cyrilzakka/clinical-trials huggingface dataset:
Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM

This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems. More specifically, cytochrome DNA testing, which provides information with regards to participant specific metabolism of medications, will be used in the evaluation of participant medication regimens. The overall aim of the project is to evaluate if the addition of genetic CYP testing to a standardized MTM Program provides increased clinical value. To answer this question, the investigators will look at the drug therapy problems (DTPs) identified by the genetic test compared to those DTPs discovered without the test.

All study participants will receive a Comprehensive Medication Review (CMR). One third will have standard MTM conducted. Another third of the participants will be randomized to MTM plus drug interaction risk analysis via YouScript software. The remaining third will be randomized to MTM along with drug interaction risk analysis via YouScript software and genetic testing. The software will identify polypharmacy patients who may benefit from pharmacogenetic testing based on their current medication regimen. Results of the testing will be mailed to both the participant and their provider. Participants who undergo testing will also receive a follow-up phone call. All participants, including those who receive MTM alone, will receive a contact 3 months later to assess quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 or over and enrolled in a Medicare Part-D Prescription Drug Plan.
* Currently prescribed ≥6 chronic medications.
* Have ≥3 chronic disease states including osteoarthritis, rheumatoid arthritis, heart failure, diabetes, dyslipidemia, hypertension, asthma, chronic obstructive pulmonary disease, atrial fibrillation, and coronary artery disease.
* Participant incurred the Medicare-mandated dollar amount in medication-related costs in the previous quarter.

Exclusion Criteria:

* Inability to perform MTM encounter due to living situation (e.g. patient is enrolled in hospice, or is in long term care facility).
* Patient is unable to perform MTM encounter due to metal health barriers as described by Brief Interview for Mental Status (BIMS) score of \<13 points.
* Patient identifies themselves as being unable to perform the oral swab function of the genetic test.
* Patient had a known MTM session within the preceding 12 months.
Lifetech AcuMark™ Sizing Balloon Post-Market Clinical Follow-up Study

The objective of this PMCF study is to:

* confirm the safety and performance of the AcuMarkTM Sizing Balloon
* identify previously unknown side-effects
* monitor the identified side-effects (related to the procedure or to the medical devices)


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;
2. The anatomy of ASD is suitable for percutaneous closure;
3. Patients are scheduled to perform ASD closure;
4. Patients or legally authorized representative(s) who are willing and capable of providing informed consent.

Exclusion Criteria:

1. Any contraindication for ASD closure;
2. Patients have ostium primum ASD or coronary sinus ASD;
3. Patients who are pregnant or breastfeeding;
4. Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.
Study of the CD40 Agonistic Monoclonal Antibody APX005M

This study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M in adults with solid tumors. Study is intended to establish the maximum tolerated dose and the overall safety and tolerability of APX005M in 3 different administration schedules.

APX005M-001 is an open-label study and comprises a dose-escalation portion of approximately 8 dose level cohorts, plus an expansion cohort.

Eligible subjects with solid tumors will receive intravenous APX005M every 3 week, every 2 week or every 1 week until disease progression, unacceptable toxicity or death, whichever occurs first.

Study objectives include:

* Evaluate safety of APX005M
* Determine the maximum tolerated dose of APX005M
* Determine the pharmacokinetic parameters of APX005M: the maximal drug concentration (Cmax), area under the curve of serum concentration over time (Area Under the Curve/ AUC), and half-life (t½).
* Preliminary assessment of clinical response

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically documented diagnosis of solid tumor
* For subjects in the every 2 week and every 1 week dosing cohorts histologically or cytologically documented diagnosis of urothelial carcinoma, melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, or any solid tumor with high microsatellite instability status (MSI-high)
* No known effective therapy options are available
* Measurable disease by RECIST 1.1
* ECOG performance status of 0 or 1
* Adequate bone marrow, liver and kidney function
* No toxicities related to prior treatment related toxicities with the exception of alopecia and neuropathy
* Negative pregnancy test for women of child bearing potential

Key Exclusion Criteria:

* Any history of or current hematologic malignancy
* Major surgery or treatment with any other investigational agent within 4 weeks
* Uncontrolled diabetes or hypertension
* History of arterial thromboembolic event
* History of congestive heart failure, symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction
* Active known clinically serious infections
Mapping Diabetes in Quebec: Validating Medico-administrative Algorithms for Type 1 Diabetes, Type 2 Diabetes and LADA

The goal of this observational study is to validate medico-administrative algorithms that classify diabetes phenotypes (Type 1, Type 2, and Latent Autoimmune Diabetes in Adults - LADA) in a population-based cohort in Quebec, including children, adolescents, and young adults up to 40 years old with diagnosed diabetes. The main questions it aims to answer are:

Can these algorithms accurately distinguish between Type 1, Type 2, and LADA across different age groups? What is the prevalence and incidence of each diabetes phenotype in Quebec? Participants will have their medical and administrative data analyzed, including data on medication usage and healthcare visits, to validate the accuracy of the algorithms. The study will involve comparing these algorithm-based classifications with clinical diagnoses or self-reported data to ensure reliability.

The goal of this observational study is to validate the effectiveness of medico-administrative algorithms developed to classify diabetes phenotypes, specifically Type 1, Type 2, and Latent Autoimmune Diabetes in Adults (LADA), in a population-based cohort in Quebec. The study focuses on children, adolescents, and young adults up to 40 years old who have been diagnosed with diabetes.

The main questions it aims to answer are:

Can these algorithms accurately differentiate between Type 1, Type 2, and LADA across various age groups? What are the prevalence and incidence rates of these diabetes phenotypes in the Quebec population? Participants, who are already diagnosed with one of the three diabetes types and receiving standard medical care, will have their data collected from existing medical and administrative records. This data includes information on medication usage, healthcare visits, and self-reported health outcomes.

The study will involve a retrospective analysis where the classifications made by the algorithms will be compared with clinical diagnoses and self-reported data to determine the accuracy and reliability of the algorithms. This validation process is crucial for improving diabetes management and public health strategies by ensuring that these algorithms can be reliably used in broader epidemiological studies.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with Type 1, Type 2, or Latent Autoimmune Diabetes in Adults (LADA) based on clinical or self-reported data.
* Participants diagnosed between 1997 and 2024.
* Residents of Quebec with available medico-administrative records from 1997 to 2024.

Exclusion Criteria:

* Non-residents of Quebec during the study period.
An Italian Multicenter Retrospective Observational Study to Assess Effectiveness and Safety of Siltuximab for Patients with Castleman's Disease Treated in Italy in a Real-life Context

The study is a pilot, observational, retrospective, and (italian) multicenter study.

The study will involve the collection of patient data from medical records for patients with Multicentric Castelman Disease Relapsed/Refractory who received treatment with at least one dose of siltuximab, as part of standard of care in a real-life context, from July 2016 till April 2022 in 31selected italian centres.

The aim of the present study is to provide useful information about use, effectiveness, and safety profile of siltuximab given to relapsed or refractory (R/R) MCD in a real-life context since approval as more data are needed to improve knowledge in this rare disease. The observational, non-interventional nature of the study is based on the retrospective observation of current clinical practice without the application of any kind of ad hoc 'intervention' for the study itself. Infact, patients participating in the study will not be subjected to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for the study are those that are already commonly collected by the physicians in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of R/R MCD HIV and HHV-8 negative patients who underwent siltuximab in a real-life context from July 2016 till April 2022.
2. Age ≥ 18 yearsatenrollment
3. Signature of written informed consent (where applicable)

Exclusion Criteria:

1. R/R MCD patients who underwent siltuximab in a clinical trial context
Exercise Training Study for Patients With Cystic Fibrosis

The aim of this study is to test the effect of a 6-month program of self-regulated, home-based exercise with telephone reinforcement on the cardiorespiratory fitness, pulmonary function and health-related quality of life of children with cystic fibrosis (CF), compared to controls. Exploring the exercise experiences of the children and parents is a secondary aim.

CF is a life-long illness that requires complex and dynamic adjustment by the patient and family. The nursing role is vital to the multidisciplinary team approach required in providing comprehensive, individualized care for these patients. Nurses facilitate the coordination of health care efforts and support the patient and family across physical and psychosocial domains. With the well-documented correlation between exercise tolerance and both survival and HRQoL, exercise represents a critical treatment focus for CF patients. Nurses contribute to standard exercise rehabilitation programs, through education, psychosocial support, and communication. In this exercise training study, the nursing role will include: a) teaching the patients and families how to use the OMNI scale, b) confirming that they understand the home-based exercise regimen, and c) ensuring that the home-care program is properly followed by placing weekly telephone calls to assess progress and barriers. Long-term nursing application will occur via dissemination of the OMNI training manual, to be developed as part of this study, for use by CF nurses in clinics worldwide.

Eligibility Criteria:
Inclusion Criteria:

* CF diagnosis
* age 10-18 years
* reliable pulmonary function tests
* living at home
* able to read
* able to ride a stationary bike
* able to walk and/or run on a treadmill.

Exclusion Criteria:

* Enrolled in another intervention study
* in structured aerobic activity for 30 continuous minutes 3 times per week
* sibling enrolled in study.
MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Renal Transplant Patients

To determine the renal function, as expressed by the glomerular filtration rate at 12 months, in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine, tacrolimus, or sirolimus, and compare it to that of renal transplant recipients receiving standard immunosuppression with mycophenolate mofetil, normal dose cyclosporine and corticosteroids.

The purpose of the SYMPHONY study is to compare four different immunosuppressive regimens. They are each given for one year. The following four combinations are tested in four groups of patients:

* Group A: Cyclosporine in a normal dosage, mycophenolate mofetil (MMF) and corticosteroids
* Group B: Daclizumab in the first two months after transplantation, cyclosporine in a lower dosage compared to group A, mycophenolate mofetil (MMF) and corticosteroids
* Group C: Daclizumab in the first two months after transplantation, tacrolimus in low dosage, mycophenolate mofetil (MMF) and corticosteroids
* Group D: Daclizumab in the first two months after transplantation, sirolimus in a low dosage, mycophenolate mofetil (MMF) and corticosteroids.

All drugs of the four immunosuppressive regimes are approved by the Health Authorities in the participating country for use in kidney transplantation. The regimen administered to the patients in Group A represents a standard treatment, currently given with success to many transplant patients in a number of countries in the world. The treatments in Groups B, C and D are experimental in the sense that either the doses administered are lower than the ones used before and/or the combination of drugs is experimental. Nevertheless, there are results of scientific studies indicating that they are all effective alternatives and that they might have advantages compared to the standard immunosuppressive regimen, in particular as far as their safety (side effects, long-term toxicity) is concerned. However, from the previous clinical experience, it is not yet clear which regimen offers the most advantages for the patients. To find this out, in SYMPHONY the four regimens are administered to the four groups of patients (A-D) and the results in the different groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 18 - 75 years
* Recipients of single-organ renal primary allograft or second renal transplants (provided that the previous graft was not lost from acute rejection within the first year) from living or cadaver donors
* Patients who provide written informed consent.

Exclusion Criteria:

* PRA \> 20% within 6 months prior to enrollment
* Cold ischemia time \> 30 hours
* Previous treatment with daclizumab
* History of malignancy (except localized skin cancer)
* Active peptic ulcer disease.
Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer

This is an open-label, single-arm, exploratory study planned to include 40 patients with HRD-positive HR +/HER2- advanced breast cancer treated with Adebrelimab in combination with fluzoparib. To observe and evaluate the efficacy and safety of Adebrelimab combined with fluzoparib in the treatment of HRD-positive HR +/HER2-advanced breast cancer


Eligibility Criteria:
Inclusion Criteria:

1. Female breast cancer patients aged ≥ 18 years and ≤ 75 years;
2. Histopathologically confirmed advanced HR +/HER2-invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; ER positive: IHC ≥ 1%, PR positive: IHC ≥ 1%
3. ECOG score 0 \~ 2;
4. In the treatment stage of recurrence and metastasis, ≤ 1 line of chemotherapy is allowed, at least ≥ 1 standard endocrine therapy (including CDK4/6 inhibitor therapy) is allowed, and ≤ 1 antibody-conjugated drug (ADC) is allowed;
5. HRD positive confirmed, known germline and/or systemic BRCA mutation status and HRR pathway-related gene mutation status allow preferential enrollment;
6. Appropriate level of organ function
7. Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.

Exclusion Criteria:

1. Active or symptomatic brain metastases Systemic anticancer therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 14 days prior to enrollment
2. Patients previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1/PD-L1 inhibitors;
3. Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.4.Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism

5.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive HBV-DNA test (HBV-DNA test was performed only in patients with negative HBsAg test and positive HBcAb test); positive hepatitis C virus (HCV) antibody test followed by positive HCV-RNA test (HCV-RNA test was performed only in patients with positive HCV antibody test) 6.Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.
A Study to Look at Safety and Tolerability of NNC0582-0001, How it is Transported Throughout the Body and How it Works in Healthy Adults

This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single subcutaneous administrations of NNC0582-0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0582 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.


Eligibility Criteria:
Inclusion Criteria:

* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) from 20.0 to 30.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimoles per mole \[mmol/mol\]) at screening.
* Any of the below laboratory safety parameters at screening outside normal range, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters):
* Alanine aminotransferase (ALT)
* Aspartate aminotransferase (AST)
* Bilirubin
* Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73m\^2 (mL/min/1.73m\^2)
Transversus Abdominis Plane Catheter: a Study of Method

Major abdominal surgery is associated with postoperative pain. Transversus Abdominis Plane(TAP) block has been shown to reduce pain and opioid-requirements after abdominal surgery. However a single block has a short effect of up to 12 hours depending on the type local-anesthetics used.

With this study we wish to investigate the possibilities to place a TAP-catheter in order to prolong the the effect of the TAP-block by giving repeatedly bolus-injections in the TAP catheter and to study the pain and the opioid requirements of patients undergoing elective colon-resection when given a TAP-catheter preoperatively.

Our hypothesis is that it is practical and technical possible to place bilateral TAP-catheters pre-operatively and that pain and opioid-requirements will be low.

Postoperative pain is a major challenge in the work of anesthesia. Epidural catheter is the golden standard for postoperative pain management after major abdominal surgery. However a number of patient have absolute or relative contraindication to the placement of an epidural catheter. It is therefore necessary to find a good alternative to epidural catheter.

Transversus abdominis plane(TAP) block has been shown to provide analgesia of the abdominal wall and reduce opioid-requirements and pain after abdominal surgery.

However the effect of a TAP block is limited to the time of efficacy of the local analgesic used. Placing a TAP-catheter in order to prolong the effect of the TAP-block by repeatedly bolus-injections in the TAP-catheters has only been sporadically described and so far never investigated in a systematic way.

We will investigate the practical and technical possibility to place bilateral ultrasound-guided TAP-catheters pre-operatively on patients undergoing elective colon-resection. Further more we will evaluate the pain and opioid-requirement postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* elective open colon-resection
* adult
* written and informed consent

Exclusion Criteria:

* re-operation within the first 48 hours
* need for sedation and ventilator-support postoperatively
* accidental removal of catheter within the first 24 hours