cyrilzakka/clinical-trials huggingface dataset:
Perioperative Oral Nutrition Supplementation in Malnourished Surgical Cancer Patients

The aim of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.

The hypothesis is pre-operative ONS feeding in malnourished surgical cancer patients is effective on improving nutritional status. An extended period of 3 months post-operative ONS feeding is effective on improving nutritional status as compared to ONS feeding post-operatively during hospital stay only. Perioperative feeding is effective on improving secondary outcomes such as sleep quality, post-operative complications and length of hospital stay.

The main objective of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ONS) on nutritional status in malnourished cancer patients undergoing elective surgery.

The specific objectives are:

1. To evaluate the baseline nutritional status of cancer patients undergoing elective surgery
2. To evaluate the effectiveness of pre-operative ONS feeding on nutritional status in malnourished surgical cancer patients
3. To evaluate the effectiveness of an extended 3 months post-operative ONS feeding after discharge versus ONS feeding only post-operatively during hospital on nutritional status
4. To evaluate secondary outcomes of perioperative feeding such as sleep quality, post-operative complications and length of hospital stay

Study Design: This is a randomised-controlled-open label-parallel group(s)-trial which will be conducted on malnourished cancer patients undergoing elective surgery.

Study duration: The participation duration for each participant is 4 months. The completion of the study will take around 30 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female from all ethnicity
* 25 to 65 years
* BMI not less than 18.0 kg/m²
* Cancer patients who are confirmed with elective surgery whose co-morbidities are stabilized based on the ASA Physical Status Classification System ASA Class 1 and 2
* Fulfil at least two characteristics of AND/ ASPEN Diagnosis of Malnutrition These characteristics are insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, localized or generalized fluid accumulation and diminished functional status as measured by handgrip strength.

Exclusion Criteria:

* Patients who require enteral or parenteral feeding
* Pregnant or lactating
* On chemotherapy or radiotherapy
* Total gastrectomy or ileostomy
* Metastasized cancer, upper gastrointestinal cancer, terminal diseases, decompensated liver or renal disease, major concurrent metabolic problem such as uncontrolled diabetes, dementia
* On regular steroids prescription
Prospective Observational Study of 1st and 2nd Line Vectibix® Use in RAS-wt mCRC Pts to Evaluate Pattern of Use and ORR

The study will shed additional light on the impact of Vectibix® under the current, standard clinical conditions of mCRC treatment in Greece. It will provide data on the duration and the outcomes of Vectibix® treatment in real-life setting.

This is a single-arm, multi-center, prospective, observational, descriptive, noninterventional study in patients with mCRC in Greece who receive Vectibix®in 1st or 2nd line according to approved indication. The aim of the study is to obtain a clear understanding of the current practices concerning real-life treatment of mCRC patients with Vectibix® in first-line in combination with chemotherapy or second-line in combination with chemotherapy in Greece. This setting will also provide the opportunity to observe in a non-selected patient population with RAS WT mCRC the real-life habits of mCRC treatment, and in particular the duration and the outcomes of Vectibix® treatment. The data generated by this study may be used for reimbursement purposes, as it becomes an increasingly common need in Greece to provide locally generated data for use of drugs in the real-life setting to regulatory agencies and/or payors. Furthermore, this study could address the existing data gap in the treatment of anti-EGFR therapy beyond progression in the real-life setting.

Primary Objective(s): To describe the pattern of use of Vectibix® in combination with chemotherapy in 1st line or in 2nd line mCRC treatments as per approved Vectibix® indication.

Secondary Objective(s): To investigate the rate of objective response (ORR, defined as either a Complete Response or a Partial Response) and the rate of stable disease as best response in 1st line or in 2nd line chemotherapy regimens of mCRC including Vectibix®.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age ≥18 years) at enrollment
* Histological documentation of mCRC diagnosis
* RAS WT tumor documented before study enrolment as per routine laboratory finding
* Subjects whose care will be managed primarily by the enrolling physician and/or all records will be available
* Measurable disease at baseline (preferably according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) if routinely used)
* Currently under (begin up to 8 weeks before informed consent) a 1st or 2nd line treatment regimen, including Vectibix® as per indication
* Tumor assessment (i.e. CT/MRI) within 16 weeks prior to first Vectibix® infusion
* Signed informed consent

Exclusion Criteria:

* Participation in any interventional clinical study (currently or during the three previous months from enrollment).
* Compromised ability to give informed consent (defined per clinical judgment).
* Unknown or mutant RAS tumor type
Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

The aim of this study is to evaluate the effect of fenofibrate versus curcumin on glycemic status, lipids profile, hs-CRP, sirtuin-1 and fetuin-A in type 2 diabetic patients who are taking glimepiride.

Method \& Proposal Steps

1- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University. 2- All participants agreed to take part in this clinical study and provide informed consent. 3- (60) Patients with DM type 2 who's taking Glimepiride will be enrolled from Internal Medicine Department, Tanta University Hospital. 4- Serum samples will be collected for measuring the biomarkers. 5- All enrolled patients will be mentioned as two groups; Group I are patients who will be prescribed glimepiride plus fenofibrate. Group II are patients who will be prescribed glimepiride plus curcumin. 6- All patients will be followed up during 3 months' period. 7- At the end of 3 months on the new regimen, steps 4 will be repeated. 8- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9- Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 3 months and lipid profile. 10- Results, conclusion, discussion and recommendations will be given.

Methodology Serum levels of fetuin-A, and Sirtuin1 (SIRT1) will be measured ELISA. Lipid profile. Fasting Blood glucose and 2 hrs postprandial Blood Glucose. Hb A1C will be measured. BMI of the patients will be measured before and after the study. High sensitivity C-reactive protein (hs-CRP) will be measured.

Eligibility Criteria:
Inclusion Criteria:

* 60 Patients with type 2 DM diagnosed clinically.
* The age ranged from 35 to 70 years.
* There are no limits to the duration of DM and gender.
* HbA1c ≥ 7

Exclusion Criteria:

1. Other types of DM
2. Hypersensitivity to the drug
3. Abnormal liver function
4. Patients with renal impairment (eGFR ≤ 60 ml/min)
5. Addition of any antidiabetic medications or insulin during follows up.
6. Pregnancy, lactation or child-bearing potential. 7. No insulin therapy and no use of antioxidants, multivitamin.
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1

Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old at the time of enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
* Expected life expectancy ≥ 3 months
* Metastatic (Stage IV) NSCLC
* Histologically or cytologically confirmed squamous or non-squamous NSCLC
* Tumor demonstrates high PD-L1 expression ( TPS\>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities.
* At least one measurable noncerebral lesion according to RECIST 1.1
* No prior systemic treatment for metastatic NSCLC.

Exclusion Criteria:

* Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.
* Has received any prior therapy for NSCLC in the metastatic setting.
* Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
* Known actionable genomic alterations for which first-line approved therapies are indicated
* Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
* Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
* Active autoimmune or lung disease requiring systemic therapy
* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
* Severe infection within 4 weeks prior to randomization
* Major surgical procedures or serious trauma within 4 weeks prior to randomization
* History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
Perception of Children With Visible Untreated and Treated Caries

In Germany about 5 to 20% of children suffer from early childhood caries (ECC). Preceding results of eye-tracking-studies on the perception of patients with unilateral cleft and patients with severe orthognathic malocclusion let us assume that caries and missing teeth might influence the observer's focus. The aim of this study is to test the hypothesis that the faces of patients with ECC and patients with signs of dental treatment (crown, gap etc.) are contemplated differently from and assessed more negatively than healthy patients. Particular attention should be paid to potential differences between the findings of the two observer-groups (medical laypersons/ dental students).

In Germany about 5 to 20% of children suffer from early childhood caries (ECC). Resulting in complications like damages of the permanent teeth, pain and developmental disorder of the affected jaw, ECC might additionally lead to social exclusion. Previous eye-tracking-studies about the perception of patients with unilateral cleft and patients with severe orthognathic malocclusion demonstrated that these variations are transferring the observer's focus from the eyes and nose to the affected region. The aim of this study is to test the hypothesis that the faces of patients with ECC and patients with signs of dental treatment (crown, gap etc.) are contemplated differently from and assessed more negatively than healthy patients. Particular attention should be paid to potential differences between the findings of the two observer-groups (medical laypersons/ dental students).

Eligibility Criteria:
Inclusion Criteria:

* healthy
* student of the University of Göttingen or Hildesheim
* age ≥ 18 years
* people who agreed to participate in the study
* right-hander

Exclusion Criteria:

* missing agreement to participate in the study
* missing cooperation,
* age \< 18 years
* left-hander
* wearer of glasses
* people with severe systemic diseases, especially states with associated temporary or permanent restriction of immune status
* people with severe mental illness who have altered perception or neurophysiological stimulus processing.
* people who take regularly or at the time of the study drug or drugs that altered a perception or neurophysiological stimulus processing
Entities and Variables Related to Catch-up Growth

A retrospective monocentric observational no-profit study with the aim of evaluating the entity and potential variables influencing the catch-up growth of childhood gluten-free diet patients with celiac disease during a 10-year follow-up. The only extrapolation of the data collected in anonymized form from the medical records of patients who match the necessary study criteria will be planned in order to achieve this aim. A 900-patient sample size will be planned.


Eligibility Criteria:
Inclusion Criteria:

* celiac disease diagnosis established at the V. Buzzi Children\&amp;#39;s Hospital in Milan between January 2010 and December 2020, excluding the extremes, in accordance with the ESPGHAN 2012 or 2020 recommendations.

Exclusion Criteria:

* patients with unclear or non-specific duodenal histological alterations (e.g., atrophy with unavailable or negative specific antibodies for celiac disease);
* patients with additional chronic illnesses;
* absence of the data required for the study;
* patients with IgA deficiency, defined as IgA \&amp;lt;20 mg/dl in children \&amp;lt;3 years old or with levels that are below normal for their age.
Efficacy Evaluation of Triple up® Collagen Drink on Skin Condition

To assess Triple up® Collagen Drink on skin condition improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
* Vegetarian
* Subjects who have large spots (area \>3 square centimeter) or abnormal acne.
Evaluation of Hypoxia by PET With F-Miso in Radiation Therapy of Prostate Cancer

With functional imaging development, it becomes possible to increase radiation dose to radioresistant areas (located inside tumor volume) using radiotherapy dose-painting. This strategy is particularly suitable for prostate cancer where tumor hypoxia plays a major role in the resistance of these tumors to radiation.

In order to develop intratumoral hypoxia targeting by radiotherapy dose-painting areas, we should characterize changes in hypoxia before treatment and during radiotherapy.

* If hypoxia does not change during radiotherapy, radiotherapy dose-painting strategy by an "integrated" boost is performed.
* If hypoxia varied (increasing or incomplete regression), a "final" boost strategy of radiotherapy dose-painting(IMRT, stereotactic brachytherapy or high dose rate) after a first fractionated IMRT could be considered.

This study should show that PET imaging with fluoromisonidazole (18F-MISO) is an available tool to physicians in assessing tumor hypoxia.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven prostate adenocarcinoma
* Absence of metastases (lymph node or bone)
* One or more tumor nodules seen on MRI and PET Choline.
* Intermediate Risk : Gleason 7 and PSA (prostate specific antigen)\<20 ng / ml, T \<T2c or Gleason 6 and PSA 10-20 ng / ml, T \<T2c
* No concomitant hormonal treatment. (NB: the introduction of hormone therapy during radiotherapy before the second 18F-MISO is a criterion to study exit)
* Indication of radiotherapy up to a total dose\> 70 Gy and 2 Gy/day fractions
* Signed Informed consent
* Social Insurance

Exclusion Criteria:

* Age \< 18 years old
* Patient protected by law
Exploring the Effectiveness of LED Phototherapy on Common Symptoms Among Elderly in Long-Term Care Institutions

The world is facing rapid population aging, the health needs of the elderly are complex, and their physical capabilities are degraded, and increased the possibility of having one or more chronic conditions. In 1900 to 2000, there were 7,600 million people in the United States, aged 65 and above age increased to 4.1% up to 12.6%, by 2050 is expected to increase 20.3%.In Taiwan, the elderly population have 83.5% is health and sub-health, in order to allow them to perform activities of daily living independently, in particular, need to pay attention to the diverse needs of the elderly, Assist the elderly to increase self-care skills, reduce disability is a very important issue.

From literature review of LED phototherapy can effectively improve symptoms in the elderly, such as hair loss, dermatitis, rotator tendonitis, epicondylitis of the tibia, wound healing, back pain, patellofemoral pain, spinal neuropathy, chronic pain relief, insomnia and depression.

Comprehensive Phototherapy and Traditional Chinese medicine(TCM) perspective, LED phototherapy is the use of physical light energy stimulation and temperature to improve the body's microcirculation and meridian dredge, Enhance the body's energy of the health and sub-health elderly, increasing physical activity perform daily functions.

Taiwanese Elderly to take self-care by the dilemmas of the many aspects. There are 21.52% physical health problems, affecting work or daily activities are limited; there are 35.12% physical or emotional health problems affecting social activities; there are 13.01% incapable perform activities of daily living.

The aim of this study was to explore the effectiveness of LED phototherapy on physiological symptoms among elderly in long-term care institutions in Taiwan. To examine the effects of physiological symptoms, such as mental state, muscle bone system, metabolism, autonomic balance and other meridian energy tests, it is expected to improve the body energy of healthy and sub-healthy elderly to increasing physical activity perform daily functions.

Eligibility Criteria:
Inclusion Criteria:

* Consciousness clear；must be able to talk

Exclusion Criteria:

* Clinical diagnosis of dementia；Seasonal mood disorder
Value of F-18 FDG PET/CT for the Prediction of EGFR Mutation in Lung Cancer Patients

To detect value of F-18FDG PET/CT as a non-invasive method for the prediction of EGFR mutations in lung cancer patients.

* Globally, lung cancer cases and deaths are rising. In 2018, GLOBOCAN estimated 2.09 million new cases (11.6% of total cancer cases) and 1.76 million deaths (18.4% of total cancer deaths). It is the most frequent cancer and cause of cancer death in men.
* Epidermal growth factor receptor (EGFR) mutations are the second most common oncogenic driver event in non-small cell lung cancer (NSCLC) and classical activating mutations are well defined as strong predictors for good clinical response to EGFR tyrosine kinase inhibitors (EGFRi).
* Over the last decade, the introduction of tyrosine-kinase inhibitors (TKIs) has showed a remarkable paradigm shift in the treatment of non-small cell lung cancer (NSCLC). However, genetic testing is sometimes unavailable.
* Data from previous studies that have investigated the value of F-18 FDG PET/CT for predicting EGFR status are conflicting.

Eligibility Criteria:
Inclusion Criteria:

* NSCLC patients who underwent EGFR mutation testing.
* All patients ≥ 18 years.

Exclusion Criteria:

* Time interval between EGFR sampling and PET/CT more than 1 month.
* Patients had been treated before sampling for the gene alteration analysis
* Patients with glucose level \< 200 mg/dl.
Glioblastoma Imaging Using a Strong Iron-like Bloodpool Contrast Medium?

Rationale: Visualization of tumor spread is of crucial importance when treating patients suffering from glioblastoma (GBM) as the success of tumor resection depends strongly on the extent of tumor infiltration. Current MRI protocols, however, cannot visualize the extent the tumor infiltration. The use of non-toxic, non-dangerous ultrasmall superparamagnetic biodegradable iron oxide (USPIO) particles as a very strong blood pool contrast agent could help visualizing this invisible infiltration Objective: To what extent, do GBMs infiltrate healthy brain tissue and can we use ultrasmall superparamagnetic iron oxide particles to visualize co-opting infiltrating tumor cells in an attempt to predict regions of tumor recurrence? Study design: This study concerns a single arm prospective observational study. Study population: Patients diagnosed with suspected glioblastoma. Intervention (if applicable): USPIO neuroimaging Main study parameters/endpoints: The main parameter of this study concerns the feasibility of using of USPIO particles in healthy controls (n=6) and glioblastoma patients (n=15).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During this study patients will be intravenously injected with low doses of USPIOs. Risks involved with this procedure include: bruising of the skin after venapunction and allergic reaction to USPIO particles.

The application of USPIO neuroimaging can improve diagnosis of patients with suspected glioblastoma, provide more information on the pathophysiology of growth of glioblastoma lesiosn, the role of neuro-inflammation in these lesions and maybe predict regions of tumor recurrence after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 75 years
* Diagnosed with suspected glioblastoma
* Eligible for neurosurgical resection and/or chemoradiation therapy.

Exclusion Criteria:

* Younger than 18 years old
* Patients unfit for surgery or lesions unsuitable for neurosurgical treatment
Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital

The purpose of this study is to determine if vaccination rate of eligible patients at a major urban public hospital will increase by having ophthalmologists screen patients for eligibility and a nurse administer the vaccine in the General Eye Clinic.

Patient vaccination behaviors will be assessed after 100 doses of the Zostavax vaccine are provided to underserved patients screened by ophthalmologists at the General Eye Clinic at a public hospital that does not normally provide the vaccine. A nurse will be at the clinic to administer the vaccine. Patients will be contacted by phone 1 month later and seen within 3 months in the Eye Clinic to determine whether there were any side effects.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* Absence of evidence of immune compromise in the medical record
* Ability to speak and read English, Spanish or Chinese and give informed consent

Exclusion Criteria:

* Vulnerable patients, including the cognitively impaired, prisoners and employee
* FDA contraindications for Zostavax vaccine