobile L, Plumari VP, Landoni G, Borghi G, Mucchetti M, Zangrillo A. Intraoperative prophylactic and therapeutic non-invasive ventilation: a systematic review. Br J Anaesth. 2014 Apr;112(4):638-47. doi: 10.1093/bja/aet465. Epub 2014 Jan 19.
citation: Cabrini L, Plumari VP, Nobile L, Olper L, Pasin L, Bocchino S, Landoni G, Beretta L, Zangrillo A. Non-invasive ventilation in cardiac surgery: a concise review. Heart Lung Vessel. 2013;5(3):137-41.