cyrilzakka/clinical-trials huggingface dataset:
ctDNA Screening in Advanced HER2 Positive Gastric Cancer

To identify molecular biomarker panel correlating with efficacy of trastuzuamb in advanced HER2 positive gastric cancer patients. To observe the molecular evolution of HER2 positive gastric cancer during treatment by ctDNA detection.

Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.

Eligibility Criteria:
Inclusion Criteria:

1. Male/female patients aged over 18 years.
2. Histologically confirmed gastric adenocarcinoma. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
3. HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH positive, HER2 negative: IHC 0/1+ or IHC 2+ plus FISH negative.
4. At least one measurable lesion should be confirmed by imaging examination.
5. Eligible peripheral blood samples
6. Patients with enough organ function and performance status (ECOG 0-2) can tolerant chemotherapy.
7. For HER2 positive patients, trastuzumab should be used as first-line treatment. The regimen of chemotherapy should be platinum plus oral fluorouracil.
8. For HER2 negative patients, clinicopathological characteristics should be matched to HER2 positive patients.
9. Willing to provide clinicopathological information and imaging information.

Exclusion Criteria:

1. Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months.
2. With second primary malignant diseases.
3. Other situations assessed by investigator can disturb quality control of the investigation.
Compensatory Training to Support Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease

The Researchers are trying to better understand if behavioral interventions can help improve memory compensation and engagement in healthy lifestyle behaviors in those with memory concerns but normal mental status exam.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 or older
* A positive complaint or concern in response to two questions ('Do you feel like your memory or other aspects of thinking are becoming worse?' and 'Does this worry you?')
* Normal cognitive performance on the Montreal Cognitive Assessment (adjusted for age and education)
* Self-reported independent function in daily life as measure by the Lawson IADL scale (IADL=8)
* English speaking
* Approval letter from a physician (due to the exercise component)

Exclusion Criteria:

* Known neurological disorder with potential cognitive symptoms (a diagnosis of Parkinson's disease, epilepsy, a history of significant TBI, etc.)
* Uncontrolled moderate or severe depression (e.g., CES-D \> 21).
White Noise to Improve Sleep in the Medical Intensive Care Unit (MICU): a Pilot and Feasibility Study

A feasibility study to evaluate the use of white noise to improve sleeping conditions in an ICU setting.

The ICU is full of alarms and critically ill patients, so it is no surprise that sleep is very much fragmented and poor in this setting, as documented in numerous studies. White noise is a simple intervention that has been shown to improve sleep, including in the ICU setting. The aim is to conduct a pilot trial evaluating the feasibility of providing white noise to patients in the ICU at night to help improve sleep. The plan to measure feasibility metrics including patient acceptance, patient tolerance, and intervention fidelity; also to seek feedback from patients, nurses, and providers. Secondly is to evaluate the benefits of providing white noise at night in the ICU on sleep as measured by actigraphy and Richards-Campbell Sleep Questionnaires and total room sound.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>18yo admitted to MICU with expected stay of at least two nights after enrollment

Exclusion Criteria:

* Excluding intubated patients (so communication can be better) and patients on high-flow nasal cannula (which is already high background noise).
* Patients who are on therapeutic hypothermia or are on comfort measures only will also be excluded
Co-producing a Novel Model an Outcome Framework for the Implementation of Falls Management in Care Home Settings.

AIM: To co-produce a novel model for implementation of falls management for older people living in care homes

SECONDARY OBJECTIVES

Component One Objectives:

Primary :To co-produce a novel model for the implementation of falls management in care homes Secondary

* To facilitate a series of co-production workshops with representation of key stakeholders
* To co-produce a novel implementation model for falls management
* To co-produce an outcomes framework to evaluate the implementation model
* To explore the feasibility of delivering the model and using the outcomes framework across Nottingham and Nottinghamshire Integrated Care Systems (ICSs)

Component Two Objectives:

* To evaluate how and the extent to which co-production occurs during the process of developing a novel model and an outcomes framework for the implementation for falls management in care homes
* To reflect on challenges and facilitators of using co-production approaches in this context
* To evaluate how care home residents can be supported to voice their priorities within the process.

Component One: Co-production of the implementation model and outcomes framework A series of co-production workshops will be undertaken using a systemic action research methodology to develop and explore the feasibility of a novel implementation model and outcomes framework. This will involve three small workshop groups consisting of residents and relatives, care home staff only, and representatives from ICS partner organisations. All participants will be invited to attend a multi-stakeholder workshop in the later stages of the process to share ideas. Data collected for component one will be collected by the PI and PhD student. The novel model will be co-produced as part of this project but may include activities such as a care home audit programme, a reporting process, training and education and a community of practice. Following co-production of the model it will be delivered across Nottinghamshire ICB and refined in line with the systemic action research process.

Component Two: Evaluating the co-production process A process evaluation will be undertaken to explore how and the extent to which co-production occurs in component one, including reflection on challenges and facilitators, and how resident involvement is supported. Data collected for component two will be collected by the PhD student.

Eligibility Criteria:
Inclusion Criteria:

- Key stakeholders within an ICS system including: carers, registered health professionals, managers and owners/executives from care homes commissioners, health care professionals and regulators involved in care home and falls management pathways, residents living in care homes relatives of residents living in care homes

* 18 years and over (no upper age limit)
* Any member of staff working in the 10 case study care homes in Nottinghamshire

Exclusion Criteria:

* Unable to read and understand written English
* Lack of capacity to give informed consent
Blood Test (Guardant Shield™) for Screening of Colorectal Cancer in Underserved Patients

This clinical trial evaluates the use of a blood test (Guardant Shield™) for colorectal cancer screening. Colorectal cancer is the third leading cancer and cause of death in the United States. Screening may help doctors find colorectal cancer early when it is easier to treat yet nearly a third of all people eligible for screening have never had a screening test performed. Currently, doctors use a stool- based test such as the fecal immunochemical test (FIT) and visual tests such as a colonoscopy. Blood based testing such as Guardant Shield™, may provide a quick and effective way to screen patients that are hard to reach or with limited access (underserved).

PRIMARY OBJECTIVES:

I. Recruit women age 45 years and older who are in need of colorectal cancer screening from minority and underserved populations via a community mammography van.

II. Obtain data regarding knowledge, attitudes and beliefs about colorectal cancer screening.

OUTLINE:

Participants undergo blood specimen collection and complete survey on study. Participants may optionally undergo standard of care FIT testing on study.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 45 years of age and older who are in need of colorectal screening
* Do not have a history of cancer
* Able to read and understand English
* Have a provider to receive the results of the test and who will follow-up test results
* Able to provide informed consent
A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between SB8 and bevacizumab.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years
2. ECOG performance status of 0-1
3. Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
4. At least one measurable lesion according to RECIST v1.1.
5. Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters

Exclusion Criteria:

1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
2. Sensitizing EGFR mutations or ALK rearrangements
3. Increased risk of bleeding determined by investigator based on radiographic / clinical findings
4. History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

* Have voluntarily signed an informed consent form.
* Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with subject.
* Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
* Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
* Male subjects must agree to comply with applicable contraceptive requirements.
* Subject is able to keep required appointments for clinic visits and all tests, including blood draws and examinations.

Exclusion Criteria:

* Subject has a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder.
* Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep disorder requiring treatment of any kind.
* Subject has a history of, or ongoing, serious medical problem.
* Subject has a history of significant allergic reaction to any drug.
* Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
* Subject requires ongoing treatment with any psychiatric medication.
"The Effect of Comprehensive Non-pharmacological Treatment on Metabolic Disorders in Type 2 Diabetic Patients"

Evaluation of the effectiveness of comprehensive non-pharmacological treatment on metabolic disorders in type 2 diabetic patients

Patients in the intervention group will participate in a comprehensive non-pharmacological treatment of type 2 diabetes, the main components are:

* changing the meal plan (individual and group counseling, assistance in developing menus and determining the calorie intake, keeping a food diary)
* individually dosed physical exercises using specific exercise program;
* comprehensive training (course of interactive lessons, self-control training). The program included group sessions with a team of specialists: nutritionist, endocrinologist, physical therapy doctor and included 3 sessions per week for 24 weeks. Each visit included teaching patients in a group format and in an interactive form (classes with specialists alternated), performing physical exercises using the specific exercise program under the supervision of a physiotherapy physician, evaluating medical indicators, and a self-control diary.

Patients in the control group will not participate in group sessions, but they had the opportunity to receive non-pharmacological care provided in the framework of free outpatient care. Their indicators will be recorded during a routine visit to the doctor at the baseline, after 12 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* medically diagnosed with type 2 diabetes mellitus
* HbA1c result of ≤7.0% within the past 2 months
* body mass index (BMI) of ≥26 kg/m\^2
* hypoglycemic therapy: metformin only

Exclusion Criteria:

* pregnancy
* the use of other hypoglycemic drugs
* the use of medication for weight loss
* cardiovascular diseases (heart attack or cardiac procedure within the past 3 months)
* had stroke or history of treatment for transient ischemic attacks in the past 3 months
* had chronic renal failure or were on dialysis
* any conditions that do not allow the patient to perform the complex of the proposed physical exercises
Effectiveness of Pharmacist Intervention on Capecitabine Relative Dose Intensity, Adherence, Knowledge & Safety Among Cancer Patients in Malaysia

Over the past decade, oral administration of chemotherapy has significantly increased and is anticipated to continue to grow. Despite the conveniences, these oral regimens can be complex and pose challenge to patient adherence. Further safety concerns are warranted due to insufficient patient education, general perception of reduced toxicity with oral treatment, improper prescribing practice, and the lack of monitoring of observable adverse effects.

Therefore, effective medication counselling and patient education is vital to empower patients and their caregivers to increase adherence and safely managed medication to achieve optimal treatment outcome.

This study aims to evaluate the effectiveness of pharmacist intervention with structured oral chemotherapy education and patient monitoring on capecitabine treatment effectiveness (Relative Dose Intensity (RDI), Adherence and Persistence), safety outcomes (Adverse Event, Drug Related Problem and Health service utilization) and chemotherapy knowledge and self-efficiency among cancer patient care in Penang, a northern state oncology referral centre.

There are numerous published studies of pharmaceutical care implementations focusing mainly on in-patient setting and currently evolving in ambulatory cancer patients especially in western countries compared to Asian region. However systematic reviews show major gap still exist with paucity of scientific evidence on the effectiveness of therapeutic educational interventions for improving patient safety and adherence to oral chemotherapy mainly due to study design and method that are unable to strongly prove the outcome.

Hence highlighting the novelty and significance for this research using randomized controlled design, standardized \& validated tools for multimodal pharmacist intervention, long-term clinical outcome such as RDI with longitudinal assessment till treatment completion.


Eligibility Criteria:
Inclusion Criteria:

Patients will be screened according to the inclusion criteria below;

1. Adult patients (≥ 18 years old)
2. Ambulatory patients (daycare or out-patient oncology department clinic)
3. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or below,
4. Diagnosis of Colorectal, Breast, Stomach cancer
5. Newly started on oral Capecitabine (Xeloda) either as a single agent or in combination with other intravenous chemotherapy
6. Adjuvant or metastatic treatment intent
7. Patients who have given written consent to participate in the study.

Exclusion Criteria:

The following patients will be excluded from the study:

1. Patients who are ongoing in other clinical trial,
2. Patients with dementia, cognitive disability, mental retardation, Alzheimer's or Parkinson's
3. Patients on concurrent radiotherapy regime with capecitabine.
4. Patients who are unable to respond to questions or could not speak and understand Malay, English or Chinese language
5. Patients who are unable to complete the questionnaires with minimal assistance from researchers
Effects and Safety of Caspofungin and Corticosteroids in Pneumocystis Pneumonia in Non-HIV Patients

Pneumocystis Pneumonia is increasing in Immunocompromised Non-HIV Infected Patients. The effects and safety of caspofungin and corticosteroids is not certain in this population. All Immunocompromised Non-HIV patients with respiratory failure were randomized into caspofungin and non-caspofungin group and corticosteroids and non-steroids group. The major outcome is 28 day mortality, the second outcome are time of respiratory rate decreases to less than 25 breath per minute, body temperature lower than 37.3℃.


Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised Non-HIV Infected Patients
* Partial arterial O2 pressure(PaO2)/FiO2≤300mmHg
* Diagnosed as Pneumocystis Pneumonia

Exclusion Criteria:

* younger than 16 years old
* severe organ failure
* allergic to sulfanilamide, caspofungin or corticosteroid
Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer

The purpose of this study is to evaluate, in terms of overall survival, the benefit of monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a deferred basis after progression to treatment with chemotherapy alone. Initially expected target population was 1950 patients (pts), in 2015 protocol was ammended to 1028 patients, because the size was sufficient to evaluate the superiority of the use of monoclonal antibodies the start time of the diagnosis against deferred use, with HR of 0.8, power of 90% and an alpha of 0.05. Finally in July 2018, recruitment was completed with a total of 1104 patients enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with metastatic colorectal cancer with biopsy positive for adenocarcinoma.
* ECOG PS0-2.
* Who have not received prior chemotherapy treatment for metastatic disease.
* Measurable or evaluable disease.
* No previous surgery for metastatic disease. Surgery for metastasis allowed after inclusion in the study aftercare at the discretion of investigadors.
* Chemotherapy treatment with doublets (CAPOX, FOLFOX, FOLFIRI)

Exclusion Criteria:

* Patients older than 70 years with frailty criteria.
Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients

Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the efficacy and safety of both topical and oral antifungal treatment options for onychomycosis in diabetic subjects. However, no study to date has specifically addressed the efficacy and safety of efinaconazole among diabetic subjects.

The objective of this noncomparative, uncontrolled study is to determine the efficacy of topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus. Specific indicators to measure efficacy of treatment will be the mycological cure rate, complete cure rate, and treatment success. Furthermore, an additional goal of the study is to gain knowledge of safety in the setting of a cohort of diabetic subjects


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of onychomycosis confirmed through positive KOH stain or positive mycologic culture findings.
* Involvement of at minimum 20% of the target great toenail.

Exclusion Criteria:

* Diagnosis of a nondermatophyte fungus infection, diagnosis of proximal subungual onychomycosis, diagnosis of superficial white onychomycosis
* Diagnosis of peripheral arterial disease or anatomic abnormalities of the target toenail
* Inability to follow through with all requisite office visits
* Routine use of a systemic corticosteroid, routine use of a systemic immunomodulator, or history of systemic antifungals within the prior five years.
* Active interdigital tinea pedis refractory to topical antifungal treatments
* Known hypersensitivity to efinaconazole
* Use, within the month preceding screening, of: topical antifungal agents, topical anti-inflammatory agents to the toes
* Any history of oral systemic antifungal with known activity against dermatophytes
AI Powered Mapping Technology for Identifying Arrhythmias

Exploratory, hypothesis-generating study evaluating the impact of vMap on procedural efficiency, acute success, and work flow optimization.

The registry is a retrospective and prospective, post-approval, multicenter, single-arm, all-comers registry with two cohorts:

Retrospective Cohort: approximately 60 patients across two sites. Prospective Cohort: approximately 50 patients across two sites. This registry aims to collect real-world data on the clinical utility, safety, and procedural efficiency of vMap-guided ablation procedures.

Eligibility Criteria:
Inclusion Criteria:

* A cardiac ablation (de novo or repeat) procedure will occur guided by vMap.
* A confirmed cardiac arrythmia has been identified on a 12-lead ECG.
* The patient is greater than or equal to 18 years old.
* The patient can provide written informed consent.

Exclusion Criteria:

* Non-inducible arrhythmia (unless pre-mapped via vMap prior to the procedure).
* Patients in whom no ablation was performed.
* Inability to obtain 12-lead ECG of sufficient quality for vMap analysis.
Multifunctional Magnetic Resonance (MR) for Radiotherapy Planning in Prostate Cancer

To determine if functional MRI methods will aid planning of a radiation dose boost within the prostate in patients with prostate cancer potentially improving safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Hormone therapy naive patients planned to be treated by radical radiotherapy after 3-6 months of androgen suppression
* Patients with low-high risk histologically confirmed localised disease are eligible, with WHO performance status 0-1.

Exclusion Criteria:

* Patients unsuitable for functional MRI of the prostate or gold seed fiducial marker insertion (e.g. patients unable to tolerate endorectal MRI examination).
* No prior pelvic radiotherapy or radical prostatectomy, previous androgen therapy, patients unsuitable for radical radiotherapy, life expectancy \<10 years, previous active malignancy within last 5 years, co-morbid conditions likely to impact on the advisability of radical radiotherapy, full anticoagulation, other exclusions to MRI (e.g. hip prosthesis or fixation, claustrophobia, ferromagnetic implants).