cyrilzakka/clinical-trials huggingface dataset:
Study to Determine the Effect of 14 Days Dosing With Darapladib (SB-480848) on Carotid Plague Composition in Patients With Planned Carotid Endarterectomy

The primary objective is to determine Lp-PLA2 activity in atherosclerotic carotid plaques after 14 (+/-4) days treatment with darapladib, compared to placebo. Secondary objectives include determination of the change in Lp-PLA2 activity in blood, Lp-PLA2 mass in blood and plaque, specified biomarkers in blood and plaque and their respective correlation's with Lp-PLA2. In addition, the study aims to characterise the PK/PD of repeat oral doses of SB-480848, and safety and tolerability in this population.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, \>35 years of age
* Females of childbearing potential must be using approved contraceptive measures
* Male patients must be willing to abstain from sexual intercourse or use a form of contraception if engaging in sexual intercourse with a woman who could become pregnant
* Planned carotid endarterectomy within a timeframe compatible with recruitment for the study and able to comply with the requirements of the study, as deemed by the investigator
* Written, informed consent to participate

Exclusion Criteria:

* Recent myocardial infarction (within the previous 4 weeks)
* Currently taking corticosteroids, warfarin, digoxin or a potent CYP3A4 inhibitor
* Recent (\<3 months) or ongoing acute infection or significant trauma associated with bruising and/or taking antibiotics. Prophylactic antibiotics for surgery are allowed
* Change in dose of lipid-lowering therapy during the previous 4 weeks from randomisation
* History of chronic liver disease (e.g. cirrhosis, hepatitis) OR ALT OR AST ≥1.5 times the upper limit of normal (ULN) at screening
* Diagnosis of systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA)
* Clinically significant anaemia
* History of severe renal impairment (serum creatinine \>1.8mg/dL)
* Unstable angina
* History of asthma , anaphylaxis or anaphylactoid reactions, severe allergic responses
* Abuse of alcohol or drugs within the last 6 months
* Any factor or clinical disease state that, in the investigator's opinion, would preclude completion of a safe surgical procedure and/or completion of the study
* Use of an investigational drugs within 30 days or 5 half-lives of their last dose prior to starting the study, whichever is the longest
Diagnosis of Pancreatic Cancer by Purine Metabolite (Hypoxanthine, Xanthine) in Urine

* This study aim to develope a diagnostic method of pancreatic cancer by using a reagent for analyzing purine metabolite (Hypoxanthine, Xanthine) in urine.
* It is safe and cost effective compare to radiologic or blood test. It can be used for initial screening test for healty population.

* CubeBio and Seoul National University Bundang Hospital signed a joint technology development agreement to compare the analytical performance of existing analytical methods and purine metabolite analysis reagents developed by CubeBio.
* Through quantitative analysis of hypoxanthine and xanthine in the urine of normal people and pancreatic cancer patients, we plan to confirm the possibility of diagnosing pancreatic cancer using reagents for analyzing purine metabolites.
* Early diagnosis of pancreatic cancer is a key determinant of cure and survival rates, and impact on all aspects of cancer, including rate of progression, treatment, and prognosis.
* This study could change the paradigm of pancreatic cancer screening by evaluating the stability and accuracy of urinary purine metabolite analysis reagents.

Eligibility Criteria:
1. pancreatic cancer group

   Inclusion Criteria:
   * Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features
   * Patients with resectable pancreatic cancer at the time of surgery (Including borderline resectable pancreatic cancer at the time of diagnosis or Locally advanced pancreatic cancer after chemotherapy or radiation therapy)
   * Patients without invasion of adjacent organs other than the left adrenal gland and mesocolon
   * Patients with informed consent

   Exclusion Criteria:
   * History of other malignancy (Inclusive if there is no evidence of recurrence after 5 years of treatment)
   * Patient with Inflammatory disease(e.g. severe pancreatitis, cholangitis)
   * Patients with underlying diseases at high risk of general anesthesia
   * Other subject whom the investigator deems inappropriate
2. control group Inclusion Criteria included healthy individuals as well as patients with benign diseases.

Exclusion criteria for the control group included a previous cancer diagnosis within the past five years, active inflammatory diseases, borderline malignant pancreatic tumors, or a postoperative pathological finding of malignancy.
Allogeneic HSCT in MDS Patients Based on Risk According to R-IPSS

An "intention-to-treat" study to evaluate the impact of allogeneic HSCT with Total Marrow and Lymphoid irradiation (TMLI), followed by Treg/Tcon adoptive immunotherapy, on overall survival in patients affected by Myelodysplastic Syndrome (MDS), according to IPSS-R.

MDS patients with Intermediate, High, or Very-High R-IPSS risk will be enrolled. Allogeneic stem cell transplantation with regulatory and conventional T cell adoptive immunotherapy will be proposed to eligible High and Very-High risk MDS patients. Intermediate risk MDS patients will be assessed for risk modification every six months and moved to transplant in case of increased risk. Intermediate risk MDS patients will be also evaluated for the presence of molecular alterations (TP53, ASXL1, RUNX1). Overall survival of the entire cohort will be assessed as primary endpoint. Incidence of Treatment Related Mortality, acute Graft versus Host Disease, chronic Graft versus Host Disease, Relapse will be also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by Myelodysplastic Syndrome with IPSS-R INT, HIGH or VERY HIGH;
* Age \<71 years;
* Signature of the informed consent.

Exclusion Criteria:

* Patients affected by Myelodysplastic Syndrome with IPSS-R VERY LOW or LOW;
* Patients affected by Myelodysplastic Syndrome/Myeloproliferative Neoplasm;
* Age \>70 years;
* No signature of the informed consent
Telepsychiatry to Enable Expedited Disposition of Psychiatric Emergencies

The goal of this observational study is to examine the effect of using a video link for evaluation of patients in the psychiatric emergency room. Under current Israeli law, the attending physician must come in to physically examine the patient before they can be admitted involuntarily. Patients often de-compensate and even may become violent while waiting for the attending to arrive. Previous studies have shown that evaluation of such patients via video-link has an extremely high concordance with in person evaluation. This study will compare patients who are evaluated via video-link with historical controls evaluated under usual conditions. This is an observational study, which is taking advantage of a change in practice to collect data on two different ways of delivering care, via chart reviews. If successful, this study will show that the video-link is feasible and acceptable to patients and staff. The following hypotheses will be tested:

1. The intervention will result in shorter ED time compared to historical controls.
2. The intervention will result in fewer violent incidents compared to historical controls.
3. The intervention will result in shorter overall hospital length of stay compared to historical controls.


Eligibility Criteria:
Inclusion Criteria:

* Must be evaluated in the psychiatric ED for potential involuntary admission

Exclusion Criteria:

* Not justice-involved (i.e., brought in by police after committing a crime)
A Study of SI-6603 in Patients With Lumbar Disc Herniation

The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
* Patients assessed as positive in the SLR test.
* Patients with sciatica in either leg.
* Patients with no improvement from conservative treatment

Exclusion Criteria:

* Patients who have 2 or more lumbar disc herniations as assessed by MRI.
* Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI.
* Patients who have received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent.
* Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies
Tofacitinib Combined With Chidamide in R/R ENKTCL

This study is to explore the efficacy and safety of tofacitinib combined with chidamide in patients with relapsed and refractory extranodal NK/T cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with primary refractory or recurrent extranodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.

  2. Adequate renal function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dL.

  3. Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \</= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 x upper limit of normal.

  4.. Adequate cardiac function with left ventricular ejection fraction \>/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.

  5. Performance status 0-1. 6. Negative Beta diffusing capacity of lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization

Exclusion Criteria:

-1. Patients relapsed after allogeneic stem cell transplant 2. Patients with active hepatitis B or C(HBV DNA \>/=10,000 copies/mL). 3. Active infection requiring parenteral antibiotics 4. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts 5. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.

6. Patients with a cQT longer than 500 ms
Bariatric Endoscopy and NAFLD

Find out how bariatric endoscopy will influence the clinical course of non-alcoholic fatty liver disease.

The study will test and investigate the impact of bariatric endoscopy (various types of intragastric balloons, endoscopic sleeve gastroplasty, aspiration therapy) on components of the metabolic syndrome in obese patients, especially on influencing non-alcoholic steatosis and steatohepatitis and signs of liver fibrotization and weight reduction. The method consists of performing a mini-invasive endoscopic procedure and, as a result, reduced food intake.

Eligibility Criteria:
Inclusion Criteria:

* Age between 21-70 years
* BMI \>27 Kg/m2
* Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study-specific procedures such as clinical assessment, endoscopy, radiography, as well as laboratory investigations
* Must be able to understand and be willing to provide written informed consent
* Patient living within radio range 300 km from the study center
* Failure of the cognitive-behavioral approach to weight reduction

Exclusion Criteria:

Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:

* BMI \<27
* History of gastric surgery.
* Previous technical difficulties in gastric and duodenal endoscopy or inability to perform endoscopy
* History of GIT diseases such as achalasia, esophageal motility disorders, severe esophagitis or gastritis, the recent history of ulcers, history of steatosis or obstruction in the GIT
* Proven celiac disease
* Previous irreversible endoscopic procedures and surgical treatment of obesity
* Chronic and acute pancreatitis
* Active or chronic infectious hepatitis
* Known liver disease or suspected PBC, PSC, autoimmune hepatitis, alpha1-antitrypsin deficiency, Wilson's disease, hereditary hemochromatosis, known cirrhosis or history of hepatic decompensation, AST or ALT\> 5-8x ULN
* Type 1 or type 2 diabetes with insulin
* History of malignant disease
* Specific genetic or hormonal disorders associated with obesity (Prader-Willi syndrome, MC4R mutations, etc.)
* Serious disorders of blood clotting and hematopoiesis
* Severe forms of psychiatric illness (endogenous depression, schizophrenia, suicidal tendencies, psychosis)
* Uncontrolled hypertension (systolic BP\> 150 mm Hg or diastolic BP\> 100 mm Hg) or severe heart disease (severe cardiac dysfunction, etc.)
* Serious autoimmune diseases or long-term use treated with glucocorticoids or immunosuppressive therapy
* Disorders of thyroid function unresponsive to processing.
* Renal impairment with GFR \<60 ml / min / 1.73 m2, or albumin excretion\> 1000 mg / day
* Substance use including excessive alcohol use (\> 21 units / week for men and\> 14 units / week for women, - 1 unit (250ml 12 ° or 330ml 10 ° beer; 100ml wine; 25ml = small spirits of spirits))
* Pregnancy
Effects of Acute Exercise on Pain and Human Movement

The aim of this research project is to evaluate the effect of an acute exercise intervention on pain intensity and movement control. It also aims to investigate potential differences in movement con-trol between patients with chronic musculoskeletal pain compared to healthy controls.

The aim of this research project is to evaluate the effect of an acute exercise intervention on pain intensity and movement control. It also aims to investigate potential differences in movement control between patients with chronic musculoskeletal pain compared to healthy controls. All tests will be conducted at Dalarna University.

After the initial baseline tests, participants will be randomised to either acute exercise intervention group or to a control group not performing any intervention groups (both patients and controls will be randomised to intervention or control). If randomised to the control group, participants rests corresponding to the time it takes to perform the intervention (30 min), and then preform the post-intervention tests similar as the intervention group.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for participants with chronic pain:

* Men and women, age 18-67 years,
* good ability to understand written and verbal information and instruction given in Swedish,
* chronic (\>3 months) musculoskeletal pain or chronic widespread pain.

Inclusion criteria for healthy controls:

* Men and women, age 18-67 years,
* good ability to understand written and verbal information and instruction given in Swedish.

Exclusion Criteria:

For participants with chronic pain

* chronic pain caused by malignancies or systemic diseases, other physical conditions that affects functional abilities and implies use of walking aid in-door,
* pregnancy after week 12, childbirth within the last 3 months or
* spinal surgery.

For healthy controls:

* chronic (\>3 months) or acute pain of any cause,
* other physical conditions that affects functional abilities, and implies use of walking aids in-door,
* pregnancy after week 12, childbirth in the last 3 months or
* spinal surgery.
Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations

This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 6 years or older
* Diagnosed with Microcystic Lymphatic Malformations
* Able and willing to comply with all protocol-required activities
* Willing and able to provide written informed consent

Exclusion Criteria:

* Any significant concurrent condition that could adversely affect participation.
* Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022
* Patient's deemed by the investigator as unwilling or unable to remain compliant with all tests and procedures, including adherence to study drug administration and other protocol-required activities.
Evaluation of Exercise Application Technology in Adolescents

The purpose of the study is to evaluate the use of an exercise phone application and a continuous glucose monitor and their impact on metabolic disease in adolescents with obesity, prediabetes and Type 2 diabetes. Participants will be asked to wear a continuous glucose monitor (Freestyle Libre) and if they are in the intervention group also participate in using an exercise phone application as well as have scheduled interval contact with a health professional in between scheduled clinic visits to assess how they are reaching their goals.

Patients will be recruited directly from the Childrens of Alabama pediatric endocrine clinic. Thirty patients who have obesity, prediabetes or Type 2 diabetes will be enrolled. During the enrollment phase, flyers will be posted in clinic and emails will be distributed to potential participants. Our study team will approach interested participants during their routine clinic visit. Consent will be obtained by study team during their endocrine clinic visit. Review of their medical records will be done and age, gender and race will be extracted from the medical record. A baseline visit with vital signs, blood work, a physical exam and nutritional counseling will be completed. Once enrolled, the patients will then be randomized.Within this pilot trial, we will randomize 15 adolescents/teenagers who either have obesity, prediabetes or Type 2 diabetes, to access to an exercise regimen and 15 adolescents to control intervention using a permuted block randomization scheme. The randomization scheme will contain 6 blocks of size 5 allowing for 30 randomized in the group with obesity, prediabetes and Type 2 diabetes.

Those who are in the intervention group will then be given access to frequent telephone counseling to follow-up their nutrition and exercise goals, access to exercise application and accelerometer as described below. Follow-up will then be completed at 3 and 6 months with a physical exam, vital signs, blood draw.

Intervention Group

Access provided to exercise application Provided with Fitbit to wear and measure activity Weekly check-in with provider to determine how exercise goals have been that week. If unable to reach, we will text securely a clinic check-in and provide a healthy tip of the week.

Meeting with nutrition at Baseline visit

Continuous glucose monitor provided (plan to wear for 14 days during each month)

Non-Intervention Group

Meeting with nutrition at Baseline visit

Continuous glucose monitor provided (plan to wear for 14 days at baseline visit, 3 month visit and 6 month visit)

Eligibility Criteria:
Inclusion Criteria for Type 2 diabetes arm

* BMI \> 95th percentile
* A1c\> 6.5%
* Age 14-17 (2 years post-menarchal)

Inclusion for Prediabetes Arm

* Age 14-17 (2 years post-menarchal)
* A1c 5.7-6.4%

Inclusion for Obesity Arm

* Age 14-17 (2 years post-menarchal)
* A1c 5.7-6.4%

Exclusion Criteria for all arms

* BMI \<95th percentile
* Specific obesity syndrome
* Inability to participate in exercise workouts
The Impact of Reactivation During Sleep on the Consolidation of Abstract Information in Humans

In any given cognitive domain, representations of individual elements are not independent but are organized by means of structured relations. Representations of this underlying structure are powerful, allowing generalization and inference in novel environments. In the semantic domain, structure captures associations between different semantic features or concepts (e.g., green, wings, can fly) and is known to influence the development and deterioration of semantic knowledge. The investigators recently found that humans more easily learn novel categories that contain clusters of reliably co-occurring features, revealing an influence of structure on novel category formation. However, a critical unknown is whether learned representations of structure are closely tied to category-specific elements, or whether such representations become abstract to some extent, transformed away from the experienced features. Further, if abstract structural representations do emerge, prior work provides intriguing hints that these representations may require offline consolidation during awake rest or sleep. The investigators have developed a paradigm in which carefully designed graph structures govern the pattern of feature co-occurrences within individual categories. Here the investigators implement a "structure transfer" extension of this paradigm in order to determine whether learning one structured category facilitates learning of a second identically structured category defined by a new set of features. This facilitation would provide evidence that structure representations are abstract to some degree. Aim 1 will use these methods to evaluate whether abstract structural representations emerge immediately during learning. Aim 2 will determine whether these representations persist, or emerge, over a delay, and whether sleep-based consolidation in particular is needed. The role of replay of recent experience during sleep will be evaluated using electroencephalography (EEG) paired with closed-loop targeted memory reactivation (TMR), a technique that enables causal influence over the consolidation of recently learned information in humans. This work will inform and constrain theories of semantic learning as well as theories of structure learning and representation more broadly.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 35

Exclusion Criteria:

* No medical or neurological illness that would impact experimental performance
* Not a member of a vulnerable population
Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating

This study is to determine the effect of intra-dermal (ID) administration of regular and of rapid-acting insulin, before eating, on blood glucose levels for several hours after a standard meal (a mixed, liquid meal). Insulin will also be given normally, subcutaneously, for control or comparison purposes. The hypothesis or expectation is that ID insulin will work more quickly and control blood glucose levels better than SC injection.

Previous studies have shown that intra-dermal (ID) insulin administration results in a more rapid onset of action in comparison to subcutaneous (SC) administration as measured by glucose infusion rate (GIR) under glucose clamp conditions.The aim of this study is to investigate whether ID administration of regular human insulin or rapid-acting insulin analogue leads to reduced postprandial glycemic excursions in comparison to SC application under highly standardized experimental conditions. Effects on the occurrence of hypoglycemia will also be investigated, as well as pK and pD comparisons between different insulin formulations administered ID. This is a mono-center, open-label, randomized, 5-period crossover study in patients with type 1 diabetes

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for 1-15 years, on multiple daily injections (MDI) or insulin pump (CSII) in stable control with HbA1c \<= 9.0%.
* Able to attend clinic for 5 different days

Exclusion Criteria:

* BMI \> 32 kg/m2
* Evidence of gastroparesis or impaired renal function or lipodystrophy