cyrilzakka/clinical-trials huggingface dataset:
Characterization of Immunogenicity of TNF Inhibitors in Arthritis Patients With Poorer Treatment Response.

The aim of the study is to explore whether the influence of gender, tobacco smoking and obesity on treatment response in tumor necrosis factor inhibitors (TNFIs) can be explained by high degree of inflammation, human leucocyte antigen (HLA) type, autoantibodies, TNF and TNFI concentration and presence of ADA.

Tumor necrosis factor inhibitors (TNFIs) have been uses with success since 1999 in Denmark in treatment of various inflammatory diseases, eg. rheumatoid arthritis (RA), Chrohn's disease, psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

TNFIs block a central cytokine in the inflammatory process, tumor necrosis factor (TNF).

Because the drugs are large proteins, they are prone to trigger an immune response and elicit anti-drug antibodies(ADA).

Epidemiologic studies have revealed that groups of patients (women, tobacco smokers, obese patients) with inflammatory rheumatic diseases have a lower response to TNFIs. The reasons for this are not fully elucidated. The hypothesis is that immunogenicity and changed pharmacokinetic of TNFI are causes of the inferior response.

The investigators will carry out a prospective clinical studies of 120 arthritis patients (RA, PsA and AS) initiating treatment with adalimumab or infliximab. The patients will be followed for 12 months and will be registered in DANBIO as normal praxis. Blood samples will be collected at baseline, 2, 4 and 12 months or at termination of the treatment.

Genotypes, autoantibodies, inflammation markers, TNFI and ADA will be measured.

The aim of the study is to explore:

A: If differences between men and women with respect to different markers of inflammation, human leucocyte antigen (HLA), autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among women.

B: If differences between smokers and non-smokers with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment among patients with arthritis who smoke tobacco.

C: If differences between obese and normal weight patients with respect to different markers of inflammation, HLA, autoantibodies, TNFI concentration and presence of ADAs can explain the lower response and adherence to the treatment.

The study will contribute with new knowledge, which hopefully can make the treatment more personalized and efficient.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Diagnosed with RA, PsA or AS.
* Starting treatment with infliximab or adalimumab.
* Co- treatment with csDMARD or glucocorticoid is acceptable.
* No new bDMARD is initiated at the time of sampling.

Exclusion Criteria:

-
To Evaluate the Efficacy of AL-38583 in the Reduction of Tear Eosinophil Count Following Conjunctival Allergen Challenge

The purpose of the study is to determine whether Al38583 Ophthalmic Solution is safe and effective in reducing tear eosinophil levels at 5-8 hours after Conjunctival Allergen Challenge (CAC).


Eligibility Criteria:
Inclusion Criteria:

* Have a positive bilateral CAC reaction (\>2 itching and \> conjunctival redness) to cat hair, cat dander, dust mites, cockroaches and/or dog dander within 10 minutes of instillation of the last titration of allergen at Visit 1

Exclusion Criteria:

* Have a known allergy to the study medication(s) or their components (ex., dexamethasone, benzalkonium chloride)
Allogeneic Microbiota-reconstitution (AMR) in Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

The investigators will perform a multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with diarrhea predominant-IBS (IBS-D) diagnosed according to Rome III criteria and the IBS-QOL questionnaire. Central supply and quality control of donor material will be used to control bias.

Primary endpoint is improvement of IBS-SSS (Severity Score System) compared to baseline. Secondary endpoints include changes in IBS-QOL, short term safety and one year follow up to control long term effects, safety and changes in and acceptance of donor microbiome after AMR using16S rDNA sequencing and quantitative diversity analysis.

This study assesses allogeneic microbiota reconstitution (AMR) as novel treatment to improve symptoms and quality of life of patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

The investigators will perform a prospective multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with IBS-D diagnosed according to Rome III criteria and the IBS-QOL questionnaire.

The experimental intervention is an infusion of donor feces via gastroscopy. The placebo intervention is an infusion of sterile saline via gastroscopy.

Planned number of patients included in the study: 42 patients Planned per-protocol group: 33 patients

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* irritable bowel syndrome of diarrhea-predominant type according to ROME III criteria
* Symptoms for \> 1 year before study inclusion
* persisting symptoms \> 1 year before study inclusion
* relevant symptoms with reduced Quality of Life (IBS-QOL \< 60 Points)
* no specific findings in gastroscopy and colonoscopy with biopsies in the last 2 years

Exclusion Criteria:

* chronic inflammatory diseases
* gastrointestinal infectious diseases
* microscopic colitis
* celiac disease
* diarrhea caused by fructose- or lactose intolerance
* gastrointestinal malignancies or intestinal polyps
* irritable bowel syndrome of other type than IBS-D
* bile acid diarrhea
* constipation
* symptoms caused by other diseases than IBS-D
* dementia
* abdominal surgery in the last months
* antibiotic therapy in the last 3 months
* pregnancy
* linguistic barrier for informed consent
On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs

The purpose of this research is to compare the effectiveness of a continuous monitoring system to assess Activities of Daily Living (ADLs) over time compared to the traditional assessments used by medical professionals as Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) progresses.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in English to understand and sign the consent or assent documents.
* Adult over 65 years of age with no children under 18 years old living in residence.
* Adult anticipates they will be living primarily at designated residence over next 18 months.
* Must receive caregiver interaction at least 6 hours/week.
* Must undergo a Mini-Mental State Exam (MMSE) assessment at baseline during recruitment as well as at the end of the study with a resulting score of 11-25 as part of the recruitment phase of the study.
* Must be willing to have home or facility equipped with sensors to obtain activity and location data.

Exclusion Criteria:

-
Imaging Inflammation in Alzheimer's Disease

This study is being done to learn about inflammation and amyloid in Alzheimer's disease. A type of brain scan called a PET scan is used measure 1) inflammation and 2) abnormal accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and do tests to measure the participants' memory and thinking.

This study is being done to determine the relationship between inflammation, cognitive impairment, and amyloid burden in elderly subjects with different clinical and biomarker profiles of Alzheimer's disease (AD). Participants will undergo amyloid PET imaging with 18F-Florbetaben with target number of completers being 15 amyloid-positive elders with impairment, 15 amyloid-positive elders with normal cognition, 15 amyloid-negative elders with impairment, and 15 amyloid-negative elders with normal cognition. Subjects will undergo screen that includes neuropsychological testing, brain MRI, and PET imaging with 18F-florbetaben to define the above 4 groups. Subjects will have 11C-PBR28 PET imaging to measure the 18 kDa translocator protein (a marker of inflammation). Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of amyloid,tau, phospho-tau, and inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

1. Age 60 and older.
2. Meet criteria for either a) amnestic mild cognitive impairment (single or mixed domain) or mild Alzheimer's disease, or b) have no cognitive impairment based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.
3. Subjects unable to provide informed consent must have a surrogate decision maker
4. Written and oral fluency in English or Spanish.
5. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
6. In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.

Exclusion Criteria:

1. Past or present history of certain brain disorders other than MCI or AD.
2. Certain significant medical conditions, which make study procedures of the current study unsafe.
3. Contraindication to MRI scanning.
4. Conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.).
5. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
6. Low affinity binding on TSPO genetic screen.
7. Participation in the last year in a clinical trial for a disease modifying drug for AD.
8. Inability to have a catheter in subject's vein for the injection of radioligand.
9. Inability to have blood drawn from subject's veins.
A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.

Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer.

UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks.

5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks.

Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
2. Tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
3. Stage III cancer by General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus (6th ed.), excluding si(ai), n(-), M(-).
4. No synchronous colorectal cancer which invade muscularis propria or deeper.
5. Tumor resection with D2 or D3 lymph node dissection was performed.
6. Pathological determination of curability of tumor resection is cur A.
7. Age at registration is above 20 and below 75 years old.
8. ECOG Performance status is 0 or 1.
9. No prior chemotherapy or radiation therapy.
10. Intake of normal diet and oral drugs is possible.
11. Major organ function is preserved. WBC\>=3,000/mcl, PLT\>=100,000/mcl, GOT\<=100 IU/L, GPT\<=100 IU/L, T.Bil \<=2.0 mg/dl, Cr\<=1.5 mg/dl
12. Adjuvant chemotherapy can be started within 9 weeks after surgery.
13. Written informed consent is taken.

Exclusion Criteria:

1. Active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). Carcinoma in situ is eligible.
2. Severe postoperative complications which do not resolve until registration.
3. There is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema
4. Pregnant or breast-feeding woman.
5. Difficult to participate with the trial, having mental disorder or psychiatric symptoms.
6. Judged to be inappropriate to register.
Proximity Work in Family Medicine Groups : the Impact of Pharmacists

The project objective is to evaluate the impact of the recent addition of pharmacists within family medicine groups (FMGs) on organizational and clinical parameters. The process by which changes occur and the level of pharmacists' activities will also be assessed. The ultimate goal of the project is the development of an accompanying guide to facilitate the work of the pharmacist in monitoring complex patients in primary care medical clinics.


Eligibility Criteria:
Inclusion Criteria:

* Willing to meet with the pharmacist and;
* Consuming drugs of four or more different pharmacological classes or having to take at least four doses per day and;
* aged 70 or over with at least two criteria of vulnerability or aged less than 70 with at least 3 criteria of vulnerability or had a recent loss of autonomy or in post- hospitalization with medication changes in the hospital.

Exclusion Criteria:

* None
Iron Supplementation of Lead-exposed Infants

The purpose of this study is to compare the efficacy of iron (12.5 mg as ferrous sulfate) and placebo given for 6 months in preventing the elevation of blood lead concentration in children 6-9 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Infants included if gestational age \>36 weeks, birth weight \> 2500g, no chronic illness, blood lead concentration \<10 mcg/dL, hemoglobin \>9 g/dL, zinc protoporphyrin \>90 mmol/mol heme
* Mothers included if 18 years or older

Exclusion criteria:

* Hemoglobin \>11.5 g/dL
Ultrafiltration on Coagulation Performance in Cardiac Surgery

In cardiac surgery patients with CPB-induced dilutional coagulopathy, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components before the weaning from CPB. The impact of UF on the clot strength is determined by analyzing the changes of maximal clot formation in EXTEM assay (MCF-EXTEM) in the ROTEM test in patients who underwent elective cardiac valve surgery in KUMC.

In cardiac surgery patients, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components during cardiopulmonary bypass (CPB). Concentrating plasma substrate of UF would be beneficial in attenuating CPB-induced dilutional coagulopathy. This study was to investigate whether MUF affected viscoelastic profiles during CPB for cardiac surgery.

Patients who underwent elective cardiac surgery and MUF at the end of CPB during January 2019-December 2021 are recruited. Using the patients' electronic medical records, the values of maximum clot firmness of EXTEM assay (MCF-EXTEM) of rotational thromboelastometry (ROTEM) test before and after applying MUF are retrospectively analyzed.

As the primary measure, we determine the changes of MCF-EXTEM after applying MUF. With an assumption that MUF increased MCF-EXTEM, the receiver operating characteristic (ROC) analysis is applied to MCF-EXTEM change. The area under the ROC curve is determined and the cut-off value is estimated with specificity and sensitivity in Youden's J statistics. The change of MCF-EXTEM in patients who show MCF-EXTEM less than the cut-off value is analyzed. The changes of hematocrit (Hct) before and after applying MUF is also determined.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent cardiac surgery during Jan 2019-Dec 2021
* Patients underwent moderate hypothermic CPB
* Patients underwent ultrafiltration during CPB
* Patients underwent ROTEM tests (EXTEM assays and FIBTEM assay) before and after applying ultrafiltration

Exclusion Criteria:

* Patients underwent packed RBC transfusion \> 3 units during CPB
* patients underwent ultrafiltration but the removed free water was \< 250 ml
* Patients underwent deep hypothermia
Patients on Antithrombotics for Colonoscopy

The use of antithrombotics (antiplatelet agents and anticoagulants) is increasing with an aging global population.Management of antithrombotics in patients undergoing invasive procedures including gastrointestinal endoscopy remains a challenge. Management approach includes taking a precarious balance between the risk of thromboembolism after interruption of antithrombotics and risk of bleeding with the continuation of antithrombotics. Colonoscopy remains one of the commonest endoscopic procedures performed. The optimal management strategy of different antithrombotics during colonoscopy remains unclear.

The use of antithrombotics (antiplatelet agents and anticoagulants) is increasing with an aging global population. Cardiovascular disease is a leading cause of death worldwide. Clinical Practice Research Datalink (CPRD) GOLD database suggests that over 915 000 people in the UK have suffered a myocardial infarction and over 1.3 million are living with angina in 2013. Two percent of people in developed countries are on long-term anticoagulation and up to 10% in the elderly population. Management of antithrombotics in patients undergoing invasive procedures including gastrointestinal endoscopy remains a challenge. Management approach includes taking a precarious balance between the risk of thromboembolism after interruption of antithrombotics and risk of bleeding with the continuation of antithrombotics. The availability of new antithrombotic agents adds to the complexity of antithrombotic management during endoscopy. Warfarin has been the only oral anticoagulant available until the introduction of direct oral anticoagulants (DOACs). Newer antiplatelet agents (prasugrel and ticagrelor, vorapaxar) are becoming more commonly used for the treatment of the acute coronary syndrome.

There remain gaps in the management approach of patients receiving antithrombotics and requiring endoscopy. It is still uncertain of the actual bleeding risk associated with antithrombotic use during endoscopy. Colonoscopy remains one of the commonest endoscopic procedures performed. It is the gold standard for direct evaluation of the colon for patients with the suspected colonic disease. It is also used as a screening test for prevention of colorectal cancer by colonoscopic polypectomy of precancerous polyps.The optimal management strategy of different antithrombotics during colonoscopy remains unclear.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be over 18 years of age
* Patients undergoing elective colonoscopy for any indication, who are receiving antithrombotics
* Informed consent is obtained

Exclusion Criteria:

* Patients under 18 years of age
* Inability to give informed consent
Healthy Living as You Age

Older persons who drink can be vulnerable to negative consequences of drinking. This trial aims to prevent harm from alcohol use in older adults through a program of screening and brief advice followed up with several health education phone calls.

Approximately 50% of persons aged 65 years and older drink alcohol. Older persons are particularly susceptible to adverse consequences of drinking such as falls, depression, sleep disorders, stomach upset, hypertension, and alcohol/drug interactions. This is because of age-related changes in the body that affect how older persons react to alcohol and also because of the age-associated increases in illness and medication use.

In the current project we aim to see if screening and brief advice given to older risky drinkers in a physician's office followed by up to 3 health education phone calls may reduce their risks associated with alcohol use. We plan to use a newly developed and tested measure, the Comorbidity Alcohol Risk Evaluation Tool (CARET), to screen for older persons (aged 55 and older) whose use of alcohol alone or in combination with their illnesses, symptoms, and medication use may be causing them harm, or increasing their risk for harm. Persons whose responses on the CARET indicate they might be risky drinkers will be randomized to receive either a brief intervention to reduce their risks or usual care.

The intervention will have the following components:

A) At the time of the recruitment visit, all intervention group patients will receive:

1. A personalized risk report;
2. An educational booklet titled "Healthy Drinking as You Age";
3. A drinking diary;
4. Brief advice to reduce their drinking by their physicians;

B) After the recruitment visit, all intervention group patients will receive up to 3 telephone calls from a health educator. After each call, intervention group patients may choose to receive a letter updating their health risks. Also, at the conclusion of their interaction with the health educator, they may choose to have a letter summarizing the calls sent to their physician.

At the time of the recruitment visit, control group patients will receive a booklet on a variety of healthy behaviors titled "Healthy Living as You Age." Both control and intervention group patients will receive a telephone call from a research associate 3 months and 12 months after initial enrollment in the study to administer the CARET again.

We will analyze our results to look for differences between the intervention and control groups at 12 months in the a) proportions of them identified as risky drinkers by the CARET; b) the amount they drink; c) the numbers of risks identifying those persons who are still risky drinkers and d) the difference in their expectations regarding aging.

Eligibility Criteria:
Inclusion Criteria:

* At least 55 years of age
* Seeing a participating physician (internists or family physicians employed at any of the participating sites)
* Have had at least one alcoholic drink in the last week

Exclusion Criteria:

* Too ill to participate
* Have received substance abuse services in past 3 months