cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information

The primary objective of this study is to compare an experimental organization for chemotherapy session planning based on early, standardized, and prioritized means of data transmission via secure e-mail (laboratory results) and the use of a smart phone (for clinical toxicity data) compared to the regular organization, in terms of the rate of prescriptions of chemotherapy prepared at the latest the day before a session and then administered in full (over a 6-month observation period) among colorectal cancer patients in need of cancer treatment in an outpatient setting.

Compare the two arms of the study in terms of:

A. each element contributing to the primary criterium;

B. the quality of chemotherapy related care;

C. logistics;

D. patient satisfaction with respect to support for chemotherapy care;

E. the feasibility and acceptability of the organization by patients will be assessed by the rate of optimal use of toxicity collection tools and patient satisfaction rates relative to the tool (experimental arm)

F. Comparison of the overall cost of care in both arms and estimated cost of the strategy

Eligibility Criteria:
Inclusion Criteria:

* The patient was informed about the implementation of the study, its objectives, constraints and patient rights
* The patient has given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 6 months of follow-up
* The patient is treated via anti-cancer chemotherapy for colorectal cancer
* The patient is starting a new adjuvant or metastatic chemotherapy protocol with a follow-up in a day-clinic setting
* The patient has already used a smartphone, or desires to learn how, or is accompanied by a person who can help the patient use a smartphone
* The anticipated chemotherapy treatment corresponds to one of the following protocols: cetuximab, FOLFIRI, FOLFIRI-aflibercept, FOLFIRI-bevacizumab, FOLFIRI-cetuximab, FOLFIRI-panitumumab, Folfirinox, Folfirinox-bevacizumab, Folfoxiri, Folfoxiri-bevacizumab, FOLFOX 4 simplified, FOLFOX 4 simplified - bevacizumab, FOLFOX 4 simplified - cetuximab, FOLFOX 4 simplified - panitumumab, Irinotecan-cetuximab, LV5FU2 simplified, panitumumab, XELOX.

Exclusion Criteria:

* The patient is participating in another study, or has participated in another study within the past 3 months, that may influence the results or conclusions of the present trial
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, or is an adult under guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The planned chemotherapy regimen includes weekly treatment cycles
* Patient who is incapable of using a smartphone either by himself/herself or via another helping person
Effects of Laughter Yoga Practiced by Nursing Students Before Clinical Practice

Aim: We conducted this randomized controlled study to determine the effect of laughter yoga practiced by first year nursing students before clinical practice on their perceptions of stress and meaning of life.

Background: Laughter yoga has a positive effect on the person's mental/general health, life satisfaction and psychological well-being and enables the person to cope with stress.

Design: In this experimental randomized and controlled study including a control group, we administered a pre-test, post-test one and post-test two to the participating students.

Methods: We conducted the study with 45 first year nursing students in the intervention group, and 45 first year nursing students in the control group. The students in the intervention group took part in eight sessions of laughter yoga for four weeks, twice a week. We used the Descriptive Information Form, Perceived Stress Scale, and Meaning and Purpose of Life Scale to collect the study data.


Eligibility Criteria:
Inclusion Criteria:

* Who did not have any diagnosed psychiatric diseases,
* Who had not done laughter yoga and / or did not have any clinical experience previously were included

Exclusion Criteria:

* Who withdrew from the study at any stage,
* Those who did not participate in the yoga sessions regularly
* Those who used another relaxation method during this period,
* Those who took antidepressants,
* Those who had a chronic cough and / or urinary incontinence,
* Those who underwent surgery in the last 3 months (abdominal surgery, uncontrolled surgery, glaucoma, hernia),
* Those who had neurological diseases such as epilepsy, multiple sclerosis,
* Those who were unwilling to participate in the study,
* Those who had neurological disorders,
* Those who lost one of their loved ones in the last 6 months were excluded from the research.
Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery Disease

The purpose of this study is to learn if CS-505 is safe and effective for slowing down or possibly reversing the buildup of tissue, cells and fatty deposits (plaque) in the blood vessels of the heart (coronary artery atherosclerosis).


Eligibility Criteria:
Inclusion Criteria:

Standard:

1. Male or female subjects, age 18 years or greater; and
2. Diagnosed or suspected coronary artery disease with a clinical indication for coronary angiography.

Angiographic:

1. Evidence of coronary heart disease
2. Identification of a target native coronary artery for the plaque volume measurement.

Exclusion Criteria:

Standard:

1. Breast feeding or lactating women, or women who have had a pregnancy (regardless of outcome) within the past 12 months;
2. Previous heart or other organ transplantation;
3. Treatment with any of the following agents within 4 weeks prior to randomization:

   * Immunosuppressive agents (cyclosporine, azathioprine);
   * Rifampin; and
   * Phenytoin, phenobarbital, valproic acid, or other anticonvulsants.
4. Any of the following manifestations of cardiac disease:

   * Myocardial infarction or unstable angina within 24 hours prior to randomization or clinically unstable;
   * Clinically significant heart disease; and
   * Coronary artery bypass surgery within previous 3 months.
5. Stroke (CVA) within previous 3 months;
6. Evidence of severe symptomatic heart failure (NYHA Class III or IV) or known ejection fraction less than 30%;
7. Uncontrolled diabetes mellitus;
8. Uncontrolled hypertension; and
9. Nephrotic syndrome, significant nephropathy, or other significant renal disease.

Angiographic:

1. Presence of any lesion with greater than 50% reduction in lumen diameter; or
2. Any lesion with a greater than 50% occlusion in the left main coronary artery;
3. A target vessel, including any of its branches, that has undergone or will be undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI);
4. A target vessel that is itself a bypass graft.
A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)

This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment.


Eligibility Criteria:
Inclusion Criteria:

- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time

Exclusion Criteria:

- Not applicable
A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery

The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.

The primary objective is to determine the safety and feasibility of administering Hemopure® (HBOC-201) to reduce myocardial necrosis, as measured by CK-MB enzyme elevation, and enhance tissue preservation during cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* Subject is between the ages of 18 and 80.
* Subject is an acceptable candidate for CABG.
* Subject is scheduled for CABG (without planned valvular repair or replacement) by cardiopulmonary bypass.
* Subject signs informed consent
* Subject and the treating physician agree that subject can comply with all study procedures and follow-up visit at time of subject screening.

Exclusion Criteria:

* Pre-operative myocardial infarction, defined as CK-MB level \> 2 times upper limit of normal 24 hours prior to CABG surgery.
* Renal failure defined as serum creatinine greater 220 µmol/L
* Subject has an ejection fraction ≤ 30% (as measured by Echocardiography within 30 days of study enrollment).
* Active infection.
* History of prior stroke within last six months or history of prior stroke with residual neurological deficit.
* Transient Ischemic attack within last 6 months.
* Subject has a history of coagulopathy.
* Subject is pregnant or currently breastfeeding.
* History of allergy to beef products.
* Pre-operative cardiogenic shock defined as cardiac index ≤ 1.8.L/min/m2 despite the use of vasopressors.
* Underlying medical conditions that would limit subject's life expectancy to less than 12 months.
* Severe pulmonary disease \[based upon clinical diagnosis or pulmonary function tests (FEV \<1 liter), if available\] that may interfere with weaning subject from ventilator.
* History of acute central nervous disorder (e.g., seizure or traumatic injury).
* Severe hypertension (≥ 160/90 mm Hg) that cannot be medically controlled despite treatment with two antihypertensive therapies.
* Severe liver dysfunction as defined by total bilirubin ≥ 51 µmol/L or 2 times the site normal limit of AST or ALT activity.
* Subject has systemic mastocytosis.
* Subject has any condition that predisposes the subject to systemic mast cell degranulation or hypersensitivity reactions or a history of severe allergic reactions to drugs or environmental allergens.
* Subject has participated in another investigational drug, biologic or device study within 30 days prior to study enrollment.
The Effect of Two Dıfferent Technıques Used in Psychomotor Skılls Traınıng on Nursıng Students

Background: Nursing education aims to provide students with knowledge and skills related to the profession and develop students in terms of personal characteristics such as clinical decision-making, problem-solving, and critical thinking. Innovative approaches and interactive learning strategies are needed during education periods to increase skills and personal development.

Aim: The study aimed to investigate the effect of computer simulation and imagery learning techniques in psychomotor skills training of nursing students on self-confidence and anxiety in clinical decision-making and academic achievement.

Design: It is an experimental study with a pretest-posttest design with two intervention groups.

Setting: The study was conducted between December 2023 and January 2024 at the faculty of health sciences of a university in Turkey's central region.

Background: Nursing education aims to provide students with knowledge and skills related to the profession and develop students in terms of personal characteristics such as clinical decision-making, problem-solving, and critical thinking. Innovative approaches and interactive learning strategies are needed during education periods to increase skills and personal development.

Aim: The study aimed to investigate the effect of computer simulation and imagery learning techniques in psychomotor skills training of nursing students on self-confidence and anxiety in clinical decision-making and academic achievement.

Design: It is an experimental study with a pretest-posttest design with two intervention groups.

Setting: The study was conducted between December 2023 and January 2024 at the faculty of health sciences of a university in Turkey's central region.

Methods: The Turkish version of the "Self-Confidence and Anxiety in Clinical Decision Making" scale was used at the beginning (pre-test) and end (post-test) of the four-week sessions of the interventions. Moreover, the "Academic Achievement Test" was used at the end of the interventions. Differences in mean scores between the groups were analyzed with mixed-design ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* taking the Fundamentals of Nursing course for the first time,
* being have to attend to the Fundamentals of Nursing course,
* having a GPA above 1.80,
* volunteering to participate in the study. It was determined that there were 96 students enrolled in the Fundamentals of Nursing course.

Exclusion Criteria:

* who did not attend regularly during the sessions
Effects of Daily Nutritional Supplementation in Combination With a Eurhythmics Training (NUDAL)

Malnutrition and lack of regular exercise are often found in older adults and have been identified as important risk factors for independence loss and nursing home admission in older community-dwelling adults.

Existing evidence suggests that high protein nutritional supplements can increase skeletal muscle protein synthesis following exercise in older individuals. However, increase of muscle strength by resistance training does not decrease the rate of falls and is not necessarily linked to an improvement of physical function. In contrast to resistance training, T'ai Chi, dance and eurhythmics have been shown to decrease fall incidence and improve mobility and physical function in older adults. The investigators will examine the combination of eurhythmics and high protein nutritional supplements.

The aim of the study is to investigate whether there is an increase in normal walking velocity due to the nutritional supplement on top of once weekly Jacques-Delacroze Eurhythmics training.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling males and females, aged ≥ 65 years
* Able to walk unassisted for 15 meters
* MMSE ≥ 24 points
* Having obtained his/her informed consent

Exclusion Criteria:

* Serum 25(OH) Vitamin D \> 100 nmol/L from the blood sampling at Screening
* Current regular (defined as \>3x /week) use of high protein oral nutritional supplements
* Milk protein allergy (Lactose intolerance)
* Severe visual impairment (corrected near vision \<0.2 in both eyes)
* Severe neurological, orthopaedic, rheumatologic or psychiatric illness causing inability to understand or follow task instructions or to walk 15 meters without assistance (if clinically questionable, final decision will be made by a senior physician)
* Terminal illness with life expectancy less than 12 months, as determined by a physician
4-week Serial FIT Analysis in Patients With CRC

Assimilation of FIT into primary and secondary care diagnostic pathways will lead to an increased prominence of the investigation in the diagnosis of colorectal cancer (CRC). Questions remain about whether serial FIT analysis improves accuracy, and what factors affect it.

Our study will analyse FIT results in recently diagnosed CRC patients to determine the risk of a false-negative FIT result and evaluate whether repeated analysis improves diagnostic accuracy. The study aims to advise on whether there is an optimal interval between sample collection to improve diagnostic accuracy and whether any patients are at risk of a false negative based on demographics, medications or other pathological factors.

Colorectal cancer (CRC) remains a leading cause of cancer death in the UK and worldwide. Improving outcomes depends in part on achieving earlier diagnosis of the disease.

The Faecal Immunochemical Test (FIT) is replacing the less accurate Faecal Occult Blood Test (FOBT) in the UK and has the potential to help achieve earlier stage diagnosis of CRC. Whilst FIT has been validated as a screening test for the Bowel Cancer Screening Programme (BCSP), its role in diagnosing CRC in symptomatic populations is yet to be defined.

Nottingham is a pioneering centre using FIT to stratify risk and determine first-investigation in its two-week-wait (2WW) pathway. To optimise use of FIT and minimise the chance of missed cancers, this project aims to better understand variation of FIT results over time and how certain factors affect FIT result.

Much of the literature has focused on the evaluation of FIT in an asymptomatic population, which is inherently low risk (4,6,7). Expanding use of FIT to stratify risk and guide investigations for cancer in (higher risk) symptomatic populations necessitates a thoroughly evaluated testing strategy. At present there is insufficient information to advise on "negative" FIT results in symptomatic patients. This study will comprehensively measure FIT variation over time in patients with the target condition (CRC) and help answer whether additional samples are likely to improve accuracy of FIT.

Risk factors for false positives and false negatives have been previously identified but are not widely established (4). Our study will record the presence of these risk factors, and evaluate their effects on FIT-positivity with subsequent statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal cancer

Exclusion Criteria:

* Less than 18 years old
* Not attending Nottingham University Hospitals for diagnosis/treatment (attending another trust)
* No histological diagnosis of colorectal cancer
* Unable to provide informed consent - for example due to language barriers or lacking capacity to join study
Acute Oral Effects of Heated Tobacco Products

Heated tobacco products (HTP) are devices which heat, but not burn tobacco. They do not produce cigarette smoke but rather an aerosol. HTPs are marketed as less harmful alternatives to smoking. Use and awareness of these devices have grown exponentially in recent years, with probably millions of people currently using them. There is very little literature about them, so it is quite important to study the effects caused on the human body by these products.

The benefits and risks of HTP use are uncertain. There is no research on the acute oral effects of HTPs in the scientific literature.

Measurements of acute oral effects before and after using HTP with bland flavour (HEETS Bronze Selection), with methol flavour (HEETS Blue Selection), conventional cigarette and placebo device:

measurement of exhaled CO changes by Smokerlyzer piCO measurement of oral mucosal blood flow changes by Perilam PSI System High Resolution (LASCA method) measurement of blood pressure and pulse by an automatic blood pressure monitor (Omron M2, Omron Healthcare Inc., Kyoto, Japan)

Eligibility Criteria:
Inclusion Criteria:

* age: 18-49 years
* signed consent form
* smoking regularly heated tobacco product and/or conventional cigarette for \> half year

Exclusion Criteria:

* not pregnant and not planning pregnancy in the next 6 month BMI index \< 30
* no severe parodontal disease
* no acute illness in the last 2 weeks
* no chronic disease (eg.: diabetes)
Bariatric Surgery and Pharmacokinetics of Escitalopram

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on escitalopram are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
German Adrenocortical Carcinoma Registry

Basic objective of the German Adrenocortical Carcinoma Registry is to improve the care of patients with adrenocortical cancer. The registration of as many patients as possible helps to collect data for the prognosis and prospects of success regarding different treatment plans. This data will be taken into consideration for planning prospective studies. With this registry, the recruitment of patients for prospective studies will be significantly facilitated. In this way - and in cooperation with networks in other countries (e.g. in Italy and France) - a structure allowing systematic improvement of therapy will be developed.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of adrenocortical carcinoma
Testosterone Implants and the Incidence of Breast Cancer

This current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.

A prior ten-year prospective, observational, study was initially approved in March of 2008 by the IRB board through the Atrium Medical Center, Premier Health Partners in Middletown, Ohio 45005 and registered through the Office for Human Research Protections (OHRP). Expedited approval continued annually through 2013 at which time the IRB board was closed. All participants signed a study consent and HIPPA consent. Recruitment closed in 2013. The original protocol was designed to investigate the incidence of breast cancer in women presenting with symptoms of hormone deficiency treated with subcutaneous testosterone implants or, testosterone combined with the aromatase inhibitor anastrozole implants. A computer program was specifically designed to track and follow patients prospectively and all patients continued to be followed through 2018.

Eligibility Criteria:
Inclusion Criteria:

* Female patients treated between March 2008 - March 2013
* Women who received at least two testosterone pellet insertion procedures
* Women previously accrued to the prospective cohort study

Exclusion Criteria:

* Pre-existing breast cancer
* Women who received a single testosterone pellet insertion