louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01376544: Trial of Weaning by Synchronized Ventilation
Official title: Randomised Trial Comparing Assist Control Ventilation to Pressure Support Ventilation During Weaning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Respiratory Failure
Keywords: Neonate
Weaning
Assist control ventilation
Pressure support ventilation
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During assist control ventilation and pressure support ventilation (PSV), the start of ventilator inflation is determined by the start of the infant's inspiratory effort. During PSV, termination of inflation is determined by the level of the infant's inspiratory flow. In a randomized trial, no significant differences were found between assist control and pressure support ventilation with regard to the duration of weaning, time to successful extubation, work of breathing, rate of asynchrony and level of respiratory muscle strength.

Detailed description: Objectives: To test the hypothesis that the duration of weaning would be shorter using assist control ventilation (ACV) rather than pressure support ventilation (PSV). To determine if any differences in the duration of weaning reflected differences in the work of breathing, the rate of asynchrony or the level of respiratory muscle strength.

Patients and methods: Thirty-six infants, median gestational age 29 (range 24 to 39) weeks, were randomized to weaning by either ACV or PSV. The duration of weaning was recorded. At baseline (study entry), 24 hours after entering the study and immediately prior to extubation, the work of breathing was assessed by measuring the transdiaphragmatic pressure time product (PTPdi), thoracoabdominal asynchrony (TAA) was assessed using respiratory inductance plethysmography and respiratory muscle strength measured by recording the maximal inspiratory pressure produced during an airway occlusion during crying (Pimax). Immediately prior to extubation, the level of active expiration was also assessed.

Eligibility criteria: Inclusion Criteria:

* Ventilated neonates less than 14 days of age

Exclusion Criteria:

* Congenital heart disease, hypoxic ischaemic encephalopathy

Primary outcomes:
measure: To determine which mode of ventilation was associated with a shorter duration of weaning.
timeFrame: Up to 28 days after birth
Secondary outcomes:
measure: Change in Work of breathing thoraco-abdominal asynchrony respiratory muscle strength
timeFrame: Baseline, 24 hours and prior to extubation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Neonatal Intensive Care Unit
Study officials:
affiliation: King's College London
name: Anne Greenough, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03950544: The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
Official title: How to Optimize the Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Antibiotic Resistant Infection
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The infection of carbapenem resistant klebsiella pneumoniae (CRKP) is increasingly serious.Based on the early experimental basis and relevant research background,this study intends to separate and purify the CRKP from the bronchoalveolar lavage fluid (BALF) of the clinical patients.Designed by checkerboard assay and time-kill assay(TKA)，this study can explore the best combination therapy based on carbapenems.

Detailed description: 1. Collect the BALF from patients diagnosed with CRKP infection in surgical intensive care unit（SICU）of Shanghai 10th people's hospital.
2. Separate and purify the BALF. Divide each CRKP into four treatment groups based on meropenem.

3.1 By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results.

3.2 Observe the effect of two antibiotics on the growth of CRKP by TKA.

4.By the above two invitro experiments, analyze the data of the experimental results and get the best combination therapy based on carbapenems.

Eligibility criteria: Inclusion Criteria:

* age from 18 to 90.
* infected with CRKP firstly .

Exclusion Criteria:

* APACHE II score \> 35
* Vital signs are unstable
* Unable to tolerate fiberoptic bronchoscopy

Primary outcomes:
measure: the fractional inhibitory concentration index (FICI)
timeFrame: 24hours-36hours
Secondary outcomes:
measure: the time-kill assay (TKA)
timeFrame: 36hours-48hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th people's hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Li Hua, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Du Y, Mu S, Liu Y, Yuan Y, Zhu Y, Ma L, Wang Q, Zhu Z, Liu Y, Wang S. The Genomic Characterization of KPC-Producing Klebsiella pneumoniae from the ICU of a Teaching Hospital in Shanghai, China. Infect Drug Resist. 2022 Jan 11;15:69-81. doi: 10.2147/IDR.S343673. eCollection 2022.
Clinical trial NCT01675544: PRospective Evaluation of Electrocardiographic Voltage Changes and Six Minute Walk Test for Predicting Readmissions in Heart Failure (PREEMT-HF Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted with acute decompensated heart failure

Brief summary: Purpose of the study: To identify whether Electrocardiographic QRS voltage changes (between admission and pre-discharge) and pre discharge 6- minute walk test in patients admitted with acute heart failure can identify patients at risk for recurrent admissions for heart failure.

Detailed description: Primary Objective Determine the ability of EKG voltage changes and pre discharge 6-minute walk test (6-MWT) to predict repeat heart failure hospitalization (HFH) in patients admitted with acute decompensated heart failure (ADHF).

Secondary Objectives

1. Determine the ability of EKG voltage changes and pre discharge 6-MWT) to predict a composite of 1 year mortality and HFH in patients admitted with ADHF.
2. Determine the ability of proportionate pulse pressure, orthostatic blood pressure changes and pre discharge inferior vena cava (IVC) diameter by portable ultrasound to predict HFH and mortality

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age, admitted with a diagnosis of ADHF and fulfilling the following criteria:

  1. Evidence of systemic congestion (manifested by any 2 of the following criteria: jugular venous distension, edema, pulmonary rales, Left ventricular S3, or radiographic evidence of pulmonary venous congestion)
  2. Elevated Brain natriuretic peptide
  3. Need for at least 1 dose of intravenous loop diuretic

Exclusion Criteria:

* Cardiogenic shock, Acute coronary syndromes (patients with mild elevation in troponin related to heart failure will not be excluded), patients who are admitted for another principal problem and develop ADHF in the hospital, pregnant females, end stage renal disease on hemodialysis, expected survival \< 6 months.

Primary outcomes:
measure: Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University
name: Venkata M Alla, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03167944: Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy
Official title: "Comparison of Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy: A Prospective Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Seroma
Keywords: Mastectomy
Seroma
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. In our study we want to compare the outcome between using the conventional electrocautery and the low thermal tissue dissection. We expected that the serum production should be lower in cases using low thermal system electrosurgery system.


Eligibility criteria: Inclusion Criteria:

* Female aged \>18 years old
* Patients that fulfill the indication of mastectomy
* Medium-sized breast volume (Breast weight \< 1500 grams)

Exclusion Criteria:

* Patients who cannot complete the informed consent
* Patients with ASA CLASS \> 3

Primary outcomes:
measure: Drainage volume after surgery
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Post operative Pain
timeFrame: Up to 24 weeks
measure: Patient's Hospital costs
timeFrame: up to 1 week
measure: Wound infection
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital
Study officials:
References:
Clinical trial NCT03452644: US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
Official title: Diagnostic Yield of Ultrasound-Guided Needle Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Neoplasm
Soft Tissue Sarcoma
Soft Tissue Mass
Soft Tissue Lesion
Keywords: US-CNB
Soft Tissue Mass
Soft Tissue Sarcoma
Soft Tissue Neoplasm
Soft Tissue Lesion
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll 350 patients who underwent US-CNB for soft tissue lesion at the Rizzoli Orthopaedic Institute

Brief summary: A retrospective evaluation of soft tissue tumors that have undergone core needle biopsy with US guidance (US-CNB)

Detailed description: The present study is designed to be the first step in the creation of an interdisciplinary platform collecting data on patients and procedures to provide a predictive tool to help physicians in the management of patients affected by a soft tissue lesion.

The primary aim of our work is to evaluate the diagnostic yield of US-CNB. The secondary aim is to exploit all the imaging data conventionally available at a Sarcoma Center before a biopsy on a soft tissue mass, to build a multiparametric model and score of prediction of malignancy, and eventually of biological behavior - grading.

Eligibility criteria: Inclusion Criteria:

* Patients undergone US-CNB for soft tissue lesions at the Rizzoli Orthopaedic Institute

Exclusion Criteria:

* Patients whose histological diagnosis is not available

Primary outcomes:
measure: Diagnostic yield
timeFrame: One year
Secondary outcomes:
measure: Prediction of malignancy
timeFrame: One year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: The Rizzoli Orthopaedic Institute
state: Bo
Study officials:
affiliation: The Rizzoli Ortopaedic Institute
name: Alberto Bazzocchi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00466544: Randomized Controlled Study of Plasmaknife Tonsillectomy Versus Monopolar Tonsillectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obstructive Tonsillar Hypertrophy
Tonsillitis
Keywords: Chronic tonsillitis
Recurrent tonsillitis
Lead sponsor: Children's Hospital of Michigan
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study objective is to provide prospective randomized controlled data on pediatric pain levels found in PlasmaKnife tonsillectomy and monopolar tonsillectomy.

Detailed description: This is a prospective, randomized controlled study to compare the efficacy of the Gyrus ACMI PlasmaKnife™ electrosurgical device used with the Gyrus ACMI Workstation versus monopolar electrosurgical device (i.e. Bovie®) for tonsillectomy.

The primary outcome will study the potential for reduced post-operative pain when the PlasmaKnife is used for tonsillectomy compared to a monopolar device. Secondary outcomes such as return to normal diet and activity as well as a range of complications including primary and secondary bleeding will be included in the study.

The study will involve approximately 100 patients at Children's Hospital of Michigan that meet the criteria for tonsillectomy (with or without adenoidectomy) for infected tonsils or airway obstruction.

The study will be documented through the use of Case Report Forms.

Eligibility criteria: Inclusion Criteria:

* Patient should be between the ages of 4 and 16 years old inclusive.
* Patient should meet criteria for tonsillectomy.
* Patient's guardian able and willing to complete patient diary and keep to the follow-up visit.
* Guardian able to understand English (written and oral).

Exclusion Criteria:

* Patient that has active medical implant(s) such as pacemaker, cochlear implant, etc.
* Patient has abnormal blood coagulation, history of easy bruising, bleeding disorders or uses anti-coagulants.
* Morbidly obese children (calculated BMI over 39)
* Patient that has history of malignancy or acute peritonsillar abscess
* Patient has Sickle Cell disease or is immunocompromised.
* Patient is pregnant or lactating.
* Active infection with fever greater than 101.5 degrees F.
* History of heart disease, diabetes or hypertension (with systolic blood pressure \> 160 mmHg).
* Craniofacial anomaly.
* Biopsy of tonsil needed to rule out neoplasm.

Primary outcomes:
measure: pain
Secondary outcomes:
measure: return to normal activity
measure: return to normal diet
measure: medication dose taken
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Children's Hospital
state: Michigan
Study officials:
affiliation: Detroit Children's Hospital
name: David Madgy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05650944: How Important Are Hematological Parameters in the Prognosis of Severe Covid-19 Patients?
Official title: Department of Infectious Disease and Clinical Microbiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Hemogram
NLR
MPV/PLT
MPV/PCT
Lead sponsor: Hisar Intercontinental Hospital
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study had 169 patients in all, including 44 women and 125 males

Brief summary: It is aimed to reveal the treatment and prognostic values by evaluating the differences in hematological parameters and indices, especially in dead Covid-19 cases.

Material Method: It is planned to retrospectively examine the hemogram parameters of 125 male, 44 female and 169 critical Covid-19 patients hospitalized between 01.03.2020 and 31.12.2021. Subjects were divided into 2 groups as deceased (77) and living (92) patients according to demographic data such as age and gender.

Statistical evaluation: All analyzes were SPSS 25.0, Kolmogorov Smirnov test was used to determine distribution, median and interquartile range (Tukey's Hinges Percentile) were used to summarize variables. The differences between the Independent-Samples Mann Whitney U Test and the data of the patient groups and the optimal cut-off values, sensitivity and specificity values will be determined by ROC analysis. It will be considered statistically significant when the p value is below 0.05 (with the two-tailed test)

Detailed description: The aim of this study is to examine the effectiveness of routine laboratory complete blood count parameters and rates as diagnostic and prognostic criteria in severe COVID-19.

Eligibility criteria: Inclusion Criteria:

1. Patients over the age of 18
2. Critical patients taken to intensive care
3. The length of stay in the ICU is more than 24 hours

Exclusion Criteria:

1) Patients under 18 years of age (2) Patients with hematological malignancies (3) The length of stay in the ICU is less than 24 hours.

Primary outcomes:
measure: Hematological parameters in the prognosis of severe Covid-19 patients.
timeFrame: 2020-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Hisar Hospital Intercontinental
Study officials:
affiliation: Istanbul Galata Universty
name: Ramazan Gozukucuk
role: STUDY_CHAIR
References:
Clinical trial NCT06334744: Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active.
Official title: Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncologic Complications
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 120
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: This project includes subjects affected by solid tumors undergoing active treatment and subjected to the SARS-CoV-2 vaccine belonging to MAC oncology clinics starting from the start of the vaccination campaign in fragile patients.

Brief summary: To evaluate the serum neutralizing antibody titre in cancer patients undergoing active treatment against variants (VOC) before and after the third dose of BNT162b2 COVID-19 vaccine.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years or older, regardless of gender;
2. Life expectancy (estimated by the treating doctor) ≥ 6 months;
3. Histological diagnosis confirmed solid neoplasm;
4. Under active treatment
5. Previous two doses of Pfizer anti-SARS-CoV-2 vaccine received (will be considered also patients who have completed the vaccination cycle with other mRNA vaccines - Modern-)
6. All participants subscribed and signed the informed consent form first of enlistment
7. Patients with a positive history of a previous diagnosis are also enrolled laboratory confirmed COVID-19
8. ECOG 0-2

Exclusion Criteria:

1. Inability to sign informed consent

Primary outcomes:
measure: Determination of the change in neutralizing antibodies against SARS-CoV-2 (CLIA method) towards VOCs before the third dose of COVID-19 vaccine and 21 days after the same.
timeFrame: 3 weeks
Secondary outcomes:
measure: Evaluation of the kinetics of neutralizing antibodies and anti-SARS-CoV-2 IgG titer (CLIA method) up to 52 weeks after the third dose of COVID-19 vaccine
timeFrame: 0, 3, 26, 52 weeks
measure: Evaluation of the incidence of virologically confirmed cases of VOC after administration of the third dose of vaccine.
timeFrame: 52 weeks
measure: Evaluation of the incidence of local and systemic adverse reactions (ARs), directly or indirectly linked to the vaccine, in an observation period up to 4 weeks later the third dose of vaccine.
timeFrame: 4 weeks
measure: Evaluation of the incidence of "New onset" immune-related adverse events (IRAEs), such as immune-related pruritus, rashes, hypophysitis, hepatitis, pneumonia, diarrhoea, colitis in patients undergoing immunotherapy.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Irccs San Matteo Pavia
state: PV
Study officials:
References:
Clinical trial NCT05539144: A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in IMRT for Head and Neck Cancer
Official title: A New Delineation Approach for Oral Cavity, Oropharynx, Larynx and Hypopharynx in Intensity-modulated Radiation Treatment for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Radiotherapy
Oropharynx Abnormality
Radiotherapy; Adverse Effect
Keywords: Oropharynx
Dosimetric parameters
Intensity-modulated radiation treatment（IMRT）
Head and Neck Cancer
Radiotherapy
Lead sponsor: Hebei Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER_GOV
First posted: 2022-09-14
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators tries a new method to delineating the oral cavity, oropharynx, larynx and hypopharynx, and use the head-and-neck region to test whether the method can to create a good IMRT plan, and alleviate the oral radiation injury, reduce the incidence of adverse reactions.

Detailed description: Purpose: To assess the dosimetric effect of new delineation approach for oral cavity, oropharynx, larynx and hypopharynx in intensity-modulated radiotherapy(IMRT) treatment planning for head and neck cancer.

Methods: Twenty head and neck cancer patients were treated by IMRT. Target volumes and several organs at risk were delineated with Corvus6．3 treatment planning system. An investigative IMRT plan was generated based on a standard treatment planning protocol, but used a new delineation approach for oral cavity, oropharynx, larynx and hypopharynx. Plans were exported to treatment planning system for quantitative analysis of dose volume parameters. Variables assessed included: maximum oral cavity, oropharynx, larynx and hypopharynx dose, equivalent uniform dose of the oral cavity, oropharynx, larynx and hypopharynx (EUD), mean oral cavity, oropharynx, larynx and hypopharynx dose, mean organs at risks (OARs) doses, and dose homogeneity inside the target volumes.

.

Eligibility criteria: Inclusion Criteria:

- patients with previously untreated of the head and neck cancer who received definitive IMRT at our institution

Exclusion Criteria:

-

Primary outcomes:
measure: Dose distribution
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Department of Radiotherapy, Hebei Province Hospital of Chinese Medicine
state: Hebei
Study officials:
References: