cyrilzakka/clinical-trials huggingface dataset:
Durvalumab and Tremelimumab for Pediatric Malignancies

The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined.

This is a first time in pediatrics study primarily designed to evaluate the safety and tolerability of durvalumab and durvalumab in combination with tremelimumab at increasing doses in pediatric patients with advanced solid malignancies and hematological malignancies (including lymphomas) and for whom no standard of care treatments exist. Although treatment efficacy is not a primary objective of this study given its early phase nature, the patients screened for this study have no curative options and this study offers the potential of some benefit.

The study will also characterize the PK of durvalumab and durvalumab in combination with tremelimumab in children and adolescents and explore potential biological activity and immunogenicity by assessing pharmacodynamics, anti drug antibody (ADA) levels, and anti-tumor activity. The results from this trial will form the basis for decisions for potential future pediatric studies

Eligibility Criteria:
Inclusion Criteria:

* Max Age =17 years
* Solid Tumors (except primary central nervous system malignant tumors): Patients must have a histopathologic confirmation of malignancy. Patients must have progressed or are refractory to standard therapies, and for whom no standard of care treatments exist
* Non-Hodgkin's Lymphoma, limited to primary mediastinal B-cell lymphoma and anaplastic large cell lymphoma. Patients must have progressed or are refractory to standard therapies, and for whom no standard of care treatments exist.
* Provision of diagnostic tumor sample mandated if available
* Evaluable disease
* No prior exposure to immune-mediated therapy
* Adequate organ and marrow function
* Life expectancy of at least 3 months

Exclusion Criteria:

* History of allogeneic organ transplantation (exceptions may be allowed for NHL after discussion with Sponsor). History of autologous bone marrow transplant may be allowed (after discussion with Sponsor).
* Active or prior documented autoimmune or inflammatory disorders (exceptions)
* Uncontrolled intercurrent illness
* History of primary immunodeficiency
* Active infection including tuberculosis, hepatitis B, C or HIV
* Any unresolved toxicity NCI CTCAE version 5.0 Grade ≥2 from previous anticancer therapy (exceptions)
The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes

The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes. The association is examined by comparing the difference in oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and 8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment with placebo. The results will be published in a peer-review journal.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* HbA1c: 6.5-9.0%
* Capable of understanding oral- and written information
* Caucasian

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \< 60 mL/hour/1.73 m2
* Currently receiving insulin treatment
* Coronary artery bypass grafting, percutaneous coronary intervention, acute coronary syndrome, stroke, lung embolism, deep vein thrombosis, or transitory cerebral ischemia within 6 months
* Genital infection within 14 days
* Plasma alanine aminotransferase ≥3 times upper normal limit
* Treatment with sodium glucose cotransporter (SGLT) -2 inhibitor within 2 months
* Hyperglycaemic symptoms
* Psychiatric disorder
* Intolerance to empagliflozin or other agents relevant to study
* Non-compliant
A Non-Pharmacological Method for Enhancing Sleep in PTSD

Sleep disturbance is nearly ubiquitous among individuals suffering from PTSD and is a major problem among service members returning from combat deployments. The proposed study aims to test a novel, inexpensive, and easy to use approach to improving sleep among service members with PTSD.

Primary outcome measures will include not only PTSD symptom improvement but also include neuroimaging of brain structure, function, connectivity, and neurochemistry changes. The proposal is firmly grounded in the emerging scientific literature regarding sleep, light exposure, brain function, anxiety, and resilience. Prior evidence suggests that bright light therapy is effective for improving mood and fatigue, and our pilot data further suggest that this treatment may be effective for improving daytime sleepiness and brain functioning in brain injured individuals. Thus, this intervention, in our own research and in the work of others, has been shown to affect critical sleep regulatory systems. Improving sleep may be a vital component of recovery in these service members. Our approach would directly address this issue. Our preliminary data have shown that this approach is extremely well tolerated and is effective for improving sleep, mood, cognitive performance, and brain function among individuals with brain injuries.

Finally, the potential impact of this study is high because of the capability of transitioning the research to direct clinical application almost immediately. If the bright light treatment is demonstrated as effective, this approach would be readily available for nearly immediate large-scale implementation, as the devices have been widely used for years in other contexts, are already safety tested, and commercially available from several manufacturers for a very low cost. Thus, the impact of this research on treating PTSD would be high and immediate.


Eligibility Criteria:
* Having experienced a traumatic event within the past 10 years
* Right handedness
* 18-50 years old
* Primary language is English
* No metal in body

Further eligibility will be determined through a phone screening. Please call (520) 626-8591 or go to uascanlab.com to check your eligibility for this study.
Revealing Microbiome Association With (Plant-based) Diet in Freshman

Aim of the study is to evaluate the impact of a vegan vs. vegetarian dietary pattern compared to an omnivore diet on body weight, saliva and stool microbiome profiles, as well as saliva, urine and plasma metabolome profile changes in freshmen after the first year at university/college.


Eligibility Criteria:
Inclusion Criteria:

* freshman
* following a vegan / vegetarian / omnivore dietary pattern for at least 3 months
* own a smartphone (including internet access and camera)

Exclusion Criteria:

* regular use of medication (excluding oral contraceptiva)
* use of antibiotics in the last 6 weeks
* chronic disease, especially gut diseases
* following a vegan / vegetarian / omnivore dietary pattern for less then 3 months
* no clear assignment of vegan / vegetarian / omnivore dietary pattern
* electrical implants
Conventional and Molecular Diagnostic Method for Patients With Suspected UTI

In this protocol, the investigators are examining the use of a novel pathogen testing technology and method of identification of antibiotic susceptibility against the conventional C \& S testing for patients with both complicated and uncomplicated UTIs. The investigators will examine the two modes in terms of objective patient related outcomes, i.e. 1) diagnostic accuracy and degree of detail of final analysis; 2) time to resolution of symptoms; 3) quality of life as defined by particularly symptomology and "bothersomeness" of the symptoms; and 4) overall cost.


Eligibility Criteria:
Inclusion Criteria:

* • Age greater than or equal to 18 and less than or equal to 89 years.

  * The PI suspects the patient has a complicated or uncomplicated UTI that requires urine testing to confirm diagnosis
  * Able to provide at least 8 ml urine total (urine for 2 pathology tests).
  * Is willing to complete one follow up surveys and send back to FH.

Exclusion Criteria:

* • Unable or unwilling to provide written informed consent.

  * Unable to read and write English (surveys are not available or validated in any other language than English).
  * Currently on any antibiotic for any clinical indication.
Screening for Undiagnosed Type 2 Diabetes in New Classes of Subjects at High Risk

The study aims to evaluate IFG, IGT or unknown type 2 diabetes mellitus in new classes at high risk to develop alterations of glucose metabolism and definition of new pathogenic mechanisms of insulin resistance and atherosclerosis.

The following classes of subjects at high risk will be considered:First degree relatives of patients with type 2 diabetes mellitus, patients with cardiovascular disease and stroke, patients with heart valve disease. age will be \> 30 years, both gender.

The primary outcome of the study is evaluation of glucose tolerance, insulin sensitivity and insulin secretion before and 2 hours post-glucose load Secondary outcomes are evaluation of endothelial function, of natriuretic peptides and free fatty acids, and inflammation before and 2 hours post-glucose load. New candidate genes will be also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Fasting glucose levels \<126 mg/dl
* Age \>30 years
* Both male and female

Exclusion Criteria:

* Type 1 diabetes
* Known type 2 diabetes mellitus
* Pregnancy
* Impaired kidney and liver function
* Previous history of malignancies
Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders

The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes compared to the flare up protocol in this group of patients.

Poor responders are women who fail to respond effectively to the usual gonadotropin stimulation protocol applied in an IVF cycle. It seems that a diminished ovarian reserve is the principal factor of poor ovarian response. Several strategies have been proposed for the management of poor responders, including flare up GnRH agonist regimens and the GnRH antagonist, which presents a new hope in this group of patients.

Comparisons: Poor responder patients (see inclusion criteria) commencing an IVF treatment cyle will receive ovarian stimulation treatment either using a GnRH antagonist (Ganirelix) or flare up agonist (Arvekap) protocol. Primary outcomes compared will be ongoing pregnancy rates in the two treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* regular menstrual cycle
* 1 or more failed IVF attempts with poor response
* 5 or fewer oocytes retrieved
* FSH\>12 IU/l on day 3

Exclusion Criteria:

* PCOS
* Normal responders
Development and Implementation of Ramadan Fasting Algorithm for Singaporeans With Type 2 Diabetes

Background: Ramadan fasting is a religious observance carried out by Muslims all over the world. During Ramadan, Muslims abstain from eating, drinking, and smoking during daylight hours. Although Muslims who are ill, including patients with diabetes, are exempted from fasting, many devoted Muslim patients still insist on fasting despite being advised not to by their healthcare providers. Concerns have been raised over how the practice of fasting may affect the metabolic control of Muslim patients with diabetes. Furthermore, it has also been postulated that the act of fasting may increase the risk of hypoglycemia or glucose toxicity. Although practice algorithms and suggestions on the use of glycemic therapies during fasting have been discussed internationally. they are not generalizable as the observances of Ramadan, duration of fasting and the food ingested differ from one country to another.

Aims: This study aims to develop and implement a clinical practice dose-adjustment algorithm dedicated to the care of Singaporean patients with diabetes who fast during Ramadan.

Hypothesis: The use of clinical practice dose-adjustment algorithm can improve both clinical and humanistic outcomes of patients with type 2 diabetes who wish to fast during Ramadan.

Methods: This is a prospective, randomized, interventional study involving patients with type 2 diabetes who wish to fast for at least 10 days during Ramadan. Eligible patient attending a primary care institution or an outpatient specialist clinic of a tertiary institution will be approached to participate in the study. Consented patients will be randomized to either intervention arm or control arm. Patients in the control arm will receive usual care while patients in the intervention arm will be given additional education session on Ramadan fasting related diabetic management advice and an algorithm that was developed by the study team members based on international guidelines, to guide them on self-management during Ramadan. The primary outcomes will be change in HbA1c. Secondary outcomes include change in fasting blood glucose, post prandial blood glucose, medication adherence and humanistic outcomes. The safety outcomes include self reported incidence of major and minor hypoglycemia as well as hyperglycemia during Ramadan month. All outcomes will be measured at baseline, during Ramadan and at 3 month post Ramadan.

Significance: The validation of the algorithm through this study will ensure effective and safe fasting of patients with type 2 diabetes during Ramadan.


Eligibility Criteria:
Inclusion Criteria:

* All Muslim patients over 21 years of age with Type 2 diabetes who plan to fast for at least 10 days during the month of Ramadan

Exclusion Criteria:

* Patients with history of recurrent hypoglycemia
* Patients who are pregnant
* Patients with eGFR\<30ml/min 3 months prior to Ramadan
* Patients with HbA1c \> 9.5%
* Patients with DM-related admission 1 month prior to Ramadan
* Patients on active short-term corticosteroid treatment
* Patients who are unable to complete the questionnaires
Sepsis in ICU:Causes and Outcomes in Diabetics and Non Diabetics

Identify prevalence of sepsis in ICU of Assiut university hospital 2.Clarify different causes of sepsis in patients admitted to ICU . 3.Compare causes and outcomes of sepsis between diabetics versus non diabetics .

4.Screening for the co1.mmonest organism causing sepsis in critically ill patients .

Sepsis, is defined as an infection with organ dysfunction, There is wide variation in sepsis rates, causative microorganisms, and outcome in ICU patients around the world.

Many conservative estimates considered sepsis as a leading cause of mortality and critical illness worldwide .

sepsis epidemiology studies worldwide revealed a highly variable incidence of 13-300 per 100,000 inhabitants per year for severe sepsis and 11 per 100,000 inhabitants per year for septic shock .

Factors such as advancing age, immunosuppression and multidrug-resistant infection play a role in increasing incidence of sepsis during recent decades .

Patients who survive sepsis often have long-term physical, psychological, and cognitive disabilities with significant health and social implications.

Patients with diabetes mellitus have an increased risk of developing infections and sepsis and they constitute 20.1-22.7% of all sepsis patients.

The prevalence of diabetes mellitus in ICU patients is as high as 30%, And such patients are at increased risk of experiencing in-hospital Complications, compared to patients without diabetes.

Infective complications may be reduced with lower blood glucose concentrations Moreover, in critically ill patients without diabetes, Hyperglycemia is associated with increased mortality, risk of infection, Kidney injury and cardiovascular complications.

Moreover, diabetes is a major risk factor for both Acute Kidney Injury and sepsis.

Sepsis also is a major cause of Acute Kidney Injury, which develops in one-fourth of all patients with sepsis and half of patients with bacteraemia or shock .

Sepsis-related AKI is associated with high mortality rates of up to 70%.

Eligibility Criteria:
Inclusion Criteria:

* according to sofa criteria Suspected /documented infection+sofa score \>_2 or +ve Q sofa defined as 2or more 1_ hypotesion SBP\<90.2_altered mental status GCS\<13 3_ Exclusion Criteria:tachypnea\>22 or septic shock criteria
* previous history of pulmonary problem Previous history of cardiac disease Previous history of autoimmune disease
Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)

This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject agrees to follow the study guidelines

Exclusion Criteria:

* Subject is a smoker
* Subject has a history of adverse reactions caused by NSAIDs or allergies/intolerance to NSAIDs
* Subject is in a situation or has a condition/disease which may interfere with optimal participation in the study
Effect of TXA on Reducing Bruising After Filler Injection

The goal of this clinical trial is to look at the effect tranexamic acid (TXA) may have on reducing bruising, swelling, and pain after facial filler injection. The main question it aims to answer is:

* Does the addition of TXA to hyaluronic acid (HA) reduce bruising, swelling, and tenderness after HA injection?

Participants will receive the study medication along with the standard facial filler injection and complete surveys.

The overall purpose of this study is to evaluate the safety and efficacy of co-administration of TXA with HA in reducing swelling, bruising and pain after facial injection. Researchers will do this by comparing HA to HA+TXA in participants undergoing facial filler injections. Participants undergoing facial filler injections almost always have the same type of injection performed bilaterally in order to maintain symmetry. This provides a unique opportunity where participants can serve as their own controls. Therefore, researchers have designed this as a half face study. Participants will be injected with HA on half of their face and the other half of the face will be injected with HA+TXA. Researchers will then assess swelling, bruising, pain, and overall satisfaction using participant self-reported surveys, physician surveys, and review of medical records.

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 but less than or equal to 89 years.
* Participants interested in facial filler (HA) injection.
* English speaking.

Exclusion Criteria:

* Minors or under the age of 18
* Participant over the age of 89
* Pregnant or breast-feeding women
* Individuals unable to give consent due to another condition such as impaired decision-making capacity.
* Individuals with a history of a thrombotic event (DVT, PE, stroke, MI) or genetic disorder that increases risk of thrombosis
* Concurrent use of estrogen
* Participants undergoing unilateral facial filler (HA) injection
* Participants with history of hypersensitivity to TXA or any of the other ingredients
* Participants that are on current therapeutic anticoagulation therapy and aspirin use
* Participants with stage 2 or greater renal failure
* Participants on hemo- or peritoneal dialysis
* History of diabetes or seizures
* Current tobacco smokers
* Acquired defective color vision
A Prospective Multicenter Post Approval Study to Evaluate the Long-term Safety and Efficacy of the Resolute Integrity in the Japanese All-comers Patients With Coronary Artery Disease (PROPEL)

This is a prospective, multicenter, historical controlled study. The present clinical study will measure non-inferiority of 12 month TLF rate compared to historical control.The selected historical control is the Xience V arm from RESOLUTE All-Comer clinical study, that study is a prospective, multicenter, randomized, two-arm, international, open-label study.The historical control did not have angiographic follow up before 12 months, in the present clinical study, only subjects with clinical follow-up conducted at 12 months without any pre-specified angiographic assessment prior to 12 month clinical follow-up will be part of this analysis cohort. Out of the total 1200 patients, 900 patients (clinical follow-up cohort) will be included in this analysis cohort.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 years or older.
* Patients with symptomatic coronary disease.
* Patients with a clinical indication for PCI and stenting of at least one coronary lesion, visually confirmed on coronary angiography.
* Patients who give informed consent to participate in this clinical study and sign the informed consent form approved by the institutional review board of each study site before the index PCI.
* Patients who agree to undergo all clinical follow-up procedures specified in the protocol for this clinical study.
* Patients in whom more than 50% occlusion or stenosis is visually confirmed in a native coronary artery with a diameter of 2.5 mm - 3.5 mm on coronary angiography and that has an anatomical structure suitable for PCI using Resolute Integrity zotarolimus-eluting stent.

Exclusion Criteria:

* Patients aged 85 years or older.
* Patients with cardiogenic shock.
* Patients who are pregnant or possibly pregnant.
* Patients who cannot comply with the antiplatelet therapy specified for this clinical study.
* Patients scheduled to undergo elective surgery within 6 months post-index PCI.
* Patients with a history of allergic reaction or hypersensitivity to zotarolimus, sirolimus, tacrolimus, everolimus, or other analogues or derivatives.
* Patients with an allergic reaction to antiplatelet or anticoagulant drugs, such as heparin, aspirin, ticlopidine, or clopidogrel, or contrast agents, or those who cannot tolerate these substances and to whom appropriate treatments cannot be given.
* Patients with hypersensitivity to cobalt, nickel, chrome, molybdenum, coated polymer (e.g., BioLinx) contained in the materials of the study device or in whom these substances are specifically contraindicated.
* Patients who are currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this clinical study.