cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effect of Pectoral Nerve Block II on Acute and Chronic Pain in Patients Undergoing Oncological Breast Surgery

The aim of this observational study is to evaluate the effect of Pectoral Nerve Block II (PECSII) on the development of pain in the acute and chronic periods in female patients over the age of 18 who underwent oncological breast surgery. The main questions it aims to answer are:

Is PECSII blockade applied to patients undergoing oncological breast surgery effective on acute pain scores compared to the non-blockade group? Is there a difference between the group with block and the group without block in terms of the development of chronic pain in the evaluation made at the 3rd month after surgery? The analgesia method applied to the patients will be recorded in the patient files and acute and chronic pain scores will be evaluated. Chronic pain score evaluation will be made by telephone survey.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will be operated under general anesthesia
* ASA score I-II-III patients
* Non-pregnant patients
* Patients who agreed to participate in the study

Exclusion Criteria:

* Patients with coagulopathy
* Patients who underwent bilateral mastectomy
* Patients with chest wall anomalies
* Patients with neuropathic pain before surgery
* Patients who did not agree to participate in the study
Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear

A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and self-evaluation questionnaires.

Bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form
2. Adult subjects (18 years or older)
3. Subjects implanted with an I1 implant
4. Fluent in Swedish

Exclusion Criteria:

1. Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g., to complete questionnaires, according to investigator's discretion.
2. Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects

To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days


Eligibility Criteria:
Inclusion Criteria:

* The informed consent must be signed before any study specific tests or procedures are done.
* Healthy male subject.
* Age: 18 to 45 years (inclusive) at the screening.
* Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.
* Ability to understand and follow study-related instructions.

Exclusion Criteria:

* Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
* Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening.
* Regular use of medicines.
* Smoking more than 10 cigarettes daily.
* Systolic blood pressure below 100 or above 145 mmHg (at screening).
* Diastolic blood pressure below 50 or above 90 mmHg (at screening).
* Heart rate below 50 or above 90 beats/ min (at screening).
Fluoxetine for Visual Recovery After Ischemic Stroke

The purpose of this study is to determine whether fluoxetine, a selective serotonin reuptake inhibitor commonly used for depression, enhances visual recovery after an acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* MRI-confirmed acute ischemic stroke resulting in an isolated homonymous visual field loss.

Exclusion Criteria:

* Known hypersensitivity to fluoxetine or other selective serotonin reuptake inhibitors
* National Institutes of Health Stroke Scale score greater than 5
* Premorbid modified Rankin Scale score greater than 2
* Premorbid monocular or binocular visual field deficits
* Premorbid retinopathy or optic neuropathy
* Premorbid depression
* History of cognitive impairment, dementia, or neurodegenerative disorder
* History of seizure disorder
* History of mania or hypomania
* History of hyponatremia
* History of angle-closure glaucoma or elevated intraocular pressure
* Current alcohol abuse or impaired liver function
* Current use of an antidepressant medication
* Current use of a medication likely to have an adverse interaction with fluoxetine
* Current use of a medication likely to impair post-stroke recovery
* Contraindication to MRI
* Pregnancy or lactation
* Hemorrhagic transformation of the index stroke, resulting in mass effect
* Enrollment in another clinical trial at the time of the index stroke
COVID-19 Registry Rhineland-Palatinate (Germany)

Documentation of all patients undergoing inpatient treatment for SARS-CoV-2 infection with regard to clinical status at admission, medical history, inpatient treatment and course of disease. The aim is to create a risk stratification of the infection on the basis of clinical data as well as therapy and disease progression of the patients. This may also contribute to a better planning of resources.


Eligibility Criteria:
Inclusion Criteria:

* In-patients fulfilling the following criteria:

SARS-CoV-2 infection In-patient treatment Written informed consent for participation in observational study

Exclusion Criteria:

* No explicit medical exclusion criteria are stated to avoid selection bias.
RAS Mutation Testing in the Circulating Blood of Patients With Metastatic Colorectal Cancer

This study will evaluate the concordance of RAS mutation detection between the results obtained from circulating tumor DNA and those obtained with the "standard" method (testing from tumor tissue).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed metachronous or synchronous metastatic colorectal cancer
* No prior chemotherapy with the exception of adjuvant chemotherapy completed ≥ 6 months prior to enrollment
* Signed written informed consent obtained prior to any study specific screening procedures
* Patients willing to provide a blood sample for Translational Research

Exclusion Criteria:

* No tumor block available
* Previous malignancy in the last 5 years
* Medical, sociological, psychological or legal conditions that would not permit the patient to sign informed consent
Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen

Morphine is the opioid used to treat pain after surgery. Acetaminophen (called APAP) can reduce the amount of opioids needed for this.

The problem is that morphine slows down digestion. That can delay pain relief from APAP pills. It can even change what the body does to the drug \[pharmacokinetics (PK)\].

Some doctors have started using intravenous (IV) APAP with morphine, instead of the pills.

This study will measure the PK of APAP pills and IV when used with morphine in healthy volunteers.

IV APAP will likely be more effective and cause fewer side effects when used with morphine to treat pain after surgery.

Acetaminophen can significantly reduce the use of opioid analgesics when both are used concomitantly for treating moderate to severe pain. The use of IV acetaminophen used concomitantly with opioids has increased in practice for postsurgical pain relief over orally administered acetaminophen because it provides an immediate peak plasma concentration and is believed to provide a faster analgesic effect. Opioids used to treat pain inhibit gastrointestinal motility, including delaying gastric emptying. In patients receiving opioids the absorption of orally administered acetaminophen may be delayed and could result in gastric accumulation of acetaminophen thereby markedly changing the pharmacokinetic profile. The opioid-induced inhibition of gastrointestinal motility would not be expected to affect IV acetaminophen pharmacokinetics. Thus coadministered IV acetaminophen with opioid would yield better outcome in efficacy and reduced risk of side effects comparing with coadministration of oral acetaminophen and opioids.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have a health status of "healthy" assessed by the investigator and defined as no clinically significant deviation from normal medical history, physical examination, vital signs, and clinical laboratory determinations.
2. Subject must have a body mass index ≥ 19.0 and ≤ 32.0 kg/m² with a minimum weight of 110 pounds (50 kg) at Screening.

Exclusion Criteria:

1. Subject has a positive test result for human immunodeficiency virus (HIV), hepatitis B (surface antigen), or hepatitis C virus antibody at screening.
2. Subject has a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen or morphine/opioids or to any of the excipients in the IV or oral formulations used.
3. Subject has an oxygen saturation of less than 95% while awake at screening and check-in.
4. Subject has a positive test result for drugs of abuse (minimum: opioids, barbiturates, cannabinoids, benzodiazepines, cocaine, amphetamine) or alcohol at the screening and check-in.
5. Subject has donated or had significant loss of whole blood (480 mL or more) within 30 days, or plasma within 14 days prior to dosing.
6. Subject has any other medical, psychiatric and/or social reason for exclusion as determined by the investigator.
Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging

Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in 1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very severe cases, pectus exacavatum involves little or no space between the heart and sternum. Because of the limited space, the Nuss procedure is more difficult to perform and there is an increased risk of complications such as injuries to the heart or large vessels. However, this increased risk can again be reduced by using the Crane technique. This technique increases the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that this technique is commonly used, it is not known what its quantitative effect is on the substernal space during the Nuss bar procedure. The subsequent aim of this study is to quantify the effect of the Crane technique during minimally invasive repair of pectus excavatum through three-dimensional scans acquired before and after application of the Crane technique.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing minimally invasive repair of pectus excavatum (through the Nuss bar procedure) in conjunction with the Crane technique.

Exclusion Criteria:

* None
Lung Ultrasound Findings in Patients With COVID-19 in a UK ED

The investigators aim to carry out a retrospective observational study, analysing lung ultrasound images from patients who have presented to A\&E for routine diagnostic purposes (ruling out cardiogenic pulmonary oedema, Pulmonary embolism and pericardial effusions) and systematically assessing for abnormalities typical for COVID-19 infection (Pleural irregularities, B lines, consolidations, pleural effusions). Doing this, the investigators will also develop a suggestion for a standardised technique for lung ultrasound which can be transferred to other clinical settings (Intensive Care, Acute medical Unit) and could form the basis for an international standard. Thirdly, the investigators aim to correlate our findings to clinical severity judged by oxygenation status on arrival in ED. To the investigators' knowledge, this is the first study of this kind.

COVID-19 is a new disease significant morbidity and mortality which has reached pandemic status. Due to its highly contagious nature, is essential to characterise the disease pathology quickly and reliably. The lung changes that can be seen in patients with COVID-19 can precede clinical symptoms and are picked up on ultrasound more reliably than on conventional chest XR. In addition, ultrasound is devoid of harmful radiation, is quick to perform, and easily learned by doctors who routinely use ultrasound such as in the Emergency Department. To date, there is no data systematically analysing the ultrasound changes in COVID-19 and relating this to disease severity. The data from our study will be contribute significantly to developing strategies for safe triage with regards to cohorting, diagnosis and prognosis of COVID-19.

In this research study, lung ultrasound scans will be retrospectively analysed that were obtained from patients who presented to the emergency department during March-May 2020 with shortness of breath, who were subsequently diagnosed with COVID-19 either by PCR test or composite diagnostic criteria of lymphopenia and positive Chest XR or CT scan report.

The lung ultrasound images will be retrospectively scored for the presence of absence of 5 lung abnormalities (pleural irregularity, B lines, small peripheral consolidation, large consolidation, small effusion (\<1cm) and large effusion (\>1cm). Scoring will be performed by 2 independent observers with experience in lung ultrasound. In addition, each abnormality will be analysed for preferential location within the lung.

The patients will be grouped into 4 groups of clinical severity (normal oxygenation, mild, moderate and severe deficit in oxygenation) based on the BERLIN criteria for ARDS, and lung abnormalities as seen on lung ultrasound will be analysed for correlation to clinical severity.

Eligibility Criteria:
Inclusion Criteria:

* Presented to the ED between March-May 2020 with dyspnoea
* COVID-19 positive either by PCR test or composite diagnostic criteria of lymphopenia and positive Chest XR report
* Received lung ultrasound as part of investigations during ED attendance

Exclusion Criteria:

* \< 18 years of age
* Not diagnosed with COVID-19
Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!

Septal myectomy is performed in selected cases to treat patients with hypertrophic obstructive cardiomyopathy (HOCM). The mechanism that causes obstruction involves both the outflow tract itself and the mitral apparatus, with the appearance of mitral regurgitation (MR) by SAM (Systolic Anterior Motion).

When the interventricular septum is not particularly thick, isolated myectomy may not be sufficient to eliminate the SAM; in these cases the concomitant treatment of the mitral valve is considered. Different approaches have been proposed: mitral replacement with prosthesis, plication or lengthening of the anterior leaflet or the edge-to-edge (EE) technique.

In addition, a small proportion of patients with HOCM may have MR from organic valve abnormalities, requiring specific treatment.

Currently, there are few studies in the literature aimed at determining the role of EE in the context of HOCM; most of these studies are characterized by short follow-up or by the scarcity of echocardiographic data.

The aim of the present study is to evaluate the long-term outcomes of EE associated with septal myectomy in patients with CMIO, both from a clinical point of view and by reporting echocardiographic data.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of HOCM with indication for surgery,
* patients operated on from 2000 to 2017
* contextual diagnosis of MR needing reparative surgical treatment
* age ≥ 18 years

Exclusion Criteria:

* hypertophic left ventricle due to other causes (aortic stenosis, arterial hypertension)
Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality

There are several therapeutic effects of the ultrasound (US) or low level laser therapy (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory response and accelerated tissue repair. The investigators hypothesis was that a combination of US, LLLT and therapeutic exercise may maximize clinical outcome.

Patients with pain, especially chronic pain, avoid movements. This is turn results in a gradual impairment of their physical condition, reducing, for example, strength, flexibility, physical functionality and occupational activity. To performed physical treatments, a prototype device was development. The device includes four diode laser beams (808 nm) around of the one ultrasound transducer.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian women
* Aged between 60 and 80 years
* Hand osteoarthritis
* Knee osteoarthritis

Exclusion Criteria:

* Psychiatric disorder,
* Neurological disease
* Metabolic disease
* Pulmonary disease
* Cardiac disease,
* Thrombosis
* Cancer.
A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China

The goal of this observational study is to learn about cytomegalovirus disease epidemiology in pediatric and adult liver transplant recipients in China. The main questions it aims to answer are:

* The incidence of Cytomegalovirus (CMV) Infections (including clinical significant CMV reactivations and CMV Diseases) among children and adults Liver transplantation patients in China
* All-cause Mortality (Survival probability at 1 year)
* Incidence of Allograft Rejection. Number of subjects with allograft rejection
* Graft Loss. Incidence of graft loss (re-transplantation)
* Late-onset CMV Disease. Incidence of late-onset CMV disease (occurring after 100 days post-randomization) as adjudicated by end point committee
* Bacterial Infections. Incidence of bacterial opportunistic infections
* Major Fungal Infections. Opportunistic fungal infections
* Major Non-CMV Viral Infections. Incidence of non-CMV viral infections We will collect demographic data of participants. All recipients and donors underwent preoperative testing for CMV pp65 antigenemia, plasma CMV DNA, and serum CMV antibody. All the recipients were followed up in a liver transplant follow-up clinic twice weekly for a month after discharge from hospital. After that, patients were followed up weekly for 3 months, fortnightly for 6 months, and monthly for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Have received their first orthotopic liver transplant (the transplanted liver may be deceased donor or live donor graft) within 10 days prior.
* Children group: Age ≤18yeas；
* Adults group: Age \>18yeas；
* Willingness to participate in the study
* Ability to understand information material
* Written informed consent

Exclusion Criteria:

* Have known Human immunodeficiency virus (HIV) infection (based on testing performed during the transplant evaluation process).
* Participation in another investigational agent trial
* Be undergoing multi organ transplant or have undergone prior organ transplant. Have expected life expectancy of less than 72 hours.
Development of Sensory Based Narrative Intervention

The goal of this study is to develop a sensory based narrative intervention and see its effect on vocabulary development in children with autism spectrum disorder. Sensory based narrative intervention will be developed, and participants of experimental group will be given this treatment for 6 weeks. Control group participants will be given only narrative intervention. Vocabulary improvement will be documented pre-post testing in both groups.

The present study aims to bridge an existing gap in the literature in Pakistan, as there are no evidence based therapeutic intervention tools available for narratives in Urdu.

The study further aims to provide a interventional resource pack for bilingual population who has Urdu as their first and dominant language. There is no therapeutic tool available for intervention that has incorporated multimodal sensory input for language intervention. Since tools developed internationally and from other countries cannot be incorporated due to cultural sensitivity and linguistic complexity, therefore, the current study will be able to incorporate these limitations. This study will provide a novel resource for intervention in the context of Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* Participants with mild to moderate ASD aged between 6-11 years as assessed by ADOS (already diagnosed).
* CARS score 30-37 (mild to moderate)
* Both male and female participants.
* ASD participants at 2 Information Carrying word-level receptively and at Blank level 1 expressively. (will incorporate nouns, verbs and adjectives as per individual linguistic level).
* Participants with Urdu as their first language (home language) and English as a second language.

Exclusion Criteria:

* Individuals with any co-morbidity with Autism spectrum Disorder, such as hearing impairment, cleft lip and palate, visual impairment etc.
* Individuals with a mild to moderate diagnosis but severe behavioral difficulties
* Participants with any known sensory difficulties restricting use of certain sensory props.
We Collected Blood Samples From Septic Shock Patients and Measured ELABELA, Creatinine, and NGAL Levels. Survival After 7 Days Was Recorded and Analyzed to Evaluate the Potential of Serum ELABELA as an Early Diagnostic Marker for Sepsis-associated Acute Kidney Injury.

The investigators selected patients diagnosed with sepsis who were admitted to the Intensive Care Unit (ICU) of Huai'an First People's Hospital between June 2022 and December 2023, as well as healthy individuals with normal kidney function during the same period, for the research. The investigators collected blood samples from patients with septic shock or sepsis at 6 hours, 12 hours, 24 hours, 48 hours, 3 days, 5 days, and 7 days after diagnosis， and also collected blood samples from the healthy individuals. The blood samples were stored in gel separation vacuum tubes containing heparin as an anticoagulant. The supernatant was removed and stored at -80°C, and the levels of plasma ELA (enzyme-linked immunosorbent assay) were measured using a standardized ELA kit. Additionally, serum NGAL (neutrophil gelatinase-associated lipocalin) and creatinine levels were measured simultaneously. The subjects were divided into three groups based on the KDIGO diagnostic criteria: sepsis-associated acute kidney injury (S-AKI) group, sepsis non-AKI group, and normal control group. Finally, the data were analyzed to determine the early diagnostic value of ELA for S-AKI. Approximately 70 specimens were collected in total.


Eligibility Criteria:
Inclusion Criteria:

Patients with sepsis admitted to the ICU.

Exclusion Criteria:

1. Under 18 years old;
2. History of chronic kidney disease;
3. Recipients of organ transplantation within the past year;
4. Patients or their families could not give informed consent.