cyrilzakka/clinical-trials huggingface dataset:
Copeptin: Disease Severity Indicator

Copeptin serves as a biomarker emanating from the pituitary gland, functioning as the precursor to arginine vasopressin (AVP). Its role in the regulation of endothelial dysfunction, inflammation, and water-electrolyte balance has been established. The measurement of AVP levels poses challenges due to its brief half-life and the intricate nature of its detection method. In contrast, copeptin provides an indirect means of gauging circulating AVP levels, as it can be conveniently assessed through a sandwich immunoassay. As a neuroendocrine stress hormone, copeptin emerges as a prognostic indicator, reflective of an individual's stress burden. Moreover, its applicability extends to various acute conditions such as ischemic stroke or myocardial infarction. Notably, copeptin proves to be a dependable tool in the differential diagnosis of diverse ailments characterized by polyuria and polydipsia.

Lower respiratory tract infection (LRTI) stands as the predominant cause of morbidity and mortality among children and adolescents globally. Notably, copeptin has demonstrated utility in forecasting the severity and complications associated with severe pneumonia in adults. While early investigations into copeptin's role in pediatric LRTI suggest its potential for diagnosing pneumonia and predicting complications, the outcomes of these studies present conflicting results.

Although there has been a notable increase in studies on copeptin in pediatric patients over the past decade, research specifically exploring its correlation with pneumonia remains scarce. This prospective case-control study is designed to investigate the potential association between copeptin levels and the severity of illness in pediatric patients with pneumonia. The study aims to determine whether copeptin levels can serve as a reliable predictor of disease severity in pneumonia, offering valuable insights for clinical application. The outcomes of this research may contribute significantly to our comprehension of copeptin's role in disease prognosis and management, thereby facilitating the development of more efficacious diagnostic and therapeutic approaches. Additionally, the study seeks to identify the factors influencing copeptin levels and establish a cut-off value for copeptin in pediatric patients diagnosed with pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with pneumonia,
* The family must have given informed consent for the study.

Exclusion Criteria:

* Individuals with underlying lung conditions (such as cystic fibrosis, bronchopulmonary dysplasia, asthma, bronchiectasis, tuberculosis),
* Individuals with underlying chronic illnesses (inclusive of heart, kidney, liver, gastrointestinal, and endocrine disorders),
* Individuals with obesity or malnutrition,
* Individuals with hyponatremia detected in their tests,
* Individuals with signs of dehydration,
* Individuals with a history of hospitalization within the last 72 hours.
A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer

This clinical trial compares the use of a shared decision-making communication tool during a clinical encounter to standard care for improving the quality of the shared decision-making process among patients with non-small cell lung cancer. Lung cancer patients are faced with many decisions about their treatment options. Studies have found that patients are most satisfied if they perceive an effort by their physician to share decision making and are afforded sufficient time to make their decision. Shared decision-making tools can help physicians guide the conversation, offer tailored estimates of the potential benefits, harms, and practical inconveniences of the available options, and support deliberations that take into account patient biological and biographical circumstances, goals, and priorities. Incorporating a shared decision-making communication tool into standard clinical encounters may improve the shared-decision making process as well as patient satisfaction with their treatment choice.

PRIMARY OBJECTIVES:

I. Encounters where standard of care and the non-small cell lung cancer (NSCLC) choice conversation aid were utilized will have an improvement in the quality of the shared decision-making process over encounters with standard of care alone.

II. Patients with encounters where the NSCLC choice conversation aid was used along with standard of care will have decreased decisional conflict in regard to treatment choice compared to standard of care alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients attend a standard of care visit with their clinician on study.

ARM II: Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.

After completion of study intervention, patients are followed up at 2 and 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* CLINICIANS:
* All clinicians within identified departments participating are eligible (doctor of medicine \[MD\]/doctor of osteopathy \[DO\], fellows/residents, physician assistant \[PA\]/nurse practitioner \[NP\])
* PATIENTS:
* Adult patients (\>= 18 years of age)
* Appointments at Mayo Clinic in Rochester
* Non-small cell lung cancer (NSCLC) stage \> 1B
* Eligible by their oncologist for adjuvant treatment

Exclusion Criteria:

* Exclude patient with major barriers to provide written informed consent or to participate in shared decision-making (i.e., dementia, severe hearing or visual impairment)
The Serotonergic Transmitter System in Dementia and Affective Disorders

The aim of this project is to examine the serotonergic transmitter system using functional imaging of the brain (positron emission tomography \[PET\]) to gain knowledge about early pathophysiological changes in Alzheimer's dementia and mood disorders.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe Alzheimer's disease
* Individuals genetically predisposed to affective disorder
* Healthy gender and age matched controls

Exclusion Criteria:

* Contraindications to magnetic resonance imaging (MRI)
* Use of psychoactive drugs
* Past or present affective disorder
* Other systemic diseases that may affect brain function
LDE225 for Patients With PTCH1 or SMO Mutated Tumors

The purpose of this signal seeking study is to determine whether treatment with LDE225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study


Eligibility Criteria:
Inclusion Criteria:

* Patient has confirmed diagnosis of a select solid tumor (except medulloblastoma, basal cell carcinoma and pancreatic adenocarcinoma) or hematological malignancy (except CML, ALL and AML).
* Patient has pre-identified tumor with a PTCH1 or SMO mutation.
* Patient has received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
* Patient has progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

* Patients has received prior treatment with LDE225.
* Patients has neuromuscular disorders associated with elevated CK (i.e. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis
* Patients has primary CNS tumor or CNS tumor involvement
* Patient has received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting study drug
Rapid Strep Test Results

This is a prospective study seeks to determine how often a rapid antigens test for group A streptococcus is positive in healthy adults

The Unites States recommends the use of rapid antigen tests, but a number of other countries do not, citing a high prevalence of streptococcal carriers and only moderate sensitivity of rapid antigen tests \[1\]. Indeed, to fully understand when rapid antigen tests should be used, we need to know the streptococcal carrier rate for adults in the United States. Although there is a fair amount of data in this regard for children \[2,3\], the only study to report this value for adults was from over 20 years ago and was from Sweden \[4\]. That studied reported a Group A Streptococcus (GAS) carrier rate of 2.4-3.7% in healthy adults.

Given how many patients seek medical care for sore throats that may potentially be streptococcal pharyngitis, the investigators believe more data about the GAS carrier rate and the rate of false positive rapid antigen tests is necessary. Thus, the investigators propose a prospective study to evaluate the rate of positive rapid antigen tests in healthy adult patients in our community.

The investigators will perform rapid antigen tests for GAS on healthy adult subjects without any symptoms. Consenting patients will fill out a brief data collection form about their medical history, and an investigator will perform a rapid antigen throat swab to assess for GAS. The results of the rapid antigen test will be recorded, and a logistic regression analysis will be performed to determine if certain factors within the subject's medical history are predictive of positive rapid strep tests.

Eligibility Criteria:
Inclusion Criteria:

* Any person at least 18 years old

Exclusion Criteria:

* pregnant
* prisoners
* currently taking antibiotics
* any acute symptoms
Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia

The purpose of this study was to assess the safety, effectiveness and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia.

We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing.

Eligibility Criteria:
Inclusion Criteria:

* Must be aged 18 to 49 years;
* Must be HIV-uninfected per same-day routine voluntary testing at the clinic;
* Must be uncircumcised (on examination);
* Must be in good general health, at the discretion of the clinician;
* Must be free of genital ulcerations or other visible signs of STI (on examination);
* Must be able to understand study procedures, and agree to abide by them including the follow-up visit schedule;
* Must freely consent to participate in the study and sign a written informed consent form;
* Must provide full contact information including cell phone number, address, and other locator information.

Exclusion Criteria:

* Has an active genital infection upon visual inspection;
* Has an anatomic abnormality (e.g. phimosis or hypospadias) that contraindicates ShangRing MMC;
* Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid; or
* Has a self-reported medical condition that would be a contraindication for elective surgery, e.g. hemophilia, extreme obesity, poorly controlled diabetes, sickle cell anemia
* Has a self-reported allergy or sensitivity to lidocaine or other local
* Is not available to be circumcised on the same day as screening.
The Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Tension-Type Headache

The purpose of this study is to compare the effectiveness of manual acupuncture between 2 types of points in decreasing tension-type headache symptoms of healthcare workers in Dr.Cipto Mangunkusumo hospital

The purpose of this study is to compare the effectiveness of manual acupuncture therapy between auricular points and body points in improving tension-type headache symptoms based on a headache diary which is consisting of intensity and frequency of headache days, a short form-36 questionnaire, and an examination of the press pressure threshold on eight pericranial muscles. If the use of auricular points is proven to be superior, then this method will benefit the patient more because it is more efficient and can be used as a protocol for providing therapy to patients with tension-type headache.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers who work in Dr. Cipto Mangunkusumo hospital
* Age 18-60 years
* Has an episodic or chronic TTH classification and is in accordance with the diagnostic criteria in the International Classification of Headache Disorders 3rd edition beta version (ICHD-3beta)
* Headache with VAS score of 10-70 mm
* Willing to participate in research and sign an informed consent
* Willing to follow the research process to completion.

Exclusion Criteria:

* Migraine headaches or secondary headaches
* Long-term (\>10 days per month) uninterrupted use of NSAIDs and other analgesia drugs 24 hours before starting acupuncture therapy
* Has contraindications to acupuncture, namely: medical emergencies, pregnancy, history of bleeding disorders (including the use of anticoagulant drugs) obtained from anamnesis history, tumor, or infection at the acupuncture site.
* Ear deformities and earlobe infections
* Fever 38°C
* Have had acupuncture therapy in the last 7 days.
Self Management Programme on the Sustained Attention and Sleep Quality of the Nurses

The aim of this study is to examine the effect of the nurse-supported self-management program on the sustained attention and sleep quality of night shift nurses. The self-management program consists of training and incentives for night shift nurses to gain healthy eating habits and improve their sleep health.


Eligibility Criteria:
Inclusion Criteria:

* Nurses working in shifts
* Those between the ages of 18-65
* Those who agree to participate in the study.

Exclusion Criteria:

* Pregnant and having suspicion of pregnancy
* Having vision and hearing problems
* Having diagnosed sleep disorder
* Having a chronic disease that will prevent participation in the study
* Having a diagnosed mental health problem
Safety Study of Cenderitide in Stable Chronic Heart Failure

Planned enrollment is approximately twelve subjects with stable chronic heart failure. Enrolled subjects will receive up to eight sequential days of continuous, stepwise, dose increasing, subcutaneous (SQ) infusions of open-label cenderitide via the Insulet Drug Delivery System. Planned infusion rates of cenderitide will be administered to subjects continuously during four, 48-hour infusion periods.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, ≥ 18 years of age
* Body Mass Index (BMI) of 18-40 kg/m2, inclusive
* Current or historical New York Heart Association (NYHA) functional class ≥ II
* At least one of the following: documented systolic heart failure with an ejection fraction (EF) ≤ 40% and/or a historical measurement of plasma BNP ≥ 150 pg/mL (or NT-proBNP ≥ 600 pg/mL)
* Systolic blood pressure 100-160 mmHg
* Stable and compliant treatment with oral heart failure medications for at least 4 weeks prior to Screening

Key Exclusion Criteria:

* Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
* Current clinical diagnosis of acute decompensated heart failure (ADHF)
* Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to Screening.
* Symptomatic postural hypotension
* Evidence of uncorrected volume or sodium ≤ 130 mmol/L or other condition that would predispose the patient to adverse events
* Clinically significant aortic or mitral valve stenosis
* Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
* Severe renal failure defined as creatinine clearance \< 45 mL/min as estimated by either the Cockcroft-Gault or the MDRD equations
* Significant pulmonary disease (e.g., history of oral daily steroid dependency, history of Carbon Dioxide (CO2) retention or need for intubation for acute exacerbation, or currently receiving IV steroids)
* Known hepatic impairment as indicated by any of the following: A) total bilirubin \> 3 mg/dL; B) albumin \< 2.8 mg/dL, with other signs or symptoms of hepatic dysfunction; C) increased ammonia levels, if performed, with other signs or symptoms of hepatic dysfunction
An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

This is a Phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' individual virologic response, and a follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and participants will continue on standard therapy only. Participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir (750 milligram \[mg\] every 8 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated interferon \[Peg-IFN\]-alfa-2a and ribavirin \[RBV\] or Peg-IFN-alfa-2b and RBV at the standard doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response, viral breakthrough, partial response, early viral kinetics and sustained viral response. Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety will be monitored throughout the study duration.

Eligibility Criteria:
Inclusion Criteria:

* Chronic genotype 1 Hepatitis (inflammation of the liver) C infection
* Never been treated for Hepatitis C Viral (HCV) infection
* No clinically significant lab abnormalities
* Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry
* Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

Exclusion Criteria:

* Contra-indications for starting anti-HCV therapy
* History or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease
* Any evidence of significant liver disease in addition to Hepatitis C
* Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B
* Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding
Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device

Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.

The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up


Eligibility Criteria:
INCLUSION CRITERIA

For all participants :

* Age greater than or equal to 18 years

For participants with metastatic breast cancer:

- Patient observed with metastatic breast cancer from the outset or metastatic fall from previously treated breast cancer with change of therapeutic line at the time of inclusion.

For participants with non-metastatic invasive breast cancer:

- Patient observed with non-metastatic infiltrative breast cancer who had not received any treatment at the time of inclusion (naïve to any treatment)

For healthy volunteers:

* Participant free of any cancer at the time of inclusion, confirmed using a mammogram whose results must be satisfactory, done at the latest one year before inclusion
* Participant with no history of cancer

EXCLUSION CRITERIA

For all participants:

* Age less than 18 years old
* Refusal to participate or withdrawal of consent
* Pregnant and/or breastfeeding women
* Discovery of a cancerous pathology (other than breast cancer for patients) during participant follow-up.

For participants with breast cancer:

- Absence of CTC during screening

For healthy volunteers:

* History of cancer
* Detection of CTC (positive profile) during screening
The eMESH 1 Feasibility Study

Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.


Eligibility Criteria:
Inclusion Criteria:

* Randomized Cohort: Requires CABG surgery with a SVG to the right coronary artery (RCA) system AND the left circumflex artery (LCX) system with a ≥ 70% stenosis in each of the two systems.
* Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCX system with a \> 70% stenosis in the system.
* Medial sternotomy with cardiopulmonary bypass (CPB) during surgery.
* Both saphenous vein graft length are adequate for planned intervention, vein outer diameter is between 3.6 mm and 7.0 mm and double wall thickness less than 1.4 mm.
* Agreement to post-procedure follow-up contact and testing (including follow-up coronary angiogram).

Exclusion Criteria:

* Concomitant non-CABG cardiac procedure.
* Prior cardiac surgery (does not include percutaneous procedures).
* Cerebrovascular or transient ischemia attack within 30 days of the CABG procedure.
* Age \> 85 years.
* Left ventricular ejection fraction ≤ 35%.
* Creatinine \> 133 μmol/L (1.5 mg/dL) prior to CABG procedure or on chronic dialysis.
* STEMI within 7 days or total CK \> 2 times the upper limit of normal prior to the CABG procedure.
* Both enrolled grafts will feed non-viable myocardial territory.
* Diffuse atherosclerotic disease (\> 70%) distal to either of the enrolled target coronary arteries.
* Randomized Cohort: By visual estimate, the target coronary artery diameter of both the right coronary system and left circumflex system must be within 1.5mm of each other.
* Planned endarterectomy of the target coronary artery.