cyrilzakka/clinical-trials huggingface dataset:
Machine Learning Prediction of Parameters of Early Warning Scores in General Wards

In the event of illness or injury, patients are medically evaluated and initially treated in acute medical outpatient clinics, emergency rooms and surgeries. If medically indicated, care and treatment can also be provided in hospital. Depending on the severity of the illness and the main medical problem, this care is provided on hospital wards, which are primarily looked after by specific specialist disciplines and assigned to them in the form of clinical departments, for example.

As part of the inpatient stay, treatment and care is usually provided through ward rounds by the medical staff. However, ward rounds are spot checks of individual measured values at predefined times.

Qualified nursing staff carry out the agreed treatment plans and check the patient's general condition several times a day. In contrast to intensive medical monitoring, however, there is no continuous monitoring and therefore an aggravation of a patient's condition is not always immediately apparent. Furthermore, in addition to known complications of existing conditions, new or unexpected complications can also occur.

Although non-intensive care monitoring is based on discontinuous monitoring, incidents and complications can sometimes be life-threatening, especially if there is no immediate response to a deterioration in the patient's condition. Even if there are early warning systems such as scores, their ability to react is limited, partly due to the frequency with which they are collected.

In addition to patient-specific limitations of inpatient monitoring, such as patient cooperation in the sense of self-monitoring, medical limitations, such as the frequency of the survey, there are also economic limitations, such as the availability of staff who can be deployed for more frequent monitoring.

Although there are telemedical approaches to monitoring, setting these up is often limited both economically and by the additional training required, for example.

Even if threshold values are (or can be) defined for the measured data (vital signs, laboratory parameters, clinical impression and others), if these are exceeded or not reached, a consequence, e.g. a therapy step, can only be initiated retrospectively. In this situation, a pathophysiological change is already so far advanced that in many cases a compensation mechanism no longer functions adequately and turns into a decompensation situation. In this situation, the affected patients in a hospital ward are potentially in mortal danger.

One way of averting the dangers described above could be to use a reduced combination of monitoring methods compared to intensive care monitoring. At the same time, the use of artificial intelligence enables the automated evaluation of the collected data and can thus lead to the prediction of changes in parameters, which enables early alerting, i.e. before the occurrence of pathophysiological decompensation.


Eligibility Criteria:
Inclusion Criteria:

* Treated in general ward between 2024-10-01 and 2026-10-31 at the study center.

Exclusion Criteria:

* None.
Sugammadex Vs Neostigmine in Reversing Neuromuscular Blocks in Outpatient ERCP. A Randomized, Double-Blinded Trial

The investigators propose a single-center,assessor-Blinded, parallel group randomized trial to compare the efficacy of reversal of rocuronium induced neuromuscular blockade by sugammadex versus neostigmine in patients undergoing Endoscopic retrograde cholangiopancreatography at Cleveland Clinic Main Campus.

The investigators propose a single-center, assessor-blinded, parallel group randomized trial to compare the efficacy of reversal of rocuronium induced neuromuscular blockade by sugammadex versus neostigmine. Participating patients and outcome assessors will be blinded to group assignment. The anesthesiologists who assume anesthesia care will not be blinded to group assignment.

American Society of Anesthesiologists (ASA) physical status 3 and 4 adults scheduled for elective outpatient ERCP procedure with general anesthesia at Cleveland Clinic Main Campus will be included in the study. Patients will be excluded if they have suspected difficult airway, neuromuscular disorders, end-stage renal disease requiring hemodialysis, are allergic to fentanyl, neuromuscular blocking drugs or neuromuscular reversal drugs, or are pregnant or breastfeeding.

Eighty patients scheduled for outpatient ERCP with general anesthesia and rocuronium-induced muscle relaxation will be randomized 1:1 to: 1) reversal by sugammadex; or 2) reversal by neostigmine. Randomization will be stratified by 2 factors: (1) patient's age (older than 60 versus younger than 60) and (2) diagnostic vs. interventional procedures. Randomization will be based on computer generated codes that will be maintained in web-based system until shortly before induction of anesthesia, thus concealing allocation so long as practical.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* American Society of Anesthesiologist physical status 3-4
* Scheduled for outpatient endoscopic retrograde cholangiopancreatography

Exclusion Criteria:

* Difficult Airway
* Neuromuscular Disorders (eg: ALS, Botulism, Myasthenia Gravis, Lambert-eaton syndrome)
* End stage renal disease requiring dialysis
* Pregnancy or breast-feeding
* Allergy to Fentanyl
* Allergy to Neuromuscular blocking drugs (eg: rocuronium)
* Allergy to Neuromuscular reversal drugs (eg: sugammadex or neostigmine)
* Allergy to glycopyrrolate
The Effect of Manipulation of the Cervical Spine on Pain Biomarkers

This study evaluates the effect of high-velocity low-amplitude thrust (HVLAT) manipulation to the cervical spine on neuropeptide expression as determined by the plasma concentration of oxytocin, neurotensin, orexin A and cortisol; and Examine the effect of HVLAT manipulation on pain perception in symptomatic females with non-specific mechanical cervical spine pain

A high-velocity low-amplitude thrust (HVLAT) manipulation or commonly known as a spinal manipulation, is an intervention frequently used by physical therapists and other healthcare practitioners as an alternative treatment to help relieve spinal pain The mechanism by which HVLAT manipulation modulates pain remains undefined, although this does not contradict the clinical effects from HVLAT manipulation. Furthermore, there is evidence that suggests analgesia after HVLAT manipulation. There is a variety of observed and proposed phenomena that can explain the mechanisms for the psychological, mechanical, or neurophysiological responses from a HVLAT manipulation associated with alterations in pain processing or sympathetic and motor systems' excitation.

Eligibility Criteria:
Inclusion Criteria:

* 20 - 45 years of age
* A score of 10 or more out of 50 on the Neck Disability Index (NDI) questionnaire
* Symptoms of pain present for 30 days or less and no pain symptoms below your shoulder

Exclusion Criteria:

* Serious condition (such as cancer, spondylolisthesis, rheumatoid arthritis, or ankylosing spondylitis)
* Cervical spinal stenosis signs (such as incoordination in hands, arms and legs, inability of walking at a brisk pace, or bowel and bladder incontinence)
* Nerve root compression (such as changes in sensation, muscle weakness, or decreased reflexes)
* Works the night shift
* Steroid medication within 3 months
* Pregnancy or postpartum
* Pending legal action regarding their neck pain
* History of whiplash associated disorder and/or cervical spine surgery
Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.

This is an open label, Phase 1, intra-patient dose escalation study to determine the feasibility of catheter-based intra-pleural and intra-peritoneal administration of tocilizumab at doses up to 50μg/mL in patients with malignant pleural effusions (MPE) and malignant ascites (MA) and to determine the frequency and type of adverse events.

Tocilizumab is a monoclonal antibody inhibitor of the IL-6 receptor, FDA-approved for intravenous administration in autoimmune disorders and cytokine release syndrome. The current study aims to adapt this agent for intra-cavitary administration in patients

A drain catheter will be placed in the patient as standard of care treatment. Following the procedure, on that day and once a week for the following 3 weeks, tocilizumab will be administered to the patient via the drain. Each treatment session will last about one hour, and participants donate 6 milliliters (1 teaspoon) of blood before and after the treatment. Fluid drained from the body cavity, which is normally discarded, will instead be collected for analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects age 18-89 years old with pleural effusion or peritoneal ascites due to metastatic cancer
2. Scheduled to undergo standard-of-care placement of pleural or peritoneal drainage catheter
3. ECOG performance status: 0-2
4. Able to read and sign consent form in English and provide informed consent

Exclusion Criteria:

1. Laboratory abnormalities that indicate clinically significant inflammatory process AST/SGOT \> 2 times the upper limit of normal ALT/SGPT \> 2 times the upper limit of normal Total bilirubin \> 2 times the upper limit of normal Creatinine \> 2 times the upper limit of normal Hemoglobin \< 8gm/dL White blood cell count \< 3,000/ mm3 Platelet count \< 70,000/mm3 Absolute neutrophil cell count \< 2,000 per mm3
2. Subjects who are unable to comply with study procedures including travel for weekly outpatient clinic visits
3. Pregnant women
4. Active immunotherapy within 30 days; concurrent chemotherapy or targeted therapy is permitted but for patients with a history of prior immunotherapy, the most recent dose should be \>30 days prior to the first treatment visit
5. Investigational drug use within 30 days prior to first treatment dose
6. History of systemic autoimmune disease
7. Patient with known hypersensitivity to tocilizumab
8. Active infection
9. Medical contraindication or history of adverse reaction to acetaminophen or diphenhydramine

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Effect of DT56a (Femarelle) on the Coagulation System in the Treatment of Postmenopausal Women

The purpose of this study is to determine if Femeralle (DT56a) has an effect on the coagulation system, measured by platelet adhesion and aggregation, of normal and thrombophilic postmenopausal women.

Women using hormone therapy (HT) are at an increased relative risk of venous thromboembolism (VTE). The frequency of inherited Factor V Leiden and other risk factors for VTE in the general population is estimated at 5-10%. This population has a 5-21 fold greater risk to develop VTE. Therefore, given the high thrombotic risk for the combination of hormone use and hereditary prothrombotic abnormalities these women's symptoms frequently go untreated for lack of alternative therapies. DT56a (Femarelle) is a soy derived compound that has been shown to act as a novel selective estrogen receptor modulator (SERM) in the alleviation of menopausal symptoms and prevention of postmenopausal bone loss without effecting the endometrium or the sex hormone blood profile. The research question of the current study is to assess the effect of femeralle on the coagulation system and determine if it is a reasonable and safe alternative for the treatment of menopausal symptoms in thrombophilic women.

Eligibility Criteria:
Inclusion Criteria:

* No previous exogenous estrogen exposure
* Symptomatic Menopause: hot flashes, sleep disturbance, or other symptoms related to estrogen deficiency
* Menopausal (see above)

Exclusion Criteria:

* History of bleeding or thrombotic disorder
* History of malignancy (particularly Breast Cancer)
* Diabetics
* Coronary Artery Disease
* Liver Disease
* Concurrent Anticoagulation therapy
Phase II AK Study in Organ Transplant Patients

The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period.

The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.


Eligibility Criteria:
Inclusion Criteria:

* Organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry
* Organ transplant patients who have had at least one biopsy-positive SCC
* Aged 18 - 75 years
* Written informed consent to the performance of all study-specific procedures

Exclusion Criteria:

* Allergy to afamelanotide (CUV1647) or the polymer contained in the implant
* History of melanoma
* Current pigmentary disorders such as melasma
* Diagnosed with HIV/AIDS, or hepatitis B or C
* Current history of drug or alcohol abuse (in the last 12 months)
* Clinically significant organ dysfunction, history of medical disorders or other factors, which in the opinion of the investigator will interfere with the interpretation of study outcome measures
* Major medical or psychiatric illness
* Pregnancy as confirmed by positive serum beta-HCG pregnancy test prior to baseline or lactating mothers
* Females of child bearing potential not using adequate contraceptive measures
* Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit
* Use of regular medications or any other factors that may affect skin pigmentation

Discontinuation Criteria:

* Initiation of treatment with systemic retinoids
* Change of class of systemic immunosuppressant treatment
Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging

Cardiac magnetic resonance imaging has emerged as a potential valuable test for the early detection of Pulmonary Arterial Hypertension. A number of reports have provided some preliminary evidence that Pulmonary Artery (PA) stiffness may be accurately detected by imaging of the pulmonary artery in order to measure PA stiffness. In addition, cardiac MRI could play provide early and effective treatment for Pulmonary Arterial Hypertension (PAH).


Eligibility Criteria:
Inclusion Criteria:

Consecutive patients aged ≥ 18 years with PAH as dictated by a comprehensive examination and echocardiography will be included for enrollment.

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Mechanical ventilation
* Acute or chronic renal failure (creatinine clearance \< 30 ml/min or requiring renal replacement therapy)
* Inability to perform MRI (i.e. claustrophobia, severe obesity (\> 150 kg), device incompatible with MRI)
* Significant arrhythmia that precludes adequate ECG-gating for the MRI (i.e. atrial fibrillation with highly variable cycle lengths)
* Prior heart or lung transplantation
* Left ventricular systolic (ejection fraction \< 50%) or diastolic failure (based on Framingham criteria for heart failure with preserved ejection fraction)
* Significant left-sided valvular disease (≥ moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation) or prior valve surgery
Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

Development of a multiomics assay for use on OriColTM sampled rectal mucus for detection of cancer and significant polyps in symptomatic patients on the Colorectal Urgent Suspected Cancer pathway.

The primary objectives of the study are:

1. Confirm the presence of established genetic, epigenetic and microbiome based biomarker signatures associated with CRC and high-risk adenoma (defined as \>10mm in diameter or the presence of high-grade dysplasia) in colorectal urgent suspected cancer referrals, who are triaged for colonoscopy.
2. To expand and refine the genomic, epigenetic and microbiome biomarker signature profiles associated with colorectal cancer and high-risk adenoma to identify rarer biomarkers in addition to those previously established.
3. To generate indicative performance metrics, including an assessment of discriminatory power, sensitivity, specificity and negative predictive values for the clinical application of Oricol™ multiomics assay.

The Secondary Objectives of the study are:

1. To assess the health economics of delivering a diagnostic service to patients referred to the urgent suspected cancer (USC) pathway via a Community Diagnostic Centre (CDC) in comparison to the current delivery mechanisms through the Two-Week Wait (TWW) pathway.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years and over
2. Patients referred from primary care to the 'urgent suspected cancer' CRC pathway during the study period.
3. Patients who provide voluntary written informed consent to participate in the study.

Exclusion Criteria:

1. Patients who are unable to undergo digital rectal examination (DRE).
2. Patients with peri-anal/anal symptoms that may limit DRE and proctoscopy examination and it would be clinically inappropriate to attempt to assess these patients. This may include conditions such as:

   * Patients who have undergone radiotherapy.
   * An acute or chronic anal fissure
   * Perianal haematoma
   * Acute thrombosed haemorrhoids
   * Post- operative anal stenosis
   * The presence of an obstructing anal/low rectal tumour or discomfort as a result of previous pelvic radiotherapy
3. Current pregnancy or suspicion of pregnancy.
Study of the Prognosis of Infectious Endocarditis (EPEI)

Infectious endocarditis (IE) is the localization and proliferation of blood-borne germs in the endocardium. It remains a complicated disease to manage due to its low incidence, diagnostic difficulties, the change in epidemiology in recent decades and high mortality rates. The annual incidence is estimated at 3-10 cases per 100,000 people.

The epidemiology of AR has changed significantly in recent years due to new risk factors. Indeed, the frequency of rheumatic heart disease, which was the first predisposing factor, decreased markedly in the industrialized countries, replaced by new predisposing factors: the presence of valvular prostheses or intracardiac materials (the risk of AR is multiplied by 50 Compared with the general population), hemodialysis, nosocomial infections, immunosuppression, increased use of injectable treatments and, above all, an aging population with an increase in degenerative diseases such as aortic stenosis and l Mitral insufficiency.

The diagnosis of IA is based on DUKE criteria. But the clinical presentation is sometimes atypical especially in case of infection on prosthesis where the diagnosis is based mainly on the results of the blood cultures and the ultrasound data.

The lesions visualized in ultrasound are: vegetations, abscesses, pseudo-aneurysms and fistulas constituting the degenerated abscess evolution, the perforation of the cusps of the native valve or the bioprosthesis giving rise to a jet of Eccentric regurgitation.

The evolution of endocarditis and its prognosis vary according to many factors: the type of germ responsible, the precocity of the diagnosis, the existence of a complication, the site of occurrence. These complications of endocarditis are frequent, sometimes revealing. EI is complicated by heart failure, atrioventricular conduction disorders, peri-vascular abscesses, embolic, neurological, renal and septic complications. Despite improvements in diagnosis and therapeutic methods, diagnosis is sometimes difficult, management remains very complicated and morbidity and mortality remain high. Studies are still needed to study the prognosis and to determine the predictive factors for hospital mortality and long-term mortality.


Eligibility Criteria:
Inclusion Criteria:

* all patients with certain infectious endocarditis according to Duke's criteria, confirmed by the presence of evocative images on the transthoracic and / or transesophageal ultrasound or by the data collected on the surgical specimens.

Exclusion Criteria:

* Patients with an infection not meeting the Duke IE criteria.
A Prospective, Open, Multicenter Clinical Trial of Eltrombopag Combined With Diacerein in Eltrombopag-inefficient or Relapsed ITP

Eltrombopag is an oral thrombopoietin receptor agonist that has been licensed for use as second line therapy in ITP patients. Diacerein is a slow-acting medicine of the class anthraquinone used to treat joint diseases such as osteoarthritis. The project was undertaking by Qilu Hospital of Shandong University and other 5 well-known hospitals in China. In order to report the efficacy and safety of eltrombopag combined with diacerein in the management of ITP.

The investigators are undertaking a prospective, open, multicentre trial of 30 ITP adult patients with eltrombopag-inefficient or relapsed from 6 medical centers in China. The initial dose of eltrombopag administration is 25 mg orally once daily, which could be transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The treatment was discontinued after 6 weeks without blood index reaction.

Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of eltrombopag combined with diacerein for the treatment of adults patients with eltrombopag-inefficient or relapsed.

Eligibility Criteria:
Inclusion Criteria:

* ITP patients with eltrombopag-inefficient or relapsed need of treatment(s) to minimize the risk of clinically significant bleeding primary ITP confirmed by excluding other supervened causes of thrombocytopenia

Exclusion Criteria:

* pregnancy hypertension cardiovascular disease diabetes liver and kidney function impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus erythematosus and/or antiphospholipid syndrome
Optimal Site of Administration for Continuous Wound Infusion After Cesarean Section

The purpose of this randomized double-blind study is to evaluate in which anatomical layer (AF versus BF) continuous wound infusion of local anesthetics combined with NSAIDs through a multiorifice catheter has the best effectiveness during the first 48 hours on postoperative pain intensity after elective cesarean delivery.


Eligibility Criteria:
Inclusion Criteria:

* elective Cesarean Section under spinal anesthesia over37 weeks' gestation

Exclusion Criteria:

* allergy to NSAIDs
* ASA III or higher
* refusal to participate