cyrilzakka/clinical-trials huggingface dataset:
Biological Assessment of Clinical Nutrition and Its Application

1. Clinical nutritional support therapy is an important progress of modern medicine.
2. Conventional methods of clinical nutrition assessment (Anthropometric, lab, etc.) not just lack of accuracy and immediacy but also difficult to dynamically reflect the fluctuation trend of nutrition status.
3. It has been reported that malnutrition affects proliferation and apoptosis of human cells in vivo. This preliminary study was initiated by the hypothesis that changes in nutritional status may be reflected rapidly in fast proliferating cells.
4. In the previous studies the investigators already found that apoptosis rate of oral mucosal epithelium could reflect changes in nutritional status.There were an obvious decreasing in apoptosis and proliferation rate of oral mucosal epithelium in malnourished patients.
5. Based on the patient's curve of apoptosis rate of oral mucosal epithelium, the plateau being achieved by increase the nutrition amount continuously, Maintain this amount of nutrition given until the end of treatment. The investigators call this amount of nutrition the "upper limit nutrition support therapy".
6. The patients applying for"upper limit nutrition support therapy" and "Formula nutrition support therapy" separately, comparing of the two methods influences on postoperative wound healing, postoperative complication rate ,inflammatory response, side effects of chemotherapy, hospital stays and hospitalization expenses.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Gastric cancer or colorectal cancer which confirmed by Preoperative pathology will be included.
2. Patients who are diagnosed as malnutrition according history, physical examination and Nutrition Risk Screening 2002 will be included.
3. patients who have digestive tract fistula because of operation complication will be included.
4. patients who need fast track recovery after colorectal cancer operation will be included.

Exclusion Criteria:

1. Patients who are diagnosed as Late stage (stage IV) gastric cancer or colorectal cancer and can not accomplish radical resection will be excluded.
2. Postoperative gastric cancer or colorectal cancer patients who is Unable to tolerate the chemotherapy or unable to complete the whole chemotherapy course will be excluded.
3. patients with Severe endocrine system disease such as diabetic mellitus, hyperthyroidism will be excluded.
4. patients with cardiac, renal, respiratory, or hepatic diseases, diabetes,active infection, evidence of sepsis, active bleeding or obstruction, and oral disease will be excluded.
Montelukast for Prevention & Treatment of OHSS

montelukast \& dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.

patients with high risk for ovarian hyperstimulation will undergo a freeze-all protocol then montelukast \& dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.

Eligibility Criteria:
Inclusion Criteria:

* PCOS high responders high numbers of ovum retrieved

Exclusion Criteria:

* hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction
Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria

The purpose of this study is to provide daptomycin, an antibiotic, to patients who are failing conventional therapy, or who cannot take approved antibiotics for one reason or another.


Eligibility Criteria:
Main Inclusion Criteria:

* Infection caused by Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, or Enterococcus faecium that requires inpatient hospitalization and treatment with injectable antibiotics\*\*
* Site of infection: complicated skin and skin structure infection; urinary tract infection; intra-abdominal infection; infective endocarditis; or bloodstream infection (including catheter-related).
* Pathogen resistant to, or patient intolerant of: beta-lactams, vancomycin, quinupristin/dalfopristin, or linezolid.
* Unable to receive any other standard commercially available antibacterial therapy for the infection.

Main Exclusion Criteria:

* Creatinine clearance less than 40 mL/min\*\*
* Hemodialysis or peritoneal dialysis
* Admitted to the hospital for drug overdose or other conditions associated with rhabdomyolysis, or is expected to require repeated intramuscular injections
* Creatine phosphokinase (CPK) level greater than 2.5 times above the upper limit of normal (ULN) at screening; if the elevation in CPK can be attributed to an obvious cause (eg, surgery)\*\*
* Central nervous system infection
* Pulmonary infection.

(\*\*) An exemption may be granted for patients not satisfying these criteria following a conversation with the Medical Monitor.
Behavioral and Environmental Sensing and Intervention

This 3-phase research plan to employ Behavioral and Environmental Sensing and Intervention (BESI) will overcome the fundamental scientific barriers to realizing prediction of agitation episodes and detection early stages of dementia related agitation. The goal of which is empowering caregivers to intervene early and ultimately reduce agitation, thus reducing caregiver burden and extending aging-in-place and improving the associated quality-of-life and cost benefits.

The dementia syndrome of Alzheimer's disease and other disorders is rapidly expanding due to the aging of society and the longevity of citizens. In its varying stages, care of the dementia syndrome requires differing sets of skills from the caregivers, and more skilled intervention is required as the disease progresses. These caregivers experience increased burden due to the challenges and stresses of caring. A recent systematic review of caregiver burden factors revealed dementia-related agitation to be the most prevalent factor leading caregivers to institutionalize community-dwelling loved ones with dementia. Tools that empower caregivers to proactively reduce the incidents and severity of agitation would reduce stress and increase self-efficacy, thereby extending aging-in-place and the associated quality-of-life and cost benefits.

This project proposes to develop, deploy, and evaluate such a tool and to address the fundamental scientific challenges to realizing the benefits of such a technology to caregivers and persons with dementia (PWD). The tool - BESI: Behavioral and Environmental Sensing and Intervention - will be an empowerment tool for caregivers of community-dwelling PWD. BESI comprises:

1. a system of body-worn inertial sensors and in-home acoustic, light, temperature, and motion sensors,
2. data analysis techniques to detect and assess agitation and environmental context from these sensor streams,
3. models for the relationship between agitation and the environment that are trained for each PWD-caregiver dyad based on a\&b, and
4. automated real-time notifications to the caregiver based on b\&c (e.g., detection of early agitation stages or of an environment (cumulative and/or instantaneous based on the models) that has led to agitation in the past), empowering the caregiver to intervene before agitation escalation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia
* Living in one home for at least 2 months without hospitalization
* Caregiver seeking support for caregiving needs
* Have a stable caregiver
* Be able to provide consent or assent

Exclusion Criteria:

* Hospitalization in the last 2 months
* Multiple and inconsistent caregivers
* Living in multiple homes
* Unable to provide consent or assent
* No known dementia
Functional Remediation for Bipolar Disorder

Bipolar Disorder is a major mood disorder with periodic mood episodes that may be very distressing, both to the individual and to others. When ill, the person is at particular risk for disruptions to social and occupational functioning, physical health, and even premature death. When not in an episode, individuals with BD may still be feeling well but have ongoing neurobiological processes, as well as the psychological sequelae from illness episodes, that can lead to subtle neurocognitive impairment that impedes overall functioning. This study is a test of an existing, published intervention that ameliorates deficits in functioning in euthymic bipolar individuals.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of bipolar I or II disorder (BD), as determined by a structured diagnostic interview
* at least three months of clinical remission (euthymia or minimal symptoms), based on the phone screen assessing mood episodes in the prior three months
* score greater than 11 on a measure of everyday functioning (FAST; described in measures section) indicating at least mild impairment
* use of a standard bipolar mood-stabilizing medication at the same, adequate dose (according to CANMAT treatment guidelines) for at least 3 months prior to screening, with ability to continue that dose during the study.

Exclusion Criteria:

* history of neurological illness or injury (e.g., stroke, brain tumor)
* documented intellectual disability
* inability to provide written informed consent
* substance dependence within last 3 months or substance abuse in last 30 days
* inability to complete the six-month intervention
* received ECT in the past 12 months
Fractalkine, a CX3C Chemokine, Act as a Mediator of Ocular Angiogenesis

Fractalkine (FKN) is a chemoattractant and adhesion molecule for leukocytes. Angiogenic effect of FKN also has been reported. We investigate FKN-mediated angiogenesis in ocular angiogenic disorders.

Fractalkine (FKN), the sole member of the CX3C chemokine family, is named for its fractal geometry. The CX3C motif, with three amino acids between the two terminal cysteines, makes fractalkine distinct from other chemokines.The structure of fractalkine, a membrane-bound glycoprotein with the chemokines domain atop an extended mucin-like stalk, also is unique.Membrane-bound FKN can be markedly induced on primary endothelial cells by inflammatory cytokines; this form promotes the robust adhesion of monocytes and T lymphocytes. Soluble FKN can be released by proteolysis at an efficient chemotactic activity level for monocytes and T cells. Thus, FKN is a versatile molecule regulating both cell-cell interactions in its membrane-bound form and directed-cell migration in its soluble form. The receptor of FKN, CXC3R1, is a G protein-couple protein, which expresses T lymphocytes, monocytes, natural killer (NK) cells, microglia, and neurons.Sulfation of tyrosine enhances the function of CX3CR1 in cell capture and firm adhesion. Fractalkine is expressed constitutively in the kidney, heart, lung, and brain. Fractalkine has demonstrated an important role in CNS inflammation, cardiac allograft rejection, arteriogenesis, renal disease, psoriasis, and during pregnancy. Silverman et al demonstrated the presence of FKN in normal cultured microvascular endothelial and stromal cells of iris and retina in vitro. Upon inflammatory cytokine stimulation, EC also express FKN and its receptors with FKN secretion in an autocrine manner. In addition to EC chemotaxis and tube formation, FKN is an angiogenic mediator in rheumatoid arthritis. Therefore, we hypothesize that FKN not only participates in ocular inflammatory reactions, but also plays an important role in ocular angiogenesis.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of proliferative diabetic retinopathy.
* who will receive vitrectomy for treatment of disease.

Exclusion Criteria:

* previous ocular surgical history.
* history of uveitis
* history of ocular trauma.
Effect of Urine-guided Hydration on Acute Kidney Injury After CRS-HIPEC

Acute renal injury (AKI) is a common complication after cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), and is associated with worse outcomes. Available evidences show that maintaining intraoperative urine output ≥ 200 ml/h by fluid and furosemide administration may reduce the incidence of AKI in patients undergoing cardiopulmonary bypass. The investigators hypothesize that, for patients undergoing CRS-HIPEC, intraoperative urine-volume guided hydration may also reduce the incidence of postoperative AKI.

Acute renal injury (AKI) is a common complication after cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC), and is associated with worse outcomes. Studies showed that less intraoperative urine volume was associated with AKI.

In studies of contrast-associated AKI, intraoperative and 4-h postoperative hydration and forced diuresis to achieve urine output ≥ 300 ml/h reduces the incidence of AKI by 44%. In patients undergoing cardiac surgery under cardiopulmonary bypass, maintaining intraoperative and 6-h postoperative urine output ≥200 ml/h by fluid and furosemide administration reduces the incidence of AKI by 52%. For patients with rhabdomyolysis, it is recommended to maintain urine output at approximately 3 ml/kg/h (200 ml/h) with volume supplementation. We suppose that forced diuresis with simultaneous hydration (balancing urine output with intravenous fluid infusion) may reduce AKI after CRS-HIPEC.

The purpose of this randomised controlled trial is to investigate whether maintaining urine output at 200 ml/h (3 ml/kg/h) or higher by forced diuresis with simultaneous hydration can reduce the incidence of AKI after CRS-HIPEC.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Diagnosed as pseudomyxoma peritonei, scheduled for cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy under general anesthesia;
* At least 14 days since the last treatment of chemotherapy, radiotherapy, or immunotherapy;
* Consent to participate in this study.

Exclusion Criteria:

* Persistent preoperative atrial fibrillation, or new-onset cardiovascular event (acute coronary syndrome, stroke, or congestive heart failure) in the past 3 months;
* Requirement of vasopressors to maintain blood pressure before surgery;
* Known furosemide hypersensitivity;
* Chronic kidney disease stage 5 or requirement of renal replacement therapy;
* Other conditions that are considered unsuitable for the study participation.
Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction

The primary objective is to investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with HFpEF.

Moreover several secondary objectives will be investigated.

This is a prospective, observational multi-center cohort study which will be conducted at the cardiology departments of the Erasmus Medical Centre (EMC) as well as five other hospitals. A total of 200 HFpEF patients will be included in the study via the outpatient clinics. The follow-up period will constitute a minimum of 2 years and a maximum of 3.5 years. Clinical data will be collected at baseline and blood samples will be collected at baseline and subsequently every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Capable of understanding and signing informed consent
* A diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the ESC or/and a high (90%) probability of HFpEF according to the H2FPEF score, i.e. a score of 6 or higher.

Exclusion Criteria:

* History of LVEF ≤40%
* Scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion
* Impaired renal function, defined as eGFR \< 20 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis at the time of screening
* Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
* COPD Gold stage IV
* Congenital heart disease
* Pregnancy
* Coexistent condition with life expectancy of \<1 year
* Unlikely to appear at all scheduled follow-up visits
* Linguistic barrier
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.

The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.

A 52-week, double-blind, randomised, multi-centre, parallel-group, Phase III study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort® (budesonide/formoterol) Turbuhaler® 160/4.5 μg 'as needed' compared with terbutaline Turbuhaler® 0.4 mg 'as needed' and with Pulmicort® (budesonide) Turbuhaler® 200 μg twice daily plus terbutaline Turbuhaler® 0.4 mg 'as needed'

Eligibility Criteria:
INCLUSION CRITERIA 1. Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required 2. Male or Female, ≥12 years of age 3. Documented diagnosis of asthma for at least 6 months prior to Visit 1 4. Patients who are in need of Step 2 treatment according to Global Initiative for Asthma guidelines 5. Patients treated with 'as needed' inhaled short-acting bronchodilator(s) only should have pre-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥ 60 % of Predicted Normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN 6. Patients treated with low stable dose of inhaled corticosteroid or leukotriene antagonist in addition to 'as needed' use of inhaled short-acting bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN 7. Patients should have reversible airway obstruction 8. To be randomized patients must have used Bricanyl Turbuhaler 'as needed' on at least 3 separate days during the last week of the run in period. EXCLUSION CRITERIA 1. Patient has a history of life-threatening asthma including intubation and intensive care unit admission 2. Patient has had an asthma worsening requiring change in treatment other than inhaled short-acting bronchodilator(s) within 30 days prior to Visit 1 or between Visits 1 and 2; or a treatment other than Bricanyl Turbuhaler from Visit 2 until randomization 3. Patient has required treatment with oral, rectal or parenteral glucocorticosteroids (GCS) within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1 4. Smoker (current or previous) with a smoking history of ≥ 10 pack years 5. Pregnancy, breast-feeding or planned pregnancy during the study.
Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.

The purpose of this clinical experience study is to determine whether CC-5013 is safe and effective (to include studying the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body \[pharmacokinetics\]) in Japanese subjects with low- or intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33) abnormality and symptomatic anemia.


Eligibility Criteria:
Inclusion Criteria:

* Must understand and voluntarily sign an informed consent form.
* Age ≥ 20 years at the time of signing the informed consent form.
* Must be able to adhere to the study visit schedule and other protocol requirements.
* Diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low- or intermediate-1-risk disease associated with a deletion 5(q31-33) abnormality
* Symptomatic anemia secondary to MDS defined as:Untransfused Hb level \< 10.0 g/dL and a Functional Assessment of Cancer Therapy (FACT)-anemia subscale score of ≤ 74 or Transfusion dependent anemia

Exclusion Criteria:

* Pregnant or lactating females.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
* Prior therapy with lenalidomide.
* Patients with any of the following laboratory abnormalities within 14 days of starting study drug: Absolute Neutrophil Count (ANC) \< 750 cells/μL (0.75 x 10\^9/L) Platelet count \< 50,000/μL (50x10\^9/L) Serum creatinine \> 2.5 mg/dL Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3.0 x Upper Limit of Normal (ULN)
Diagnosis and Clinical Presentation of Iliac Graft-Enteric Fistula: A Case Report

Abstract

Introduction:

Aorto-enteric fistula (AEF) is a life-threatening complication arising from abnormal connections between the gastrointestinal tract and major arteries. One uncommon type, iliac artery-enteric fistula (IEF), can occur following vascular interventions such as arterial stent-graft placement.

Case Presentation:

We report the case of a 47-year-old male presenting with hematemesis and abdominal pain, who was diagnosed with an iliac graft-enteric fistula. Timely recognition and management were crucial for a favorable outcome.

Clinical Discussion:

Diagnosing AEFs remains challenging, requiring a multidisciplinary approach and high clinical suspicion. While computed tomography angiography (CTA) is commonly used for diagnosis, its sensitivity may be limited, emphasizing the importance of integrating clinical history and findings. Management strategies vary based on etiology and patient status, with surgery being pivotal.

Conclusion:

Aorto-enteric fistula, which can arise from a thrombosed graft, presents diagnostic challenges due to its rare formation. In patients with a history of vascular interventions and gastrointestinal bleeding, AEF should be considered. This case underscores the need for heightened awareness among healthcare professionals regarding AEF diagnosis and management to reduce severe morbidity, mortality, and prolonged hospital stays.


Eligibility Criteria:
Inclusion Criteria:

n/a

Exclusion Criteria:

n/a
Elderly Patient at Risk of Loss of Mobility, Exercise - Primary Care, Prevention, Care Pathways

Loss of mobility is predictive of a loss of autonomy and is often the first sign of functional decline. Loss of mobility is also associated with poor perceived quality of life, depressive symptoms, high risk of adverse events such as falls and fractures, to an increased risk to input in institution and mortality's increase.

Consequences and frequency of loss of mobility make essential its identification, evaluation and the practice of preventive measures in primary care.

The implementation of effective interventions in primary care to prevent or delay the loss of mobility is a public health priority.

PRISME-3P program aims to develop and evaluate a dedicated care pathway, in primary care, based on a personalized multimodal intervention: screening, support combining physician, teaching exercises by a specialized Monitor in Adapted Physical Activities (MAPA) and nutritional counseling.


Eligibility Criteria:
Inclusion Criteria:

* Aged \> 70 years
* With at least 2 of the following signs:

  1. Difficulty in carrying a shopping bag (load about 4.5 Kg)
  2. Difficulty in getting up from a chair without using arms
  3. Difficulty in climbing 10 stairs
  4. Difficulty in moving, walking slow
  5. Difficulty in walking more than 400 meters without stop
  6. Running time \<1 hour / week
  7. Fatigue at modest physical effort: shopping, housework ...
  8. At least two falls in the last year
  9. Weight loss ≥5% in 1 month or weight loss ≥10% in 6 months
* Short Physical Performance Battery score \< 10

Exclusion Criteria:

* Locomotor disability not allowing implementation of the protocol according to the investigator
* Life expectancy less than 6 months
* Severe chronic progressive pathologies incompatible with the completion of the physical activity program
* Patient institutionalized in nursing homes
* Advanced Cognitive impairment (MMSE \<20)