louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05281705: Feasibility@48: Cross Sectional Study of Intensive Care Unit Mobility Practices Across the United Kingdom
Official title: Feasibility@ 48: A Cross Sectional Multi-centre Study of Intensive Care Unit (ICU) Mobility Practices Across the United Kingdom.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Rehabilitation
Keywords: Physiotherapy
Rehabilitation
Mobilisation
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
First posted: 2022-03-16
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient in level 2 \& 3 ICU beds in the UK

Brief summary: Intensive Care Unit (ICU) patients commonly experience muscle loss at a rate of 2-3% day. Traditionally, critically ill patients have been managed in bed, however current research suggests that prolonged bedrest cause mechanical silencing of the muscles and exacerbates this muscle wasting. This ICU acquired weakness (ICUAW) leads to poor functional outcome and higher mortality. Research suggests that early out-of-bed mobilisation should occur within 48-hours of ICU admission to militate against this risk, however, this is only achieved in 30% of cases. Common barriers to mobilisation are unstable blood pressure, ventilation, sedation and fatigue. It is plausible that 48-hours is an unrealistic timeframe for mobilisation.

The aim of this study is to explore the mobility practices on a given day in UK adult ICUs. The objectives are to:

1. Determine the level of mobility that is achieved by each patient on adult ICUs, on a given day in the UK.
2. Determine the typical physiological profile of patients on ICU that are both able and unable to participate in antigravity exercise
3. Determine the proportion of adult ICU admissions that achieve out of bed mobilisation in the first 48-72 hours
4. Explore clinician decision making about mobilisation

This is a multi-centre cross-sectional study on one-day only. Over a 24-hour period data will be collected for all ICU patients at the participating centres. The lead physiotherapist will record the highest level of mobility achieved that day, and the physiological parameters from clinical observations. The reasons for the level of mobility achieved will be ranked in order of importance. These data are routinely collected. Data will be anonymised.

Data will be analysed to determine feasibility of mobilisation at 48hours and develop a flow diagram of mobilisation decision-making.


Eligibility criteria: Inclusion Criteria:

All patients who are admitted to a participating ICU on the study day will be included

Exclusion Criteria:

None

Primary outcomes:
measure: The proportion of patients achieving a ICU mobility scale more than 3 on the day of the study
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT06069505: Detection of Azole Resistance Inducing Mutations on DNA Extracted Directly From Serum or Plasma of Immunocompromised Patients With an Invasive Aspergillus Infection Azole Resistance PCR Optimalization-study
Official title: Detection of Azole Resistance Inducing Mutations on DNA Extracted Directly From Serum or Plasma of Immunocompromised Patients With an Invasive Aspergillus Infection Azole Resistance PCR Optimalization-study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Aspergillosis
Keywords: invasive aspergillosis
PCR
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 haematology patients with a radiologically suspected invasive pulmonary aspergillosis and undergoing a bronchoalveolar lavage. After the BAL diagnostic tests have become available, confirmation of the suspected infection is expected in 25 patients and therefore 25 evaluable patients will remain. The investigators decided that another 50 patients should be included because only 25% had an invasive fungal infection after interim analysis of the first 50 patients included.

Brief summary: Invasive aspergillosis (IA) is the most common mould infection in immunocompromised patients with haematological disease. Voriconazole, a triazole, improves overall survival of patients with an IA and is the mainstay of therapy. Resistance of A. Fumigatus emerged as an important clinical problem and infections with azole resistant Aspergillus have a high mortality. Nowhere in the world, azole resistance is more prevalent than in the Netherlands. Rapid detection of resistance is key to improve the patient's outcome but fungal cultures take time and are often negative. The investigators aim to detect azole resistance associated mutations in fungal DNA extracted directly from serum or plasma to accelerate diagnosis and improve outcome of patients infected with azole resistant A. fumigatus.


Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Lung CT shows lesions that fulfil the EORTC/MSG radiological criteria of possible invasive fungal infection.
* A bronchoalveolar lavage is planned or has been performed \<48hrs earlier

Exclusion Criteria:

- Patients unable or unwilling to provide consent

Primary outcomes:
measure: Performance of two different PCR test
timeFrame: 1 week
measure: Performance of two different media for the PCR test
timeFrame: 1 week
measure: Determination of best PCR cycle threshold
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center (EMC)
state: Zuid Holland
Study officials:
References:
Clinical trial NCT05884905: Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
Official title: Randomized Study Evaluating Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency
Cis-Platinum Nephropathy
Keywords: renal impairment
cisplatin
hydration protocol
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2023-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate safety of short hydration with cisplatin administration. The main outcome is renal dysfunction following cisplatin use with short hydration protocol. Another group of patients received conventional hydration is the historical control for comparison (Randomized phase II design with a reference standard treatment control arm)


Eligibility criteria: Inclusion Criteria:

* Cancer patient who has plan to receive first cycle of cisplatin \>= 60 mg/m2
* Normal serum creatinine and creatinine clearance \>= 50 ml/min
* Age \< 75 years old
* Serum albumin \>= 3 g/dl
* Plan to receive optimal antiemetic regimen consisting of olanzapine or neurokinase 1 receptor antagonist

Exclusion Criteria:

* The patient who receives other chemotherapy with adminstration volume higher than 500 ml
* Prior heart failure or known left ventricular ejection fraction \> 50%
* Prior renal dysfunction within 3 months
* Uncontrolled renal disease
* current use of diuretic or non-steroidal anti-inflammatory drug (NSAIDs) or starting angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockade (ARB) within 3 months

Primary outcomes:
measure: renal dysfunction at least grade 1 following cisplatin treatment in short hydration group
timeFrame: from starting cisplatin to 4-week after cisplatin discontinuation
Secondary outcomes:
measure: renal dysfunction >= grade 2 following cisplatin treatment in short hydration group
timeFrame: from starting cisplatin to 4-week after cisplatin discontinuation
measure: rate of cisplatin modification due to adverse effects in short hydration group
timeFrame: from starting cisplatin to 4-week after cisplatin discontinuation
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
References:
Clinical trial NCT04002505: The "Concussion or Brain Bleed" Trial
Official title: Shared Decision Making for Patients With Minor Head Injury: The "Concussion or Brain Bleed" Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Head Injury
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Researchers are trying to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Present to the Emergency Department with a blunt head injury within the past 24 hours
* Determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider.

Exclusion Criteria:

* Patients who are pregnant
* Non-English speaking
* In police custody
* Undergoing psychiatric evaluation
* Found to have drug or alcohol intoxication

Primary outcomes:
measure: Rate of CT Scans
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Neha Raukar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04504305: To Assess the Efficacy of Investigational Product on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
Official title: A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Investigational Product Nerve Support Formula on the Neuropathic Pain in Individuals Suffering From Type II Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Insomnia Due to Medical Condition
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study is to be carried out to examine the effect of Investigation product on diabetic individuals suffering from diabetic neuropathic pain.


Eligibility criteria: Inclusion Criteria:

* Male and Females aged ≥ 40 and ≤ 65 years of age.
* Participants with primary complaints of lower limb pain.
* History of Diabetes mellitus for more than one year.
* Participants with HbA1c ≥ 7.1 and ≤ 9.5%

Exclusion Criteria:

* Diagnosed with severe cardiac disease
* Uncontrolled hypertension defined as systolic blood pressure ≥ 139 and diastolic blood pressure ≥ 85.
* Type II DM with history of foot ulcers in the last six months prior to the study
* History of nerve damage not due to Painful Diabetic Neuropathy.

Primary outcomes:
measure: effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by 11 point numeric rating scale.
timeFrame: 42 days
Secondary outcomes:
measure: effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Brief pain inventory.
timeFrame: 42 days
measure: effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by insomnia Severity index.
timeFrame: 42 Days
measure: effect of investigational product on diabetic individual suffering from diabetic neuropathy assessed by Neuropathy total symptom score - 6 .
timeFrame: 42 Days
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Stress Test Clinic
state: Maharashtra
city: Mumbai
country: India
facility: Shantaee
state: Maharashtra
Study officials:
References:
Clinical trial NCT04244305: Endurance Training in Patients Undergoing Lung Transplantation
Official title: Endurance Training in Patients Undergoing Lung Transplantation: Differences Between Treadmill and Cycle Ergometry Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Transplantation
Keywords: Exercise Therapy
Physical Therapy Modalities
Functional Capacity
Lead sponsor: University Hospital A Coruña
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 80
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: Lung Transplantation is usually the last option for patients with chronic respiratory conditions in the late stages of the disease. Pulmonary rehabilitation and, particularly, endurance training, is a cornerstone in the management of these patients both during the pre-operative as well as the post-operative period as it improves cardiopulmonary fitness, muscle mass, muscle strength, health-related quality of life and potentially, survival. However, very few studies have been published addressing which modality of training, intensity, frequency or duration of training provides the best possible results in these patients. Therefore, the objective of this study was to compare two training modalities (treadmill walking versus cycle-ergometry) on functional capacity, muscle strength and lung function.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing lung transplantation at the Thoracic Surgery Unit of the Hospital Clínico Universitario de A Coruña.
* Adults \> 18 years.
* Ability to attend post-surgery exercise training for a minimum period of one month.
* Sign informed consent.

Exclusion Criteria:

* Torpid post-operative recovery with a prolonged stay at the Post-Anaesthesia Care Unit \> 12 days.
* Diagnosed with intensive care unit acquired muscle weakness.

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: 1 month
Secondary outcomes:
measure: 6 Minute Walk Test
timeFrame: 3 Months
measure: Maximal isometric strength
timeFrame: 1 and 3 months
measure: Sit-to-stand
timeFrame: 1 and 3 months
measure: Forced Expiratory Volume 1st second (FEV1)
timeFrame: 1 and 3 months
measure: Incremental Symptom-Limited Test
timeFrame: 1 and 3 months
measure: Maximal inspiratory and expiratory pressures
timeFrame: 1 and 3 months
measure: Forced Expiratory Capacity (FVC)
timeFrame: 1 and 3 months
measure: Peak Expiratory Flow (PEF)
timeFrame: 1 and 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03473405: Air Barrier System for the Reduction of Airborne Colony Forming Units During Total Knee Arthroplasty
Official title: Air Barrier System for the Reduction of Airborne Particulate and Colony Forming Units (CFU) During Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Total knee replacement
Operating room airborne CFU
Lead sponsor: Nimbic Systems, LLC
Sponsor class: INDUSTRY
Collaborators: name: Texas Orthopedic Hospital
First posted: 2018-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total knee arthroplasty surgeries.

Detailed description: The Air Barrier System (ABS) is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne CFU at the surgery site during total knee arthroplasty surgery.

Eligibility criteria: Inclusion Criteria:

* Candidate for total knee arthroplasty

Exclusion Criteria:

* Prior history of infection
* Revision surgery
* Screens positive for MRSA

Primary outcomes:
measure: Compare the number of colony-forming units captured at incision sites
timeFrame: Four months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Texas Orthopedic Hospital
name: Gregory Stocks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12.
Clinical trial NCT04981405: Real-world Evidence of COVID-19 Vaccines Effectiveness
Official title: Real-world Evidence of COVID-19 Vaccine Effectiveness Against COVID-19 Hospitalization: the Case-control Study in St. Petersburg, Russia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID-19 Pneumonia
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
Collaborators: name: European University at St. Petersburg
name: Medical Institute named after Berezin Sergey
First posted: 2021-07-29
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Saint-Petersburg, Russia

Brief summary: This is an observational case-control study to evaluate COVID-19 vaccine effectiveness against hospitalisation with COVID-19 related conditions in St. Petersburg, Russia. Two sets of cases and control will be retrospectively analyzed to compare vaccination proportions and other characteristics to infer vaccine effectiveness from odds ratios. The first set of cases will be extracted from the data on hospitalisation of patients with COVID-19 to First Pavlov State Medical University of Saint-Petersburg hospitals, and controls will be patients hospitalised with other conditions. The second set of cases and controls will be based on patients referred to Medical Institute named after Berezin Sergey for computed tomography. Cases will be patients with positive SARS-CoV-2 status computed tomography confirmed pneumonia or patients referred to hospitalisation, and control will be patients without pneumonia and not referred to hospitalisation.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized to clinics of First Pavlov State Medical University of Saint-Petersburg
* Patients referred to Medical Institute named after Berezin Sergey for computed tomography
* Available vaccination status

Exclusion Criteria:

- Refusal to provide information for research purposes at the time of hospitalization or reference to computed tomography

Primary outcomes:
measure: Effectiveness of full vaccination against hospitalization with COVID-19 pneumonia
timeFrame: 3 months
Secondary outcomes:
measure: Effectiveness of partial vaccination against hospitalization with COVID-19 pneumonia
timeFrame: 3 months
measure: Effectiveness of vaccination against hospitalization with COVID-19 pneumonia in different age groups
timeFrame: 3 months
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Mikhail Cherkashin
state: Saint-Petersburg
city: Saint Petersburg
country: Russian Federation
facility: Oksana Stanevich
Study officials:
References:
citation: Barchuk A, Bulina A, Cherkashin M, Berezina N, Rakova T, Kuplevatskaya D, Skougarevskiy D, Okhotin A. Gam-COVID-Vac, EpiVacCorona, and CoviVac effectiveness against lung injury during Delta and Omicron variant surges in St. Petersburg, Russia: a test-negative case-control study. Respir Res. 2022 Oct 10;23(1):276. doi: 10.1186/s12931-022-02206-3.
Clinical trial NCT00314405: Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope
Official title: Identification of Sentinel Lymph Node (SLN) in Breast Cancer Care: Clinical and Economical Evaluation of a Double Method Using Isotope and Methylene Blue Dye Injection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infiltrative Breast Cancer
Keywords: sentinel lymph node
SLN
probe
breast cancer
lymphoscintigraphy
methylene blue dye
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-04-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed. After the surgery, SLN will be submitted to serial analysis and immunohistochemistry. A comparison of the two methods and an economical evaluation of the complete procedure will be performed.


Eligibility criteria: Inclusion Criteria:

* patients with infiltrative breast cancer (diagnosed pre-operatively by core biopsy)
* approval and informed consent

Exclusion Criteria:

* chemotherapy
* locoregional radiotherapy
* prevalent axillary lymph node

Primary outcomes:
measure: Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.
Secondary outcomes:
measure: Comparison of the results of SLN serial sectioning, with H&E and IHC staining
measure: Economical evaluation of SLN procedure.
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie-Obstétrique, Hôpital Civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Jean-Pierre Bellocq, MD
role: STUDY_DIRECTOR
References: