cyrilzakka/clinical-trials huggingface dataset:
Alzheimer's Caregiver Communication Study

The point of this research is to improve the communicative relationship between the caregiver and care receiver. It is input from the caregiver on these communicative behaviors that will inform the process of understanding how to reduce the caregiver burden that comes from this communicative relationship.

This research study is developing a new checklist to measure communicative coping behaviors of persons with Alzheimer's Disease in the home environment. The Communicative Coping Behavior Checklist (CCBC) is an observation checklist to be completed by the caregiver or knowledgeable informant. The current version includes 23 behaviors to be rated for frequency and effectiveness. The behaviors that will be observed cover management of memory loss within three broad categories: humor, explanations, and general coping behaviors.

Two kinds of couples will participate in this study. One includes a person with Alzheimer's Disease and their caregiver. The second includes a cognitively intact participant and study partner, both over the age of 60, to serve as controls.

Study Visit 1 (3 hours long) During the first visit, the person with Alzheimer's Disease/control participant can expect to be asked questions about their memory, thinking and concentration, demographics, quality of life, and mood. The caregiver/study partner will be asked about their quality of life, mood, and daily activities.

At the end of the visit the caregiver/study partner will be given a copy of the CCBC and asked to take it home. S/he will be instructed to rate the person with Alzheimer's Disease/ control participant's communicative coping behavior over the course of the next two weeks. At the end of that time, a research assistant will call the caregiver/study partner and administer the CCBC over the telephone.

Study Visit 2 (3 hours long) The second visit will occur in the clinic approximately 12 months from the date of the first visit. As with the first study visit, again both the person with Alzheimer's Disease/control participant and the caregiver/study partner will answer questions about their memory, quality of life, mood, and daily activities. Once again, the caregiver/study partner will be given a copy of the CCBC and asked to take it home and complete.

Both visits will take about three hours for the caregiver/study partner and about two hours for the person with dementia or control subject.

Eligibility Criteria:
\*Note\* Currently enrolling participants for control group only

Inclusion Criteria:

* Couples including spouse or family member who spend at least 2-3 hours per day together
* Both must be cognitively intact

Exclusion Criteria:

* Cognitive impairment
Red Light Childhood Myopia Proof-of-concept

In this project the research team will begin to find out whether shining a red LED light at the eyes can slow down the worsening of short-sightedness in children.

This is important, because short-sightedness now starts at a younger age and worsens faster than in the past. Many people are at risk of permanently losing their eyesight in middle-age because of short-sightedness.

The researchers plan to use red LED light, which is safe to use. Red-light treatment improves the blood flow at the back of the eye, in a layer called "choroid", which can be measured on eye-scans. The team have done a study with healthy adults, which showed that red-light is safe and gently improves the blood flow at the back of the eye. In adults, this has no effect on myopia, because their eyes are fully grown. In children, red-light may slow down myopia, and in this project, the researchers want to find out which level of red-light is needed to have this effect. The researchers will ask 24 children age 5-12 years to use red-light for three minutes twice a day for three months. Three will be 4 groups of children, and each group will use a different level of brightness. The researchers will measure the eye length and the thickness of the choroid at the start and 1 and 3 months later and compare the change in eye length between the different groups.

In practice, children will need to use the treatment for several years. The researchers will use the results of this study to prepare a longer study with more children.


Eligibility Criteria:
Inclusion Criteria:

* short-sightedness between -1.00D and -6.00 diopters in both eyes
* best-corrected visual acuity 0.1 logMAR or better in both eyes

Exclusion Criteria:

* underlying condition/syndrome causing myopia
* previous or current myopia-modifying treatment
* abnormal ocular refractive anatomy or previous intraocular or ocular surgery
Dexmedetomidine or Lidocaine for Lessening the Hemodynamic Responses to Laryngoscopy and Intubation

Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

Hemodynamic responses to laryngoscopy and intubation are a significant concern for the anesthesiologist. Laryngoscopy, tracheal intubation, surgical stimulation, and extubation unleash remarkable sympathetic activity and are associated with transient but significant hemodynamic changes. These hemodynamic derangements can be lethal in patients with multiple comorbidities. The need to blunt these noxious responses effectively has led to using several techniques and pharmacological agents, local anesthetics, beta-adrenergic-blockers, calcium channel antagonists, and opioids with varied success. This study aims to evaluate the effect of nebulized and intravenous either dexmedetomidine or lidocaine for attenuating the hemodynamic responses to laryngoscopy and intubation.

Eligibility Criteria:
Inclusion Criteria:

* The American Society of Anesthesiologists (ASA) physical status I \& II. BMI: ((≤ 35 kg/m2)). The patients are to be scheduled to undergo elective surgery under general anesthesia.

Mallampati grade I, II

Exclusion Criteria:

* Uncooperative patient. History of allergy to study drugs. Hemodynamically unstable patient. Renal or hepatic dysfunction or hypertensive patients.
Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer

The purpose of this study is to test a new treatment of pancreatic cancer that cannot be removed by surgery. This treatment is a Phase I dose escalation research study which will combine one drug at increasing doses with a fixed dose of a second drug and radiation therapy. The drug that will be used at increasing doses is gemcitabine whereas 5-fluorouracil will remain the same for all patients.

* Ultimately we plan to find the maximum tolerated dose of the combination of gemcitabine, 5-fluorouracil and radiation therapy. We also hope to assess the number of people who respond to this therapy and to assess the feasibility of giving intraoperative radiation therapy following gemcitabine, 5-fluorouracil, and external beam radiation therapy.
* A surgical procedure, either laparotomy or laparoscopy, will be required to check the amount of disease before treatment is started.
* All patients will receive the same two chemotherapy drugs and radiation therapy. Both gemcitabine and 5-fluorouracil will begin on the first week of radiation therapy. 5-fluorouracil will be given continuously by intravenous infusion and will continue until the external beam radiation therapy is completed. The gemcitabine will be given (at different doses for each cohort of patients) once per week for seven weeks. Radiation therapy will be given daily for five days for seven weeks. On those days when gemcitabine is given, radiation therapy will be given approximately four hours after the gemcitabine dose.
* Four weeks after completing the radiation therapy and chemotherapy, patients will undergo a scan to check the extent of disease. Following the scan, patients will be considered for a repeat surgical procedure to remove the tumor, if possible. If removal of the tumor is not possible, patients will receive intraoperative radiation therapy.
* After completing the therapy, patients will be seen at least every 3 months for one year. A complete physical exam and CT scan will be done regularly.

Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of locally unresectable pancreatic adenocarcinoma. Patients with either measurable of evaluable disease are eligible.
* Unresectable, non-metastatic tumors. Unresectable patients include those with local extension of the tumor into adjacent structures and/or nodal metastasis.
* Total bilirubin \< 2.0 mg/dl
* AST \< 3x ULN
* Serum creatinine \< 2.0 mg/dl
* WBC \> 3,000/mm3
* Platelets \> 100,000/mm3
* ECOG performance status \< or = to 2
* Life expectancy of greater than 12 weeks

Exclusion Criteria:

* Evidence of peritoneal seeding by malignancy
* Prior radiation therapy or chemotherapy for pancreatic cancer
* Myocardial infarction in the past 6 months
* Major surgery in past two weeks
* Uncontrolled serious medical or psychiatric illness
* Pregnant or lactating women
* Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Pediatric Nursing Students' Self-efficacy Regarding Pediatric Medication Administration and, Clinical Comfort and Worry: A Study on a Two-group Pre-post-test Design Comparing Nurse and Peer Mentoring

Children are a particularly vulnerable population to medication mistakes, and it is critical to improve the self-efficacy, clinical comfort, and worry levels of student nurses who will care with them. As a result, the purpose of this study was to investigate the effects of postgraduate nursing students' and clinical nurses' mentoring practice on pediatric nursing students' self-efficacy in pediatric medication administration, clinical comfort, and worry levels. The nurse mentoring group finished the study with 70 students, while the peer mentoring group (postgraduate nursing students) completed the study with 73 students, for a total of 143 students. For data collection, the "Participant Information Form," the "Medication Administration Self-Efficacy Scale in Children for Nursing Students," and the "Pediatric Nursing Students Clinical Comfort and Worry Tool" were utilized. The data is still being analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Third-year student at Department of Nursing
* Taking a Child Health and Disease Nursing course
* Successful completion of the Pharmacology course in the first year (2nd semester)
* Participating in research as a volunteer

Exclusion Criteria:

- Failure in the pharmacology course
Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders

Researchers are trying to learn more about how individuals break down and process specific medications based on their genes. Pharmacogenomics (PGx) is a new, specialized field within individualized medicine. PGx is the study of how genes may affect the body's response to, and interaction with, some prescription medications. Genes carry information that determines things such as eye color and blood type. Genes can also influence how individuals process and respond to medications. Depending on genetic make-up, some medications may work faster or slower or produce fewer side effects.


Eligibility Criteria:
Inclusion Criteria

* Rome IV criteria for functional nausea and vomiting disorders (chronic nausea vomiting syndrome, cyclic vomiting syndrome), abdominal bloating/distention, dyspepsia, irritable bowel syndrome, chronic abdominal pain, functional diarrhea, or chronic constipation.
* On 1 or more medications identified in Appendix 1 on a daily basis for at least six months.
* Symptoms of moderate or severe severity on either of these 2 instruments: For IBS-SSS, use moderate (175-300) or severe (\> 300) IBS. For FD - Score ≥ 3 for any symptom on Nepean Dyspepsia Index.
* No prior pharmacogenomics assessment.
* Willingness to adjust medications based upon results of PGX testing.
* Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.
* Patients must have the ability to complete questionnaires by themselves or with assistance.

Exclusion Criteria:

* Patients who decline to be evaluated by a mental health professional during their evaluation.
* Rumination syndrome, cannabinoid hyperemesis syndrome, patients with a significant GI disease process (e.g., intestinal pseudo-obstruction, severe gastroparesis, megacolon) which, in the opinion of the investigator, is likely irreversible.
* Patients who, in the opinion of the investigator, are likely to undergo another major therapeutic intervention during the next 6 months (e.g., surgery or pelvic floor retraining by biofeedback therapy). However, other changes (e.g., medications) will not preclude participation in the study.
* Patients with any of the following per history, and review of medical record prior to study entry: any psychotic disorders, bipolar disorders, or major cognitive disorders; any active substance use disorders, other than tobacco; currently active suicidal ideation; current treatment with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS); discharge from a psychiatric inpatient hospital or intensive psychiatric outpatient program within 6 weeks prior to GI consultation.
* Patients who are unwilling or cannot, for any reason, adjust their medications.
PET/MRI Evaluation of Cardiac Amyloid

Cardiac amyloidosis is a disorder characterized by the deposition of abnormal proteins called amyloid in the heart tissue. This makes it difficult for the heart to function properly. The investigators wish to evaluate if the radiopharmaceutical 18F-Florbetaben (Neuraceq®) that targets beta amyloid can also identify cardiac amyloid deposition.

The use of hybrid positron emission tomography/ magnetic resonance imaging (PET/MRI) scanners in clinical practice enhance the ability to evaluate the heart from both an anatomical and functional perspective. It is hypothesized that an increased PET signal of 18F-Florbetaben (Neuraceq®) will be detected in cardiac amyloid deposits within the heart tissue, while the MRI provides the anatomical information. The ability to reliably and non-invasively image amyloid deposition in the heart would be potentially advantageous in the following scenarios:

1. Diagnosis of cardiac amyloidosis
2. Decreasing unnecessary invasive myocardial procedures.

The investigators believe this trial will help expand the use of current PET amyloid tracers and help many patients who currently undergo myocardial biopsy for the diagnosis of cardiac amyloid.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old at the time of the scan
* Patient with known or suspected cardiac amyloidosis.
* Patient is capable of complying with study procedures

Exclusion Criteria:

* Patient is pregnant or nursing
* Metallic implants (contraindicated for MRI)
* History of renal insufficiency (only for MRI contrast administration)
CVD Risk Factor Knowledge Across Age Groups

This study was to examine the knowledge level regarding cardiovascular disease risk factors among participants of varying ages. Then to see if there was any type of previous education that led to greater knowledge levels.

This study used a survey tool that assessed the participants' method(s) of prior education regarding cardiovascular disease (CVD) risk factors. Then the participant was asked eleven questions regarding CVD risk factors which tested their knowledge of those factors. Analysis was done to evaluate overall knowledge level of each group and compare the knowledge levels across age groups. Then analysis was done to see if any method(s) led to better knowledge level within and/or between age groups.

Eligibility Criteria:
Inclusion Criteria:

* were specific to age for each participant group and then also included full completion of the survey for all groups.

Exclusion Criteria:

* age outside of specified population for each participant groups or incomplete survey for any participant regardless of group.
Resistance Exercise Training in Children.

The purpose of this study is examine the effects of 8 weeks (3 days/week) of resistance exercise training in children 8 to 10 years of age on muscle strength, activation, and lipids of the vastus lateralis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer males and females ages 8 - 10 years.

Exclusion Criteria:

* No history or ongoing neuromuscular diseases, musculoskeletal injuries, or a disease that effects metabolism.
Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)

Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein (AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC).

The purpose of this study is to investigate an autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ET140203 T cells are autologous T cells genetically modified to carry a TCR-mimic (TCRm) construct capable of mediating cell killing by targeting tumor specific intracellular antigens and addressing solid tumor therapy challenges.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed HCC with serum AFP \>100ng/ml at time of screening and following most current line of therapy OR radiographic diagnosis of HCC with serum AFP \>400ng/ml at time of screening and following most current line of therapy.
* Metastatic or locally advanced, unresectable HCC
* Must have failed or not tolerated at least two (2) different anti-HCC systemic agents
* Molecular Human Leukocyte Antigen ("HLA") class I allele typing confirms participant carries at least one HLA-A2 allele
* Life expectancy of at least 4 months
* Karnofsky Performance Scale greater than or equal to 70
* At least 1 measurable lesion on imaging by RECIST
* Child-Pugh A6 or better
* Absolute neutrophil count greater than or equal to 1,500/mm\^3
* Platelet count greater than or equal to 75,000/mm\^3

Exclusion Criteria:

* Clinically significant cardiac disease
* Clinically significant pre-existing illness or active infection
* Clinically significant Central Nervous System (CNS) or neural dysfunction
* Active autoimmune disease requiring therapy
* Active malignancy other than HCC with the exception of cholangiocarcinoma (CCA) or any malignancy with an expected survival ≥ 3 years without any treatment (exception: hormone/androgen-deprivation therapy) and without any organ involvement
* History of organ transplant
* Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction
* Advanced HCC involving greater than 50% of the liver
Reading Disability in Children With NF1

A national, multicenter, randomized, transverse clinical trial, estimating the existence of phonological deficits in children with NF1 children compared with control children without NF1 with the same reading level.

To determine the phonological and visio -spatial performances at the NF1 children.

Eligibility Criteria:
Inclusion Criteria:

* Age included between 8 and 12 years
* Child presenting a type 1 neurofibromatosis according to 2 criteria in the following criteria list :

  * At least 6 café au lait spots
  * 2 or more neurofibromas or 1 plexiform neurofibroma
  * axillary or inguinal freckling
  * 1 optic nerf glioma
  * 2 or more Lisch nodules
  * 1 osseous lesion as sphenoid dysplasia or thinning of the long bone cortex with or without pseudoarthrosis
  * 1 A first degree relative (parent, sibling, or offspring) with NF1 by the above criteria
* Membership in a national insurance
* Consent of the child and the parents

Exclusion Criteria:

* Mental retardation (QI T \< 70)
* Treated or untreated epilepsy
* Visual deficit (visual Acuteness \< 4/10
* Presence of a symptomatic optic glioma
* Presence of a brain tumor.
Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033)

This estimation study (no hypotheses) will evaluate the safety, tolerability, and efficacy of gefapixant (MK-7264) in Japanese adult participants with unexplained or refractory chronic cough.


Eligibility Criteria:
Inclusion Criteria:

* Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator.
* Has had chronic cough for ≥ 1 year and a diagnosis of refractory chronic cough or unexplained chronic cough.
* For female participants, is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
* Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

Exclusion Criteria:

* Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with a pack-year history \>20 pack-years
* Has a history of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status
* Has a history of chronic bronchitis
* Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
* Has a history of malignancy ≤5 years
* Has a screening systolic blood pressure \>160 millimeters of mercury (mmHg) or a diastolic blood pressure \>90 mm Hg
* Has a history of cutaneous adverse drug reaction to sulfonamides with or without systemic symptoms or history of anaphylaxis to sulfonamides
* Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
* Has a known allergy/sensitivity or contraindication to gefapixant
* Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
* Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study
Effect of Inflammation on Voriconazole Concentration

Voriconazole is a broad-spectrum antifungal agent. There is evidence for a relation between the efficacy and safety of voriconazole and voriconazole trough concentrations. There are several factors that could influence voriconazole concentrations. Inflammation could be one of these factors. In a retrospective study was observed that reduced metabolism of voriconazole was related to inflammation in patients with severe infections. Reduced metabolism of voriconazole resulted in high voriconazole levels and low N-oxide metabolite (inactive metabolite of voriconazole) levels. The purpose of this study is to determine an algorithm to guide dosing of voriconazole during severe inflammation and to develop a multiple linear regression model to describe the contribution of CRP concentrations to the variability in voriconazole levels and metabolic ratio.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 yrs
* treatment with voriconazole
* written informed consent

Exclusion Criteria:

* concomitantly using a strong inhibitor or inducer of CYP P450