cyrilzakka/clinical-trials huggingface dataset:
Effect of SLC01B1 (rs2306283) Polymorphism on the Efficacy and Safety Profile of Atorvastatin in Pakistani Population

The goal of this prospective cohort study was to identify the effect of SLC01B1 gene polymorphism in the Pakistani population. The main questions it aims to answer are:

To identify polymorphism in SLOC1B1 (rs2306283) in the Pakistani population. To determine the association between SLOC1B1 (rs2306283) polymorphism and the clinical efficacy of atorvastatin To determine the association between SLOC1B1 (rs2306283) polymorphism and the safety profile of atorvastatin.

The goal of this prospective cohort study was to identify the effect of SLC01B1 gene polymorphism in the Pakistani population, due to the high prevalence of this variant in the Pakistani Population

The main questions it aims to answer are:

To identify polymorphism in SLOC1B1 (rs2306283) in the Pakistani population. To determine the association between SLOC1B1 (rs2306283) polymorphism and the clinical efficacy of atorvastatin To determine the association between SLOC1B1 (rs2306283) polymorphism and the safety profile of atorvastatin.

The participants' blood samples were taken and further genotyping was performed using conventional tetraARMS PCR. The results were visualized by gel electrophoresis.

Eligibility Criteria:
Inclusion Criteria:

1. Pakistani individuals aged between 30 to 60 years
2. Patients with deranged lipid profile
3. Newly diagnosed patients of dyslipidemia taking atorvastatin (Lipiget) 10mg/day
4. Normal hepatic and renal function

Exclusion Criteria:

1. Patient taking other lipid-lowering medications
2. Moderate and severe systemic diseases
3. Pregnancy
4. Patients taking medications and diet that can interact with atorvastatin
5. Hypothyroidism
6. Recent history of surgical procedure or trauma
A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR

A prospective, single blind, randomized, parallel controlled trial was conducted to evaluate the analgesic effect and safety of MR based "cognitive distraction focus relaxation therapy" in patients clinically diagnosed with chronic moderate to severe pain

Multi-center, prospective, single-blind, randomized and parallel controlled trials are used to evaluate the role and impact of "digital chronic pain treatment system equipment" based on MR mixed reality technology in the clinical basic treatment of patients clinically diagnosed with chronic pain.

Eligibility Criteria:
Inclusion Criteria:

1. 18-85 years old male and female;
2. Patients clinically diagnosed with chronic pain;
3. Chronic pain lasts for more than 3 months;
4. The average intensity of pain in the past month is 40mm and above (VAS);
5. Willing to abide by the relevant regulations of the experiment;

Exclusion Criteria:

1. Serious cognitive impairment;
2. Current or previous diagnosis of epilepsy, dementia, migraine or other neurological diseases may hinder the use of mixed reality or have adverse effects;
3. Symptoms of nausea or dizziness;
4. Sensitive to luminous screens;
5. No stereo vision or severe hearing impairment;
6. Eye, face or neck injuries, which hinder the comfortable use of glasses;
7. The evaluated patient GAD-7 questionnaire 10 points and above, PHQ-9 questionnaire 10 points or above;
8. Have used VR or MR and other related devices to treat pain;
9. Other clinical studies have been completed now or recently (the past 2 months);
10. Currently pregnant or planning to get pregnant during the study;
11. At present, or some immediate family members work in a digital health company or pharmaceutical company that provides acute and chronic pain treatment.
MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer

This is a prospective, multicenter, non-interventional, controlled clinical study. Evaluate MDT performance and benefit analysis in patients with advanced gastric or colorectal cancer after MDT discussion under real medical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Histopathological diagnosis of recurrent / metastatic gastric or colorectal cancer.
2. Participate in formal MDT discussions at the Research Center.
3. MDT decision-making at least two subjects involved in treatment.
4. Patient informed consent and signed written consent.

Exclusion Criteria:

1. Early or locally advanced gastric cancer or colorectal cancer.
2. Accept informal MDT discussions.
3. MDT decisions recommend only a single subject for treatment of patients.
4. MDT decisions recommend only palliative patients.
ADVANCE MPI 1: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)

Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.

ADVANCE MPI 1 is a multi-national, double-blind, randomized, active-controlled, parallel group clinical trial to evaluate the safety and efficacy of regadenoson in SPECT MPI compared to that of the approved pharmacological stress agent, Adenoscan. Patients referred for a clinically indicated pharmacological stress MPI study will be eligible for enrollment. The trial is designed:

* to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan, and
* to compare the safety and tolerability of the two stress agents.

Eligibility Criteria:
Inclusion Criteria:

* Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study

Exclusion Criteria:

* Any condition precluding the safe administration of Adenoscan for a SPECT myocardial perfusion imaging study
* Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control
A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials

The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family. The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers. The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment. The team can make referrals to other specialists. Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.

Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination.

Secondary Objective(s):

1. To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care.

Exploratory:

1. To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care.
2. To compare caregiver burden and quality of life between the study arms.

Eligibility Criteria:
Patient Inclusion Criteria:

* Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention.
* Patients are eligible to enroll on this study with or without the enrollment of their caregiver.

Patient Exclusion Criteria:

* Patients diagnosed with a hematologic malignancy.

Caregiver Inclusion Criteria:

* Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support.
* Caregivers must be willing to complete surveys at baseline and on monthly basis.

Caregiver Exclusion Criteria:

* Caregivers who are solely professional, paid caregivers
Impact of Age and Geriatric Co-morbidities on Lymphocyte Phenotype in Patients 70 Years of Age and Older

An individual's immune profile changes with age, and can sometimes be involved in the development of certain diseases such as infections or cancers, in a process called immunosenescence. Some data tend to show that there is a link between this immune profile and geriatric fragility (autonomy, difficulties with walking, memory, undernutrition, co-morbidities, depression). The aim of this study is to describe this profile, or immune phenotype, and to see if there is a link with the different aspects of geriatric assessment in patients without cancer or infection. In addition, these data will serve as a basis for comparison with the same analyses performed on breast cancer patients at the Centre Georges François Leclerc.


Eligibility Criteria:
Inclusion Criteria:

* Person who has not opposed to inclusion in the study
* Male or female aged 70 and over admitted to the Champmaillot Geriatric Center on an inpatient or outpatient basis.

Exclusion Criteria:

* Person not affiliated to national health insurance system
* Person subject to a measure of legal safeguard (curatorship, etc)
* Person with an acute infection
* Person with suspected cancer or active cancer
* Long-term immunosuppressive or corticosteroid therapy
* HIV and/or HBV and/or HCV positive serology
Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure

Our hypothesis is early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-HLA immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event).

Observation or Investigation Method Used :

The study is :

* multicenter
* prospective
* open
* randomized: patients are divided into two parallel groups:

  * study group: transplantectomy within six weeks after return to dialysis, antiproliferatives stop at the start of dialysis, Maintenance anticalcineurin-based-immunosuppression without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of anticalcineurin two weeks after transplantectomy. Corticosteroids: 5mg per day until one month after transplantectomy then stop within one month.
  * control group: No systematic transplantectomy. Antiproliferatives stop at the start of dialysis.Anticalcineurins half dose for 3 months, ¼ dose for 3 months and then stop. Corticosteroids:5 mg per day for 6 months, and then tapered and stop within 3 months.

In the case of transplantectomy for cause in the control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 Years.
* Patients affiliated to health protection system, social security in France or any similar regimen.
* Renal transplant patient with end-stage transplantation, regardless of the number of previous transplants.
* Patient receiving immunosuppressive protocol based on anticalcineurin or mTOR inhibitors
* Patient should have resume hemodialysis within 4 weeks
* Duration of transplantation more than one year
* Patient with asymptomatic graft
* immunogenic potential residual \>50% (calculated PIR during the re-dialysis)
* Patient not covered by any measure of legal protection.

Exclusion Criteria:

* Immunogenic potential residual \<50%
* Graft infection uncontrolled by treatment
* Active infectious pathology
* Inflammatory graft
* Uncontrolled arterial hypertention
* Inflammatory syndrome of undetermined origin with CRP\>50mg/l
* Fever of unknown origin for more than 8 days T\>38°C
* Contra-indication to surgery
* AVK treatment
* Patient candidate for a living donor within 12 months
* Monotherapy with calcineurin inhibitors or mTOR inhibitors
* Treatment directed against the humoral response in the 6 months preceding the recovery of dialysis (Rituximab IV-Ig or high doses)
* Presence of another transplant (pancreas, liver, heart, lung)
Cytological Diagnosis of Hepatic Angiosarcoma and Its Histopathologic Correlation

Cytological diagnosis of hepatic angiosarcoma by fine-needle aspiration (FNA) or imprint cytology is difficult due not only to its various cytomorphologic features but also clinical rarity. Vasoformative features, such as pseudo-acini, branching pseudo-capillary structure, and intracytoplasmic lumina, are clues to achieve the diagnosis. But these features are not always present. In order to find clues for cytological diagnosis of angiosarcoma, we collected cases of hepatic angiosarcoma to study their cytological features. And then compared these features with those in their histopathological biopsy or resection.

Hepatic angiosarcoma is a rare hepatic malignant tumor. Although diagnosis of hepatic angiosarcoma by FNA cytology has been reported since 1982, followed by several studies, its cytomorphologic features were still not well recognized by cytopathologists because of its clinical rarity and various morphologic features.

We reviewed literatures about cytomorphology of hepatic angiosarcoma by FNA. There are only 11 cases retrieved in 10 articles searched from Medline. The sex M/F ratio was 6/4 (one unknown); age range was 56 to 79 years old. In initial cytological evaluation, four cases got angiosarcoma or consistent/suspicious angiosarcoma diagnosis. Positive for malignancy, sarcoma, and poorly differentiated spindle cell lesion were in one case respectively. One was diagnosed as atypical cells. Remaining three were unavailable by their reports.

In cytological morphologic features, all but one met least 2 of 3 cytological cellular criteria of angiosarcoma cells: spindle cells, epithelioid cells, and pleomorphic cells. In cytological architectural features, 7 of 11 cases showed vasoformative structures; 5 of 11 cases showed intracytoplasmic lumen or erythrophagocytosis. Ten of 11 cases had histologic/pathologic confirmation as angiosarcoma. One case reported interrelation of tumor structures and their own accompanied liver tissue in cell blocks.

Eligibility Criteria:
Inclusion criteria:

Consecutive patients of hepatic angiosarcoma performed FNA and/or imprint cytological examinations in our hospital.

Exclusion criteria:

1. Patients without pathological confirmation.
2. Patients who are not angiosarcoma by pathological reviews.
Homecare Integral Support Program for IPF Patients

Homecare patient support program especially designed for covering IPF patient needs, implemented for 12 months, for improving quality of life

The proposed comprehensive IPF home care programme consists of: 1) improving patient's quality of life (autonomy, activity, emotional well-being and symptoms), 2) reducing the number and severity of side effects associated with the anti-fibrotic drug, 3) reducing the number of hospitalisations attributable to the disease, and 4) providing a rapid response to any problem associated with the disease (after diagnosis or progression) that may cause distress or require early action.

Eligibility Criteria:
Inclusion Criteria:

* IPF patients with FVC \> 50% and DLCO \> 30%, in whom pharmacological treatment with nintedanib was started at least one month before the start of the programme.

Exclusion Criteria:

* Hospitalised patients or those who have been hospitalised in the previous month, due to any kind of respiratory exacerbation or due to any other respiratory cause.
* Patients who are under home care controls (PADES) as this implies an advanced stage of the disease (forced vital capacity \[FVC\] less than 50% and the diffusion capacity of the lungs for carbon monoxide \[DLCO\] less than 30%) or, patients thathave a lack of autonomy due to comorbidities or respiratory failure
* Patients diagnosed in incipient phase who have neither symptoms nor limitation in their usual activities.
* Patients who have suffered any other life-threatening disease in the last 2 years, such as cancer or uncontrolled ischaemic heart disease.
* Inability to understand the information given to the patient, relating to the legal aspects of the informed consent.
Psoriatic Arthritis and Psoriasis Treatment Decision Aid

The purpose of this study is to create and test a patient decision aid that facilitates the shared decision-making process when patients with psoriasis and/or psoriatic arthritis are starting or switching to a new therapy.

Prior to the interventional study, we will develop a decision aid using design thinking. In this interventional study, we will implement and test a patient-centered decision aid for therapy selection among patients with psoriasis and/or psoriatic arthritis who are starting or switching to a new medication.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Diagnosis of psoriasis (as confirmed by dermatologist) or psoriatic arthritis (as confirmed by rheumatologist)
3. Treated at Penn

   In addition to the above, for the observation and implementation phases of the study:
4. Initiation of a new psoriasis or psoriatic arthritis treatment

   * Biosimilars that have been approved by the FDA and available on the US market will similarly be eligible for participation
   * Patients may be taking other traditional DMARDs.
   * A washout period is not required.

Exclusion Criteria:

1. Unable to give informed consent
2. Youth, under the age of 18 years
3. Patients without psoriasis or psoriatic arthritis
4. Not being treated at a Penn clinic

   In addition to the above, for the observation and implementation phases of the study:
5. Not starting or switching to a new medication
Evaluation of Information on Bowel Preparation for Morning Colonoscopy

Background: In randomized controlled trials, split-dose bowel preparation for colonoscopy has been shown to provide better bowel cleansing than day before bowel preparation. However, people who volunteer to be in clinical trials may be more adherent to a challenging bowel preparation regimen than people in the general community undergoing colonoscopy. This may be especially true for colonoscopies scheduled for the morning, when the later dose of the split-dose bowel preparation would be administered in the early morning hours. Hence the results of the available trials may not be applicable to patients undergoing morning colonoscopy in routine medical practices.

Aims: To compare the effectiveness of mandatory split-dose bowel preparation to optional split-dose bowel preparation protocols for morning colonoscopies in a non-inferiority pragmatic trial.

Anticipated results and significance: The study will produce a better understanding of the most effective approach to bowel preparation for early morning colonoscopies and suggest specific recommendations for colonoscopy practice.

Patient will be randomized by the central booking office. Patient experience survey will be administered prior to colonoscopy. Chart review will be done to obtain data from the medical records and endoscopy reports. Please see outcomes and planned analysis.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older
* Must have colonoscopy appointment with any 4 of the participating GI doctors at Health Sciences Centre-Winnipeg
* Must use 4 liter type of bowel preparation

Exclusion Criteria:

* Has colonoscopy appointment with non-participating GI doctor and/or a non-participating endoscopy hospital/clinic
* Patient and/or referral doctor requested a non-4 liter bowel preparation
Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy

Pancreatic cancer is one of the few cancers whose survival rate has not improved significantly due to high local recurrence and systemic metastasis despite advances in diagnosis and treatment over the past 40 years. And currently pancreatic cancer is the fifth leading cause of cancer-related death in Korea. For this reason, various anti-cancer therapies and radiotherapy have been tested to improve survival.

Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal tissue while maximizing radiation to tumor tissues due to the distinct physical properties of proton beam. Low toxicity have been reported. In addition, retrospective analysis of pancreatic cancer patients (n=37) who performed proton therapy (PBT) from June 2013 to July 2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months; Grade ≥ 3 Toxicity, 0%). In addition, gene polymorphisms of several genes (CD44, CD166, XAF1, MMP9, MUC1/4, SMAD7, SMAD4 (DPC), RRM1, ERCC1, HER2, etc.) in pancreatic cancer have been reported to be associated with recurrence and prognosis.

Pancreatic cancer is one of the few cancers whose survival rate has not improved significantly due to high local recurrence and systemic metastasis despite advances in diagnosis and treatment over the past 40 years. And currently pancreatic cancer is the fifth leading cause of cancer-related death in Korea. For this reason, various anti-cancer therapies and radiotherapy have been tested to improve survival.

Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising treatment for pancreatic cancer because it can reduce radiation dose from surrounding normal tissue while maximizing radiation to tumor tissues due to the distinct physical properties of proton beam. Low toxicity have been reported. In addition, retrospective analysis of pancreatic cancer patients (n=37) who performed proton therapy (PBT) from June 2013 to July 2016 showed promising therapeutic performance and less toxicity (survival rate, 19.3 months; Grade ≥ 3 Toxicity, 0%). In addition, gene polymorphisms of several genes (CD44, CD166, XAF1, MMP9, MUC1/4, SMAD7, SMAD4 (DPC), RRM1, ERCC1, HER2, etc.) in pancreatic cancer have been reported to be associated with recurrence and prognosis. Therefore, in this study, a prospective cohort of pancreatic cancer patients treated with proton beam therapy was established to analyze local control, survival, recurrence, toxicity, proton treatment plan information, gene expression information to analyze local control (LC), overall survival (OS), recurrence-free surival (RFS), and factors predicting treatment-related toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic cancer patients scheduled to be proton beam therapy
* Agreed to participate in this study

Exclusion Criteria:

-Disagreed to participate in this study