cyrilzakka/clinical-trials huggingface dataset:
Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients

Statins are widely used as lipid-lowering agents to lower cardiovascular risk with a favorable safety profile. In our recent in vitro study, the addition of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data). So we planned this study to investigate the synergistic effect of simvastatin combined with capecitabine and radiotherapy in locally advanced rectal cancer patients.

1. Primary Objective: pathologic complete response rate
2. Secondary Objectives:

   1. rate of sphincter-sparing surgical procedure
   2. rate of R0 resection
   3. disease-free survival
   4. overall survival
   5. pattern of failure
   6. safety and toxicity
   7. lipid lowering effect of simvastatin

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed adenocarcinoma of rectum
* AJCC/UICC clinical stages of cT3-4 or cN+
* age ≥ 20 years
* ECOG performance status 0-1
* No prior chemotherapy and radiotherapy
* Adequate major organ functions as following:
* Written informed consent
* Willing and able to comply the protocol

Exclusion Criteria:

* Prior statins therapy within 1-year from the date of study entry
* Uncontrolled or severe cardiovascular disease :

New York Heart Association class III or IV heart disease Unstable angina or myocardial infarction within the past 6 months History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality.

* Past or current history (within the last 5 years prior to treatment start) of other malignancies except rectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)
* Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection
* Pregnant nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
* Patients with CPK \> 5 X ULN at baseline
* Concomitant use with clarithromycin, erythromycin, itraconazole, ketoconazole, nefazodone, telithromycin, gemfibrozil, cyclosporine, danazol, amiodarone, verapamil
Socio-psychological Status of Healthcare Workers During SARS-CoV2 Pandemic

The aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the SARS-CoV2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination.

Severe Acute Respiratory Syndrome - Corona Virus 2 (SARS-CoV2) was detected by the Chinese Center for Disease Control and Prevention on 7 January 2020 in a patient with atypical pneumonia in Wuhan, China, via a nasopharyngeal swab. On March 11, 2020, the World Health Organization declared it a "Pandemic". SARS-CoV2 quickly turned into a global epidemic, with a total of 134,957,021 confirmed cases and 2,918,752 deaths reported in April 2021.Since SARS-CoV2 is a highly contagious disease, the risk of infection in healthcare workers is quite high. In one of the earliest studies in Wuhan, 29 percent of patients (40 out of 138) were reported to be healthcare workers. A report from the American Centers for Disease Control and Prevention (CDC) stated that a total of 9,282 healthcare workers were diagnosed with COVID-19, including 27 deaths, between February 12 and April 9, 2020. Eleven to nineteen percent of COVID-19 cases have been identified as healthcare professionals.As the investigators have seen in studies of SARS or Ebola outbreaks, the sudden onset of an immediately life-threatening epidemic can place an extraordinary amount of pressure on healthcare workers. Increased workload, physical fatigue, inadequate personal equipment, nosocomial transmission, and having to make ethically difficult decisions can have dramatic effects on their physical and mental health. The weight of working conditions together with the risk of illness of their social environment and families can cause mental health problems such as fear and anxiety in healthcare workers.When an effective vaccination program is in place, population uptake should be as high as possible to achieve herd immunity. Vaccination hesitancy, defined as a delay in acceptance or rejection of vaccination despite the availability of vaccination services, is one of the barriers to this. It is a complex special case that varies with time, place, and vaccines. It is influenced by factors such as peace of mind, convenience, and trust. Vaccine hesitations have been identified as one of the ten global health threats of 2019.The aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the SARS-CoV2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination.

Eligibility Criteria:
Inclusion Criteria:

* All healthcare workers aged between 18-65 who works at Siran Government Hospital

Exclusion Criteria:

* Participants who did not agree to participate in the study
* Uncooperative participants
Neuromodulation for Schizophrenia

Our proposed study employs a novel approach to determine the clinical and functional imaging effects of brainstem neuromodulation, with an investigational study device, on illness awareness in schizophrenia - a significant contributor to medication non-adherence and poor treatment outcomes, and arguably the most treatment resistant manifestation of the disorder.

The study device under investigation provides a safe and non-invasive method of brainstem stimulation that will be used in conjunction with a neuroimaging biomarker to measure brain changes associated with treatment and illness awareness.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female inpatients or outpatients ≥ 18 years of age
2. Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder
3. Voluntary and capable of consenting to participation in the research study
4. Fluent in English
5. Moderate-to-severe lack of illness awareness ≤7 on the VAGUS-SR, which corresponds to a rating of ≥3 on PANSS G12 Insight and Judgment item
6. On a stable dose of antipsychotic and other concomitant medications for at least 2 months, and unlikely to undergo changes in dose during the study

Exclusion Criteria:

1. Unwilling or unable to consent to the study
2. Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
3. Had eye surgery within the previous three (3) months
4. Ear surgery within 6 months prior to entering the study
5. Active ear infection or perforated tympanic membrane
6. Diagnosis of vestibular dysfunction
7. Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures
8. Acute suicidal and/or homicidal ideation
9. Formal thought disorder rating ≥4 on PANSS item P2
10. DSM-V substance dependence (except caffeine and nicotine) within one month prior to entering the study
11. Positive urine drug screen at the screening visit
12. Metal implants or a pacemaker that would preclude the MRI scan
13. Pregnancy
Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children

This study evaluates the effects of either Pediasure or Nourish formulas on the gastrointestinal microbiome in critically-ill children. Patients will be randomized to received either Pediasure or Nourish.

The gastrointestinal microbiome has been shown to be altered in critically-ill children such that there is a larger shift toward pathogenic bacteria. Previous studies have shown that probiotics, fecal transplants, antibiotic decontamination, and dietary interventions can shift the gastrointestinal microbiome toward a metabolically favorable microbiome profile and be associated with improvements in disease burden.

This study will randomize critically-ill children who are stable enough for enteral tube feedings to receive either Pediasure or Nourish. Pediasure is a commercially-made formula that is used commonly in pediatric patients. Nourish is an organic, whole-food formula with a high fiber content. High-fiber diets have been correlated with metabolically favorable microbiome profiles. This study will look at the microbiome before and after initiation of enteral tube feedings to determine if either formula is associated with a shift in the microbiome toward a favorable profile.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the pediatric intensive care unit
* Age 1-17 years old
* Previously placed enteric tube designed for enteric feeding

Exclusion Criteria:

* Vasoactive medication use
* History of allergies or intolerances to either Pediasure or Nourish
* Whey allergy or intolerance
* Gluten sensitivity or intolerance
* Medical condition that necessitate the use of specific formulas and/or nutritional needs (e.g. epilepsy requiring ketogenic diet, genetic metabolic dysfunction with specific formula requirements)
Integrative Oncology for Patient Symptoms

The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Organizations such as the American Society for Clinical Oncology and the European Society for Medical Oncology have included CIM modalities in their treatment guidelines, and many of today's leading cancer centers include CIM in their supportive care service. The proposed study will prospectively examine the impact of a CIM treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment.

A total of 750 patients will undergo an integrative oncologist (IP) consultation followed by a series of 8 CIM treatments consisting of either acupuncture or touch-related therapies (reflexology, Shiatsu, Tuina, etc.) with the goal of relieving their symptoms. Patients will be allocated to one of the two study treatment arms: the "Patient-Preference Arm", for patients who specify their preference for either acupuncture or touch therapy; and the "Randomized Treatment Arm", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. Patients will be asked to complete the following study questionnaires before and after the treatment regimen: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); the Edmonton Symptom Assessment System (ESAS); and the Measure Yourself Concerns and Wellbeing (MYCAW) tool. The primary study outcome will be the change in EORTC Global Health-Status / Quality of Life scores, from pre- to post-treatment. Secondary study outcomes will include EORTC QLQ-C30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; ESAS severity scores for 10 quality-of life related items; and MYCAW severity scores for the 2 most significant symptoms, as well as post-treatment narratives. Other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* undergoing active oncology treatment
* fully understand the study plan
* agree to sign the study informed consent form.

Exclusion Criteria:

* not fulfilling all of the study criteria
* not interested in attending all 8 weekly CIM treatments sessions
The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants

Thirteen hospitals in China will participate in the study, which aims to provide data on serum bilirubin levels in the first 168 hr after birth in term and late-preterm neonates, and estimate the incidence of severe neonatal hyperbilirubinemia and the underlying causes.

We hypothesize that the study can be value in identifying and implementing strategies for risk reduction.

Neonatal hyperbilirubinemia resulting in clinical jaundice is a common problem among infants, particularly during the first weeks of life.

Information about the incidence and risk factors of neonatal jaundice is not available from China where is one of the highest countries of the incidence of severe neonatal hyperbilirubinemia.

Eligibility Criteria:
Inclusion Criteria:

Term or late-preterm newborn infants with GAs of ≥35 weeks and birth weights of ≥2,000 g were included.

Exclusion Criteria:

All sick newborn infants who were admitted to the intensive care unit.
Homemade Fenestrated Physician-modified Stent-grafts for Arch Aortic Degenerative Aneurysm

The aim was to evaluate early and medium-term outcomes of single and double fenestrated physician-modified endovascular grafts (PMEGs) for endovascular aortic arch degenerative aneursym repair.

The evolution of stent-graft technology recently has meant the development of custom-made branched stent-grafts to achieve total endovascular aortic arch repair for high-risks patients. The disadvantages of custom-made include manufacture and deliver times for urgent cases and the associated high costs. Unfortunately there is also a high rate of embolization associated with this approach probably related to the complexity of deploying a multi-branched unibody stent-graft. A further alternative is physician modified endografts (PMEGs) for zone 0 TEVAR involving the deployment of a conventional stent-graft device ex-vivo, fashioning of customized fenestrations (for supra aortic trunk) and re-constrainment into the delivery system. The authors have previously shown the feasability in vitro and they have reported their experience for arch aortic lesion. The aim of this study is to evaluate the outcomes for aortic arch degenerative aneursym repair which is the most risky procedure


Eligibility Criteria:
Inclusion criteria:

- patients operated on in our department between 2000 and January 2020 for a thoracic endoprosthesis

Exclusion Criteria:

- Patient who reject the study protocol
Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People

This prospective study evaluates the effect of abstaining from tourniquets on pain reduction during the venous puncture of the elderly people.

Almost 3 million people aged 70 and over are hospitalized once or more each year. The implementation of multiple treatments in these fragile patients, often poly-pathological requires a regular biological monitoring. For these patients, samples must be taken on average every two days.

This population often has a fragile venous capital due to reduced skin elasticity, undernutrition more or less associated with dehydration, the use of certain venous-toxic treatments and / or repetition of the gesture taking into account the monitoring biological closely related to long-term therapies.

With the aim of well-treatment and well-being, the reduction of patient pain is one of the major concerns of caregivers and in particular pain induced by treatment.

In children, the practice of harvesting without tourniquet is already frequent (18) and our preliminary study has confirmed us on the tourniquet as one of the acts responsible for the pain that the caregiver can possibly abstain.

No study had been conducted on this subject in the adult population and more particularly the elderly population. This prospective study evaluates the effect of abstaining from tourniquets on pain reduction during the venous puncture of the elderly people.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 75 years and over,
* Hospitalized in internal medicine or geriatric department,
* For which the 2 upper limbs are accessible to venous puncture (due to the multiple attempts that may be necessary to take a sample during the hospitalization),
* For which at least one vein is visible or palpable on an upper limb,
* Without venous puncture since admission in the department,
* Patient who did not receive a topical anesthetic before the venous puncture (Emla type)
* Communicating patient, able to assess their pain on a digital scale,
* Patients with affiliation to a social security system or beneficiary ,
* Written informed consent (IC) obtained.

Exclusion Criteria:

* Patient already included,
* Previous pain localized to the upper limbs,
* Hematoma at the planned site of skin-vascular breakage,
* Hemiplegic or quadriplegic patient,
* Patient with lymphedema in the upper limbs,
* Patient with behavioral disorders that may interfere with the proper functioning of the sampling,
* Patient with cognitive impairment preventing understanding of the study and adequate assessment pain (CODEX cognitive score of category C or D),
* Patient placed under legal protection (guardianship).
Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease

The purpose of this study is to investigate the beneficial effects of regular exercise and the impact of food supplement carnosine on cognitive, motoric and metabolic functions as well as on specific biologically active substances in volunteers with subjective (SCI) or mild (MCI) cognitive impairment, as well as in patients in early stages of Parkinson's disease. The investigators assume the immediate intervention-associated health benefit for volunteers.

Standard Operating Procedures for patient recruitment, data collection, data management, data analysis routinely used in Biomedical Research Center, Slovak Academy of Sciences, University Hospital Bratislava and Comenius University, Bratislava will be employed.

Statistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age 55 - 80 years
* Presence of Subjective Cognitive Impairment (SCI), Mild Cognitive Impairment (MCI) or early stage of Parkinson's Disease (Hoehn-Yahr 1st-2nd stage), assessed by experienced neurologist

Exclusion Criteria:

* Serious systemic cardiovascular, hepatic, renal disease, cancer
* Lack of compliance
Lysosomal Storage Disease: Health, Development, and Functional Outcome Surveillance in Preschool Children

Hypothesis: Children diagnosed with a lysosomal disease will exhibit developmental, adaptive, and behavioral strengths and difficulties depending upon 1) biomedical risk factors (i.e. the specific genetic disorder responsible for the illness); 2) available modifying interventions, whether medical or behavioral; and 3) social risks in the children's families, neighborhoods and communities. A valid and reliable telephone-based surveillance system can successfully collect the data required to elucidate these developmental, adaptive and behavioral strengths and difficulties.

Children who have lysosomal disease experience declines in health status and central nervous system integrity which result in motor, communication, self-care, learning and behavioral challenges. Medical interventions such as enzyme replacement therapy (ERT) and hematopoietic stem cell transplantation can improve the health and functioning of children with lysosomal disease. To date, however, there is no established system for evaluating the health status, developmental status, behavioral outcomes or functional outcomes of these preschool-aged children across time and differing settings. The primary objective of this study is to develop a valid and reliable telephone-based data-gathering system for obtaining health status data, developmental status data, behavioral outcomes data, and functional outcomes data which reflect skills of daily living including feeding, moving, communicating and responding to others.

The secondary objective of this study is to assess the validity of several early-childhood standardized assessment tools as compared to the standard neuropsychological assessment battery specified by the Lysosomal Disease Network's 'Neurobehavioral Core.'

The third objective of this study is to describe the impact of lysosomal disease upon the families of lysosomal disease-affected children.

Eligibility Criteria:
Inclusion Criteria:

Children aged 1 to 84 months who have been diagnosed with MPS types I, II, III or VI. Children aged 1 to 84 months who have been diagnosed with some other lysosomal disease. Children aged birth to 18 years who have been diagnosed with Krabbe disease, or who have a positive screening for Krabbe disease.

Exclusion Criteria:

Children who do not have a lysosomal disease are excluded from this study.
Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Branch Retinal Vein Occlusion

This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Recent onset (less than 3 months) BRVO

Exclusion Criteria:

* Any previous intervention
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer

The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.

Lucitanib is a selective, orally available tyrosine kinase inhibitor targeting FGFR1-3, VEGFR1-3, and PDGFRα and β, with activity in relevant cell lines and animal models.

The first in human trial of lucitanib demonstrated that daily dosing with lucitanib can provide durable clinical responses in patients with FGFR1- or 11q (FGF3, FGF4, Cyclin D1, or FGF19)-amplified breast cancer. RECIST partial responses (PRs) were also observed in patients not known to have FGF abnormalities.

Based on these results, this study is designed to explore the safety and anti-tumor activity of daily lucitanib in breast cancer patients with and without alterations of the FGF pathway.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment
* Prior treatment with standard first line therapy in the metastatic setting
* Availability of tumor tissue sufficient for confirmatory testing of FGFR1 and 11q amplification status
* Demonstrated progression of disease by radiological or clinical assessment (Measurable disease according to RECIST Version 1.1 is NOT required for enrollment)
* Estimated life expectancy \>6 months

Exclusion Criteria:

* Current or recent treatment with biologic anticancer therapies
* Ongoing AEs from prior anticancer therapies
* Active central nervous system (CNS) metastases
* Clinically significant or uncontrolled hypertension or cardiac disease
* Females who are pregnant or breastfeeding