cyrilzakka/clinical-trials huggingface dataset:
Evaluating Central Line Hub Contamination Using a Novel Capping Device

Excelsior Medical has developed SwabCap™, a luer access valve disinfection cap. The SwabCap™ provides passive disinfection of valve top and threads without activating the luer access valve. This product promotes technique standardization and compliance in cleansing of the luer access valve prior to access. It acts as a physical barrier from touch and airborne contamination for up to 96 hours. This product has been endorsed and will be adopted for use at NorthShore University HealthSystem as a quality improvement initiative. This research study protocol is designed to confirm the anticipated benefit of this change in practice at NorthShore during the planned implementation and use.

If the product performs as it has been designed to, the baseline rate of hub and subsequently intraluminal contamination will be diminished, thereby protecting patients with central lines from bloodstream infections due to contaminated hubs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with peripherally inserted central catheters (PICC) inserted during their index hospitalization plus 5 or more consecutive PICC line days were consented and enrolled.

Exclusion Criteria:

* Minors and adult inpatients without PICCs or with PICCs for \< 5 days
Assessment of Somatic Symptom in Chinese Community-Dwelling People

With the rapid aging and worsening psychological problems worldwide, the special focus on somatic symptom and other psychological diseases of the older population is needed. However, there is no research comparing the incidence of somatic symptom between elderly and non-elderly, and clinical relevance with somatic symptom is uncertain. The study aims to clarify the prevalence of somatic symptom, depression and anxiety disorders in China, to compare physical and psychological difference between the elderly and non-elderly and to explore risk factors for somatic symptom in the elderly.

With the steadily increasing of life expectancy, the aging people is expected to 2 billion by 2050, which brings the deeper demand on the quality of life improvement. The psychological problems is an important factor affecting the quality of life. As reported, 73.6% of urban residents were with mental sub-health, indicating that psychological problem has grown into inevitable issues in hindering healthy development. The elderly, compared with the non-elderly, have unique social and biological characteristics, so psychological problem of the older population deserves special focus. Literatures have investigated aged people with depression or anxiety disorder, but somatic symptom in elderly have rarely been addressed. Somatic symptom disorder prevalence in elderly in European ranged from 0-13.5%. However, there is no research comparing the incidence of somatic symptom, anxiety and depression between elderly and non-elderly and revealing the prevalence of somatic symptom under Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.

Investigators use Somatic Symptom Scale-China (SSS-CN) questionnaire to assess the presence and severity of the symptoms. Patient Heath Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Screener (GAD-7) are used to evaluate depression and anxiety disorder respectively. The study aims to clarify the prevalence of somatic symptom, depression and anxiety disorders in China, to compare physical and psychological difference between the elderly and non-elderly and to explore risk factors for somatic symptom in the elderly.

Eligibility Criteria:
Inclusion Criteria:

1. voluntary participants and gave written consent to participates the study;
2. undertook SSS-CN questionnaire, PHQ-9 and GAD questionnaires；

Exclusion Criteria:

1. patients who have lost their self-assessed abilities or refuse to participate ;
2. patient with cancer and central nervous system disease;
3. patients who have been previously confirmed serious mental disorders, mental retardation or dementia.
Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study

The aim of this prospective follow-up study is to investigate 5-year clinical outcome in patients with ST-elevation myocardial infarction undergoing remote ischemic conditioning before primary percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Chest pain before admission to hospital within 12 h of onset, ST-segment elevation of \> 0,1 mV in 2 or more contiguous leads, 18 years or older.

Exclusion Criteria:

* left bundle branch block, previous myocardial infarction, fibrinolytic treatment in the previous 30 days, previous coronary bypass surgery, left main stem stenosis requiring coronary bypass surgery, severe heart failure requiring mechanical ventilation or use of an intra-aortic balloon pump.
The Role of No-Calorie Beverages Within a Weight Loss Program

The no calorie drink study is looking for over 300 people to participate. The study is evaluating the effect of no calorie beverages on weight loss and weight maintained over time in people who drink diet beverages every day as compared to water only drinkers during the 1 year study period.

This investigation aims to test the hypothesis that the amount of weight lost and maintained over time in an intensive behavioral weight management program will be equivalent in subjects consuming beverages containing no calorie sweeteners as compared to water beverages.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index: 27 - 40 kg/m2
* Must drink no calorie, sweetened drinks

Exclusion Criteria

* Cardiovascular disease
* Uncontrolled blood pressure
* Smoker
* Medications that affecting metabolism
* Oral steroids
* History of stroke or seizures
* Thyroid disease
* Type 1 or 2 diabetes
* Cushings syndrome
* Renal disease
* Liver disease
* Cancer in the past 5 years
* HIV
* Active tuberculosis
* Major psychiatric disorders
Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) NASH.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 to 75 years, inclusive
* Elevated ALT
* F1-F3 NASH
* BMI ≥ 25

Exclusion Criteria:

* Use of prohibited medication/supplements
* Poorly controlled type 2 diabetes
* Hepatic decompensation
* Chronic liver disease
* Planned surgeries/procedures
Endoscopic Full Thickness Resection Without Exposure to Peritoneum

This study evaluates the feasibility of endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) in patients with gastric tumor.

Current endoscopic full-thickness resection (EFTR) methods are limited by their transmural communication and exposure of tumor to peritoneum. Recently, endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) was developed. This new technique includes the steps of laparoscopic seromuscular suturing with a barbed suture thread (V-Loc), which results in inversion of the stomach wall; EFTR of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips.

This study evaluates the feasibility of simple non-exposure EFTR technique in patients with gastric tumor. This study is single arm study and will be performed in single center.

Eligibility Criteria:
Inclusion Criteria:

* Gastric subepithelial tumor
* Tumor invades of muscularis propria on endoscopic ultrasonography (EUS) finding
* Tumor size more than 1.5cm or increasing size during observation

Exclusion Criteria:

* Tumor size more than 5cm
* Refuse to be enrolled to study.
* Bleeding tendency,
* Inappropriate condition for surgery with general anesthesia
Impact of the CRRT Management Protocol on Prognostic Outcome in Patients With Septic Acute Kidney Injury

The implementation of CRRT nursing team management program in the treatment of SAKI can significantly reduce the incidence of adverse events and complications in CRRT nursing, which has a positive role in improving the success rate of CRRT treatment and the clinical outcome of patients.


Eligibility Criteria:
Inclusion Criteria:

* The Guidelines for Emergency Treatment of Sepsis / Septic Shock in China (2018)\[4\]Diagnostic criteria for moderate sepsis; ② meets the Organization for Improving Global Kidney Disease Outcomes (KDIGO) Clinical Practice Guidelines: AKI\[5\]Relevant diagnostic criteria in; ③ received CRRT as indicated for CRRT; ④ in ICU for longer than 24 hours; ⑤ signed consent.

Exclusion Criteria:

* with chronic organ failure, or advanced malignancy; ② with previous history of chronic kidney disease, retrorenal urinary tract obstruction; ③ with incomplete clinical data.
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects

This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy men and women, ages 18 to 45 years
* Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations
* Women of child bearing potential are eligible for enrollment.
* Women must have a negative pregnancy test

Exclusion Criteria:

* Evidence of organ dysfunction
* Any significant acute or chronic medical illness
* Inability to: tolerate oral medications, be venipunctured
Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy

To determine the effects of aerobic training on spasticity and gross motor function in children with diplegic Cerebral palsy.Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. . The spastic CP is found to be the commonest presentation followed by athetoid, ataxic and mixed types. Children with cerebral palsy (CP) have decreased capacity to participate in play and sports activities .Reduced capacity to perform typical childhood activities contributes to low habitual physical activity and declining gross motor function in adolescence. Exercise opportunities are restricted in the population of cerebral palsy with spasticity, and so muscle strength may be reduced by disuse. Aerobic Training via Lower-extremity cycling is a rehabilitation tool used by physical therapists to improve spasticity, gross motor function and cardio-respiratory fitness, appears well-suited as a therapeutic intervention for children with CP. The tools used will be GMFM-66 and Modified Ashworth Scale. Study will be conducted on Thirty two patients in two Groups. Group A will be Control Group that will be provided with conventional physiotherapy (Stretching exercises , Trunk control training, walk and breathing exercises) and Group B will be Experimental Group that will be provided with conventional physiotherapy with cycling for 30 minutes with three sessions per week over the period of 12 weeks. Data will be analyzed using spss 22.0.


Eligibility Criteria:
Inclusion Criteria:

* 6-12 years of age both genders will be included.
* Ability to follow simple verbal instructions.
* Ability to walk independently, with or without an assistive device, for short distances (gross motor function classification system \[gmfcs\] levels i-iii)
* Spastic Diplegic Cerebral Palsy scoring on Ashworth Scale of 1, 1±, 2

Exclusion Criteria:

* Orthopedic surgery, neurological surgery, or baclofen pump implantation within the preceding 12 months
* Botulinum toxin injections within the preceding 3 months
* Serial casting or new orthotic devices within the preceding 3 months
* Initiation of oral medications that affect the neuromuscular system (eg, baclofen) within the preceding 3 months
* Inability or unwillingness to maintain age appropriate behavior
* Serious medical conditions such as cardiac disease, diabetes, or uncontrolled seizures
* Significant hip, knee, or ankle joint contractures preventing passive movement of the lower limbs through the pedaling cycle
Evaluation of Carbothera in the Treatment of Foot Ulcers

Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with kidney disease. Patients with kidney disease receiving dialysis have an increased prevalence of critical limb ischemia. Carbon dioxide (CO2) foot bathing has been reported to improve subcutaneous microcirculation. The proposed clinical study will evaluate the therapeutic potential of CO2 enriched water (produced by the Carbothera device) on treating foot ulcers in patients with critical limb ischemia and undergoing hemodialysis. Forty individuals how have a distal extremity ulcer who are currently undergoing hemodialysis will participate in this study.

This is a multi-centered, placebo controlled and randomized clinical study designed to evaluate the therapeutic potential of CO2 enriched water on the treatment of distal extremity (foot) ulcers in patients with critical limb ischemia undergoing hemodialysis. Study participants will be patients receiving dialysis at two local hospitals in Winnipeg and will have been diagnosed with CLI and foot ulceration. Patients will be randomized to receive either treatment with CO2-enriched tap water, 1,000-1200 ppm CO2 (TREATMENT GROUP), or non-enriched tap water (CONTROL GROUP), bath therapy at 37ºC on the same day as dialysis (typically 3 times/wk), for 15 min for 4 months,. Blood (approximately 20 ml) will also be collected at baseline and at the end of every month of the treatment period (for a total of 5 collections) for the measurement of the different biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants ≥ 18 years of age with at least one distal extremity ulcer (arterial ischemic ulcer).
2. No acute medical illness and on conventional medical management prior to Carbothera.
3. Willingness and ability to provide written informed consent

Exclusion Criteria:

1. DVT or PE within 12 months.
2. Subjects with known active cancer, HIV, hepatitis B virus, hepatitis C virus, human transmissible spongiform encephalopathy, Treponema pallidum.
3. Subjects who are deemed to have an infection of the distal extremity ulcer.
4. Women who are pregnant
5. Unstable angina.
6. Acute MI within 1 month.
7. Stroke within 1 month.
8. Patient scheduled for revascularization during the 4-month intervention period.
Randomized Controlled Trial of Tenofovir in Patients of Reactivation of Hepatitis B Presenting as Acute on Chronic Liver Failure

Background: Reactivation of hepatitis B is a well-characterized syndrome marked by the abrupt reappearance or rise of hepatitis B virus (HBV) DNA in the serum of a patient with previously inactive or resolved HBV infection. Reactivation can be spontaneous, but is most commonly triggered by cancer chemotherapy, immune suppression, or alteration in immune function. Spontaneous acute exacerbation of chronic hepatitis B infection is seen with a cumulative probability of 15±37% after 4 years of follow-up.2 Significant number of patients of spontaneous acute exacerbation of chronic hepatitis B may present with very high ALT levels, jaundice and liver failure.3 This condition should be defined as acute-on-chronic liver failure (ACLF) according to a recent Asia-Pacific consensus recommendation.

The short term prognosis of patients of spontaneous acute exacerbation of chronic hepatitis B leading to ACLF like presentation is extremely poor, with a mortality of 30-70% in different series.8,9,10 Liver transplantation has been the only definitive therapy available to salvage this group of patients. However ,this is not readily available and affordable. Another therapeutic option is antiviral therapy but has limited data. The efficacy of lamivudine was evaluated and compared by historical control but was not found to be beneficial.8,9,10 However ,a study from Taiwan showed a survival benefit in a subgroup of patients who were on lamivudine and had baseline bilirubin below 342 mmol/L (20 mg/dL).11 Tenofovir disoproxil fumarate (TDF) is a potent, rapidly acting, oral acyclic nucleotide analogue, reverse transcriptase inhibitor that has been shown to be highly effective in suppressing hepatitis B virus replication.12 Tenofovir has also shown excellent activity against HBV in both LAM- naïve and LAM-resistant patients.13,14. Its efficacy has not been evaluated in patients of reactivation of hepatitis B who present as ACLF Hypothesis: The investigators hypothesis that Tenofovir reduces the morbidity and mortality in patients with Spontaneous reactivation of hepatitis B by reducing HBV DNA.


Eligibility Criteria:
Inclusion Criteria:

* Reactivation of chronic hepatitis B characterized by rise in ALT level \>5 times upper limit of normal along with HBV DNA level \>105 copies/ml (\~1.8x104 IU/ml) presenting as ACLF
* Acute hepatic insult
* Jaundice (bilirubin ≥5 mg/dL) and coagulopathy (INR\>1.5)
* Complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease.

Exclusion Criteria:

* Superinfection with other viruses (Hepatitis E, A, D and C)
* Coexistent hepatocellular carcinoma (HCC)
* Portal vein thrombosis
* Coexistent renal impairment
* Pregnancy
* Co-infection with HIV infection or Patients received previous course of any antiviral
* Immunomodulator or cytotoxic/immunosuppressive therapy for chronic hepatitis or other illness within at least the preceding 12 month.
Insulin Treatment in Cancer Cachexia

The study is designed to evaluate whether daily insulin treatment to weight losing cancer patients attenuates progression of cancer cachexia and improves metabolism.

Randomized study with long-term follow-up based on survival, health related quality of life, food intake, resting energy expenditure, body composition, exercise capacity and measurement of metabolic efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Weight loss
* Systemic solid cancer

Exclusion Criteria:

* Diabetes
* Brain metastases
* Expectant survival of less than 6 months
* Serum creatinine above 200 umol/l
* Persistent of recurrent fever
* Cholestasis
Emergency Department Management of Patients With Renal Infarction

The aim of this study is to investigate laboratory parameters from medical records of patients diagnosed with renal infarction in our emergency clinic to establish early diagnostic indicators. Additionally, we will evaluate imaging methods such as CT or CT angiography and identify mortality-morbidity markers to contribute to the literature.

It is planned to include 80 patients who presented to the hospital emergency department and were diagnosed with renal infarction between January 1, 2014, and June 1, 2023, in the study.

he data of patients diagnosed with renal infarction will be retrospectively collected from the hospital database and recorded in a data collection form. This includes information such as CBC (complete blood count), neutrophils, lymphocytes, platelets, lactate, anion gap, pH, bicarbonate, creatinine, urea, AST, ALT, fibrinogen, D-dimer, LDH, CRP, CT scan, and CT angiography results. Patients' demographic characteristics, physical examination findings, imaging, and laboratory results will be evaluated using patient records and the hospital registry system.

Our aim is to identify early morbidity and mortality indicators in cases of renal infarction where diagnosis is often delayed or missed, contributing to the survival of patients. We believe that the findings from our statistical analysis can guide routine practice, especially in the management of patients presenting to the emergency department with complaints of abdominal and/or flank pain

Eligibility Criteria:
Inclusion criteria:

Adult patients aged 18 years and older Cases diagnosed with renal infarction presenting to the Emergency Department of Dışkapı Yıldırım Beyazıt Training and Research Hospital

Exclusion criteria:

Patients without imaging methods Patients with incomplete laboratory and file follow-ups Patients previously diagnosed with renal infarction and currently under treatment Patients diagnosed with other clinical conditions such as pyelonephritis, lower urinary tract infections, nephrolithiasis
Pre-operative Screening of Functional Fragilities Before Open Aortic Surgery: a New Area

Aneurysmal or occlusive abdominal aortic pathology has seen its prevalence increase over the years despite the various cardiovascular risk factor management campaigns deployed.

Currently, a large proportion of these aortic pathologies require effective and definitive treatment by open surgery. In fact, minimally invasive endovascular treatment, which can provide good results in certain cases, cannot be generalized simply and can even lead to sometimes incomplete treatments requiring even more complex secondary open surgery.

The preoperative assessment before open aortic surgery is relatively well coded with cardiological and respiratory assessments in particular. However, the literature has so far never focused on the overall vision of the patient with a complete functional assessment which would make it possible to consider a specific preoperative fragility scale and would thus give practitioners corrective targets before such an intervention. in order to simplify the patient's post-operative journey by limiting complications.

The investigators therefore propose to collect a certain number of elements already collected in standard care in a systematic and prospective manner in order to create a risk scale. All of these elements being modifiable, they should ultimately make patients more robust for such an intervention.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing open aortic surgery in the vascular surgery department

Exclusion Criteria:

* patient refusal