cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis

The purpose of this open-label, pilot, proof of concept study is to evaluate the safety, tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary cholangitis (PBC).


Eligibility Criteria:
Key Inclusion Criteria:

* Males or females aged 18 to 80 years (inclusive) at the time of screening, with confirmed Primary Biliary Cholangitis (PBC) diagnosis based upon at least 2 of 3 criteria:

  * Anti-mitochondrial antibodies (AMA) titer \>1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies (anti-GP210 and/or anti-SP100)
  * Alkaline phosphatase (ALP) \>1.5 x upper limit of normal (ULN) for at least 6 months
  * Liver biopsy findings consistent with PBC
* Use of ursodeoxycholic acid (UDCA) for at least 6 months prior to screening (stable dose for at least 3 months immediately prior to screening)
* Participants must have ALP \>1.5 x ULN but \<10 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<5 x ULN, and total bilirubin \<ULN, at all screening visits
* AST, ALT, ALP, and total bilirubin must have 2 values at least 4 weeks apart that are within 20% of each other

Key Exclusion Criteria:

* Chronic liver disease of a non-PBC etiology. However, PBC participants accompanied with primary Sjögren's syndrome (pSS) are eligible to be enrolled.
* History or evidence of clinically significant hepatic decompensation
* Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
* Clinically significant infections within 6 weeks prior to treatment start, or infection with hepatitis C virus anytime in the past
* Immunosuppressive, immunomodulating, or investigational agents within 30 days prior to treatment start
* Treatment with obeticholic acid (OCA) within 30 days prior to Day 1

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study

Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States. These viruses are sometimes found in drinking water, ice, shellfish and in other foods. They can be spread easily from contact with water, food, objects or hands that have even small amounts of feces from someone who was sick.

The purpose of this research study is to the effectiveness of high hydrostatic pressures processing (HPP) treatment on norovirus infected shellfish. Norwalk virus can survive in shellfish and still be able to cause sickness. HPP inactivates microorganisms living both on the surface and on the interior of the food. The goal of the study is to determine whether HPP treatment on oysters spiked with norovirus will reduce infection rates in people consuming raw infected oysters.


Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteer
* Age must be between 18 and 50 years of age

Exclusion Criteria:

* Have a job in which you handle food
* Are a health care worker with direct patient contact
* Work in a child care, elderly care center or if you live with young children or anyone who has a weak immune system
* Are not willing or able to wash your hands every time after you go to the bathroom, or before and after you prepare or handle food throughout the whole study
* Are anemic
* Are not willing to give us permission to store and use your data and samples
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer

Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.

The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.

1. immediate before anesthesia induction
2. postoperative 1 hours
3. postoperative 24 hours

Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay

Eligibility Criteria:
Inclusion Criteria:

* patient who was planned to undergo colon cancer surgery.

Exclusion Criteria:

* age \< 20 years old
* history of hypersensitivity reaction in propofol or sevoflurane
* history of previous cancer
* patient with ongoing inflammation
Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure

OBJECTIVES: I. Determine the pharmacokinetics of exogenous liothyronine administered in children undergoing the modified Fontan procedure.

II. Determine the liothyronine supplementation dose that counters the fall in serum liothyronine concentrations and provides the greatest potential myocardial benefit after the modified Fontan procedure.

III. Evaluate the potential toxicity of exogenous liothyronine administered in children undergoing a modified Fontan procedure.

PROTOCOL OUTLINE: This is a randomized, placebo controlled, dose escalation study.

Initially, patients are randomized to receive either 1 of 3 different dosages of liothyronine or placebo after undergoing the Fontan procedure. If no unacceptable toxicity is observed in this group, a third dose level of liothyronine is added to the randomization. A total of 7 patients are enrolled at each dose level. All randomized study drugs are administered by continuous infusion over 1 hour after surgery.

Cardiac function is assessed 5 days after surgery.

Eligibility Criteria:
* Single ventricle congenital cardiac malformation
* Must undergo modified Fontan procedure
* No concurrent medications known to interfere with thyroid metabolism including propranolol and amiodarone
* No hepatic dysfunction
* No renal dysfunction
* No pre-existing thyroid dysfunction
Effect of a Nutritional Support System for Improving Gross Motor Function in Cerebral Palsy

Background: Most patients with cerebral palsy (CP) are dependent on parents due to the spasticity and limitations in their gross motor function. Additionally, many of them do not respond to physical therapy due to deterioration in their nutritional status, which is secondary to gastrointestinal disorders, parasitosis, dysbiosis and the catabolic state of the disease itself. Evidence suggests that greater independence and better clinical response can be achieved by correcting the nutritional status. However, basic treatments only contemplate the calculation of energy requirements and do not consider important nutrients in particular, supplementation with glutamine, arginine, zinc, selenium, colecalciferol, nicotinic acid, spirulina, omega 3, ascorbic acid, vegetal protein or even probiotics.

Objective: To determine the effect of using a nutritional support system (NSS) diet, supplements and probiotic on the gross motor function in children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III).

Material and methods: In an exploratory study with controlled clinical trial design, 30 patients were randomly assigned to receive: 1) dietary surveillance and conventional therapy (FG), 2) deworming and WHO diet (CG), or 3) deworming and the NSS (IG). The patients were recruited from the Children´s Telethon Rehabilitation Center (CRIT) in Tlalnepantla Estado de México. Males and females aged 4-12 years were included with CP and spastic diparesic GMFCS III, who had a full-time caregiver and whose parents agreed to participate. They were studied for thirteen weeks. Gross motor function was evaluated at baseline and at 7 and 13 weeks after therapy using the GMFM scale.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CP with spastic diparesia and GMFCS III
* Re-entry
* Presence and support of a full-time caregiver
* To tolerate oral feeding
* Parents or guardians agree in writing to participate in the project
* Patients treated at the CRIT of Tlalnepantla Edo. Mex
* That the children, in the case of being able to write, accept in writing to participate in the project

Exclusion Criteria:

* Presence of any other catabolic disease, which further increases the risk of malnutrition (renal, cardiovascular, pulmonary, hepatic, immunological)
* Have had infectious problems or have received antibiotic treatment 15 days prior to the start of the study.
* Have received botulinum toxin therapy in the last 4 months
* Muscle relaxants in the last 6 months
* Severe gastroesophageal reflux
* Patients with any type of surgery performed with a period shorter than 9 months
* That can walk by themselves
Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis

This is a 6-month prospective interventional clinical trial designed to evaluate the impact of whey protein isolate oral supplement on protein status. Differences in protein status will be evaluated with review of the medical chart from standard of care monthly blood collection for serum albumin, total protein, and normalized protein catabolic rate (nPCR) as detected by serum urea nitrogen. Mid-arm circumference and weight will be measured to ensure no significant changes. Quality of life will be measured to detect if the addition of protein aided in overall quality of life. There will be a 3-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial. After the recruitment period has finished, eligible participants will sign the consent form in order to participate in the study. At this point, participants will be provided the supplements for the month and instructed with the amount of water and how to mix with the provided measuring and drinking cup.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* diagnosed with stage 5 Chronic Kidney Disease for at least 3 months prior to the starting date of the trial
* on peritoneal dialysis at least three months prior to the starting date of the trial
* can provide signed informed consent
* have no dietary restriction
* no food allergies
* no chewing/swallowing difficulties.

Exclusion Criteria:

* not meeting the above
* pregnant/lactating as either self-reported or determined by the medical director

  * Chronic Kidney Disease patient stages 1-4.
  * Chronic Kidney Disease patient undergoing hemodialysis.
* use of other protein supplement
Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

The purpose of this randomized, prospective trial is to determine wether (a) a once weekly glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic patients on conventional insulin treatment.

The design is an open, prospective, randomised, multicentre parallel group study. The total duration will be 5 years with patient recruitment over 4 years and an individual observation period of 1 year. 300 participants from 43 study centres, hospitals and private practices were recruited. The study will run for one year and aims to determine, whether there is an advantage with regard to HbA1c levels when (a) a regular three-monthly HbA1c or (b) a weekly 4-point glucose profile is taken and reported.

After screening, patients will be assigned at random to one of the following study arms:

1. no regular blood-glucose self-monitoring, no regular HbA1c
2. regular blood glucose self monitoring, no regular HbA1c
3. no regular blood glucose self monitoring, regular HbA1c
4. regular blood glucose self monitoring, regular HbA1c

The control for all participants is that urinary glucose should be monitored at least once a day, preferably in the late morning, as the highest increase in plasma glucose level occurs after breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Type 2-diabetes (ADA/WHO-Criteria)
* Conventional insulin therapy ( 1-3 daily injections of basal- and/or mixed insulin also in combination with oral agents.)
* Age:\> 40 years
* BMI:\> 20 kg/m²

Exclusion Criteria:

* Impaired liver function, defined as \> 2 times upper limit of normal
* Impaired renal function defined liver enzymes as serum-creatinine \> 1.3 mg/dl
* Gastro-intestinal diseases (disturbances, diagnoses)
* Inability to perform study-related activities according to the present protocol
* Pregnancy not certainly excluded
* Abuse of alcohol and/or other drugs
* Participation in other clinical trials during the past 3 month
* Threat to general state of health
* Intensified insulin therapy (at least 3 times rapid-acting insulin)
* Frequent blood glucose self monitoring during the past 3 months (more than one 4-point glucose profile per week or more than one blood glucose/ urinary glucose test per day )
A Study to Learn About the Adherence and Clinical Outcomes in Colombian Patients With an E-Device for Etanercept Administration in Rheumatoid Arthritis

This is a descriptive, ambispective, and single-site study in Colombia, which is designed to evaluate the adherence, persistence, and clinical outcomes (defined as the patient's disease activity and functional status) of RA patients within 40 weeks after the patient administered the first injection of the etanercept medication through the Smartclic® device. The study data seeks from medical records containing the Smartclic device injection log and pharmacy claims database available from an institution specialized in rheumatological care. The study will only include records of patients treated or starting treatment with etanercept and whose indicated autoinjection device has been Smartclic.

Non-interventional study: The clinical records of eligible patients will be identified by the rheumatologist from the patients who attended the rheumatologist visit or institutional training sessions according to the standard of care. Patients have been prescribed etanercept according to the standard of care, and Smartclic has been indicated as an administration method.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* Patients aged ≥18 years with an established diagnosis of rheumatoid arthritis according to EULAR-ACR criteria recorded in medical record.
* Patients who are on etanercept treatment and are being switched to Smartclic, or new etanercept patients that have been prescribed Smartclic® device (either in combination with a conventional synthetic DMARD or in monotherapy).
* Medical records and pharmacy claims database of the IPS available after the index date for a period of 40 weeks.

Exclusion Criteria:

- Any serious ongoing infections, pregnancy, or other social or medical conditions that are anticipated in the investigator's judgment to lead to discontinuation of etanercept administration with the device during the 40 weeks of data collection.
A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study will assess how effective Upadacitinib is in changing the disease symptoms in Canadian participants with RA.

Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult Canadian participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 390 participants will be enrolled this study, in multiple sites within Canada.

Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 24 months.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe Rheumatoid Arthritis (RA) according to the investigator.
* Decision to initiate UPA treatment by investigator according to the local product label independent of the participant's participation in the study.
* Has been previously treated with Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and corresponds to one of the following subgroups:

  * Has not been previously exposed to any Biologic Disease-Modifying Antirheumatic Drugs (bDMARD) or Targeted Synthetic Disease-Modifying Antirheumatic Drugs (tsDMARD).
  * Has not been previously exposed to tsDMARD and has been previously exposed to \<= 2 bDMARDs.
  * Has been previously treated with one tsDMARD and \<=1 bDMARD prior to treatment with that tsDMARD.

Exclusion Criteria:

* Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the treatment of RA.
* Diagnosis of rheumatic disease other than RA.
* Diagnosis of juvenile RA.
* Currently participating in an investigational clinical trial.
* Has prior exposure to a bDMARD after exposure to a tsDMARD.
* Has prior exposure to tsDMARD in an investigational clinical trial.
Media, Morphokinetics, and Mosaicism

Embryonic aneuploidy is the underlying etiology for the majority of failed implantation and miscarriage. Preimplantation genetic screening (PGS) with transfer of a euploid embryo has been advocated as a strategy for increasing live birth rates with a single embryo transfer. Culturing embryos to the blastocyst stage for trophectoderm biopsy is a requirement for PGS. Several commercially-available single-step embryonic culture media with varying composition have been established for use in the IVF laboratory. Early reports have suggested differences in clinical outcomes, such as aneuploidy and miscarriage rates, with distinct culture media currently in standard use. However, there have been no clinical trials demonstrating the superiority of any one commercially-available culture media formulation. As a result, clinics use media with varying composition based upon familiarity and cost.


Eligibility Criteria:
Inclusion Criteria:

All subjects planning blastocyst culture for preimplantation genetic screening (PGS) will be offered enrollment.

Antral Follicle Count (AFC) \>8 Male and female partner \> 18 years of age

Exclusion Criteria:

Female partner age \>42 years of age Cleavage stage biopsy
Integrated Chiropractic and Acupuncture Treatment for Low Back Pain

This study is being conducted to compare the effectiveness of integrated chiropractic and acupuncture care for the management of low back pain.

This study is being conducted at the Southern California University of Health Sciences. Eligible subjects will be randomized to one of three treatment groups: chiropractic care alone, acupuncture care alone, and chiropractic and acupuncture care combined.

Subjects will be treated on pragmatic basis for 60 days and then followed up for an additional 60 days. All examinations and treatments will be provided free of charge. The expected benefits for the participants are decreased pain and improved function.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 years or older
* Have a current episode of low back pain

Exclusion Criteria:

* Received chiropractic treatment or other manipulative therapies within the last month
* Received acupuncture treatment within the last month
* Visceral, systemic or joint inflammatory disease with referred pain to the back or pelvis
* Non-mechanical low back pain
* A history of low back surgery
* Osteoporosis
* Spondylolisthesis
* Coagulation disorder or are taking anticoagulant medication
* Prolonged systemic corticosteroid medication
* Progressive unilateral lower limb muscle weakness
* Symptoms or signs of cauda equina syndrome (e.g., bowel or bladder dysfunction)
* Severe concurrent illness (e.g., cancer, heart diseases, psychiatric disorders)
* Known pregnancy
Effects of Polyunsaturated Fatty Acids on Intestinal Lipid Metabolism in Insulin-resistant Men

The overaccumulation of apolipoprotein (apo)B-48-containing lipoproteins of intestinal origin observed in patients with insulin-resistance is now thought to be attributable to both elevated intestinal production and reduced clearance of these lipoproteins. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease (CVD) risk. Therefore, reduction of atherogenic plasma TRL levels of intestinal origin appears to be crucial to improve CVD risk associated with insulin-resistance. In this regard, there is some evidence that the clinical recommendation to replace dietary saturated fatty acids (SFAs) by n-6 polyunsaturated fatty acids (PUFAs) reduces CVD risk in the general population. Although the beneficial impact of n-6 PUFAs on CVD risk has been related primarily to favorable changes in plasma LDL-cholesterol levels, recent data suggest that chronic n-6 PUFA consumption may also exert beneficial effects on CVD risk by reducing postprandial lipemia. The impact of substituting SFAs by n-6 PUFAs on postprandial lipid response may be of even greater significance in dyslipidemic patients with insulin-resistance among whom intestinal triglyceride-rich lipoproteins (TRLs) represent a large proportion of the atherogenic lipoproteins. The general objective of the proposed research is to investigate how dietary n-6 PUFAs in place of SFAs modify intestinal lipoprotein metabolism in men with dyslipidemia associated with insulin-resistance. The investigators hypothesize that the intestinal secretion of apoB-48-containing lipoproteins will be lower following a diet rich in n-6 PUFAs than after consuming a diet rich in SFAs. The investigators also hypothesize that substitution of SFAs by n-6 PUFAs will be associated with significant alterations in expression of key genes and proteins involved in intestinal lipoprotein metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18-60 years
* Waist circumference \> 102 cm
* HDL-cholesterol \< 1.1 mmol/L
* Triglycerides \> 1.7 mmol/L
* Fasting blood glucose \> 6.1 mmol/L
* Normal blood pressure (\<130/85)

Exclusion Criteria:

* Women
* Men \< 18 or \> 60 years
* Smokers (\> 1 cigarette/day)
* Body weight variation \> 10% during the last 6 months prior to the study baseline
* Subjects with a previous history of cardiovascular disease
* Subjects with type 2 diabetes
* Subjects with a monogenic dyslipidemia
* Subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa
* Subjects with endocrine or gastrointestinal disorders
* History of alcohol or drug abuse within the past 2 years
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.