cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis

The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 5-17 years, with appropriately obtained informed consent and assent.
2. Subject has a documented history of ulcerative colitis for at least 3 months.
3. Subjects who are currently on 5-ASA or product(s) containing or metabolized to mesalamine must have been on a stable regimen for at least 4 weeks prior to first dose of investigational medicinal product.
4. Subjects who are not currently on a drug regimen, or on a 5-ASA or product containing or metabolized to mesalamine, must have been on a stable regimen for at least 4 weeks prior to first dose at least 4 weeks prior first dose of investigational medicinal product.
5. Body weight of 18kg-82kg inclusive.

Exclusion Criteria:

1. Current or recurrent disease (eg cardiovascular, renal, liver, malignancy or other conditions) that could affect the colon, the action, absorption or disposition of the IMP, or clinical or laboratory assessments with the exception of their existing ulcerative colitis.
2. Ulcerative Colitis known to be confined to the rectum (isolated rectal proctitis).
3. Any history of hepatic impairment or moderate to severe renal impairment.
4. The use of systemic or rectal steroids within the last 4 weeks, immunomodulators within the last 6 weeks, biologics within 6 months, antibiotic use within the last 7 days prior to the first dose of investigational medicinal product.
Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection

The purpose of this clinical trial is to find out the effectiveness of voronasan in combination with aluminum phosphate gel in the treatment of post-operative ESD ulcers. It will also find out about the safety of vunorasan in combination with aluminum phosphate gel. The main questions it aims to answer are:

1. Do vonorasan in combination with aluminum phosphate gel clinically effective in the treatment of post-operative ESD ulcers?
2. What medical problems do participants have when taking drug vonorasan in combination with aluminum phosphate gel? Researchers compared the drug voransen in combination with aluminum phosphate gel to esomeprazole in combination with aluminum phosphate gel to see if voransen in combination with aluminum phosphate gel worked better for post-operative ESD ulcers.

Participants will:

Intravenous lansoprazole 1-3 days after ESD and oral voronasan combined with aluminum phosphate gel or esomeprazole combined with aluminum phosphate gel 3-56 days after ESD.

Record their symptoms, endoscopic ulcer grading, ulcer size and Calculate ulcer healing rate at weeks 2 and 8.


Eligibility Criteria:
Inclusion Criteria:

* Meets surgical indications for ESD
* Age 18-70 years, regardless of gender
* Normal coagulation
* ESD Postoperative ulcers ≤3cm
* Voluntary participation in the study

Exclusion Criteria:

* Patients with severe complications or failure to achieve curative resection after gastric ESD surgery need supplementary surgery
* Women who are pregnant or breastfeeding, or who may conceive during clinical trials
* The patient has other serious organic diseases that affect the evaluation of the study, such as severe liver disease, heart disease, renal disease, malignant neoplasm and alcoholism
* Patients who need to take antiplatelet and NSAIDS drugs for a long period of time
* Co-administration of unspecified anti-ulcer drugs during the trial period;Allergic reactions to vornoxan, aluminium phosphate gel or esomeprazole
* Patients with no capacity for autonomous behaviors, unable to correctly express their main complaint, such as those with mental illness, severe neurosis, and unable to cooperate with this experiment
* ESD Postoperative ulcers \>3cm
Renal Denervation With Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension

The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China.


Eligibility Criteria:
Inclusion Criteria:

* Individual is ≥18 years and ≤65 years old.
* Primary hypertension.
* Screen criteria: Individual who received a stable anti-hypertensive medication regimen including 2 or more anti-hypertensive medications of different classes prior to screening, and at the initial screening visit, he has an office systolic blood pressure(SBP)≥ 150mmHg, and ≤180mmHg, is entering the screening period after writing the informed consent. Individual is receiving a 4week standard dose of amlodipine besylate (Norvasc) and Losartan Potassium and Hydrochlorothiazide tablets (HYZAAR®), and has a SBP≥150mmHg and\<180mmHg at the second week after screening, and has an Ambulatory 24-hour daytime average systolic blood pressure monitoring ≥140mmHg and \<170mmHg at the fourth week after screening.

Exclusion Criteria:

* Secondary hypertension.
* History of prior renal artery intervention including balloon angioplasty or stenting.
* Renal artery stenosis (≥50%) in either renal artery.
* Main renal arteries with \<4mm, or \>8mm in diameter.
* Main renal arteries with \<20mm in length.
* Estimated glomerular filtration rate (eGFR) of \<40 ml/(min•1.73m2).
* History of Stroke or TIA within 6 months prior to screening period.
* History of Acute coronary syndrome within 6 months prior to screening period.
* Structural heart disease without receiving effective treatment; Coronary heart disease with β blockers; severe peripheral artery disease that affecting blood pressure measurement and other unqualified conditions evaluated by investigator.
* Heart failure (NYHA classification Ⅲ-Ⅳ).
* Coagulation disorders associated with significant bleeding tendency, and history of other blood system diseases.
* History of cancer.
* Type 1 diabetes mellitus; Type 2 diabetes mellitus with target organ injuring.
* Acute or severe systemic inflammatory response syndrome.
* Any other serious medical condition unqualified to participate in this study evaluated by investigator.
Effect of Acute Protein Supplementation in Diabetic Patients

The goal of this trial is to test the effect of house cricket (Acheta domesticus) preload on glycemic response in diabetic patients. The main question\[s\] it aims to answer are: whether house cricket powder could lower blood glucose spike and stimulate higher insulin response. Participants will consume either house cricket powder, whey protein isolate or placebo which will be mixed with a chicken-flavored soup. Participants fingers will be pricked for up to 2 hours.

Researcher will compare house cricket powder with placebo to see if the glycemic response is better in house cricket supplemented group.

Researcher will compare house cricket powder with whey protein isolate to see if both supplement induce comparable glycemic response.

Participants blood will be collected at 8 time points:

Baseline 20 minutes after pre load 15 minutes after Oral Glucose Tolerance Test (OGTT) 30 minutes after OGTT 45 minutes after OGTT 60 minutes after OGTT 90 minutes after OGTT 120 minutes after OGTT

Eligibility Criteria:
Inclusion Criteria:

* Suffering from type 2 diabetes mellitus (HbA1c \> 6.5%)
* Consume metformin for at least 6 months

Exclusion Criteria:

* Consume other type of anti-diabetic drugs
* Presenting any food allergy
* Recent surgery or infections that may affect oral glucose tolerance test
* Consume other drugs that may affect oral glucose tolerance test
* Not consuming any anti-diabetic drugs
* Pre-diabetes (HbA1c 5.7 - 6.4%)
A Study of Vemurafenib in Participants With Metastatic Melanoma

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer \[AJCC\]) metastatic melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist
* Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
* Participants may or may not have received prior systemic therapy for metastatic melanoma
* Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2
* Adequate hematologic, renal and liver function

Exclusion Criteria:

* Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib
* Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
* Concurrent administration of any anti-cancer therapies other than those administered in the study
* Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
* Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption
Effects of Pilates-based Therapeutic Exercises on the Postural Control

The Pilates Method (PM) has been widely used in the daily practice of many professionals. It is well known that anticipatory postural adjustments (APAs) have a strong relation with the improvement in performance through motor control improvement. However, no studies have investigate the PM exercises performed with pelvis in different positions on the improvement of performance, APAs and these influences on motor control. This study aims to compare the effects of practicing a single session of Pilates-based therapeutic exercises with posterior pelvic tilt and neutral position of the pelvis on the APAs of elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* no history of previous abdominal or spine surgery in the last two years
* no history of low back pain in the past 2 years (as incapacitate pain lasting at least seven days)
* no neurological disorder diagnosis

Exclusion Criteria:

* significant postural asymmetry (misalignment that exceed 2 cm of the anterior superior iliac spine)
Effect of Acai Berry Consumption on Blood Glucose Levels in Healthy Adults

Type 2 Diabetes Mellitus is a chronic disease that results in hyperglycaemia. This study aimed to identify whether the anthocyanins contained in acai berries can mitigate postprandial glycaemia in healthy adults when consumed in conjunction with carbohydrate. Study design was double blind randomised crossover with glycaemic levels assessed via capillary blood samples taken at baseline and over a 2 hour post-prandial period.

Type 2 Diabetes Mellitus (T2DM) is a group of chronic metabolic disorders, characterised by insulin resistance and relative insulin deficiency, that results in hyperglycaemia. In the UK an estimated 4.3m people live with T2DM, and it is a major cause of kidney failure, heart attacks, stroke, blindness and lower limb amputation. The primary digestive enzymes that affect carbohydrate digestion and hence postprandial glycaemic levels have been identified as α-amylase and α-glucosidase. Inhibition of these enzymes therefore reduces the rate of glucose absorption and is the principle behind T2DM medications such as acarbose, miglitol and voglibose. Whilst acai berries have been found to be rich in α-amylase and α-glucosidase, no research has been conducted on healthy adults to ascertain whether the consumption of acai berries in conjunction with carbohydrate mitigates the rise in postprandial glycaemia.

10 participants were recruited for a double blind randomised crossover study where participants consumed smoothies containing either acai or placebo after 10 hours of fasting. Capillary blood samples were taken at baseline then at 30 minutes intervals until 2 hours after consumption. The study included data for sex (female/male), age (years), weight (kg), height (cm), body mass index (kg/m2) and blood glucose (mmol/l). All data collection, smoothies preparation, smoothies consumption and blood sampling procedures were completed at St Mary's University during the period November-December 2020. Statistical analysis was conducted on the data for postprandial glycaemic response to ascertain whether the consumption of acai mitigated the glycaemic response relative to the placebo.

Eligibility Criteria:
Inclusion Criteria:

• BMI of 18.5 - 24.9 kg/m2.

Exclusion Criteria:

* Known allergy to acai/berries or lactose.
* Pregnant or lactating.
* Alcohol/drug dependency.
* Smoking.
* Currently on an energy-restriction diet or have had a body weight change \>10% in last 2 months.
* Eating disorders.
* Diagnosed with diabetes or another chronic condition.
* Taking chronic medication.
* Allergy to any of materials used in, or an unsurmountable fear of, the finger-prick procedure.
Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET

This is a single-centre, non-randomized, two-stage design, proof-of-concept study evaluating the radiolabelled PARP inhibitor \[18F\]-olaparib als potential tracer for imaging of tumour PARP expression by PET.


Eligibility Criteria:
Inclusion Criteria:

1. Patients \>18y, with biopsy-proven HPV-negative HNSCC, or patients \>40y with HPV-positive HNSCC and high-risk features (i.e. \> 10 smoke packs/year AND ≥N2b)
2. Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated
3. Recent archival tumour tissue (\<8 weeks prior to inclusion) should be available with suffi-cient residual material for determination of tumour PARP1 levels
4. Presence of a tumour lesion ≥10 mm in diameter
5. ECOG performance status 0-2
6. Negative pregnancy test in women with childbearing potential
7. Life expectancy \>3 months
8. Signed written informed consent and able to comply with the protocol
9. For stage II only: re-biopsy should be deemed feasible by the investigators (assessed by head-and-neck surgeon)

Exclusion Criteria:

1. Recent treatment with PARP inhibitors or other investigational therapies \<30 days.
2. Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.
Postprandial VLDL-triglyceride Metabolism in Type 2 Diabetes Patients With and Without NAFLD

Non-alcoholic fatty liver disease (NAFLD) covers a spectrum from simple reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (NASH). The mechanisms behind why some subjects progress from NAFLD to NASH are not clear and the responsible mechanism for storage of excess amounts of liver fat in patients with NAFLD are poorly understood.

Patients with type 2 diabetes mellitus (T2D) and abdominally obese subjects very often have accumulation of liver fat (NAFLD).

T2D is also associated with abnormal lipid metabolism (dyslipidemia), including free fatty acids (FFA), hypertriglyceridemia and excessive postprandial hyperlipidemia which increases the risk of ischemic cardiovascular disease (CVD) and heart failure.

In healthy, insulin sensitive subjects the postprandial increase in triglycerides (TG) is primarily caused by meal derived chylomicrons, whereas endogenously produced TG (VLDL-TG) and decreased peripheral TG clearance only becomes quantitatively important in insulin resistant subjects .Thus, postprandial lipidemia in T2D results from both chylomicronemia as well as a reduction in both insulin mediated suppression of VLDL-TG secretion and lipoprotein lipase (LPL) mediated peripheral clearance. A recent study demonstrated that the ability of insulin to suppress hepatic VLDL-TG after a fat-enriched meal and the duration of the postprandial hyperlipidemia was similar in patients with T2D compared with age- and BMI matched individuals without T2D, indicating that the degree of insulin mediated VLDL-TG secretion and hyperlipidemia primarily depends on insulin sensitivity and not the presence of T2D diabetes per se.

In these studies, the investigators want to examine the effect of a fat enriched mixed-meal on hepatic VLDL-TG handling and adipose storage capacity in patients with T2D with and without NAFLD. Investigators will address these questions using carboxyl-14C triolein labeled VLDL-TG, magnetic resonance (MR) spectroscopy of liver, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression.

The overarching goals are to define abnormalities and differences between patients with T2D with and without NAFLD in terms of hepatic lipid metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 2 Diabetes with and without NAFLD (steatosis FF% \> 5,6% on MR spectroscopy for NAFLD and NASH groups)

Exclusion Criteria:

* Active smoking
* Comorbidity other than hypertension and hyperlipidemia
* Fixed medical drug consumption (including insulin) except statins and anti-diabetic medications. However, statins must be paused 2 weeks before the examination date and other antidiabetic medication on examination date.
* Patients with cancer or former cancer patients
* Blood donation within the last 3 months prior to the study
* Participation in experiments involving radioactive isotopes within the last 3 months
* Alcohol abuse (over 21 items per week for men and over 14 for women)
* Pregnancy
An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments

This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)
* Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started

Exclusion Criteria:

* None
EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy

Many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. Coeliac plexus neurolysis (CPN) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. It can be with different approaches, such as percutaneously guided by fluoroscopy, echo-endoscopically or surgically with endoscopic approach being the more popular one in many centers equipped with echo-endoscopic services. The effect of CPN has been well established by some retrospective series. The overall response rate to CPN ranges from 70-90%, however, the analgesic effect is limited and up to roughly around 3 months. It is believed that the short-lasting analgesic effect is related to incomplete neurolysis by absolute alcohol injection.

Recently, radiofrequency ablation (RFA) of coeliac plexus has been introduced as another mode of CPN. So far, only one small single center randomized controlled trial (RCT) suggesting superior performance in favour to CPN using RFA. This result has to be validated and by a RCT with larger sample size. In addition, data concerning the quality of life (QOL) improvement and cost-effectiveness need to be further elucidated. Therefore, the aim of this study is to perform a RCT to look into these issues.

The aim of this study is to compare the efficacy of EUS-guided CPN versus radiofrequency ablation in patients with pain related to pancreatic cancer. By performing a randomized controlled trial, the clinical outcomes and cost-effectiveness of this new RFA treatment approach can be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 year-old
* Patients who give informed consent to the study
* Suboptimal pain control with regular analgesics
* Inoperable cancer of pancreas

Exclusion Criteria:

* Patients who refuse to give consent
* Patients aged \<18 years
* EUS not possible due to:

Problem related to scope insertion such as trismus, stenosis of the upper GI tract Coagulopathy with INR \>1.5 or platelet count \< 70

* Low oxygen saturation or extreme blood pressure render endoscopic procedure unsafe
CDP-choline Treatment in ATS Users

This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.

This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline (CDP-choline) in amphetamine-type stimulants-using adolescents. Multi-level assessments will be performed to determine whether CDP-choline administration with supportive psychotherapy, compared to placebo administration with supportive psychotherapy, will 1) repair ATS-induced neural cell damage of the target brain regions, 2) improve cognitive deficits and normalize the relevant target neural circuits, and then 3) reduce ATS-taking behaviors in ATS-using adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Aged 14-40 years
* Amphetamine (or amphetamine-like) use disorder (DSM-IV-TR)
* Informed consent
* Seeking treatment

Exclusion Criteria:

* Major medical or neurological illnesses
* Psychiatric illnesses requiring hospitalization, prescription of psychotropic medications, or emergency psychiatric interventions
* Current and past diagnosis of a psychotic disorder, bipolar disorder, conduct disorder, or attention-deficit hyperactivity disorder
* Occasional ATS use (less than monthly use)
* IQ of 80 or lower
* Pregnancy or breastfeeding
* Clinically significant suicidal or homicidal ideation
* Substance use disorders (substances other than amphetamine or MA)
Laser Tongue Debridement for Oral Malodor

Malodor is a multifactorial condition with oral pathology representing the main culprit and the tongue being the first to second contributor to the malodor. Bacterial load can represent a quantifiable measure regardless of the original pathology. It is hypothesized that reduction in malodor can be represented by tongue changes both in appearance, bacterial and biofilm load reduction (measured by CFU and volatile gases measurement), organoleptic measurement and subjective improvement.

Methods: A randomized controlled prospective study under IRB approval. Diagnostic criteria for enrollment and follow up were organoleptic test by 2 judges, halimeter reading, tongue colores changes HALT questionnaire and direct aerobic and anaerobic tongue cultures measured by CFU. Patients were treated with laser tongue debridement (LTD) with an Er,Cr:YSGG solid state laser has been shown to be effective in biofilm reduction.


Eligibility Criteria:
Inclusion Criteria:

* an individual (male or female) who can understand and voluntarily sign an informed consent form
* a baseline organoleptic oral malodor score of at least 2

Exclusion Criteria:

* severe caries,
* signs of gingival inflammation on intraoral exam
* possible extra-oral halitosis (tonsillitis, sinusitis, and pulmonary pathologic conditions, or a condition that may contribute to systemic halitosis, such as hepatic cirrhosis or uncontrolled diabetes)
* antibiotic treatment within 1 month prior to study
* pregnant