cyrilzakka/clinical-trials huggingface dataset:
Development and Evaluation of E-training and Mentoring Support Program on Dementia Care for Home-care Workers

This study evaluate the effects of three-month dementia care e-training and mentoring support program on home-care workers using a two-group randomized controlled trial.

Home care staff often have insufficient knowledge and skills of caring people with dementia at home. Many training courses for home care staff are not developed according to their educational background and workplace needs.

An innovative evidence-based online training with peer support program in dementia care was developed and consists of online cloud platform with various training courses and resources, on-the-job mentoring support by senior peers, and social networking in dementia care.

They can access to the online cloud platform by computers or smart phones anytime for immediate access to information in dementia care. They can also consult with senior peers for care problems by social network platform and attend monthly dementia care forum.

The interventional group attendance staff will accept 3-month e-training care online course, which was supervised by the supervisor and participated in the monthly counseling mentoring support group. The control group will accept the traditional dementedness care traditional classroom teaching course and will not accept any e-training .

The curriculum and counseling support group will collect information on the knowledge, attitudes, care abilities, work stress and burnout of the two groups in the pre-test, 3rd and 6th months and learn about their effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Qualified as a care worker for the elderly welfare law, and at least three months as a home servant,
* Literacy
* Can communicate in Mandarin and Taiwanese,
* Caring for community clients with cognitive impairment or dementia
* Willing to participate in the study and provide informed consent

Exclusion Criteria:

* If it does not meet the conditions for receiving the case, it will not be included in the study.
A Study in Healthy Men to Test How Well Different Doses of BI 1584862 Are Tolerated

The goal of this trial is to investigate safety, tolerability and pharmacokinetics of BI 1584862 in healthy male subjects of Japanese ethnicity following oral administration of single rising doses.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs blood pressure (BP) and pulse rate (PR), 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening visit.
2. Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
3. Age of 18 to 45 years (inclusive) at screening visit.
4. Body mass index (BMI) of 18.5 to 24.9 kg/m\^2 (inclusive) at screening visit.
5. Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
6. Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the start of trial medication until 90 days after the last medication:

   * Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration
   * Vasectomized (vasectomy at least 1 year prior to enrolment)
   * Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner
   * Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit.
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg) , diastolic blood pressure outside the range of 40 to 99 mmHg, or pulse rate outside the range of 40 to 99 beats per minute (bpm) at screening visit.
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit.
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
First Line Osimertinib in the Real World: an Inter-regional Prospective Study

This study (FLOWER) will investigate effectiveness, safety, progression patterns and clinical management of untreated advanced NSCLC patients receiving fist-line osimertinib in the real-world.

FLOWER is a real-world, prospective, observational study enrolling patients with histological and/or cytological diagnosis of EGFR-mutant aNSCLC, receiving first-line treatment with the third-generation EGFR-TKI, osimertinib. All the patients received osimertinib at the recommended dose of 80 mg, orally, once a day. Dosing interruptions or reductions required, based on individual tolerability, were managed according to clinical practice in compliance with label indications.

The FLOWER study aims at evaluating effectiveness, safety, progression pattern and clinical management of untreated EGFR-mutant aNSCLC patients in the real-world.

Eligibility Criteria:
Inclusion Criteria:

* histological confirmed diagnosis of NSCLC and EGFR mutation in exon 18-21;
* locally advanced inoperable or metastatic disease (stage III and IV according to 8th edition of the TNM classification for lung cancer);
* first line treatment with the third generation EGFR TKI, osimertinib;
* age \>18 years
* written informed consent

Exclusion Criteria:

Patients who receive study drugs in clinical trials will be excluded.
Heart Transplant Registry of Városmajor

The purpose of this registry is to determine the long term outcomes of heart transplantations performed at the Semmelweis University Heart and Vascular Center. All eventual interventional and non-interventional procedures will be accounted for and summarized.


Eligibility Criteria:
Inclusion Criteria:

* Heart transplant recipient
* \>18 years old
* Signed informed consent
* Cared for at the Semmelweis University Heart and Vascular Center

Exclusion Criteria:

* Denies consent to registry
Lidocaine Supplement for Minimal Invasive Parathyroid Surgery

Primary Objective:

1. To determine if the application of lidocaine to the airway will obtund or abolish the laryngeal reflexes. This in turn will lead to a quiescent controlled surgical field.

Lidocaine is a local anesthetic that causes numbness to the throat when misted into the air. This numbness in the throat should stop the urge to clear the throat in the middle of the operation. Therefore, this should stop the interruptions during the surgery.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. Participants in Group 1 will receive the saline mist. This will moisturize and soothe the throat. Participants in Group 2 will receive the lidocaine mist. Lidocaine or saline is misted into the air that you breathe during the surgery. You and your surgeon will not be told which group you were assigned to. At the end of the surgery, your surgeon will answer some questions to help determine if the use of lidocaine or saline is beneficial.

You will be considered off-study once you are sent to the recovery room after surgery.

This is an investigational study. Lidocaine is FDA-approved and commercially available for local anesthesia. If you are in the lidocaine or the saline group. Up to 105 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

* All outpatients scheduled for MIPS at the ACB by Dr N Perrier, Dr D Evans and Dr JE Lee.

Exclusion Criteria:

* Patients who are excluded will be any who require elective endotracheal intubation as a preoperative decision by the anesthesia team. These patients will be those with sleep apnea, BMI\>35, uncontrolled gastro esophageal reflux.
* Patients who have a history of allergy/hypersensitivity to lidocaine.
Cardiovascular Disease Study

Coronary heart disease (CHD) is a leading cause of death in the spinal cord injured (SCI) population, occurring at younger ages than in the able-bodied population. Conventional risk factors for CHD include high concentrations of low-density lipoprotein (LDL), low concentrations of high-density lipoprotein (HDL), diabetes mellitus (DM), smoking history, and family history. Other factors that may influence progression of CHD include C-reactive protein (an inflammatory marker), and fibrinogen (a pro-coagulant marker). Individuals with SCI with longer duration and greater completeness of injury are more likely to have significantly worse carbohydrate tolerance compared to other neurological deficit subgroups. Muscle atrophy after SCI is associated with increased insulin resistance. Prolonged inactivity has been shown to be associated with hyperinsulinemia and impaired glucose tolerance. Body composition changes after SCI to indicate significantly more total body fat mass and percent fat and less lean mass compared to able-bodied individuals. Carotid intima-media thickness is correlated with atherosclerosis progression and abdominal adiposity. Individuals with abdominal adiposity are at a higher risk for CHD, DM, hypertension, insulin resistance, and dyslipidemia. Abdominal adiposity and insulin resistance are contributors to postprandial lipemia, which may be a more sensitive indicator of CHD risk and progression.

The purpose of this study is to determine the prevalence of conventional risk factors by assessing the 10-year risk for CHD, and identify emerging risk factors for CHD in the spinal cord injured population. Subjects will have the option to participate in a high fat meal test to determine postprandial lipemic responses. Knowledge of this information may be able to detect and prevent future cardiovascular events related to CHD.


Eligibility Criteria:
Inclusion Criteria:

* Male 45-75 years old with at least 5 years of SCI
* Female 45-50 years old with at least 10 years of SCI
* Female 50-75 years old with at least 5 years of SCI

Exclusion Criteria:

* Acute medical illness
* Pregnant females
* Chronic debilitating disease (i.e., heart disease, pulmonary disease, etc.)
* Atrial fibrillation
* History of percutaneous coronary angiography with stent placement
Pediatric Rehabilitation for Children With Cerebral Palsy Through PVT Using AI to Reduce Spasticity

The study foucs on pediatric rehabilitation for children with cerebral palsy through personalized vibration therapy powered by artificial intelligence.

Innovative approach to reduce spasticity, improved motor function, quality of life. Vibration therapy reduces spasticity by activating the body's natural stretch reflex, which in turn triggers muscular contractions. Furthermore, it has been proposed that the primary ends of the muscle spindle Ia afferent are stimulated by muscular vibration. This leads to the excitation of alpha motor neurons, subsequent contractions of motor units, ultimately producing a tonic muscle contraction. This study will modify vibration therapy by introducing Artificial intelligence to rehabilitate the patients suffering from spastic CP.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed spastic CP as per neurologist report, GMFCS level I-III
* Ability to safely withstand intensity of vibrating device.
* have no planned surgery within 5 months before/after entering the study

Exclusion Criteria:

* A bone fracture within 12 weeks of enrollment.
* History of using anabolic agents, glucocorticoids (excluding inhaled), or growth hormone (regardless of dose) for at least 1 month, within the 3 months prior to enrollment.
* History of botulinum toxin injection into the lower limb(s) within the 3 months before enrollment.
* History of an illness or findings on physical examination that might prevent the child from completing the study (e.g., acute thrombosis, tendinitis).
A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease

The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease


Eligibility Criteria:
Inclusion Criteria:

* Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
* MMSE score of 22 to 30 (inclusive) at baseline
* CDR global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5.
* Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria
* Have a study partner who will provide written informed consent to participate

Exclusion Criteria:

* Contraindication to MRI or PET scans
* Have known allergies to LY3372689, related compounds, or any components of the formulations
Goal-directed CPR Using Cerebral Oximetry

The proposed study is a single-center, randomized controlled pilot trial of adults who suffer in-hospital cardiac arrests. Using cerebral oxygenation and end-tidal carbon dioxide physiological targets to predict survival and neurological outcome, the impact of physiological-feedback CPR will be assessed. 150 adult patients who have a cardiac arrest event at NYU Tisch Hospital will be randomized to one of two treatment groups: (1) Physiological-Feedback CPR or (2) Non-Physiological (Audiovisual) Feedback CPR.


Eligibility Criteria:
Inclusion Criteria:

1. In-hospital cardiac arrest patient
2. Age ≥18 years
3. Age \<80 years
4. CPR lasting ≥5 minutes

Exclusion Criteria:

1. Patients \< 18 years of age or \> 80 years of age
2. Out of hospital cardiac arrest patients
3. ≥3 acute organ failures (defined as acute renal failure requiring dialysis, fulminant liver failure i.e. liver failure with INR≥1.5, respiratory failure requiring mechanical ventilation)
4. Repeat in-hospital cardiac arrest event within 14 days of a prior cardiac arrest
5. Presence of known raised intracranial pressure
6. Presence of known traumatic brain injury or subarachnoid hemorrhage \<14 days old, frontal lobe brain tumors or subdural hemorrhage
7. Hyperbilirubinemia \>1.0 mg/dl (based on the absorption of near-infrared light by bilirubin)
8. Resuscitation using extra-corporeal membrane oxygenation (ECMO)
iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD)

The present study aims to evaluate the efficacy and safety of different combinations of oral antidiabetics in patients with inadequate glycemic control on metformin monotherapy.

This is a phase III, multicenter, randomized, double-blind, double-dummy clinical trial to evaluate the efficacy and safety of the he fixed-dose combination in patients diagnosed with type 2 DM (Diabetes mellitus), with or without cardiovascular or renal complications, and who did not reach the therapeutic goals of glycemic control with previous guidance on diet and physical exercise, on monotherapy with metformin at the maximum tolerated dose, and who, at the discretion of the Investigator, may benefit from the addition of trial drugs.

The trial will have a total duration of a maximum of 144 days (approximately 20 weeks), with a screening/run-in period of up to 4 weeks and 16 weeks (112 ± 4 days) of treatment. The trial will include a screening visit (V-1), a baseline randomisation visit (V0), three follow-up visits (V1, V2, V3) and a final visit (V4).

Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree with all the purposes of the trial, signing and dating the ICF in two copies;
* Age equal to or over 18 years old and less than or equal to 80 years old
* Diagnosis of type 2 DM with uncontrolled glycemia with a history of HbA1c ≥7.5% and ≤10.5% (up to 12 previous months) with previous guidance on diet and physical exercise and monotherapy with metformin at the maximum tolerated dose (≥1,000 mg/day, stable and without signs of intolerance in the last 12 weeks) and who, at the Investigator's discretion, may benefit from the addition of the trial drugs

Exclusion Criteria:

* Any clinical observation finding (clinical/physical assessment) or laboratory condition that is interpreted by the investigating physician as a risk to the research Subject's participation in the clinical trial or the presence of uncontrolled chronic disease(s);
* History of alcohol or illicit drug use disorder in the two years prior to the Visit;
* Subjects who are pregnant, breastfeeding or planning to become pregnant, or female subjects of childbearing potential who are not using a reliable method of contraception;
* Known history of allergy or hypersensitivity to any of the trial treatments, or to the excipients in the formulas, or in case of rare hereditary diseases which may be incompatible with the excipients in the product formulas (such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption);
* Subjects with type 1 diabetes mellitus;
* History of fasting blood glucose ≥ 270 mg/dL.
Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Japanese Patients With Neovascular AMD

This study will evaluate the safety and to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese patients with neovascular age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Japanese male or female patients
* Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)

Exclusion Criteria:

* History of or active periocular, ocular, or intraocular infection
* Previous use of ocular anti-angiogenic therapy within 1 month (ranibizumab), 6 weeks (pegaptanib), or 2 months (bevacizumab and aflibercept) of Day 1 for the treatment of neovascular AMD or neovascular eye diseases other than AMD
* Macular hemorrhage that involves the center of fovea in the study eye
* Previous use of verteporfin photodynamic therapy (PDT) or previous therapeutic radiation in the region
* Treatment with ocular corticosteroid injections or implants within 6 months in the study eye
* History or evidence of eye surgery: Pars plana vitrectomy, Submacular surgery or other surgical interventions for AMD, Incisional glaucoma surgery or Cataract or refractive surgery within the last 3 months
* AMD or neovascular eye diseases other than AMD in the non-study eye that require anti-VEGF treatment
Vitamin D and T-Regulatory Cells in Coronary Artery Disease

The purpose of this study is to evaluate the effect of Vitamin D supplementation on cardiovascular disease and certain cells (T-regulatory cells) in the body that play a role in plaque formation in arteries. This study will determine the levels of Vitamin D and T-regulatory cells in subjects with coronary artery disease and if Vitamin D supplementation will affect future events such as heart attach and stroke.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 30 and 80 years
* have a history of medically treated coronary artery disease

Exclusion Criteria:

* history of smoking in the past 2 years
* history of diabetes mellitus
Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.

This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 6 and 12 years
* Myopia between -1.00 and -4.00 D

Exclusion Criteria:

* Participating in any clinical or other research study
* Contact lens wearer
Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

A simulated clinical use testing on the DropSafe safety pen needle

This study aims to evaluate the safety of the use of DropSafe safety pen needle in the prevention of needle stick injuries (NSI) and to evaluate the user's satisfaction with regards to the handling characteristics of the product.

Eligibility Criteria:
Inclusion Criteria:

1. Minimum of age 18.
2. Able to understand and provide signed consent for the study.
3. Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
4. Have no concerns about the ability to perform the simulated injections.
5. Have no financial interest in the sponsor (HTL-Strefa S.A.) or the MRO (NAMSA).

Exclusion Criteria:

1. If in the opinion of the sponsor or MRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including for reasons such as mental health.
Evaluation of the Modified Early Warning Scoring System

In this study, it was aimed to determine the effect of HRU and HG on patient outcomes in the care process in surgical patients followed according to MEUSS.

The sample of the study, which was conducted as a randomized-controlled clinical trial, consisted of 252 patients who underwent surgical intervention under general anesthesia in a university hospital between 29 July 2022 and 31 October 2022.

Postoperative patients are at risk of clinical worsening and minimizing this is vital. Nurses play a vital role in the early detection and management of clinical deterioration as they are the group of professionals with the highest patient contact. MEUSS is stated as a simple risk management tool based on physiological parameters that can allow early detection of clinical deterioration and initiation of the relevant intervention, improving the quality of care and patient safety provided to surgical patients.

In this study, with a larger sample, patients will be followed up with MEUSS and a nursing guide for 2 hours in the clinic where they are transferred both after and after ASBU. Our study is a research with the highest sample in this field, in which patients are followed for the longest period of time, and it is thought that MEUSS and nursing guide applications can identify risky patients in the postoperative period and reduce postoperative complications with strict follow-up applied to these patients. The aim of this study; To determine the effect of Nursing Guide Practice (HRU) and Nursing Interventions (HG) on patient outcomes in the care process in surgical patients followed according to MEUSS.

Eligibility Criteria:
Inclusion Criteria:

* Having operated under general anesthesia
* transferred to the post-anesthesia care unit (ASBU) and then to the service/ICU followed for 2 hours,
* between 18-65 years old,
* who have not had an operation with general anesthesia in the last six months,
* no serious life-threatening complications developed during surgery,
* patients willing to participate in the study

Exclusion Criteria:

* data unavailable,
* complications during surgery,
* patients who did not undergo general anesthesia