cyrilzakka/clinical-trials huggingface dataset:
A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants

The study involves 4 injections of insulin lispro and its purpose is to:

* Determine if 2 formulations of insulin lispro are treated by the body in a similar way.
* Compare how the 2 formulations of insulin lispro affect blood sugar level.
* Determine the safety of each insulin lispro formulations and any side effects that might be associated with them when given to healthy participants. The study is expected to last up to approximately 9 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Are healthy males or females
* Body mass index (BMI) between 18.5 and 29.9 kilogram per meter squared (kg/m\^2)
* Are nonsmokers
* Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.

Exclusion Criteria:

* History of first-degree relatives known to have diabetes mellitus
* Evidence of significant active neuropsychiatric disease
* Evidence of an acute infection with fever or infectious disease
* Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
* Have used systemic glucocorticoids within 3 months prior to entry into the study.
* Have donated blood of 1 unit or more within the last 3 months prior to study entry
* Excessive alcohol intake
* Have a fasting venous blood glucose (fasting blood glucose \[FBG\], plasma) \>6 millimoles per liter (mmol/L) at screening
* Have positive hepatitis B surface antigen.
Infusion of T-Regulatory Cells in Kidney Transplant Recipients (The ONE Study)

This research study is for patients who are going to receive a kidney transplant from a living donor. After kidney transplantation, it is necessary for transplant recipients to take "immunosuppressive drugs". These drugs work by preventing the body's immune cells from attacking and "rejecting" the new kidney. Taking these drugs long-term may also cause harm to the transplanted kidney. Therefore, the transplant community is very interested in finding ways to decrease immunosuppressive drug treatment and further reduce the risk of kidney rejection. One method to do so is known as "induction of tolerance", which is when the person who receives a transplant has treatment to make their immune cells tolerant to the donor cells.

In this study, we will try to induce tolerance by mixing recipient cells and their donor's cells together with belatacept, an immunosuppressive drug. Belatacept is a protein that attaches to immune system cells, interferes with the immune response and results in tolerance induction.

After we mix the recipient cells with the donor's cells, we will sort out one particular kind of immune cell, called a regulatory T cell, and inject them back into the recipient. Regulatory T cells are the cells that are affected by induction to reduce rejection of donated organs. This method for inducing tolerance has been used in bone marrow transplantation, but this is the first time it is being done in kidney transplantation.

This study is being conducted as part of a unique collaboration of US and EU centers called The ONE Study. The ONE Study centers have agreed to work together using common protocols and procedures but with each testing their own regulatory population for safety and the ability to promote kidney survival. Sharing data among the participating sites will permit a deeper understanding of how and why some treatments might succeed while others work less well.


Eligibility Criteria:
Key Recipient Inclusion Criteria:

* Chronic renal insufficiency necessitating kidney transplantation
* Aged at least 18 years
* Donor is ABO (Blood type) compatible

Key Recipient Exclusion Criteria:

* HIV positive, EBV negative, or suffering from chronic viral hepatitis or tuberculosis
* Previously received any tissue or organ transplant other than planned kidney graft
* Genetically identical to the prospective organ donor at the HLA loci (0-0-0 mismatch)
* Panel Reactive Antibodies (PRA) \>20%
* Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non metastatic basal/squamous cell carcinoma of the skin)
* Ongoing treatment with systemic immunosuppressive drugs at study entry
Timing of Coronary Artery Bypass Surgery Among Patients With Acute Coronary Syndromes Initially on Ticagrelor

Ticagrelor, a more potent P2Y12 inhibitor, has been shown to reduce major adverse cardiac events (MACE) in acute coronary syndromes (ACS). It is increasingly used as a first line therapy in ACS. However, more potent P2Y12 inhibition has been associated with increased bleeding. This may be of particular concern for patients with ACS who require coronary artery bypass surgery (CABG). In particular, the timing for cessation of ticagrelor before proceeding to CABG is unclear. RAPID TITRATE CABG is a randomized vanguard study to evaluate the feasibility and preliminary safety of a strategy of early versus delayed CABG in ACS patients initially treated with ticagrelor and to identify potential mechanisms underlying benefits or complications of early bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* ACS patient referred for CABG and have received \>= 1 dose of ticagrelor before decision for CABG made

Exclusion Criteria:

Patients are excluded if they:

* refuse consent for enrollment
* are deemed to require immediate CABG (Day 0 or day 1)
* have a ST-elevation myocardial infarction (STEMI )initially treated with primary PCI
* are undergoing concurrent valve surgery
* are intolerant or allergic to aspirin
* have been on an oral anticoagulant (including a vitamin K antagonist or a NOAC)
* received adjuvant therapy with a glycoprotein IIbIIIa inhibitor
* have a co-morbidity with life-expectancy of \< 1 year
* have active bleeding
Stress Management for Cancer Survivors

Determine the efficacy of a brief and inexpensive psychosocial intervention, (called expressive writing) in improving health outcomes for cancer survivors.

This study aims to evaluate a computer-based stress-management therapy called expressive writing. This involves logging in to an online survey and writing in the survey about your thoughts and feelings about your cancer or to type in your everyday experiences. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples.

Eligibility Criteria:
Inclusion Criteria:

* have completed their cancer radiation treatment (intent to cure),
* are cancer free, i.e. do not have currently have a diagnosis of primary/secondary cancer or any recurrence/relapse of cancer,
* are in the re-entry phase of cancer survivorship, i.e. 2-12 months post-treatment completion,
* have access to a computer and internet in a private setting, e.g. at home,
* are fluent in English,
* are able to provide informed consent.

Exclusion Criteria:

* patients scheduled to undergo any type of cancer treatment (intent to cure/palliative) in the future (e.g. surgery after completing radiation),
* patients on any kind of corticosteroid medication (e.g. long-term prednisone therapy),
* patients having any condition that affects function of the adrenal glands (e.g. adrenal hyperplasia),
* patients with limited ability to produce saliva, e.g. patients that received radiation (or surgery) on the face region or on salivary glands; or patient's suffering from dry mouth (e.g. Sjögren's syndrome),
* patient's suffering from inflammation of the oral cavity (e.g. gingivitis).
Comparing the Color Stability of Acrylic Denture Teeth in Different Staining Solutions

The purpose of this (In Vitro Experimental Trial) is to assess (the color stability of acrylic denture teeth) in( different staining solutions) at (time intervals).

The (acrylic denture) teeth will be immersed in (staining solutions) and the values will be recorded at (different time intervals).

Three groups will be made:

* Group A- Control group
* Group B- Study group
* Group C- Study group

In this study, two brands of acrylic denture teeth will be used for comparing the color stability in different staining solutions at time intervals. Identified staining substances which are tea, coke, and turmeric will be used for the staining effect evaluation. Honey solution will be used for the first time as a staining agent because honey consumption is most common in all the age groups due to its therapeutic effects. In this study, all the color values will be measured by using Portable Colorimeter (NH300, China).These values will be measured before the immersion and then after 7-days, 15-days and 21-days interval after the immersion in the solutions.

The purpose of this study is to assess the color stability of acrylic denture teeth in different staining solutions at time intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Maxillary central incisor teeth
2. Teeth with normal flat labial surfaces
3. Inter-penetrating polymer network (IPN) teeth

Exclusion Criteria:

1. Posterior teeth
2. Teeth with stains
3. Fractured and worn-out teeth
A Survey of Darvadstrocel in People with Crohn's Disease

This study is a survey in Japan of Darvadstrocel injection used to treat Crohn's disease people with complicated anal fistula. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from Darvadstrocel injection and to check if Darvadstrocel injection improves symptoms of Crohn's disease. During the study, participants with Crohn's disease will take Darvadstrocel injection according to their clinic's standard practice. The study doctors will check for side effects from Darvadstrocel for 36 months.


Eligibility Criteria:
Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.

Exclusion Criteria None
Diabetes Footcare Companion App for Patients and Carers

Diabetes education and self-management support can be delivered via mobile phones. This protocol aims to assess the feasibility and acceptability of Well Feet, a conversational agent, as a diabetic foot care companion. By utilizing feedback and responses to evaluative questions posted on the app's interface, the investigators intend to examine the app's technical, functional, and operational feasibility.

Diabetes puts patients with diabetes at risk of foot complications. Besides well managed diabetes, providing diabetes foot care education and self-management support is key to reducing the risk of developing diabetic foot ulcers, a serious and costly complication of diabetes. Although, education and self-management support for people with diabetes can improve patients' quality of life, they are still commonly not provided or inadequate. Digital technologies have the potential to offer a new convenient, interactive, and engaging mode of self-management education and support.

This study aims to examine the feasibility of the Well Feet app for diabetes foot care education and self-management support in promoting optimal foot care behaviour. In recognizing that many people with diabetes, especially the elderly, require the support of informal carers, the app also targets their knowledge and support needs.

Eligibility Criteria:
Inclusion criteria for patients:

1. Patients diagnosed with type 2 diabetes and attending Tan Tock Seng Hospital Diabetes Clinic
2. Aged 21 years or above
3. Able to speak and read English
4. Own a smartphone or tablet
5. Can download the app
6. Have internet access
7. Able to give informed consent
8. Singapore nationality or permanent residents

Inclusion criteria for carers:

1. Provide care for a type 2 diabetes patient for the past 6 months
2. Aged 21 years or above
3. Able to speak and read English
4. Own a smartphone or tablet
5. Can download the app
6. Have internet access
7. Able to give informed consent

Exclusion criteria for patients and carers:

1. Pregnant
2. Inpatient
3. Received formal training in medicine or allied health services
Optimal Evaluation to Reduce Cardiovascular Imaging Testing

In daily clinical routine, the evaluation of new-onset and stable chest pain (SCP) suggestive of chronic coronary syndrome (CCS) remains a challenge for physicians. Although coronary computed tomography angiography (CCTA) seems to be the first-line cardiac imaging testing (CIT) according to the recommendations from current guidelines, the optimal diagnostic strategy to identify low risk patients who may derive minimal benefit from further CIT is the cornerstone of clinical management for SCP. Recently, different diagnostic strategies were provided to effectively defer unnecessary CIT, but few studies have prospectively determined the actual effect of applying these strategies in clinical practice. Therefore, the OPERATE study was designed to compare the effectiveness and safety of two proposed diagnostic strategies in identification of low risk individual who may derive minimal benefit from CCTA among patients with SCP suggestive of CCS in a pragmatic randomized controlled trial (RCT).

OPERATE trial was an investigator-initiated, multicenter, prospective, CCTA-based, 2-arm 1:1 parallel-group, double-blind and pragmatic RCT planned to include 800 subjects with SCP suggestive of CCS. Subjects were assigned randomly to two groups: 1) 2016 National Institutes for Clinical Excellence guidelines-determined diagnostic strategy (NICE strategy) and 2) 2019 European Society of Cardiology guidelines-determined diagnostic strategy (ESC strategy) The primary objective of OPERATE trial is to compare the rates of CCTA without obstructive CAD according to NICE and ESC strategy. The key secondary objective is to assess whether the two strategies have no significant difference in terms of major adverse cardiac events (MACE). The investigators hypothesize that when comparing with NICE strategy, ESC strategy which sequentially incorporated the ESC-PTP model with RF-CL model will decrease the probability of CCTA without obstructive CAD but not at the expense of safety and cost over a follow-up period of 1 year.

Eligibility Criteria:
Inclusion criteria

1. SCP or equivalenta suggestive of CCS and clinically stability
2. No history of CAD (prior myocardial infarction, CR or any CAD documented by previous CIT)
3. Age ≥30 years
4. Willing and able to provide informed consent

Exclusion criteria

1. Prior CIT within 1 year prior to randomization
2. Clinically instability (e.g. cardiogenic shock, ACS, severe arrhythmias or NYHA III or IV heart failure)
3. Non-sinus rhythm
4. Concomitant participation in another clinical trial
5. Complex structural heart disease
6. Non-cardiac illness with life expectancy \< 2 years
7. Allergy to iodinated contrast agent
8. Estimated glomerular filtration rate\<60 ml/min/1.73m2 within 90 days
9. Body mass index \>35kg/m2
10. Expressing a clear preference for undergoing CIT or not
11. Pregnancy
Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder

The purpose of this randomized, sham-controlled study is to evaluate the effectiveness of DBS therapy in individuals suffering from severe OCD and to investigate DBS treatment with functional \[18F\]FDG-Brain-PET.

The overall planned study duration per subject is 36 weeks, whereby inclusion is timepoint zero and implantation of DBS will be conducted during the first four study weeks. Patients will then undergo an 8-week open-label active DBS treatment phase followed by a 12-week double blind active or sham treatment and finally a 12-week crossover period with the inverse (active/sham) treatment with at least biweekly study visits. Patients as well as patient handling study psychiatrists will be blinded to active/sham. In case of unbearable aggravation of the symptoms during sham, the sham-period will be shortened to a tolerable length. After maximal 38 weeks all study procedures will be completed, and active DBS treatment will be maintained as long as clinically necessary.

Eligibility Criteria:
Inclusion Criteria:

* a score of 25 or higher on the Yale-Brown Obsessive Compulsive Scale
* previous failure to respond to at least two medication trials with serotonin reuptake inhibitors at or, if tolerated, beyond the FDA maximum recommended dose for a minimum duration over at least ten weeks each.
* at least one trial with tricyclic medication at or, if tolerated, beyond the FDA maximum recommended dose for a minimum duration over at least ten weeks each.
* at least one trial of augmentation with antipsychotic medication, lithium, a benzodiazepine or buspirone
* at least on trial of psychotherapy (cognitive behavioral therapy or comparable techniques) for at least 20 sessions
* ability to provide written informed consent

Exclusion Criteria:

* any history of current or past psychotic disorder
* a manic episode within the preceding three years
* any current clinically significant medical or neurological disorder, that is a contraindication against DBS
* any disease that could lead to an altered glucose reactivity (e.g. diabetes)
* any clinically significant preoperative MRI abnormality or inability to undergo presurgical MRI
* current or unstable remitted substance abuse or dependence except nicotine
* pregnancy or high risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception
* Any current severe personality disorder except comorbid anankastic personality disorder
* Inability to follow the study protocol or adhere to operational requirements
* Current and unstable suicidality
Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples

Observational study evaluating the diagnostic accuracy of rapid point-of-care molecular Group A strep diagnostic tests in saliva as compared to standard culture- and PCR-based techniques for the management of children aged 3-15 years of age presenting with sore throat to primary care.

Group A streptococcus (GAS) is found in 20% to 40% of cases of childhood pharyngitis; the remaining cases are viral. Streptococcal pharyngitis ('strep throat') deserves antibiotics, while these are not indicated in viral cases. Because signs and symptoms of streptococcal and viral cases overlap, most guidelines recommend relying on a diagnostic test to identify Group A streptococcus to select who should receive antibiotics. In most settings, the first-line test to detect Group A Streptococcus is a rapid antigen detection test based on a throat swab, and the reference standard to identify streptococcal cases is throat culture. Recently, new rapid tests were developed. They use molecular techniques, such as rapid PCRs or LAMP, based on throat swabs. We hypothesize that these new molecular tests are sensitive enough to be performed on saliva swabs instead of throat swabs. Collecting saliva is less invasive and could be done by personnel with limited training.

Eligibility Criteria:
Inclusion Criteria:

* children 3-15 years
* seen in primary care (general practitioner or primary care pediatrician)
* with a diagnosis of acute pharyngitis defined as an inflammation of the pharynx and/or tonsils (erythema with or without exudate) or acute sore throat (even if without local signs of pharyngeal inflammation)
* non-opposition of the accompanying parent(s)

Exclusion Criteria:

* children who received antibiotics within 7 days before inclusion
* children already enrolled in the study for the same episode of pharyngitis
Treatment of Orthostatic Hypotension in SCI

The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.


Eligibility Criteria:
Inclusion Criteria:

* traumatic spinal cord injury
* at least 12 months post injury
* injury level of C1-T6
* AIS A, B or C
* non-ambulatory
* non-ventilator

Exclusion Criteria:

* Active psychiatric disorder
* Stroke or cerebrovascular disease
* Alzheimer's Disease or dementia
* Unmanaged cardiac arrhythmias
* Concurrent systemic, hepatic, or renal disease
* Suspected or diagnosed malignancy
* Neurological disease other than SCI
* Self-reported history of three or more symptomatic episodes of AD per day
Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients

Peritoneal dialysis (PD) is a home-based dialysis therapy and peritonitis is a serious complication in PD. A reliable point-of-care test to detect peritonitis is important for patients to self-detect peritonitis at home as delayed diagnosis and treatment of peritonitis will translate to poor outcomes in PD patients. The study aims to examine the effectiveness of Periplex®, point-of-care test, in the diagnosis of peritonitis in PD patients.

A reliable point-of-care test to detect peritonitis is indeed needed for early diagnosis of peritonitis at home and seeking medical help early.

We hypothesize that Periplex® is not inferior to routine leukocyte testing of PD Fluid effluent in the diagnosis of peritonitis. The test strip is designed to detect the inflammatory markers (IL6 and MMP-8) which are usually released during peritonitis. The strip is intended to be used in the PD patients who suspected to have symptoms of peritonitis. The target population is all adult PD patients who are followed up in Singapore General Hospital and have signs and symptoms suspected of peritonitis during the study period. The test is considered positive for peritonitis if one or both test lines appear in the window of the test strip.

The test will be performed at 2-time points, one at the presentation of peritonitis and one at the completion of antibiotics for the current episode of peritonitis, to document resolution of peritonitis.

The results of the tests will be compared with the leukocyte testing of PD effluent.

Eligibility Criteria:
Inclusion Criteria:

* Adult PD patients who are followed up in Singapore General Hospital and presented with signs and symptoms suspected of peritonitis including fever, abdominal pain or cloudy effluent will be recruited for the study.

Exclusion Criteria:

* 1. PD patients who are not followed up in SGH 2. Patients with mentally challenging conditions and who are unable to provide a valid consent 3. Non-PD patients 4. PD patients who do not have signs or symptoms suspected of peritonitis