cyrilzakka/clinical-trials huggingface dataset:
Use of Continuous Glucose Monitors in Coronavirus Disease 2019 ICU and Potential Inpatient Settings

The objective of the study is to improve glycemic control in inpatient/ICU settings using real- time continuous glucose monitors (CGM) data for insulin titration. It may help reduce Coronavirus disease 2019 patient contact with healthcare workers as well.

Due to the increasing need for acute care of COVID-19 patients in ICU settings, the use of continuous glucose monitors (CGM) as a means to reduce patient contact and remotely improve glycemic control for diabetic COVID-19 patients needs to be explored. As demonstrated by recent data published in China, Wuhan province patients with diabetes made up 22.2% of COVID-19 ICU patient populations with a subsequent mortality of 7.3% (3). Not only during COVID-19 pandemic but also previous experiences with SARS and influenza viral respiratory infections demonstrated increased mortality in those patients with hyperglycemia (4).

Using CGMs provides timely access to glucose trends, commonly used to determine insulin dosing decisions in outpatient settings (5). Implementing their use for hospitalized patients could be expected to improve healthcare worker insight into glycemic control therapies.

Considering the ease of transmission of the SARS-Cov-2 virus, it is important to minimize duration and frequency of patient contact in order to maintain the safety of COVID-19 healthcare workers without compromising on their glycemic control. The WHO recommends that any healthcare provider coming into direct contact with COVID-19 patients should be utilizing appropriate PPE for each encounter. In this time of limited PPE supply (6), remote glucose monitoring can allow for rational use of these limited resources. With appropriate training on CGM data interpretation, nursing and ordering providers could expect to develop and implement more efficient insulin plans, requiring fewer physical contact with COVID-19 positive patients.

Eligibility Criteria:
Inclusion Criteria:

* Coronavirus disease 2019 tested positive patient
* Age over 18 years
* Admitted to Coronavirus disease 2019 specific ICU, with possible transfer to inpatient unit when stable
* Patients with known or acquired Type 1 or Type 2 Diabetes requiring insulin therapy during admission

Exclusion Criteria:

* In state of active diabetic ketoacidosis (DKA) at time of enrollment
* Two or more vasopressors in use at time of sensor placement
* Unable to use at predetermined sensor site based on assessment of skin health
Virus Surveillance in Pediatric Solid Organ Transplant Recipients

Viral infections are an important complication of transplantation. Immunosuppressive therapy interferes with T cell immunity resulting in a high incidence of viral infection. Newer agents, such as mycophenolate mofetil (MMF) and sirolimus, have been associated with an increased risk of herpes virus infection. The introduction of these more potent immunosuppressive agents over the past decade correlates with an increase in the rate of hospitalizations of transplant patients with infections. This prospective study will determine the role of sub-clinical herpes virus infections in the development of complications such as chronic allograft nephropathy (CAN) and Post Transplant Lymphoproliferative Disease (PTLD). By focusing on treatable herpes virus infections, these studies have the potential to identify therapeutic strategies that can be used to diminish the burden of graft loss from CAN, significantly improving renal allograft survival and quality of life in transplant patients. Future specific interventions to test the hypothesis of a direct causal relationship between sub-clinical herpes virus infection and CAN may include the use of anti-viral therapy in response to sub-clinical infection of the renal allograft and/or peripheral blood.


Eligibility Criteria:
Inclusion Criteria:

* Age from birth to 21 years
* All solid organ transplant recipients receiving their care at Seattle Children's Hospital
* Signed consent, and when age appropriate, signed assent

Exclusion Criteria:

* Lack of consent
Neonatal Neurologic Intensive Care Network of China

The purpose of this study is to create a neonatal neurologic biological big data center named Neonatal Neurologic Intensive Care Network in China with neonatal systematic information, biological samples and genomics \& genetic data on neonates born with neonatal severe encephalopathy. It also can predict brain injury as cerebral function monitoring through big data and recommend appropriate treatment. In addition, the following samples will be collected in a bio-bank in for future studies: blood, urine, and cerebrospinal fluid (CSF) samples.

The purpose of this study is to create a neonatal neurologic biological big data center named Neonatal Neurologic Intensive Care Network in China with neonatal systematic information mainly including demographic, medical history, family condition, perinatal stage information, birth, growth \& feeding status, imaging, biological samples and genomics \& genetic data on neonates born with neonatal severe encephalopathy. It also can predict brain injury as cerebral function monitoring through big data and recommend appropriate treatment. There are seven children's hospitals from 6 provinces in China to join in the collaboration network in first recruiting. In addition, the following biological samples will be collected in a bio-bank for future studies: blood, urine, and cerebrospinal fluid (CSF) samples.

Eligibility Criteria:
Inclusion Criteria:

1. Postnatal age \< or = 28 days
2. Written informed consent of parent or guardian

   With one of the following items
3. Hypoxic ischemic encephalopathy (HIE)
4. Hydrocephalus
5. Hypotonia
6. Interventricular hemorrhages
7. Intracranial calcifications
8. Intracranial hemorrhages
9. Meningitis and other brain infections
10. Metabolic diseases
11. Microcephaly
12. Neonatal stroke
13. Spina bifid
14. Cerebral arteriovenous malformations (AVMs)
15. Congenital brain malformations

Exclusion Criteria:

1. Known other major congenital anomalies but not not neurologic disease.
2. Failed to get sample or the volume of collected biosamples is not enough.
3. Parents refuse consent.
The Effect of Consuming a guaraná and Vitamin/Mineral Complex Pre-exercise on Affect, Exertion, Metabolism and Cognition

Consuming a guaraná and vitamin and mineral complex can improve mental fatigue and cognitive function at rest; guaraná also contains caffeine, which can reduce perceived exertion and increase fat burning during exercise. The purpose of this study is to test whether consuming a guaraná and vitamin and mineral product before exercise influences affect (mood), physical exertion and fat burning during exercise and mental fatigue, cognitive performance and affect post-exercise.


Eligibility Criteria:
Inclusion Criteria:

Individuals must be:

* Healthy
* Male
* Aged between 18 and 35years
* Habitually active (exercising at least twice a week)
* Able to run at a moderate pace for 30 minutes non-stop on a treadmill

Exclusion Criteria:

Individuals will not be eligible to take part in this study if they:

* have a history of neurological or psychiatric diseases excluding anxiety or depression
* have a current diagnosis of depression or anxiety
* have a history of significant head trauma, metabolic, endocrine or cardiac disorders
* have smoked within the last 3 months,
* have high blood pressure \>140/90mmHg
* consume \> 500 mg caffeine per day from all dietary sources
* have adverse reactions to caffeine containing products (i.e. tea, coffee, energy drinks, cola, Pepsi)
* are currently taking any pharmaceuticals
* have habitual taken dietary supplements within the last 4 weeks (defined as ≥3 consecutive days or ≥4 days in total per week)
* have current or history of drug or alcohol abuse
* have participated in another clinical trial within 30 days prior to screening
* have any condition which may interfere with your ability to perform assessments
* have any history of hypersensitivity to the investigational product or its active or inactive constituents or any food allergy or intolerance
E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through observation of dose limiting toxicity (DLT), which is in advance defined, in patients with peripheral or cutaneous T-cell lymphoma.


Eligibility Criteria:
lnclusion Criteria:

* Male and female patients 20 to less than 80 years of age at the time of informed consent
* Patients histologically or cytologically diagnosed to have peripheral T -cell lymphoma
* Patients with a history of chemotherapy (including PUVA and retinoid) that resulted in relapse, recurrence and treatment resistance (just for the administration of E7777 alone)
* Patients subject to CHOP therapy and without a history of prior treatment with anthracycline or anthraquinone anticancer drugs (just for the administration of E7777 in combination with CHOP therapy)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* No carry-over of beneficial or adverse effects of the prior treatment that may affect the safety evaluation of the investigational drug (excluding Grade 1 neuropathy and alopecia)

Exclusion Criteria:

* Brain metastasis with clinical symptoms which requires treatment
* Serious systemic infection requiring intensive treatment
* Serious complications or histories
* History of hypersensitivity to protein therapeutics
* Known to be positive for HIV antibody, HCV antibody, or HBs antigen
* History of malignancy other than peripheral T-cell lymphoma and less than five years have elapsed since the last remission
* Patients who have undergone allogeneic hematopoietic stem cell transplantation
* Patients with a relapse within 6 months after autologous hematopoietic stem-cell transplantation
Exercise for Elderly Peripheral Revascularized Patients

The purpose of this study is (1) to determine whether a 3-month exercise rehabilitation program will improve claudication distances, free-living daily physical activity, and health-related quality of life of older, revascularized patients with peripheral arterial disease, and (2) to determine whether the primary mechanisms by which exercise rehabilitation affects the above functional outcomes are through alterations in walking efficiency, peripheral circulation, and cardiopulmonary function.

Peripheral arterial disease (PAD) patients with critical limb-threatening ischemia have improved peripheral circulation following infrainguinal revascularization. Despite this hemodynamic benefit, little change in functional status occurs, and many patients have residual ambulatory dysfunction. The lack of functional improvement in revascularized patients may be due to extreme physical deconditioning secondary to their pre-existing critical limb-threatening ischemia. Therefore, we hypothesize that a program of aerobic exercise training is necessary to optimize ambulation, free-living daily physical activity, and health-related quality of life through the mechanisms of improved walking economy, peripheral circulation, and cardiopulmonary function.

This is a prospective, randomized controlled clinical trial comparing an exercise group undergoing a program of graded treadmill walking, and a non-exercise control group. Eighty PAD patients will be randomized into either the exercise group (N = 40) or the non-exercise control group (N = 40) following successful lower extremity arterial bypass or angioplasty. The 3-month exercise program will consist of graded treadmill walking 3 times per week with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 80% of exercise capacity.

Eligibility Criteria:
Inclusion Criteria:

* lower extremity arterial bypass at least 3 months prior to screening
* infrainguinal percutaneous transluminal angioplasty (PTLA) at least 2 weeks prior to screening

Exclusion Criteria:

* persistent rest pain due to (peripheral artery disease (PAD) (Fontaine Stage III for PAD),
* persistent tissue loss due to PAOD (Fontaine Stage IV for PAD),
* medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.)
* cognitive dysfunction (mini-mental state examination score of less than 24)
A Potential Novel Marker for Liver Fibrosis in NASH: the Soluble Secreted Form of the Human Asialoglycoprotein Receptor

Soluble secreted proteins that are expressed uniquely in specific organs and whose formation of secretion is regulated by disease states are excellent markers for the disease. This is because the disease can be diagnosed by simply measuring the levels of the secreted protein in serum. A soluble form of the asialoglycoprotein receptor could be a promising candidate for such marker in the case of liver fibrosis secondary to steatohepatitis for which the existing markers are not satisfactory. The human asialoglycoprotein receptor (ASGPR) is expressed only in hepatocytes. The H2a alternatively spliced variant of the ASGPR H2 subunit differs from H2b variant only by the presence of an extra pentapeptide. EGHRG, in the exoplasmic domain next to the membrane-spanning segment. H2a is rapidly cleaved to a36 kDa fragment, comprising the entire ectodomain, which is secreted. H2a does not participate in a membrane bound receptor complex with H1 as in the case for H2b and thus it is not a subunit of the receptor but a precursor for a soluble secreted form of the protein (sH2a). Although H2a is a type II transmembrane protein, signal peptidase is probably responsible for the cleavage to the soluble form.

The objective in this research proposal is to study the association between the level of sH2a. in the serum and the severity of fibrosis in steatohepatitis in patients undergoing bariatric surgery due to morbid obesity.

The existence of sH2a in normal human serum is at very constant levels. On the other hand the membrane ASGPR (expressed exclusively in hepatocytes) is profoundly down - regulated in liver cancer and cirrhosis. The investigators will analyze the levels of sH2a in serum from patients with steatohepatitis in different stages of fibrosis and compare with healthy subjects. A possible early down-regulation of sH2a in fibrosis may prove to be a valuable diagnostic tool.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Patient candidate to bariatric surgery.

Exclusion Criteria:

1. Liver biopsy during the last 12 months.
2. The surgeon consider liver biopsy as a special dander in a specific patient.
Omega-3 Fatty Acids Enriched Food and Microvascular Reactivity

Previous studies have shown that omega-3 fatty acid pills intake have beneficial effect on vascular health in overweight and/or hypertensive patients.

However, there is a lack of studies showing the effect of everyday consumption of omega-3 fatty acids enriched food (not pills) on lipid profile and microvascular reactivity in healthy population.

This study aimed to determine the effect of omega-3 enriched chicken eggs consumption on microvascular reactivity and lipid profile in young healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

- healthy volunteers

Exclusion Criteria:

* oral contraceptives
* drugs that could affect endothelium
* hypertension
* coronary artery disease
* diabetes
* hyperlipidaemia
* renal impairment
* cerebrovascular and peripheral artery disease
Effect of Dihydrocapsiate on Energy Expenditure in Women

The objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.

Capsaicin, a substance found in chili pepper, is known to stimulate thermogenesis. Dihydrocapsiate, a capsinoid, found in the non-pungent CH-19 sweet pepper has similar thermogenic effects without the gastrointestinal side effects. The objective of this project is to test the effect of 12 weeks of daily consumption of 9 mg dihydrocapsiate on resting energy expenditure relative to baseline when compared to a control group consuming products without DCT.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 18.5-34.5 kg/m2
* Good general health
* Low to mild physical activity
* Willing to maintain habitual diet and physical activity patterns throughout the study period
* Premenopausal and cycling regularly or using oral contraceptives
* Willing to attend study visits only during the follicular phase or bleed phase of their menstrual cycle
* Understands study procedures and signs forms providing informed consent to participate in the study
* Have spoken and written English literacy

Exclusion Criteria:

* Diabetes mellitus or any conditions that might affect energy metabolism
* Weight change ±2 kg over previous three months
* Known sensitivity or allergy to ingredients of the study products
* Non-breakfast eater
* Recent use of antibiotics
* History of smoking during the six months prior to study
* Recent signs or symptoms of infection, including cold or flu-like symptoms
* Concurrent or recent intervention study participation
* Instability in breathing patterns or energy expenditure measures
* History of drug or alcohol abuse
* Lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use
* Weight loss medication
* Pregnant or lactating
* Unwilling to be randomized to any experimental group and unable to meet all requirements of the study
Post Operative Pain Following Pulpectomy Versus Pulpotomy in Primary Molars Wit Irreversible Pulpitis

Study will evaluate and compare post operative pain for primary molars with irreversible pulpitis after pulpotomy and pulpuectomy


Eligibility Criteria:
Inclusion Criteria:

* Healthy individual
* Has primary tooth with irreversible pulpitis
* Cooperative child

Exclusion Criteria:

* Mentally, physically or medically compromised children
* Uncooperative children
Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Controls and Dementia Patients

Previous studies showed that anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) improved episodic memory performance, indicating a possible use as an intervention for patients suffering from memory impairments. At the same time, only scant evidence (provided by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS)) exists regarding the underlying mechanisms, thus hindering a more targeted application.

The present study aims at establishing a connection between the stimulation-induced change in episodic memory performance on the behavioural level and neurophysiological parameters. TDCS effects and the underlying mechanisms will be compared between different study conditions, receiving either real anodal tDCS or sham stimulation over the left dorsolateral prefrontal cortex during an episodic memory task.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Right-handedness
* Non-smokers
* Native German speakers or comparable level of fluency
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Neurological or psychiatric condition (other than diagnosed cognitive impairment)
* Past head injuries
* Magnetizable implants
* History of seizures
* Current or life-time alcohol or drug abuse
* Pregnancy
* Skin diseases
Phase IIT Trial of SNA014

68Ga labeled Claudin 18.2 contrast agent combined with PET/CT for gastric or gastroesophageal junction


Eligibility Criteria:
Inclusion Criteria:

* Age range of 18 to 75 years old (including boundary values);
* Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
* Diagnosed G/GEJ adenocarcinoma and pancreatic cancer;
* Gastroscopy/CT/MRI/PET-CT examination results within the past month (if any);
* Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).

Exclusion Criteria:

* Merge patients with other clearly diagnosed malignant tumors:
* Uncontrolled severe infections or individuals with other serious illnesses;
* Those with an expected survival period of less than or equal to three months;
* Pregnant or lactating patients, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial;
* investigators determine that patients who are not suitable to participate in this study;
Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial

This is a prospective, randomized trial to evaluate canal wall down mastoidectomy (CWDM) healing outcomes using Biodesign® small intestine submucosa graft compared to autologous temporalis fascia graft.

Patients 18 or older will undergo primary canal wall down mastoidectomy. Patients with known biologic sensitivity or cultural objection to use of porcine materials will be excluded.

Data will be derived from the medical record and surgeon reports as detailed on pre-op and follow-up forms. Variables collected include age, gender, medical co-morbidities, body mass index, pre-operative audiometric values (including word recognition score, pure tone average, and air bone gap), side of surgery, size of operative cavity, infectious state (draining versus dry), exact surgical procedure, presence of cholesteatoma, time to dry cavity, time to complete epithelialization (as observed directly by the surgeon), and post-operative complications (such as persistent perforation, drainage, granulation tissue formation, and facial nerve outcomes). Dates and patient number will be recorded. Patients will be randomly assigned using randomization software, whereby patients will be assigned a sequential research number that is pre-randomized to one research arm. The study cannot be blinded, as the surgeon will be able to identify which graft will be used. De-identified photographs of the post-operative outcomes at each time point will be recorded photographically. Three physicians will review these photographs without prior knowledge of the treatment arm.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary canal wall mastoidectomy

Exclusion Criteria:

* Patients with a known biologic sensitivity or a cultural aversion to the use of porcine materials.
Are Dental Neglect and the Siblings Risk Factors in Children

Neglect insidiously affects a child's overall health in all aspects. The aim of this study was to determine whether the presence of siblings caused dental neglect, and whether there was a relationship between dental neglect and anxiety.

Dental neglect is an intentional failure of parents or caregivers to take precautions and fulfil necessary dental treatment, and has a close relationship with dental caries and anxiety. Oral health status of the children was evaluated using the DMFT/dmft, PUFA/pufa, and OHI-S indices. In addition, the parents completed the Dental Neglect Scale (DNS) and a questionnaire, and the Modified Child Dental Anxiety Scale (MCDASf) was administered to the children to assess their dental anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 6 and 12 years old
* Being healthy
* Being volunteer for the study

Exclusion Criteria:

* Systemic and mental disorders
* Syndromes or other major health diseases
* Cooperation problems