cyrilzakka/clinical-trials huggingface dataset:
A Drug-drug Interaction Study Evaluating the Perpetrator Potential of LY4100511 (DC-853) on Midazolam, Repaglinide, Digoxin, Rosuvastatin in Healthy Participants

The main purpose of this study is to assess the safety and tolerability and pharmacokinetics of LY4100511 (DC-853) when administered alone or in the presence of cytochrome P450 substrates in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Females must be of childbearing potential
* Males must agree to use contraception
* Have body mass index (BMI) between 18.0 and 32.0 kilogram/square meter (kg/m²), inclusive, and a body weight of greater than or equal to 50 kg.
* In good health, as determined by no clinically significant findings from medical history, 12-lead ECG and vital signs measurements, and clincial laboratory evaluations (congentical nonhemolytic hyperbilirubinemia) at screening and check-in, and from the physical examination at check-in as assessed by the investigator.

Exclusion Criteria:

* Have a 12-lead ECG abnormality that, in the opinion of the investigator,

  * increases the risks associated with participating in the study
  * may confound ECG data analysis
  * a QTCF \>450 msec for males, or \>470 msec for females

    * short PR interval \<120 msec or PR interval \>220 msec
    * second or third degree atrioventricular block
    * intraventricular conduction delay with QRS \>120 msec
    * complete right bundle branch block
    * left bundle branch block, or
    * Wolff Parkinson-White syndrome.
* Have had current or recent acute infection
* Show evidence of active or latent tuberculosis (TB)
* Had any surgical procedures within 12 weeks prior to screening or any planned surgical procedure scheduled to occur during the study.
* Have a history or presence of multiple or severe allergies, or an anaphylactic reaction to prescription or non prescription drugs.
* Are immunocompromised
* Presence of active suicidal ideation or positive suicide behavior using baseline/screening version of the C-SSRS
The Association Between Blood Eosinophilsp in Thai COPD Patients: A Prospective Study

The association of blood eosinophil as a biomarker for eosinophilic Thai COPD patients, such as COPD exacerbation, hospital admission, lung functions and mortlity.

The prospective one year study in Thai COPD patients for the clinical outcomes of COPD compare between eosinophilic and non-eosinophilic which determine by blood eosinophil counts equal or more than 300 cells/microliters. The primary outcomes was COPD exacerbation, the secondary outcomes were lung function, dyspnea and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of COPD by GOLD criteria

Exclusion Criteria:

1. high blood eosinophil from known causes such as systemic corticosteroid use, malignancy, parasitic infection
2. Patients who had previous acute exacerbation within 30-day before study entry
3. Patients who had previous systemic corticosteroids used within 30-day before study entry
A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib

The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or intolerant of Imatinib and/or Sunitinib.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic or locally advanced or unresectable GIST who have intolerance of or disease progression following prior treatment with imatinib and/or sunitinib
* ECOG (Eastern Cooperative Oncology Group) performance status ≤2
* Must have measurable disease per RECIST (Response Evaluation Criteria in Solid Tumors)
* Recovery from toxicity from prior therapy to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 or to subject's baseline status
* Adequate organ and marrow function
* Sexually active subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months following discontinuation of study drugs.
* Female subjects of childbearing potential must have a negative pregnancy test at enrollment.

Exclusion Criteria:

* Therapy with imatinib or sunitinib within 14 days before the first dose of study drug
* Chemotherapy, immunotherapy, targeted therapy, chemoembolization, or any investigational drug for the treatment of GIST after the last dose of imatinib or sunitinib
* Anticoagulation with warfarin or coumarin-related compounds
* Radiation to ≥25% of bone marrow within 28 days of study entry
* Treatment with other investigational agents within 28 days of the first dose of XL820
* Known central nervous systems metastases
* Uncontrolled or intercurrent illness
* Pregnancy or breast-feeding
* Active bacterial or viral infection requiring systemic treatment
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease

The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.

While opioid analgesia is currently the mainstream for management of pain in the perioperative setting, it often leads to significant morbidity, including opioid tolerance and hyperalgesia. Looking at ways to decrease the need for opioids with the use of adjunct medications allows for the long-term goal of decreasing physiologic tolerance in children. This is especially relevant in the pediatric congenital heart population.

Dexmedetomidine is in a class of drugs known as alpha-2 agonists and is known to provide analgesia, attenuate opioid tolerance and inhibit the sympathetic stress response. While there are numerous published case studies of dexmedetomidine validating its effectiveness and safety, the pharmacologic and pharmacodynamic profile has not been established.

This study will examine the hemodynamics, pharmacokinetics, and pharmacogenomics of dexmedetomidine in patients with congenital heart disease. The dose-ranging effect of dexmedetomidine will also be investigated. The three groups being studied will be: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.

Comparison: Compare both invasive and noninvasive hemodynamic parameters at baseline sevoflurane and during maintenance dosing on dexmedetomidine. The pharmacokinetics of dexmedetomidine in the pediatric population following escalating loading doses and continuous infusion at timed intervals will be estimated. The efficacy of dexmedetomidine will be estimated by the amount of rescue doses of propofol that are given.

Eligibility Criteria:
Inclusion Criteria:

* age is birth to 18 years
* \> or = 6 kg.
* American Society of Anesthesiology (ASA) I, II, or III
* undergone prior cardiac transplant, Fontan or has a patent ductus arterious or atrial septal defect.
* scheduled for cardiac catheterization

Exclusion Criteria:

* subject or family history of malignant hyperthermia
* known hepatic disorder determined by history physical exam or laboratory tests
* pregnant or lactating female
* receiving inotropic agents or has a pacemaker
* weighs less than 6 kg.
The Effects of L-arginine Supplementation on Anaerobic Exercise Performance

The purpose of this study is to evaluate if acute ingestion of L-arginine will enhance anaerobic exercise performance in young, healthy, and recreationally active adults.

After being enrolled in the study you will be measured on a number of parameters including: body circumferences, body composition via bioelectrical impedance analysis (BIA), height, weight, resting blood pressure, and resting heart rate.

All participants will be asked to complete the same protocol for this study. The study design is a randomized, double-blind, placebo controlled, cross-over type of study. What this means is that each participant in the study will complete two exercise sessions after ingesting either a placebo (dextrose - a sugar molecule) or the active ingredient \[insert supplement\] plus dextrose. Neither you nor the research assistant testing you on the exercise sessions will know which ingredient you are ingesting before each exercise trial (i.e., the double-blind portion of the study). We will also randomize the order of which supplement plus placebo or placebo alone you will ingest so neither you nor the research assistant testing will know this either. The cross-over part of the study is that you will complete 2 testing sessions to assess some physical performance variables (grip strength, jump height and power, and anaerobic energy system power output) with one-week of a wash-out period between them. This will allow us to compare the placebo session to the active nutritional supplement plus placebo condition to evaluate if the supplements improve exercise performance acutely.

You will also be asked to fill in a 24-hour food and fluid log for the period before your initial exercise test. Then you will be asked to repeat this food and fluid intake when completing the second session. No caffeine, alcohol, or vigorous exercise will be allowed for the 24-hours prior to each trial.

Eligibility Criteria:
Inclusion Criteria:

* Recreationally physically active individuals will be recruited for the study. In this context it means all participants perform 1-hour of exercise per day over 3-days per week at a minimum for 1-month. All participants will be between the ages of 18-39 years of age.

Exclusion Criteria:

* Exclusion criteria for the study includes: 1) smokers; 2) unhealthy (have cardiovascular, metabolic, neurological, or psychological disease); 3) taking medication for any condition; 4) any known allergy to the supplements of interest (L-arginine or placebo \[dextrose\]).
Cognitive Impairment in Older Emergency Department Users and Associated Adverse Outcomes

This study examines the prevalence and incidence of older ER users with cognitive impairment (i.e., dementia and/or delirium) using the ER2 item temporal disorientation in older ED users who are participants of the ER2 cohort study database.

The Emergency Departments (EDs) in North America are under duress because of overcrowding, delays and diversions, which increase to epidemic proportions. The aging of Canadian's population amplifies the magnitude of this situation because older ED users are the fastest increasing group of ED users and they have complex and specific needs.

There are simple interventions with which providers must proceed in order to cure or prevent short-term ED adverse events. Delirium, motor deconditioning, polypharmacy-related adverse drug reactions, and inappropriate home support are the main conditions to target when taking care of older ED users. We previously demonstrated that acting on these conditions may significantly accelerate the discharge and significantly reduce the length of ED and hospital stay. Evidence-based medicine showed that simple and early interventions may prevent delirium (e.g., through hydration, avoiding restraint, mobilizing and satisfying basic needs, time and place reorientation) and motor deconditioning (e.g., through encouraging mobility, up to chair at mealtime during daytime hours, providing appropriate walking aid) in older patients. Medication reconciliation is also an efficient intervention to prevent adverse drug reactions. Furthermore, an early assessment of home support is a crucial step in adjusting services for an early and smooth discharge back home. Based on this evidence, we have modified the 6-item Emergency Room Evaluation and Recommendations (ER2) by adding an interventional component to the assessment portion of the tool. The interventional part depends on the assessment's results and is based on recommendations designed to encourage easy and basic interventions that prevent delirium, motor deconditioning, adverse drug interactions and inappropriate home support. These recommendations are based on answers to the ER2 items

Eligibility Criteria:
Inclusion Criteria:

- An unplanned ED visit and to be on a stretcher

Exclusion Criteria:

-
A Study to Compare the Relative Bioavailability of Brigatinib When Swallowed as a Solution Versus When Swallowed as a Tablet in Healthy Adults

The main aim of this study is to compare the amount of brigatinib in the blood of healthy adults after they have swallowed one dose either as a solution or as a tablet.

The drug being tested in this study is called brigatinib. Brigatinib is being tested to assess its relative bioavailability when administered as an oral solution versus as an immediate-release tablet in healthy participants.

The study will enroll approximately 12 participants. Participants will be randomly assigned to one of the treatment sequences:

* Sequence 1: Treatment A followed by Treatment B
* Sequence 2: Treatment B followed by Treatment A wherein Treatment A is a 90 mg oral solution dose and Treatment B is a 90 mg tablet dose.

There will be a washout period of at least 14 days between brigatinib administration in each study period. The follow-up contact will occur 14 (±2) days post the last dose of study drug.

This single-center trial will be conducted in the United States. The overall study duration is approximately 56 days.

Eligibility Criteria:
Inclusion Criteria:

1. Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study.
2. Body mass index (BMI) ≥18.0 and ˂32.0 kilograms per meters squared (kg/m\^2) at screening.
3. Pulse rate between 60 and 100 beats per minute (bpm) and a blood pressure between 90 to 140 millimeters of mercury (mmHg) systolic and 40 to 90 mmHg diastolic at screening and prior to dosing of Period 1.
4. Creatine phosphokinase is ≤1.1x upper limit of normal \[ULN\]; lipase, amylase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, glucose, and activated partial thromboplastin time (aPTT) are ≤ULN at screening and check-in of Period 1.

Exclusion Criteria:

1. Any history of major surgery.
2. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
3. Unable to refrain from or anticipates the use of any drug, including prescription and nonprescription medications, herbal remedies, or vitamin supplements within 28 days prior to the first dosing and throughout the study.
4. Positive results at screening for Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV).
5. Positive coronavirus disease 2019 (COVID-19) results at first check-in.
6. Donation of blood or significant blood loss within 56 days prior to the first dosing.
7. Plasma donation within 7 days prior to the first dosing.
Conventional Versus Automated Measurement of Blood Pressure in the Office (The CAMBO Study)

To determine if the use of automated office blood pressure readings can improve management of systolic hypertension in routine clinical practice. Automated office SBP recordings in routine clinical practice using the BpTRU device will reflect more accurately the mean awake ambulatory systolic BP than will manual BP readings taken with conventional mercury sphygmomanometry. This should lead to improvements in the management of systolic hypertension with optimization of drug therapy in practices using the BpTRU device.


Eligibility Criteria:
Inclusion Criteria:

* Both treated and untreated patients with systolic hypertension under routine FP care
* For untreated patients, routine office SBP as measured by the patient's FP at the last routine office visit using a mercury device must have SBP ≥ 160 mmHg and DBP \<= 95 mmHg
* For patients already receiving antihypertensive therapy, the last routine office BP as measured by the patient's FP using mercury sphygmomanometry must be SBP ≥ 140 mmHg and DBP \<= 90 mmHg

Exclusion Criteria:

* Presence of target organ damage such as MI, stroke, and serum creatinine twice normal
* Diabetes mellitus treated with insulin or oral hypoglycemic therapy
* Secondary hypertension
* Participation in another research study involving measurement of BP
* Patient's insistence on using self BP measurement outside of the study
* Any conditions or circumstances which might preclude the successful completion of the study
Breastfeeding Rates at the Department of Neonatology of University Hospital Cologne

The objective of this study is to measure the breastfeeding success for all preterm and term newborns in our department of neonatology during the hospital stay and at the age of six months.

A score was established which combines information on breastfeeding rate and breastmilk feeding rate, and used to monitor daily breastfeeding success.

Eligibility Criteria:
Inclusion Criteria:

* Inborn or referred to our Department of Neonatology in the first week of life
* Informed consent of both parents or legal guardian

Exclusion Criteria:

* No informed consent of parent or legal guardian.
SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)

Pancreatic robotic surgery (PRS) has moved from an almost testimonial procedure to a moment of expansion that is not yet clearly defined. In the pioneering centres, the results achieved are superior to those of open surgery. At present, it is not known how many centres perform CRP, what type of operations they perform, what percentage of the total number of pancreatic operations CRP represents and what results are obtained. The aim of our project is to establish a national multicentre registry of robotic pancreatic surgery that will allow us to answer all these questions.

Methodology: This is a one-year prospective multicentre registry involving all general and digestive surgery units in Spain that have a DaVinci robotic platform and wish to participate and perform robotic pancreatectomies.

All adult patients undergoing robotic pancreatectomy at participating Spanish centres who meet the inclusion criteria will be included. The registry will be open until 31 March 2026 to include post-operative morbidity and mortality at 90 days. The number of pancreatic surgeries performed in that centre during the same period will be counted to determine the percentage of robotic pancreatic surgery per centre. Intraoperative complications will be measured according to the Satava classification modified by Halls et al. Postoperative complications will be classified according to the Clavien-Dindo classification and the CCI (Comprehensive Complication Index). Pancreatic fistula, postoperative bleeding and delayed gastric emptying were classified according to the ISGPS classification and biliary fistula according to the ISGLS classification.


Eligibility Criteria:
Inclusion Criteria:

* robotic pancreatic resections
* Asa I-III
* Signed informed consent

Exclusion Criteria:

* Less than 18 years old.
* ASA IV
UTSW NORC Pilot Spinal Cord Injury Dietary Program

The goal of this observational study is to learn about the effects of a 9-week dietician-guided program modified from the National Diabetic Prevention Program (modified DPP-diet) in people with spinal cord injury on body composition and insulin sensitivity.

The main question it aims to answer is:

Does 9 week modified DPP-diet reduce body fat percentage and insulin resistance?

Participants will:

Have 9 weeks of Telehealth visit with dietician certified in providing DPP. Visit the laboratory before, immediately and 9 weeks after completion of the modified DPP-diet.

Share with the researcher on the perceived benefit and obstacles in implementing the modified DPP-diet as part of their daily activities.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years old
* have had SCI for more than one year
* not independently ambulatory
* primarily uses a wheelchair for mobility
* community-dwelling
* without comorbidities listed in the exclusion criteria

Exclusion Criteria:

* uncontrolled type 2 diabetes mellitus
* pregnancy
* active systemic disease, e.g., heart disease, real failure/insufficiency, multiple myeloma, lupus with nephropathy, sickle cell disease, symptomatic myasthenia gravis, poorly controlled hypo- or hyperthyroidism.
Urinary and Vaginal HPV Testing in Cervical Cancer Screening

Cervical cancer, caused by high-risk human papillomavirus (HPV) infection, poses a problem worldwide as it is the fourth most common female cancer. Fifty percent of all invasive cervical cancers occur among the 25% not attending cervical cancer screening. To reach these women, this project will contribute to the development of a novel and accurate urinary and vaginal screening tool, which allows women to collect the screening samples at home. This project tests the hypotheses: 1) urinary HPV testing is non-inferior to HPV testing on clinician-collected cervical samples for detection of high-grade cervical pre-cancer, 2) Vaginal HPV testing is non-inferior to HPV testing on clinician-collected cervical samples for detection of high-grade cervical pre-cancer and 3) DNA methylation testing is suitable as a colposcopy triage test among women with HPV-positive urine and/or vaginal samples to prevent unnecessary colposcopies and overtreatment of women without clinically meaningful HPV infections. If confirmed, urinary and vaginal HPV testing could revolutionize todays screening programs and keep Denmark at the forefront of cervical cancer prevention.

Paired urine, vaginal, and clinician-collected cervical samples will be obtained from approximately 330 women aged 23-64 years referred for colposcopy and cervical biopsies due to abnormal screening result or referred for cervical excision due to treatment of CIN2+. Upon informed consent, the women will collect a first-void urine sample and a vaginal self-sample. Before colposcopy or excision, a clinician will collect a cervical sample. Among women referred for colposcopy, four cervical punch biopsies will be taken. For women referred for excision, a cone biopsy will be taken using a loop electrosurgical excision procedure. Upon arrival in the laboratory, the paired urine, vaginal and cervical samples will be HPV tested using the Cobas 4800 HPV DNA assay. Histological results will served as reference and be grouped as ≤CIN1 (normal tissue, CIN1) versus CIN2+. The performance of the six individual methylation markers and combinations thereof will be evaluated using the histological results as reference.

The primary endpoint will be the relative sensitivity and specificity of HPV testing in first-void urine, vaginal self-sample versus clinician-collected cervical samples to detect CIN2+. Non-inferiority of HPV testing between sample types will be evaluated against a margin of 90% for sensitivity and 98% for specificity. The performance of each methylation marker will be illustrated by ROC curves and assessed by the area under the curve.

Eligibility Criteria:
Inclusion Criteria:

* Females
* Aged 23-64 years
* Referred for colposcopy and cervical biopsies or referred for cervical excision

Exclusion Criteria:

* younger than 23 years
* older than 64 years
* not provided informed conte