cyrilzakka/clinical-trials huggingface dataset:
Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients

Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .

Some of these markers as procalcitonin and CD14, are costly and not feasible options for low- and middle-income countries . While other biomarkers are feasible and accessible to be evaluated as Triglyceride\\glucose index (TyG) , Relative Distributive Width of red blood corpuscles to albumin ratio (RAR), C-reactive protein,Neutrophile \\Lympocyte ratio and serum lactate levels .

Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,

There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .

Triglyceride-glucose (TyG) index has emerged as a surrogate marker of insulin resistance which is often prevalent in patients with sepsis. Red blood cell distribution width (RDW) is a common clinical hematology indicator that reflects the heterogeneity of red blood cell size. As a simple and inexpensive parameter, RDW has been successfully used to predict the prognosis of many diseases, including cardiovascular disease, kidney disease, diabetes mellitus, and liver disease .

Recent studies have also shown that RDW is significantly associated with the mortality of sepsis. RDW to albumin ratio was evaluated as a novel and simple biomarker of inflammation.

-C-reactive protein (CRP) is a sensitive indicator of the body, reflecting damage and infection .

Serum albumin level drops significantly in the acute stage of infection (16). CRP/ALB ratio (CAR) could be a marker to predict mortality in sepsis.

The neutrophil-lymphocyte ratio (NLR) is an-inflammatory biomarker that can be used as an indicator of systemic inflammation. It is a simple that does not add costs to complete blood count laboratory examinations, which are performed routinely in hospitals. It was tested as a guide for the prognosis of various diseases, such as cancer, community pneumonia and sepsis.

Although these various biomarkers that have been proposed, no single clinical or biological indicator of sepsis has gained general acceptance . And to our knowledge, no previous study compared between these indicators in prediction of sepsis outcome or determined the clinical significance of combination of multiple biomarkers in prognosis of sepsis .

Eligibility Criteria:
Inclusion Criteria:

- patients whom will be diagnosed with sepsis

Exclusion Criteria:

* patients diagnosed by hematological disease
* patients refused to participate in the research
* patients less than 18 years
Value of Right-sided Hemicolectomy for Chldren With High-risk Neuroendocrine Tumors of the Appendix

The goal of this observational study is to investigate the beneficial value of complementary surgery for appendiceal neuro-endocrine tumours in children.

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Aim Current guidelines recommend complementary right-sided hemicolectomy for high-risk (pT2(with risk factors)/pT3) neuro-endocrine tumors (NET) of the appendix (based on adult studies). In contrast to adults, high-risk NET of the appendix in children seems to be a relatively benign disease with high disease-free survival (100% versus 70-80% in adults), but high quality data are lacking. Therefore these recommendations are now being questioned. We aim to investigate the value of complementary right-sided hemicolectomy for children with high-risk NET of the appendix. Ultimately leading to the development of a consensus guideline and solid information for patients/parents.

Plan of investigation In order to generate big data, an international historical cohort study is planned to compare complementary right-sided hemicolectomy with appendectomy alone for children with high-risk NET of the appendix. Results will be CONFIDENTIAL used by an international expert group to formulate treatment recommendations. Subsequently, these recommendations will be tested in an international Delphi study in order to develop a consensus guideline on the treatment of pediatric high-risk NET of the appendix.

Expected results The cohort study will generate high quality information on overall/disease-free survival, recurrence, complications, costs, and hr-QoL. Recommendations made will be tested in a Delphi study; not only on the beneficial value of complementary right-sided hemicolectomy, but also on follow-up protocols and preoperative work-up. Ultimately, an international consensus guideline that redefines low-risk and high-risk NET of the appendix will be developed, leading to global de-escalation and uniformity of treatment.

Relevance for childhood cancer Results are relevant for pediatric oncologists/surgeons/gastro-enterologists across the world, as redefining low-risk and high-risk patient groups, will lead to de-escalation of treatment. Furthermore, QoL of child and parents can be improved by reducing exposure to complications after complementary right-sided hemicolectomy, and by reducing the fear of recurrence by obtaining high-quality data to accurately inform patients and parents.

Eligibility Criteria:
Inclusion Criteria:

* All patients that were treated for an appendiceal NET before the age of 18 years old
* Time period: 1990-2020

Exclusion Criteria:

* Other appendiceal malignancies/tumours, for example:
* goblet cell carcinoma
* adenocarcinoma
* neuroendocrine carcinoma
Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block

This study compares the efficacy of the ultrasound with fluoroscope in guidance of lumbar sympathetic block (LSB). The goals of the study are; 1) To show that US-guided LSB results in shorter performance time compared to fluoroscope-guided LSB, 2) To evaluate the efficacy and safety of US-guided LSB, and 3) To verify that US-guided LSB has similar success rates to fluoroscope-guided LSB. 50 patients who are supposed to undergo LSB due to sympathetically maintained pain, satisfy criteria of inclusion and exclusion, and voluntarily sign the informed consent will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have sympathetically-mediated pain and are supposed to undergo LSB procedure (e.g. pain with asymmetric skin temperature of lower limb in previous thermography, small fiber disorder in previous quantitative sudomotor axon reflex test (QSART), vascular insufficiency in lower extremities, diabetic polyneuropathy, postherpetic neuralgia, complex regional pain syndrome, cancer-related neuropathic pain such as chemotherapy-induced peripheral neuropathy, other lower extremity neuropathies, lower extremity crush injury etc.)
* Numeric rating scale (NRS) ≥ 4/10
* Failure of previous conservative treatments, such as physiotherapy, oral medication, or other noninvasive treatment

Exclusion Criteria:

* Previous lumbar sympathetic neurolysis
* Bleeding tendency
* Local infection
* Allergy to local anesthetics or contrast media
* Pregnancy
* Severe variation near procedure site-scoliosis, tumor, abdominal aneurysm, etc.
* BMI ≥ 30 kg/m2
* Cognitive dysfunction
Clinical Trial to Compare Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis

The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis

The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis.

Anticipated result is to prove superiority of Rebamipide/Nizatidine combination therapy at 2 weeks compared to Nizatidine Monotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 19 years or older and under 75 years
2. Subject who was diagnosed with acute or chronic gastritis in upper gastrointestinal endoscopy conducted within 7 days prior to the start of administration of medications for clinical trials and identified at least one labyrinth (defect of mucosal surface layer)
3. Subject who voluntarily decides to participate in the trial after hearing the explanation of this clinical trial and signs the informed consent form.

Exclusion Criteria

1. Subject who is unable to examine the upper gastrointestinal endoscope
2. A person with the following past history

   * Surgery to suppress gastric acid secretion or gastrointestinal and esophagus surgery
   * Malignant tumor of the digestive system
   * overreacted to the components of medicine for clinical trials and H2 receptor blockers
   * Drug or alcohol abuse
3. A person accompanied by the following diseases

   * Digestive ulcers (excluding half a scar)
   * Reflux esophagitis
   * Inflammatory bowel disease (cron disease, ulcerative colitis)
   * Thrombotic diseases (such as cerebral thrombosis, myocardial infarction, thrombotic venous inflammation, etc.)
   * Zollinger-Ellison syndrome
   * Subject with mental illness, cardiovascular system, respiratory system, endocrine system, central nervous system who the investigator determined that it is difficult to participate in this clinical trial
4. A person who needs to administer a taboo drug during the clinical trial period.
5. Pregnant women and nursing women
6. Fertilized women and men who have a pregnancy plan or do not have the will to use the appropriate contraceptive method during the clinical trial period.
7. Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
8. Severe liver disorder (AST or ALT \> 3 times the normal upper limit of the organ)
9. Serious nephropathy (creatinine clearance \< 50 mL/min)
10. Subject who has been administered (applied) other clinical medications or medical devices within 4 weeks of screening
11. Subject who the investigator determined it is inappropriate to participate in this clinical trial.
Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy

To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of surgery for PVR.


Eligibility Criteria:
Inclusion Criteria:

* Cases of rhegmatogenous retinal detachment complicated by PVR grade C undergoing vitrectomy and silicone oil tamponade.

Exclusion Criteria:

* History of trauma
* Presence of diabetic retinopathy
* History of vein occlusion
* Giant retinal tear
Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy

In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to full mouth periodontal debridement.

This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. Patients were enrolled from January 2020 to December 2022. The local ethical committee of approved the study protocol (125/PO) and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 88 patients, aged 27 to 65 (mean age 57) were assessed for eligibility. In all subjects, subgingival plaque will acquired from 4 separate proximal periodontal sites.

Eligibility Criteria:
Inclusion Criteria:

1. good condition of general health,
2. a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm,
3. no involvement of the furcation,
4. a minimum of a six teeth per quadrant, respectively.

Exclusion Criteria:

1. periodontal therapy during the last 12 months,
2. assumption of antibiotics during the last 6 months,
3. pregnancy,
4. any systemic condition which might affect the effects of the study treatment,
5. previous or current radiation or immunosuppressive therapies,
6. use of mouthwash containing antimicrobials during the previous 3 months,
7. no use of hormonal contraceptives,
8. medication by anti-inflammatory and immunosuppressive drugs,
9. previous history of hard-drinking,
10. smoking,
11. class II and III tooth mobility.
A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers

This study aims to refine and evaluate feasibility of a telehealth intervention for persons with Alzheimer's disease and their caregivers. The intervention will use evidence-based techniques for decreasing symptoms of depression, anxiety, and poor sleep, that are commonly reported among this vulnerable group during the COVID-19 pandemic. Improved symptoms among this group may improve their other health outcomes and quality of life and furthermore the quality of care that caregivers provide for persons with Alzheimer's disease during this challenging time.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patients

* Have a diagnosis of AD (probable or possible), other related dementia, or mild cognitive impairment as documented in electronic medical record
* Community-dwelling
* Aged \> 50 years
* Have no previously diagnosed sleep disorders (e.g., sleep apnea, restless legs syndrome)
* Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
* Have an eligible caregiver

Inclusion criteria for caregivers

* Aged \>18 years
* Live with the eligible patient
* Have regularly assisted the care recipient with \>1 of 7 basic activities of daily living (ADLs; i.e., eating, dressing/undressing, grooming, walking across a room, getting in and out of bed, bathing, toileting) or \>1 of 7 Instrumental ADL (IADLs; i.e., using the telephone, getting to places beyond walking distance, shopping, preparing meals, doing housework, taking medicine, handling money) for the past 6 months
* Have no history of cognitive impairment
* Can communicate in English.

Exclusion Criteria:

-Professional caregivers will be excluded. Patients will be excluded if they are bedbound. If the eligibility criteria for either a patient or a caregiver are not met, their dyads will be excluded for this study
Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)

The objectives of this study are to describe characteristics, treatment patterns, and outcomes of patients with schizophrenia newly initiated on 1 of 4 FDA-approved atypical Long Acting Injectable (LAI) antipsychotics (ABILIFY MAINTENA®, ARISTADA®, INVEGA SUSTENNA® or RISPERDAL CONSTA®)

This is a non-interventional, prospective, multi-center observational cohort study. Patients at behavioral health clinics will be enrolled and evaluated by health care professionals (e.g., psychiatrists) according to the standard of care. All patients will be followed for approximately 12 months from their enrollment visit.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to speak, read and understand English
* Diagnosis of schizophrenia as defined by the treating clinician
* Newly initiating treatment with 1 of 4 atypical Long Acting Injectables (LAIs): Abilify Maintena, Aristada, Invega Sustenna, or Risperdal Consta)
* Additional criteria may apply

Exclusion Criteria:

* Currently participating or planning to participate in an interventional clinical study, or has completed participation in an interventional clinical study within 30 days before enrollment
* In the opinion of the investigator, is currently an imminent danger to himself/herself. \[Note: A prior history of suicidal ideation or suicidal attempt is not exclusionary.\]
* Additional criteria may apply
Safety, Tolerability and Efficacy of A6 in Patients With Chronic Lymphocytic Leukemia (CLL)

This study will assess the efficacy, safety and pharmacodynamic markers of the study drug, A6, in patients with CLL and small lymphocytic lymphoma (SLL).

In patients diagnosed with CLL or SLL, study medication will be injected subcutaneously two times a day in an outpatient setting for up to 6 cycles (28 days = 1 cycle) prior to the primary endpoint assessment.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CLL or SLL based on IWCLL Criteria
* Measurable or evaluable disease based on IWCLL criteria
* Previously untreated patients who have been counseled on approved alternative therapeutic options. Not a candidate for fludarabine/cyclophosphamide/rituximab (FCR) or has preference to not receive chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) status of 0-2.
* Adequate bone marrow, renal, liver, cardiac and pulmonary function.
* Life expectancy of greater than or equal to 6 months.

Exclusion Criteria:

* Receipt of other cancer therapy, immunomodulatory drug therapy or immunosuppressive therapy within 4 weeks prior to 1st dose.
* Receipt of corticosteroids \> 20 mg/day within 4 weeks prior to1st dose
* Major surgery or radiation within 4 weeks prior to 1st dose
* Presence of uncontrolled infection requiring systemic therapy
* Active second malignancy other than non-melanoma skin cancer
* Uncontrolled autoimmune anemia or thrombocytopenia
* Receipt of any investigational agent within 4 weeks prior to 1st dose
* Pregnant or lactating female
* Any severe, acute or chronic medical or psychiatric condition, or lab abnormality that may increase the risk associated with trial participation, study drug administration or interfere with informed consent process or compliance with requirements of the trial.
Longitudinal Evaluation of Energy Expenditure in ICU Patients From Admission to Discharge Using A Novel Indirect Calorimeter: LEEP-Forward Trial

The purpose of this study is to utilize the new indirect calorimetry Q-NRG device to the measurement of energy expenditure (EE) throughout your intensive care unit (ICU) stay and ultimately address fundamental questions about metabolism and energy requirements for critically ill patients. The study will use a new, investigational calorimeter called the Q-NRG (the study device, supplied by Cosmed, Italy). The word "investigational" means the study drug or device or biologic is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). A calorimeter is a device that connects to your breathing machine tubing for a short period (about 30 minutes) and helps to determine what nutrition you may need in your current condition.

There are FDA approved calorimeters that have been used as the current standard of care. These devices and the new Q-NRG calorimeter measure oxygen consumption and carbon dioxide production (the gas you breathe out when you exhale) and calculate energy expenditure. Unfortunately, previously existing calorimeters are complicated to use, cumbersome and require time for measurements. It is hoped the new calorimeter will be easier and more practical to use and, through the measurements we take, we will have a better understanding of a patient's caloric needs for healing.

Muscle mass and quality play a role in determining EE and metabolic needs. Massive loss of muscle mass and quality that occurs in critical illness significantly affects EE and nutritional needs and should be accounted for in clinical nutrition delivery. Imaging (standard of care abdominal CT and MSK ultrasound) will be used to assess muscle mass, and muscle quality (amount of intramuscular adipose content; IMAT).


Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients requiring mechanical ventilation for \> 48 hours
* Patients admitted to Duke Surgical/Trauma ICU, Medical ICU, Cardiothoracic ICU, and Neuro ICU
* Patients must be enrolled within 72 hours of ICU admission

Exclusion Criteria:

* Fraction of inhaled oxygen (FIO2) \> 70%
* Positive end expiratory pressure (PEEP) \> 10cmH2O
* Peak ventilatory pressure \> 30cmH20
* Presence of air leaks from thoracic drain tube
* Changes in vasoactive agent dose (\>20%, \<1 hr before or during IC)
* Agitation or change in sedative/analgesic dose (\>20%, \<1 hr before and/or during IC)
* Change in body temperature (\>0.5°C, \<1 hr before and/or during IC)
* Expected duration of ICU stay \< 24 hours
* Expected survival of the patient \< 24 hours
* Continuous Renal Replacement Therapy (CRRT/CVVH that does not experience an appropriate interruption of at least 60 minutes to allow for indirect calorimetry measurements
Comparison of ELDOA and Mechanical Traction Technique on Pain and Disability in Patients With Lumbar Disc Herniation

To compare the effect of ELDOA and Mechanical traction technique on pain in patients with lumbar disc herniation.

To compare the effect of ELDOA and Mechanical traction technique on disability in patients with lumbar disc herniation.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-65 years
* Both gender Male \& Female
* Patients having Lumbar radiculopathy diagnosed with lumbar disc herniation.

Exclusion Criteria:

* Patients presented with motor deficit,
* Qauda equina syndrome,
* lumbar fracture
* spinal stenosis,
* osteophyte formation
* facet joint pathology
* spondylolisthesis.
* malignancy,
* degenerative disorders
* recent back surgery and patient whom surgery for lumbar disc herniation/prolapse intervertebral disc already advised by neurosurgeon