cyrilzakka/clinical-trials huggingface dataset:
E-Drone: Transforming the Energy Demand of Supply Chains Through Integrated UAV-to-land Logistics for 2030

Vans are the fastest-growing category of licensed road vehicle in the UK with growing carbon dioxide (CO2) emissions. The proposed research into how Unmanned Aerial Vehicles (UAVs) and land logistics systems can be combined and managed will provide fundamental new understanding into the impacts of regulation and operating criteria on energy efficiency and costs. Medical logistics could be the first domain to utilise UAVs on a commercial scale, with preliminary analysis on pathology logistics within Southampton indicating that UAVs would significantly reduce CO2 emissions. With the National Health Service (NHS) spending an estimated £2.5 billion annually on pathology logistics and with patient numbers rising, there is a need to re-think how logistics costs could be reduced whilst improving bleed-to-diagnosis times for patients and energy demand.

The research vision is to examine the energy reduction potential of logistics solutions involving UAVs operating alongside sustainable last-mile delivery solutions (cargo cycles and walking porters via micro-consolidation points).

This involves understanding UAV operations in airspace shared with manned aircraft. The project focuses on a case study and trials based around NHS pathology sample transportation in the Solent and Dorset region. The key research objectives are to:

1. Investigate the collective transport and energy impacts of current 'business-as-usual' NHS pathology logistics across the Solent region;
2. Develop new simulation tools to quantify the energy consumption of UAVs and land logistics systems resulting from new types of traffic regulation for shared airspace and the operating requirements of UAVs;
3. Evaluate the impact on air space and energy use of a large scale take-up of UAVs for medical logistics across the Solent region;
4. Understand stakeholder concerns about UAVs;
5. Understand the regulatory and governance needs associated with UAV interventions that will lead to energy benefits in logistics.


Eligibility Criteria:
Inclusion Criteria:

* Work Package 1

  * Task 1.1: key informants in appropriate job roles, with attention purposefully paid to gender and age balance of participants.
  * Task 1.2: Interviews - a purposeful recruitment strategy will seek participants with a range of socio-demographic characteristics. Questionnaire - Prolific (or a similar commercial company) will distribute the questionnaire (n\~1000) to achieve a representative sample of the UK population.
  * Task 1.3: key informants in appropriate job roles, with attention purposefully paid to gender and age balance of participants.
* Work Package 5

  • Stakeholders with an interest in UAV use with a purposeful selection of participants with a range of socio-demographic characteristics.
* Work Package 6 • Anyone interacting with the serious game in dissemination events.

Exclusion Criteria:

• There are no specific exclusion criteria, though clearly some tasks require key informants with specific knowledge.
Effectiveness of a Dietary Counseling to Prevent Early Consumption of Added Sugar and Ultra-processed Foods

The purpose of the study is to prevent the early introduction of added sugar and ultra-processed foods and evaluate the impact on breastfeeding duration, complementary feeding quality, growth and prevalence of caries during the first year of life.

This randomized field trial will be performed at the maternity wards of Friendly Hospitals Initiative in three regions of Brazil: North, Northeast and South. After delivery, mothers who accepted to participate in the study will be randomized into control and intervention groups.It will be performed a weekly block randomization to prevent the contamination of information among mothers of different groups in the same facility. The intervention mothers will be advised not to give added sugar and ultra-processed foods during the first year of life, including a leaflet with colored images as a reminder for mothers. The control group mothers will not receive the study intervention but will be have all the routine health assistance of the maternity. At 6 months and 12 months, mothers of both groups will be visited in their homes and dietary evaluation and anthropometric measurements of their babies will be assessed. At 12 months of age the infants will have dental examinations and hemoglobin concentration through a capillary blood test.

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Eligibility Criteria:
Inclusion Criteria:

* Newborns with gestational age ≥ 37 weeks
* single birth
* Mother with at least 18 years old

Exclusion Criteria:

* Mothers with HIV or HTLV1 positive
* Infants with clinical occurrences or other conditions that prohibit breastfeeding or requires specific dietary treatment.
Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.

This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data, and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation.

Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5);
* Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol;
* Must complete a visit within 10 days after IOL implantation;
* Successful capsular bag implantation with no surgical complications;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL;
* Ocular or intraocular infection or inflammation at the time of the preoperative visit;
* Any ocular surgery or intraocular laser procedure at or prior to the surgical visit;
* Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit;
* Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit;
* Known history of Type 1 or 2 diabetes for more than 5 years;
* Any ocular or systemic co-morbidity at the preoperative visit;
* Pregnant at the preoperative visit or at the time of Postoperative Visit 2;
* Preoperative corneal astigmatism ≤ 0.50 D;
* Participation in another clinical study at the preoperative visit or at the time of the final study visit;
* Other protocol-specified exclusion criteria may apply.
Mechanical Ventilation During Cardiopulmonary Bypass

The study is about a protocol of protective mechanical ventilation during cardiopulmonary bypass used during cardiosurgery for the correction of congenital heart diseases, to evaluate what's the best for the lungs


Eligibility Criteria:
Inclusion Criteria:

* congenital heart diseases
* younger than 5 years
* CPB longer than 30 minutes in hypotermia
* elective surgery
* stable clinical conditions

Exclusion Criteria:

* genetic anomalies
* mechanical ventilation before the surgery
* kidney injuries
* hepatic failure
Ultrasonic Measurement of the Optic Nerve Sheath Diameter Predicting Outcome After Cardiac Arrest

Rationale: An important proportion of patients with return of spontaneous circulation (ROSC) after cardiac arrest remain comatose as a result of post anoxic encephalopathy (PAE). Specific treatments to promote cerebral recovery are lacking. Early identification of patients without potential of recovery of brain functioning may prevent inappropriate continuation of medical treatment and improve communication between doctors and families. Intensivists currently use a combination of diagnostic measures, including brainstem reflexes, motor response, status myoclonus, SSEP measurements and (increasingly) the EEG. However, together all these measure identify only 20-50% of the patients with severe PAE precluding cerebral recovery. At the moment, there is a high demand for bedside measurements that contribute to the neurological prognostication of comatose patients after cardiac arrest. Non-invasive bedside measurements of the optic nerve sheath diameter (ONSD) using ultrasound hold potential to improve outcome prediction.

Objective: To estimate the value and feasibility of repetitive measurements of the ONSD in comatose patients after cardiac arrest.

Study design: Prospective cohort study

Study population: 160 subsequent comatose adult patients after cardiac arrest, admitted to the ICU of Rijnstate hospital

Intervention: In addition to standard treatments, patients will undergo ultrasonic measurements of the ONSD during the first 3 days after cardiac arrest. Survivors will be followed upon hospital discharge. ONSD measurements will be followed over time and related tot neurological outcome.

Main study parameters/endpoints: The primary outcome measure is neurological outcome, defined using the Cerebral Performance Category (CPC) score at 6 months. CPC 1-2 indicates favourable neurological outcome, and CPC 3-5 indicates unfavourable neurological outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Cardiac arrest
* Admitted to the ICU with Glasgow Coma Scale ≤ 8

Exclusion Criteria:

* Pregnancy
* Traumatic head injury
* Eye surgery in medical history, including cataract surgery
* Pre-existing dependency in daily living (CPC 3 or 4)
* Any known progressive brain illness, such as a brain tumour or neurodegenerative disease
Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1

The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance.

Patient-related outcome measures (PROM) will be acquired to investigate functional outcome and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Indication for a TKA with the OrthoPilot® Navigation System with a Aesculap total knee endo-prosthesis
* Written signed informed consent of patient
* Willingness and mental ability to participate at the long-term follow-up examinations

Exclusion Criteria:

* Pregnancy
* Patients \< 18 years or \> 80 years
* Patients unable to participate at the follow-up examination (physically, mentally)
* Previous joint replacement at the index knee
* ASA classification \> 3 ( ASA I: A healthy patient without systemic diseases. ASA II: A patient with a mild systemic disease that is well controlled (e.g., well-controlled diabetes or hypertension). ASA III: A patient with a severe systemic disease that causes functional limitations (e.g., poorly controlled diabetes, COPD). ASA IV: A patient with a life-threatening systemic disease (e.g., severe heart failure, sepsis). ASA V: A dying patient who is not expected to survive without the operation. ASA VI: A deceased patient whose organs are being removed for donation.)
The Characteristics and Risk Factors of Breast Cancer Patients Trend Distinctive Regional Differences: a Cross-sectional Study

This cross-sectional study, conducted at the Sindh Institute of Urology and Transplantation (SIUT), involved a retrospective data review of all the patients diagnosed with breast cancer from March 2017 to December 2021. The demographic characteristics, clinical presentation, stage of the disease, and histopathological characteristics were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with breast cancer

Exclusion Criteria:

* The patients that were lost to follow-up after the first consultation and those consulting for a second opinion were excluded from the study.
A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults

Casopitant may affect liver enzymes that metabolize ketoconazole. This study is designed to test the safety and the extent of the Casopitant affect on ketoconazole levels in healthy human subjects.


Eligibility Criteria:
Inclusion criteria:

* A female subject who is non-childbearing potential or using acceptable contraceptive methods.
* Adequate organ system functions.
* Able to swallow and retain oral medication.
* Subject is able to understand and comply with protocol requirements and instruction and is likely to complete the study.

Exclusion Criteria:

* Current clinically relevant abnormality, medical condition, or circumstance that makes the subject unsuitable for the study per the study doctor.
* History of drug or other allergy which, in the opinion of the study doctor, contraindicates participation.
* Use of an investigational drug within 28 days or 5 half-lives.
* Use of prescription or non-prescription drugs, supplements or vitamins (excluding multivitamins) within 14 days, or 5 half-lives prior to first dose of study medication.
* Blood donation in excess of 500mL within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit.
* Iron deficiency.
* Positive stool for occult blood.
* Female subject who is pregnant or lactating.
* Male subject who has a history of hypogonadism.
* Positive urine drug screen.
* Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen.
* Use of tobacco-containing products within the past 12 months prior to screening.
* History of drug or alcohol abuse or dependence within 6 months of screening.
* History or presence of uncontrolled emesis.
* Presence of active infection.
* History of cholecystectomy or biliary tract disease.
* Active peptic ulcer disease (PUD) or a history of PUD of unknown etiology.
* Any degree of heart failure.
* Consumption of any food or drink containing grapefruit or grapefruit juice, apple juice, Seville oranges, kumquats, pommelos or vegetables from the mustard green family within 7 days prior to the first dose unless prior approval is received.
Effect of Non-surgical Periodontal Treatment on Cardiovascular Risk Markers

The research question was to investigate whether non-surgical periodontal therapy could reduce cardiovascular risk markers in Coronary heart disease (CHD) patients.

CHD patients or non-CHD with or without periodontitis were included. They were provided with non-surgical periodontal therapy (NSPT). Periodontal parameters and cardiovascular risk markers were measured at baseline and 3 months and 6 months after NSPT.

Eligibility Criteria:
Inclusion Criteria:

* non-CHD or CHD (at least 50% diameter stenosis in at least one coronary artery and clinically stable with absence of any potentially confounding inflammatory conditions for at least 6 months)
* had at least 14 natural teeth excluding third molars

Exclusion Criteria:

* received anticoagulant drugs
* had chronic conditions (e.g. diabetes mellitus, rheumatoid arthritis, malignancy, autoimmune disease) or acute conditions (e.g. trauma, surgery) or medications known to affect systemic inflammatory markers (e.g. antibiotics, immunosuppressive, contraceptives) within 3 months
* pregnancy or lactation
* presence or history of other infections
* periodontal treatment within 6 months
* tooth extractions within 2 months prior to the study.
Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients

The aim of the study is to evaluate if the electrophysiological study (EPS) guided therapy, including the prophylactic implantation of implantable cardioverter defibrillator (ICD), in inducible patients, is able to improve survival in comparison with conventional therapy (CONV strategy) in Myotonic Dystrophy type 1 patients with conduction disorders.

Trial design:

This is a double-arm prospective observational study.

Patient population:

To be included in the study, DM1 patients had to have at least 18 years old, LVEF \>35% on two-dimensional echocardiography, permanent pacing indication after non-invasive electrocardiographic evaluation or invasive EPS evaluation, according to the current guidelines. The following exclusion criteria were applied: electrolyte imbalance, thyroid disorders, prior cardiac surgery, prior cardiac arrest, prior spontaneous sustained ventricular arrhythmias, absuntion of antiarrhythmic drugs or medication known to affect cardiac conduction. All eligible DM1 patients underwent EPS for programmed ventricular stimulation; those in whom a sustained ventricula arrhythmia was inducible underwent subsequently ICD implantation. Non-inducible DM1 patients did not receive an ICD and underwent pacemaker implantation.

Endpoints:

The primary endpoint was all-cause mortality. Secondary end-points were sudden death (SD), death due to cardiac arrhythmias, ICD interventions and arrhythmic events in implanted patients.

Eligibility Criteria:
Inclusion Criteria:

* MD1 diagnosis genetically confirmed
* LVEF \>35% on two-dimensional echocardiography
* Permanent pacing indication according to the current guidelines

Exclusion Criteria:

* Electrolyte imbalance
* Thyroid disorders
* Prior cardiac surgery
* Prior cardiac arrest
* Prior spontaneous sustained ventricular arrhythmias
Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision

Background: An exact lymph node staging is essential in the treatment of rectal cancer.

Objective: The aim of this study was to assess the effect of indigo carmine injection on the number of retrieved and positive lymph nodes after transanal total mesorectal excision (taTME).

Design: This is a retrospective, non-randomised study. Settings: This study was conducted at a tertiary hospital by a multidisciplinary team.

Patients: Between 2013 and 2019, patients undergoing transanal total mesorectal excision were analysed. Patients with indigo carmine injection (intervention group) were compared to those without (control group).

Interventions: Transanal total mesorectal excision was performed with or without ex vivo intra-arterial indigo carmine injection.

Main Outcome Measures: The number of retrieved and positive lymph nodes was the primary outcome measure.


Eligibility Criteria:
Inclusion Criteria:

* elective, oncologic rectum resection in TaTME technique for proven or highly suspected rectal cancer.

Exclusion Criteria:

* abdominoperineal resection
* extended colon resection
* previous surgery of the rectum, the left colon or the mesocolon/-rectum
* patients rejecting retrospective data analysis
Imaging of Soft Tissues

The purpose of this study is to evaluate the potential importance of tissue elasticity in the assessment of soft tissues including muscles, tendons and ligaments and other soft tissue structures.

The evaluation of tissue elasticity (easily stretched or moveable) may assist in assessment of various soft tissue structures, such as fatty atrophy of muscles, tendon/ligamentous injury and healing and other soft tissue structures.

This is a prospective study that will recruit males and females 18 years of age and older who present to the department for a clinically indicated ultrasound of a superficial soft tissue abnormality with prior or following MRI / CT assessment ordered for clinical purposes.

The elasticity properties of tissues depend on their molecular building blocks and on the organization of these blocks. Injuries, disease etc are known to be associated with changes in tissue elasticity. Little research has been done on the potential of sonoelastographic (elasticity ultrasound imaging) assessment of normal, injured or healing muscles, tendons or ligaments.

Elasticity changes in muscle, ligaments and tendons following injury may have implication on the choice of treatment and help in determine how the length of time needed to heal from an injury.

Stiffness/elasticity of the tissue can be assessed by mechanical excitation with measurement of resultant tissue motion. Reconstruction of the elastic deformability (strain imaging) in real time ultrasound is known as sonoelastography.

Elasticity ultrasound imaging will be performed on the area being evaluated clinically.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who present for a clinically ordered ultrasound for evaluation of a soft tissue abnormality.

Exclusion Criteria:

* Women who are pregnant
Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)

Based on the anti-inflammatory and stabilising effect of the AbM, (Agaricus Blazei Murill) based mushroom extract AndoSanTM on cytokine release in blood in vivo and ex vivo in healthy volunteers after 12 days consumption, the aim in this study is to investigate whether same effect is valid in patients with IBD (inflammatory bowel disease). In addition, calprotectin an abundant cytosolic protein in neutrophils and a surrogate marker for degree of intestinal inflammation will be measured in blood and feces of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Moderate disease activity

Exclusion Criteria:

* No use of Imurel (Azathioprin) or anti-TNF treatment
Caspofungin Maximum Tolerated Dose in Patients With Invasive Aspergillosis

This study investigates the safety and tolerability as well as the efficacy and pharmacokinetics of caspofungin in four escalating dosages in adult patients with hematologic malignancies and proven or probable invasive aspergillosis.

Due to its efficacy and a broad antifungal spectrum against relevant fungal pathogens, lack of cross-resistance to azoles and amphotericin B, documented efficacy against human Aspergillus infections, favorable pharmacokinetic properties, and excellent tolerability according to the current data, caspofungin is a highly promising candidate for improving the results of treatment of invasive fungal infections.

Preclinical and clinical data indicate a dose dependent antifungal efficacy of caspofungin as well as of other echinocandins such as micafungin and anidulafungin. Thus it appears reasonable to investigate the impact of higher doses of caspofungin to improve the results already achieved with this component so far.

The maximum tolerated dose (MTD) of caspofungin and the distribution of the drug in patients following administration of doses of 70 mg or more are not yet known. We therefore investigate the safety, tolerability and pharmacokinetics of caspofungin in rising doses in a dose escalation study in adult patients with proven or probable invasive aspergillosis.

Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised due to hematologic malignancies, bone marrow failure syndromes, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy, treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections.
* Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria

Exclusion Criteria:

* Concomitant other systemic antifungal agents are not permitted on study.
* Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for \> 4 weeks preceding entry into study
* Prior systemic therapy of ≥ 4 days with any polyene anti-fungal agent within 14 days of study enrollment
* Prior systemic therapy of ≥ 4 days with non-polyenes for the current, documented IFI.