cyrilzakka/clinical-trials huggingface dataset:
Effects of Neutrophil/Lymphocyte, Platelet/Lymphocyte, CRP/Albumin and Lactate on Mortality in Trauma Patients Admitted to Intensive Care

Intensive care units are medical units where patients are closely monitored 24 hours a day due to critical health problems that threaten their lives and where rapid interventions are made when necessary. The clinical conditions of patients in these units can change rapidly. There are many studies in the literature indicating that inflammation indicators such as Neutrophil/Lymphocyte, Platelet/Lymphocyte and C-Reactive Protein/Albumin ratios and blood gas values such as Lactate and Base Deficit are simple, cheap and rapid biomarkers that can provide an early idea about the clinical course of patients.

Intensive care units are medical units where patients are closely monitored 24 hours a day due to critical health problems that threaten their lives and where rapid interventions are made when necessary. The clinical conditions of patients in these units can change rapidly. There are many studies in the literature indicating that inflammation indicators such as Neutrophil/Lymphocyte, Platelet/Lymphocyte and C-Reactive Protein/Albumin ratios and blood gas values such as Lactate and Base Deficit are simple, cheap and rapid biomarkers that can provide an early idea about the clinical course of patients. The researchers aimed to evaluate the relationship between Neutrophil/Lymphocyte, Platelet/Lymphocyte and C-Reactive Protein/Albumin ratios and biomarkers such as Lactate and Base Deficit with the clinical course and survival of trauma patients admitted to the ICU and to see the compatibility of our data with the existing literature.

Eligibility Criteria:
Inclusion Criteria:

* 1. All trauma patients admitted to our general intensive care unit

Exclusion Criteria:

- 1. Patients whose follow-up and treatment started and completed in the services.

2. Patients whose data is missing or whose data cannot be accessed.
Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age

This study evaluates the effect of zinc over the duration, severity and relapse of acute diarrheic disease, in children between 6 and 59 months of age. One study group will receive a tablet that contains 20 mg of zinc, and the other study group will receive a tablet,that does not contain zinc, it is a tablet that investigators will use as control.

In Mexico acute diarrheal diseases mortality in children continues to be a public health issue, being between the main causes of morbidity and mortality, with an important load for the health systems. Consequently, there exists a necessity for the implementation of alternate strategies for this condition, nutrition being one of the pillars to strengthen.

Zinc administration during the diarrhea episode is a simple intervention for clinical picture reduction and relapse. The recommendation of including zinc in the treatment of ADD is not part of the Mexican normativity. The evaluation of the efficacy of zinc administration in Mexican children is insufficient and a program or national strategy for zinc treatment does not exist.

The objective of this study is evaluates the efficacy of oral zinc sulfate administration, during the diarrhea clinic picture in children of Mexico City.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* Children attended in the sentinel centers
* Clinical diagnosis of acute diarrhea disease
* Parents have not planned moving to other location in a time period of at least one year.

Exclusion Criteria:

* Deficient intestinal absorption syndrome
* Acrodermatitis enterohepatic
* Zinc sulfate hypersensitivity
* Leucine metabolic disorders
* Secondary lactose intolerance
* Galactosemia lactase primary deficiency
* Allergy to cow milk protein
* Children that are supplemented with zinc for the last 6 months
Gait Asymmetry Assessed Using Portable Gait Analysis System

To date, detailed analysis of movement patterns in orthopaedic conditions are mainly performed in research projects. Because these tests are time consuming, they are not feasible in clinical routine or in standard examinations. Novel technologies allow capturing detailed movement patters within a few minutes. The aim of this regional study is to compare aspects of movement tasks measured using a mobile gait analysis system to those measured using laboratory based systems and to determine aspects of gait patterns relevant for different orthopaedic conditions. Moreover, the researchers will investigate if these relevant aspects can be altered using surgical treatment or manual therapy.

This is a cross-sectional study. Pre- and post-treatment data will only be collected in patients undergoing routine orthopaedic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years, for patients: diagnosed osteoarthritis at the ankle, knee or hip, lumbar spinal stenosis or limited range of motion at the knee

Exclusion Criteria:

* Body mass index \> 35kg/m2
* Use of walking aids
* Inability to walk for 6 minutes
* Neuromuscular disorders affecting gait
* Cardiovascular disease
* Inability to follow procedures due to psychological disorders or dementia
BPDO-1603 Intervention Trial in Patients With Moderate-to-severe Alzheimer's Disease

A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of BPDO-1603 in patients with moderate-to-severe Alzheimer's disease


Eligibility Criteria:
Inclusion Criteria:

* A voluntary, written informed consent from the patient or the patient´s representative.
* Male or female patients ≥ 45 years of age as of the date of informed consent.
* Diagnosed with probable AD according to the National Institute on Aging-Alzheimer's Association \[NIA-AA (2011)\] criteria.
* MMSE score of ≥ 5 and ≤ 20 during screening period.
* CDR-GS of 2 \~ 3 or GDS of 4 \~ 7 during screening period.
* Ongoing cholinesterase inhibitor therapy with stable dose of 10 mg/day donepezil hydrochloride for more than 12 weeks (inclusive) prior to screening, and can continue this therapy until randomization without any change in the dosage regimen of donepezil hydrochloride.

Exclusion Criteria:

* Magnetic resonance imaging (MRI) or computed tomography (CT) findings obtained within the past 12 months (ie, 48 weeks) from screening or at screening, as a cause of dementia other than probable AD.
* History of other organic disease, such as vascular dementia, CNS infections (e.g., human immunodeficiency virus \[HIV\], syphilis), head injury, Creutzfeldt-Jakob disease, Niemann-Pick's disease, Huntington's disease, Parkinson's disease, epilepsy, or stroke.
* Evidence of other neurological disorders which include seizure disorder that may interfere with the patient's cognition or ability to perform the study procedures.
* Use of Memantine Hydrochloride within 1 month prior to screening
Patient Preferences and Experiences of Waiting for Heart Surgery

Waiting for heart surgery could be difficult and anxiety-provoking for some patients. Research suggests that some specific factors (e.g., individual coping strategies, communication with the clinical team, having a more active role in care decision-making) could reduce the stress associated with waiting. However, most of this research has looked at patients waiting for other types of surgery (e.g., cancer surgery). Therefore, more research focusing on patients waiting for heart surgery is needed.

This project aims to investigate patients' experiences, perceptions and preferences about waiting for elective (non-emergency) heart surgery across four London-based National Health Service (NHS) hospitals that belong to King's Health Partners (KHP): Royal Brompton, Harefield, St Thomas', and King's College hospitals. The project is led by the research team at King's Improvement Science, (King's College London), in collaboration with clinicians and patients with lived experience of waiting for heart surgery.

This project will look at:

* how patients feel their heart condition affects their day-to-day life;
* how patients experience being on a waiting list;
* what factors patients consider as most important for their upcoming surgery (e.g. to have their surgery as soon as possible, at their nearest hospital, or carried out by a specific surgeon);
* patients' opinions about how the heart surgery waiting list process could be improved.

Adult patients (\>18 years old) waiting for elective heart surgery at the four hospitals listed above will be invited, via a text message and a letter, to complete an online survey (i.e. a list of questions). Completing reading study information and completing the survey will likely take approximately 30 minutes. The survey will be open for 8 weeks in total.

Findings from this project, together with other work looking at clinical processes and outcomes across heart surgery services at the four KHP hospitals, will inform a wider quality improvement project.


Eligibility Criteria:
Inclusion Criteria:

* being on a waiting list for elective cardiac surgery under any of the following surgical prioritisation categories P2, P3, and P4;
* being at least 18 years old;
* being on a waiting list for cardiac surgery across any of the four KHP participating sites: RBH, HH, STH, and KCH.

Exclusion Criteria:

* being on a waiting list for cardiac surgery at sites other than Royal Brompton Hospital, Harefield Hospital, St Thomas Hospital, and King's College Hospital;
* not having any recorded contact details in the form of mobile phone and home address
Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock

This study evaluates if improvement of renal resistive index when mean arterial pressure increase (at 65 mmHg to 85 mmHg) in early phase of septic shock is predictive of better renal survival.

Learned societes (survival sepsis campaign and ESICM) are currently recommending a mean arterial pressure (MAP) target at 65 mmHg in septic shoc with a potential increase to 85 mmHg in patients with medical history of arterial hypertension.

A high renal resistive index on the first day of septic shock was associated with acute renal failure more frequently on the 5th day. A decrease in the renal resistance index was also objectified during the increase in MAP.

The main objective of this trial is to study the relationship between the improvement of the resistance index during a test of increase in average blood pressure during septic shock and the improvement of renal function

In this interventional monocenter trial, we will measure the renal resistive index after stabilization of the MAP at 65 mmHg for two hours, then after 2 hours of stabilization at 85 mmHg. This part allows us to define the patients "responding" to the renal resistive index (improvement of the resitive renal index when the MAP increases).

Then, patients will be randomized into two groups :

* first group with a MAP target at 65 mmHg
* second group with a MAP target at 85 mmHg. There will be a stratification on the responder character to the renal resistance index.

Finally, we will assess renal function on the 7th day (with the assessment of serum creatinine and the change of stage of the KDIGO classification)

Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥ 18 ans)
* Admitted to the intensive care unit of Angers with
* arterial hypotension requiring the etablishment of catecholamines
* In a context of proven or suspected sepsis, whaterver the cause of this infection.
* norepinephrine dose ⩾ 0.1µg/kg/min
* After 2 hours of stabilization at 65 mmHg of mean arterial pressure

Exclusion Criteria:

* Pre-existing chronic renal failure (glomerular filtration rate \< 60 mL/min with MDRD)
* Solitary kidney (anatomical or functional)
* History of united or bilateral stenosis of the renal arteries
* decision to stop or limit treatment
* patient with an emergency indication of renal replacement therapy (severe hyperkalemia, severe metabolical acidosis with pH \<7.15, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration \> 40 mmol/l and oliguria/anuria \> 72 h.)
* pregnant, lactating or parturient woman
* patient deprived of liberty by judicial or administrative decision
* patient with psychiatric compulsory care
* patient subject to legal protection measures
Economic-demographic Assessment of the Aseptic Mobilization of Knee Prostheses Through the RIPO Registry and Radiographic Analysis of the Case Series From the II Clinic of IOR

The increase in life expectancy is leading to an increase in the average age of patients undergoing total knee arthroplasty (TKA), and, consequently, an increase in the number of revisions. The main cause of TKA failure is aseptic mobilization, which is described as the loss of integration between the prosthetic component and the bone in the absence of infection. This represents a significant impact on professional and economic resources for the Italian healthcare system. Aseptic mobilization can be caused by inadequate initial fixation of the implant and/or mechanical or biological loss of fixation over time, factors that often occur simultaneously. A careful, methodical evaluation of post-operative radiographs of TKAs remains an important diagnostic tool. The analysis of the causes of aseptic mobilization of TKAs and the associated economic impact in the Emilia Romagna region is useful for providing an estimate of the problem and identifying potential areas for improvement.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing knee prosthesis revision for aseptic mobilization
* Follow-up ≥ 2 years
* Willingness to participate in the study
* Both sexes
* Patients ≥ 18 years old

Exclusion Criteria:

* Patient refusal to participate in the study and sign the informed consent
* Simultaneous participation in other studies
A Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety

The aim of the study is to evaluate the effectiveness of a digitalized cognitive-behavioral treatment for anxiety among school aged children. The participants are screened from the general population, as a part of the routine school health care check-ups. Half of the children with anxiety will receive the digitalized treatment program, while the other half will receive education about anxiety in internet.


Eligibility Criteria:
Inclusion Criteria:

- Scoring ≥22 on SCARED

Exclusion Criteria:

* no access to internet
* insufficient language (Finnish until summer 2019, Finnish and Swedish from autumn 2019 onwards, when also Swedish version of the intervention was available) skills
* visual or hearing impairment that hinders the use of the program
* the child's mental retardation, autism spectrum disorder, suicidal intentions or severe mental disorder
* the child's psychotherapy (ongoing or starting within 6 months)
* the child's medication (for anxiety) started / changed within 2 months
* current involvement with child protection services (i.e., removal of child custody, investigation of child abuse or neglect)
* parent's severe psychiatric / somatic disease or other reason that hinders the parent to actively participate in the program
Developing Viability Index for Machine Perfused Livers

Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-75 years of age.
* Candidate for a deceased-donor liver allograft.

Exclusion Criteria:

* Seropositivity for HIV-1.
Preeclampsia Educational Program Study (PrEPS)

Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions.

Preeclampsia complicates approximately 8% of all pregnancies. While many patients improve following delivery, the disease process remains a leading cause for postpartum morbidity and mortality. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. There is a gap in the literature regarding effective, patient-centered educational tools specifically addressing these elements, especially in the postpartum period.

The investigators propose a pilot, randomized controlled trial of postpartum patients with preeclampsia. The intervention of interest is an illustration-based, educational mobile device application (app) focused on the short- and long-term risks associated with preeclampsia and warning signs and symptoms of worsening disease postpartum. The control for this study will be the same information in a text-only format, also accessed through a mobile device app.

The investigators central hypothesis is that an illustration-based app will improve knowledge of preeclampsia among postpartum patients compared to text-only educational material.

Specific Aim 1: Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education 24 hours post intervention (short-term). The investigators hypothesize that patients who receive illustration-based education will have a) higher preeclampsia knowledge scores at 24 hours post-intervention compared to text-only educational materials and b) a greater increase in preeclampsia knowledge score from baseline (pre-test) compared to text-only education.

Specific Aim 2: Compare the difference in preeclampsia knowledge score from text-only versus illustration-based education \>4 weeks post intervention (long-term). The investigators hypothesize that patients who receive illustration-based education will have a) higher preeclampsia knowledge scores at \> 4 weeks post-intervention compared to text-only educational materials and b) a greater increase in preeclampsia knowledge score from baseline (pre-test) compared to text-only education.

Eligibility Criteria:
Inclusion Criteria:

* Preeclampsia with or without severe features
* Able to read and speak English
* Consistent access to mobile device with QR-reading capability and ability to access mobile-device application.
* Pre-and postnatal care provided by OB Clinic (resident clinic) or Magella (maternal-fetal medicine)

Exclusion Criteria:

* Patient age \< 18 years old
* Non-English speaking
* Current enrollment in another trial targeting postpartum preeclampsia parameters
* Arm width \>40cm (XL Cuff)
Impact of Whole-body Vibration Training on Muscle Flexibility and Fatigue After Lower Extremity Thermal Burn Injury

Tight hamstring muscles limit the anterior tilt of the pelvis in spinal flexion resulting in aggravated muscle and ligamentous tension in the lumbar region which leads to significantly higher compressive loads on the lumbar spine. Other postural changes associated with tightness of the hamstrings can influence the sacroiliac joint stability in an indirect way. Hence, flexibility of hamstring muscles is crucial for overall well-being and optimal physical fitness.


Eligibility Criteria:
Inclusion criteria:

1. Patients with a deep second-degree thermal burn of the lower extremity, 35%-40% total body surface area (TBSA) of burn as measured with the rule of nine, after six weeks from the injury or complete wound healing.
2. Patients with 20 to 50 years old.
3. Absence of any neurological disorder i.e.: stroke, ataxia, or parkinsonism.

Exclusion criteria:

1. Patients with open wounds.
2. Patients with recent fractures.
3. Patients with severe obesity BMI ≥40.
4. Patients with cardiorespiratory disorders.
5. Patients with bone disease, joint replacement, and traumatic spine history since last year.

In order to apply the inclusion and exclusion criteria, all cases will be subjected to an interview and assessment.

Those subjects who will be eligible to take part in the study will sign an informed consent before participation in the study.
SINEFIX-2022 Pilot Phase

Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. Its incidence furthermore is expected to grow as the population ages. A wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full-thickness rotator cuff tears (RCTs). The latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the SINEFIX implant and instruments, are intended.

Despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. RCTs may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however RCTs typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. Instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative RCTs.

For RCTs, treatment options include both surgical and non-surgical (conservative) procedures.

In this context, the SINEFIX implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patient indicated for surgical repair of the rotator cuff tear according to current guidelines
* Patient aged 18 years or older
* Up to 2 cm tear size of supraspinatus, infraspinatus (medio-lateral)
* Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior)

Exclusion Criteria:

* Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder
* History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments
* Inflammatory arthropathies
* Subject with a contraindication/non-compliance for MRI examination
* Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule
* Pregnant and breastfeeding woman