cyrilzakka/clinical-trials huggingface dataset:
Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug

The combination of methotrexate (MTX) with a biological disease-modifying antirheumatic drugs (bDMARD) is the next step in treatment with MTX monotherapy in rheumatoid arthritis (RA). Estimation of MTX and bDMARD impregnation could be performed with the erythrocyte MTX polyglutamate (MTX-PG) and bDMARD assays before to move to a second bDMARD. In RA patients treated with MTX (prescribed for at least 6 months at a stable dose for at least 3 months) in combination to a first bDMARD (prescribed since at least 3 months), an assay of MTX-PG and bDMARD will be performed in tow subsets of RA according to the level of disease activity. The first subset is active RA defined by a DAS28 (disease activity score 28)\>3.2. The second one is RA in clinical remission defined by a DAS28\<2.6. The main hypothesis is the association between the low concentration of MTX-PG and the clinical response of RA patients treated with subcutaneous methotrexate injection associated to a first bDMARD. Adherence to MTX will be reviewed by the Compliance Questionnaire Rheumatology (CQR) questionnaire. This assay could be useful to improve MTX management before to move to a second bDMARD.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and have social security affiliation.
* Patients followed in the Rheumatology Department at the hospital of St Etienne.
* Rheumatoid Arthritis patients in remission (Disease Activity Score 28\<2.6) with methotrexate (MTX) treatment for at least 6months, and with a stable dose for 3months.
* Patients with a High Disease Activity Rheumatoid Arthritis activity (Disease Activity Score 28\>3.2) with methotrexate (MTX) treatment (≥ 15 mg/week), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (≥ 15 mg/week) treatment during the previous 3 months.
* Signed informed consent.

Exclusion Criteria:

* Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD)
* Another diagnostic than rheumatoid arthritis
Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

This is a single-arm, single institution pilot registry of liver transplantation in patients with unresectable colorectal liver-only metastases at Weill Cornell Medical College. Patients with liver predominant colorectal liver metastases will be screened based on eligibility criteria in a specified clinical hepatobiliary and colorectal liver metastasis tumor board consisting of the principal and co-investigators, representing medical oncology, transplant surgery, radiology, and pathology. The registry aims to track basic demographic data as well as referral patterns, in addition to specific oncologic data such as tumor burden, extent of disease, extent of disease on explant, recurrence rates, patterns of recurrence and survival rates.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the colon or rectum
2. No evidence of extrahepatic metastases or local recurrence based on PET/CT and colonoscopy
3. No signs of extrahepatic metastases or local recurrence according to PET/CT 4 weeks prior to consideration of transplant
4. Age 18-65 years old
5. Good performance status with ECOG 0-1
6. Stability or regression of liver metastasis for at least 6 months
7. Minimum of 1 year between diagnosis of colon cancer and liver transplant and 6 months from primary tumor resection and liver transplant
8. Minimum of 6 months chemotherapy
9. CEA \< 200 ug/L 3 months prior to transplant
10. Adequate organ and marrow function with Hb \> 10 g/dL, ANC \> 1000/uL, platelets \> 100,000/uL, bilirubin \< 2x ULN, AST/ALT \< 5x ULN, Creatinine \< 1.25 x ULN, Albumin above LLN

Exclusion Criteria:

1. Evidence of extrahepatic disease or local recurrence
2. Previous resection of lung metastases
3. MSI-H/dMMR or BRAF mutation
4. Any other medical or co-morbid condition that would preclude liver transplantation, as determined by the transplant team
The Study Compare and Evaluate the Safety and PK Data of a Single Dose Administration of 'AD-115A' or 'AD-1151'

The study compare and evaluate the safety and pharmacokinetic characteristics of a single dose administration of 'AD-115A' or 'AD-1151' in healthy adults.

A randomized, open-label, single-dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of AD-115A and the administration of AD-1151 for healthy subjects in fasting state

Eligibility Criteria:
Inclusion Criteria:

* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
* Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit

Exclusion Criteria:

* Individuals who have taken drugs that induce (e.g., barbiturates) or inhibit drug-metabolizing enzymes within 30 days prior to the start of the study (first dosing day), or have taken drugs that may affect this study within 10 days prior to the start of the study (first dosing day)
* Other exclusions applied
Pre- Vs Postoperative Thromboprophylaxis for Liver Resection

Thromboprophylaxis for liver surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in liver surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing liver surgery. As far as we know, there are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with liver surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Traditionally, many liver surgery units have been reluctant in using preoperative thromboprophylaxis due to the potentially increased risk of bleeding complications. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in liver surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in liver surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in liver surgery in a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing liver resection

Exclusion Criteria:

* Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during last month pre-surgery
* Emergency operation (e.g. for trauma or infection)
* Age \< 18 years
* Allergy or other contraindication to planned low-molecular weight heparin
* Inability to give written informed consent
* Liver resection not performed (removed from analyses after randomization)
Prevalence and Long-term Impact of Non-atherosclerotic CAD

Despite a relatively high prevalence of non-atherosclerotic coronary artery disease (NACAD) among young women, the majority of these abnormalities were misdiagnosed in this population, and thus treatments were not targeted adequately in this patient population. Furthermore, the short and long-term cardiovascular outcomes of young women with NACAD have not been evaluated. Given the importance of NACAD in young women, the challenges of diagnosis and subsequent treatment, and unknown outcomes with NACAD, we propose a prospective registry to further evaluate this population. We propose to evaluate young women (age \< or equal to 55) presenting with myocardial infarction (MI) prospectively, to diagnose the etiology of MI differentiating atherosclerotic versus NACAD, to correlate the prevalence of FMD in other vascular territory, and to evaluate the long-term outcome of young women with NACAD in comparison to those with atherosclerotic CAD over a 5-year follow-up.

All women aged 55 or younger having a coronary angiogram for acute coronary syndrome (ACS) will be approached prior to their procedure. A pregnancy test will be performed (standard for pre-menopausal women due to potential radiation exposure). If the cause of the heart attack is uncertain (eg no obvious infarct-related narrowing or occlusion), intravascular ultrasound or optimal coherence tomography will be performed within the context of the angiogram to better view the artery wall. A picture of the iliac and renal arteries will be accomplished by aortography (one dye shot down the aorta); in the case that the renal arteries are not well visualized, selective renal angiography will be performed (catheter at the entry to the renal artery). In the case of suspected non-atherosclerotic abnormalities, a head CT angiogram wil be performed. Referral to appropriate specialists for detected abnormality will occur. If symptoms continue, the subject will be followed by a cardiologist. A research coordinator will contact the subject at 1, 6 and 12 months and then annually to collect data on medications, hospitalization and symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 55 or younger with a troponin positive acute coronary syndrome (ST and non-ST elevation myocardial infarction or Acute Coronary Syndrome (ACS)) having a coronary angiogram
* negative pregnancy test for women of child bearing age

Exclusion Criteria:

* Creatinine clearance \<50
* not willing to undergo an angiogram
* troponin negative ACS
Metabolic and Cardiovascular Impact of CD36 Deficiency in African Americans

CD36, a protein that facilitates tissue uptake of fat, as a common link between blood fat concentrations and metabolic disease states such as diabetes mellitus. Genetic variants in the CD36 gene are more common in African Americans compared to Whites and it may confer protection against metabolic diseases by altering the amount of fat in the blood.

The purpose of this study is to compare the levels of fat in the blood and to assess endothelial dysfunction among carriers versus non-carriers of the coding SNP, rs3211938 of the CD36 gene after a high fat meal challenge


Eligibility Criteria:
Inclusion Criteria:

* African American men and women age 18-65 years of age
* BMI 25-45 kg/m2

Exclusion Criteria:

* Diabetes
* Pregnancy
* Use of nicotinic acid for dyslipidemia
* History of nutrient malabsorption
* Clinically significant hepatic or renal disease, OR serum creatinine or liver function tests \> 2times upper limits of normal
* Symptomatic acute or chronic gallbladder disease
* Any underlying or acute disease requiring regular medication which could in the principal investigator's opinion possibly pose a threat to the subject or make implementation of the protocol difficult
* Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
* Patient unwilling or unable to give informed consent
Effects of Two Different Exercise Programs and Diet in Obese Subjects With NAFLD

The aim of the study is to estimate the effectiveness of two different exercise programs combined with the Mediterranean diet versus diet alone on inflammatory status in subjects aged 18-65 years with obesity (BMI\>30) and Non-Alcoholic Fatty Liver Disease (NAFLD) (CAP \>248 dB/m).

The main objective of the study is to estimate the effect of two exercise programs of different type and intensity combined with a Low Glycaemic Index Mediterranean Diet (LGIMD) compared to diet alone on the systemic inflammation index (SII) and biomarkers related to the inflammatory state: TNF-alpha; IL-1, IL-6, IL-10, CK-18, PCR and VES, in patients with obesity and NAFLD aged 18-65 years after a 4-month intervention.

The secondary objectives are: to assess whether the adoption of the two exercise programs of different types and intensities associated with an LGIMD compared to diet alone in patients with obesity and NAFLD can significantly modify body composition, inhibiting the risk of sarcopenia, in turn, favored by NAFLD, improve physical efficiency (fitness), understood as cardio-respiratory fitness muscular strength and flexibility, may also lead to improvements regarding the gut microbiota, in terms of abundance of microbial taxa, by studying, starting from the data obtained from the 16S, the metabolic pathways of the microbiota and fecal metabolome, as well as Quality of Life, by filling in specific questionnaires, and the evaluation of the fatty acid profile of erythrocyte membranes.

The two different types of exercise will be: - outdoor walking, understood as a moderate-intensity aerobic exercise, carried out 4 times a week, for a duration of 60 minutes for 4 months; - High-Intensity Interval Training carried out 3 times a week, for a period of 50 minutes at a time for 4 months in a gymnasium affiliated with the organization.

The diet will be the same for all project participants and will follow advice based on the Low Glycaemic Index Mediterranean Diet. All subjects will be followed by specialized personnel regarding both diet and exercise.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30 kg/m2 or an abdominal circumference (waist) \> 94 cm in men and \> 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterise metabolic syndrome
* Age range 18-65 years, both sexes
* Diagnosis of hepatic steatosis, formulated on the basis of recognised criteria (fibroscan (CAP (controlled attenuation parameter) \> 238 dB/m)).

Exclusion Criteria:

* Normal and underweight subjects
* Presence of any pathology that may influence the presence of steatosis apart from pathologies that are inclusion criteria, neurological and psychiatric pathologies, gastrointestinal, oncological and cardiovascular diseases
* Pregnancy or breastfeeding
* Subjects with osteoarticular pathologies that may prevent regular exercise
* Inability to quantify the degree of NAFLD by Fibroscan
* Person not in possession of a medical certificate of fitness for non-competitive physical activity.
Open-label Extension Study of ADP101

This is an open-label, safety extension study for participants who participated in the Harmony study (protocol ADP101-MA-01).

This study is enrolling participants by invitation only. This is a multicenter, open-label, long-term extension study of the safety and efficacy of ADP101 for oral immunotherapy in food allergic children and adults who completed the Harmony study (protocol ADP101-MA-01).

Eligibility Criteria:
Key Inclusion Criteria:

• Subjects must have completed the ADP101-MA-01 (The Harmony Study) and been compliant with study drug per protocol

Key Exclusion Criteria:

* History of or current EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia
* Hypersensitivity to epinephrine or any of the excipients in ADP101
* Prior or concurrent therapies as follows:

  * beta-blockers, ACE inhibitors, ARBs or calcium channel blockers
  * regular steroid medication use
  * therapeutic antibody treatment currently or within the previous 6 months
  * any food immunotherapy currently or within the previous 12 weeks, except ADP101
  * investigational agents other than ADP101
  * in the build up phase of non-food immunotherapy
* Any other condition that might preclude safe participation in the study
Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea

To compare the effects of Functional and Core stability exercises on pain and sleep quality in Patients with Primary Dysmenorrhea and to check the results of exercises may be effective in pain during Menstrual and before cramping in menses.


Eligibility Criteria:
Inclusion Criteria:

* Having used medication for menstrual pain and not having used oral contraceptives during the three months prior to admission to the study.
* Pain must be periodic (at least following 3 menstrual cycles).
* Lower abdominal cramps pain ends after periods and gradually diminish over 12 to 72 hrs.
* No history of blood disorders including thalassemia and folate or iron-deficiency anemia

Exclusion Criteria:

* Pelvic inflammatory disease
* Ovarian cysts
* Chronic abdominal pain
* Fibroids, obstructive endometrial polyps,
* Irritable bowel syndrome
* Major abdominal or pelvic surgery
* Intrauterine devices.
An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits

Patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. This extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive deficits related to traumatic brain injury. This extension will enable further evaluation of patients, as well as analyses to be conducted examining response to treatments in the original drug and placebo groups.


Eligibility Criteria:
Inclusion Criteria:

* Have a deficit in the areas of attention and/or memory.
* Have current cognitive deficits which were present from the time of the injury, are persistent, and are deemed to be the result of the brain injury;
* Be at least 12 months post brain injury;

Exclusion Criteria:

* A history of a major brain surgery;
* A penetrating brain injury (e.g., gun shot wound);
* A current diagnosis of epilepsy;
* Had more than one seizure in the past year (patients who have had a single seizure within a year post-injury will be considered on a case by case basis);
* Previous exposure to rivastigmine.
Cardiovascular Health Assessment of Preterm- and TERm-born Children

The purpose of the CHAPTER study is to help understand how complications during pregnancy, such as preterm birth, affect how childrens' hearts and blood vessels develop.

Young adults born preterm (less than 37 weeks gestation) have alterations in the structure and function of the heart, with similar changes observed in preterm infants in the first three months of life. It is unknown whether these early changes in the heart seen in the first few months of life are relevant to long-term changes in heart structure and function. Heart changes have also not been well studied in children born preterm. To investigate this, the study will follow up children from the EPOCH study and will perform two study visits for each child (n=100 preterm and n=100 term) that will use echocardiography and cardiovascular magnetic resonance. Individuals in the EPOCH study had echocardiography measures done at birth and three months postnatal age. It will therefore be possible to do longitudinal echocardiography measures from birth up to ages 12 years to determine whether postnatal heart changes in preterm infants track into childhood. Cardiovascular magnetic resonance will allow for the determination of whether these early heart changes influence heart pump function. Finally, by measuring lung function, blood vessel structure and function, and blood pressure, it will be possible to determine how heart changes relate to other components of the cardiovascular system. This data will be used to confirm the relevance of early heart remodelling in preterm-born offspring over time and provide more comprehensive heart phenotyping for preterm-born children. Together, this information can be used to design future intervention strategies in preterm-born individuals to reduce cardiovascular risk in this growing subgroup of the population.

Eligibility Criteria:
Inclusion Criteria:

* Participant's parent or legal guardian gives consent and the participant, where age-appropriate, gives assent for participation in the study.
* Participant is male or female, aged 3-9 years at enrolment.
* Participant previously took part in the EPOCH study, or the participant's friend or sibling took part.

Exclusion Criteria:

* Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status

For exclusion of MRI component only:

* Contraindication to MRI
* Unsuitable for MRI based on the responses to the MRI screening form
Analysis of Blood Metabolomics to Identify Potential Biomarkers of Gastrointestinal Bleeding

Despite advances in gastrointestinal endoscopy and pharmaceuticals, gastrointestinal bleeding is still a significant emergency disease with a high mortality rate of 1.9-5 per 100 people due to excessive bleeding and shock.

There are several indicators using pulse rate, blood pressure, hemoglobin, etc. to select patients who require endoscopic intervention, or hospitalization, but these are inaccurate and with a high false-positive rate and low specificity at 35-40%.

Therefore, tests with high diagnostic accuracy for gastrointestinal bleeding patients are required and findings specific biomarkers for gastrointestinal bleeding are of great importance.

Recently, with the development of metabolomics, efforts are being made to improve the diagnosis and treatment of diseases through metabolomics analysis, but there are no studies related to gastrointestinal bleeding. If the degradation/metabolism process of blood that accumulates in the gastrointestinal tract is well studied and understood, there is a possibility of finding specific biomarkers for gastrointestinal bleeding.

Thus, this study aims to analysis of metabolomics of blood degradation/digestion using in vitro digestion model to identify potential biomarkers of gastrointestinal bleeding.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants, aged between 21 and 55 years old.
2. A body mass index (BMI) between 18.5 and 29.9 kilograms per meter square.
3. English-literate and able to give informed consent in English.

Exclusion Criteria:

1. Smokers.
2. Clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastrointestinal, neurological, metabolic or immunodeficiency disorders, cancer, hepatitis, or cirrhosis.
3. Had surgery of the gastrointestinal tract or any other medical condition considered likely to affect the gastrointestinal absorption.
4. Use of oral iron supplement within the past 30 days.
5. Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit.
6. Significant change in weight (≥ 3 kg body weight) in the past 3 months.
7. Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week.
8. Poor peripheral venous access based on past experiences with blood draw