cyrilzakka/clinical-trials huggingface dataset:
Technology-Enhanced Palliative Care for Advanced Cancer Patients

This trial investigates technology-enhanced palliative care for patients in phase I trials with cancer that has spread to other places in the body (advanced). The goal of this study is to learn if the technology-enhanced palliative care symptom-monitoring program, when combined with in-person clinic visits and standard remote care visits (by phone or video call), helps increase quality of life and care for patients with advanced cancer participating in phase 1 immunotherapy trials.

PRIMARY OBJECTIVE:

I. To assess the effect size of each palliative care intervention technology-enhanced palliative care, standard palliative care \[SPC\]) on the symptom burden of patients prior to or while on a phase I trial.

SECONDARY OBJECTIVES:

I To estimate the effect size of each palliative care intervention (TEC, SPC) on symptom burden over a 12-week period of a phase I trial.

II. To estimate the effect size of each palliative care intervention (TEC, SPC) on clinical outcomes at 6 months post-enrollment.

III. To qualitatively assess patients' and caregivers' perceptions of receiving each TEC-based palliative care (PC) Intervention.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive standard symptom management by palliative care team once every 4 weeks for 12 weeks. Patients and caregivers also may participate in an interview with supportive care nurse over 30-45 minutes during week 8.

ARM II: Patients in Phase I immunotherapy trials will receive in-person clinic visits or standard remote care encounters at least once every 4 weeks and the e-ESAS and PC provider-initiated remote contact every week. Patients and caregivers may participate in an interview with supportive care nurse over 330-45 minutes during week 8.

ARM III: Patients in Phase I non-immunotherapy clinical trials will receive in-person clinic visits or standard remote care encounters at least once every 4 weeks and the e-ESAS and PC provider-initiated remote contact once a week. In all 3 arms, follow-up communication will occur as deemed necessary by the PC team. Patients and caregivers may participate in an interview with supportive care nurse over 30-45 minutes during week 8.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT: Diagnosis of advanced solid tumor
* PATIENT: Oncologic plan for a phase I trial
* PATIENT: High symptom burden (defined as a score of \>= 4 on at least 1 Edmonton Symptom Assessment Scale \[ESAS\] symptom, AND a global distress score \[GDS\] of \>= 20)
* PATIENT: Reliable telephone and internet access
* PATIENT: Able to communicate verbally in English and provide informed consent
* CAREGIVER: Able to communicate verbally in English and provide informed consent
* CAREGIVER: Reliable telephone and internet access

Exclusion Criteria:

* PATIENT: Low symptom burden defined as scores \< 4 on all ESAS symptoms OR GDS \< 20
* PATIENT: Delirium (i.e. Memorial Delirium Assessment Scale \> 8)
* PATIENT: No reliable telephone or internet access
* CAREGIVER: Refusal to participate in this study
* CAREGIVER: No reliable telephone or internet access
Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy

The purpose of this study is to assess the neurological efficacy of acupuncture in patients with cancer who experienced peripheral neuropathy, which is induced by chemotherapy.

Background: Chemotherapy may lead to peripheral neuropathy up to 40% in cancer survivors, especially in some types of patients with cancer. The effect of acupuncture, an ancient Chinese medicine technique, was recognized by the World Health Organization (WHO) in the treatment of several diseases. The postulated mechanisms associated with acupuncture in analgesia or neurogenesis are still under investigation. Considering a moderate recommendation for duloxetine in the treatment of chemotherapy-induced peripheral neuropathy (CIPN) based on based on neuropathic pain, and a few treatment options with evidence for CIPN, acupuncture might be another option. Nowadays, only small scale pilot studies provided initial proof of acupuncture in CIPN, particularly in decreasing neuropathic pain and improving neurotoxicity, the study aims to determine the beneficial effects of acupuncture on CIPN with a large-scale, multicenter, randomized sham-controlled clinical trial. Furthermore, the aim of the study will provide evidence for the clinical therapeutic guideline of CIPN in the future.

Eligibility Criteria:
Inclusion criteria:

The study will enroll patients with a symptom of peripheral neuropathy, including paresthesia, numbness, glove-and-stocking sensory loss distribution or pain in four limbs, and meet the following inclusion criteria:

1. All adult cancer patients (Age≧20-year-old) who received chemotherapy regimens, including adjuvant and neoadjuvant therapy
2. Stage I-III cancer patients
3. Completed chemotherapy regimens more than3 months, including Taxanes (paclitaxel or docetaxel), platinum (cisplatin, oxaliplatin, carboplatin)
4. Baseline von Frey Monofilament test (Target force at hand) ≧ 0.07gms
5. Baseline von Frey Monofilament test (Target force at foot) ≧ 0.4gms
6. Eastern Cooperative Oncology Group (ECOG) performance status ≦3
7. Grading of peripheral sensory neuropathy in National Cancer Institute- common terminology criteria for adverse events,v5.0 (NCI-CTCAE5) ≧1
8. Patients were restricted acupuncture treatment for one month before recruitment
9. Written patient informed consent

Exclusion criteria:

Participants with any of the following conditions will be excluded:

1. Uncontrolled Diabetic Mellitus, HbA1c≧7% is inappropriate\[19\].
2. Diabetic neuropathy diagnosed before receiving chemotherapy
3. Neuropathy from any type of nerve compression (e.g., carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy)
4. Concomitant with duloxetine, or another analgesia, including Pregabalin, Venlafaxine, Minocycline, Topical gel, Oxycodone, Naloxone, Cannabinoids, and Angiotensin II type 2 receptor antagonist
5. Severe hemorrhagic coagulopathy or bleeding tendency
6. Unstable cardiovascular disease
7. Severe skin lesions around the treatment sites The researchers will exclude any participants considered to be inappropriate for the study.
Studying Biomarkers in Patients With Pancreatic Cancer

RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with pancreatic cancer.

OBJECTIVES:

* To determine whether the cellular localization of BRCA1 can predict how patients with pancreatic cancer will respond to cytotoxic agents (e.g., fluorouracil or gemcitabine hydrochloride) or radiotherapy.
* To identify pre-treatment markers that can be used to correlate with clinical outcomes of survival and recurrence.
* To determine if a method of extracting and identifying secreted cytokines and growth factors from biopsy tissue can now be applied to the pancreatic cancer population.

OUTLINE: Tissue samples from biopsies performed during pancreatectomy are collected from the Vanderbilt Ingram Cancer Center Human Tissue Acquisition Core for laboratory biomarker studies. Proteins secreted by cancer cells and/or cancer-associated cells are studied by extracting and identifying secreted cytokines and growth factors from biopsy tissue. The integrity of the DNA repair pathway in pancreatic cancer is analyzed by Rad51 and phosphorylated DNA-PK foci formation. Markers are correlated with clinical outcome.

Patients are followed for recurrence, relapse, and death from disease.

Eligibility Criteria:
Inclusion criteria

* Any subject with excess tissue collected at time of routine surgery for pancreatic cancer is eligible.
* All subjects participating in this protocol will be followed for recurrence, relapse and death from disease
Physical Recovery After Laparoscopic vs. Open Liver Resection

The role of laparoscopic liver surgery with respect to clinical outcome remains unclear.

The role of laparoscopic liver surgery with respect to clinical outcome remains unclear. The investigators hypothesized that laparoscopic liver resection (LLR) is associated with better postoperative recovery than open liver resection (OLR).

Twenty-one patients who underwent LR were included in this study (11 OLR (52.4%) and 10 LLR (47.6%), respectively). Postoperative recovery was measured by bicycle stress testing at months 1 and 6 after surgery and compared to preoperative stress testing. Standardized performance for bicycle stress testing was calculated based on age, sex, height and weight. Postoperative recovery was compared between groups as change of performance (%).

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing liver resection (open vs. laparoscopic)
* all patients willing participate and gave written informed consent

Exclusion Criteria:

* pregnancy
* significant traumatic injury within 30 days prior to study enrolment
* inability or unwillingness to comply to the protocol or to perform bicycle ergometry
Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device

The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.

Primary objective:

- To assess the safe usability of the VIBEX MTX device for subcutaneous (SC) self-injection of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) after standardized training by site personnel and review of written instructions

Secondary objectives:

* To evaluate the reliability and robustness of the VIBEX MTX device
* To evaluate the safety and local tolerance of an SC self-injection of MTX using the VIBEX MTX device
* To evaluate the effectiveness and ease of use of the VIBEX MTX device patient education tools for SC self-injection

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \>18 years of age, diagnosed with Rheumatoid Arthritis

Exclusion Criteria:

* Pregnant females
* Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk
Generic Testing of Antigen Tests for COVID-19 in Denmark

To evaluate the analytical and clinical sensitivity and specificity of antigen tests performed as oropharyngeal swabs, outer nasal swabs, saliva swabs or breath tests including self-tests for SARS-CoV-2 towards standard RT-PCR testing.

For each test 200 SARS-CoV-2 positive and 200 SARS-CoV-2 negative individuals previously defined by RT-PCR are tested. When tested an additional RT-PCR test is performed to verify status.

Analytical sensitivity and specificity is determined on 210 SARS-CoV-2 positive samples with known Cq and 100 SARS-CoV-2 negative samples.

30 companies with a total of 55 tests participate in this nationwide study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over,
* Capacity to give informed, written consent
* Be able to cooperate to the additional testing.

Exclusion Criteria:

* Individuals not fulfilling the inclusion criteria
* Declining additional oropharyngeal, nasal or saliva swabs.
Measurement of Lipogenic Flux by Deuterium Resolved Mass Spectrometry Via Non-invasive Breath Analysis

This proof of concept- study is to measure de novo lipogenesis (DNL) non-invasively in exhaled breath in overnight-fasted humans by triggering feeding response by deuterium resolved mass spectrometry.

The study objective is to measure the DNL by ingestion of a single oral dose of 70% 2H2O at 2 g/kg body-water. The subjects will consume a Yoghurt consisting of 300g of 'Excellence Joghurt Nature gezuckert' which contains 410 Kcal, 28g fat, 34g carbohydrates and 9g protein. The exhaled air of the subjects will be measured several times per hour to analyse de novo lipogenesis (DNL) non-invasive by deuterium resolved mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers
* English speaking, or good knowledge of the English language
* Able to understand the study
* Able to give informed consent

Exclusion Criteria:

* Current pregnancy
Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of Sepsis Scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy

Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of sepsis scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non M3 Acute Myeloid Leukemia according to WHO (World Health Organization) 2008 criteria
* Age \>= 18 years and \<= 70 years
* Patient had received intensive chemotherapy either as induction or consolidation regimen
* Period of observation: January 2001 - December 2019
* Written informed consent

Exclusion Criteria:

* Diagnosis of Acute Promyelocytic Leukemia (M3 AML)
* Age \< 18 or \>70 years
* Patient had not received intensive chemotherapy
The Adherence of Immunosuppressive Therapy Including Tacrolimus Once-daily in Italian Kidney Transplant Recipients

Non-adherence is widespread in the transplant community. Addressing issues associated with non-adherence remains a key challenge in transplantation, in part due to the difficulty in assessing its prevalence, as there is currently no 'gold standard' for use in routine clinical practice.

The purpose of this study is to evaluate the non-adherence to immunosuppressive therapy, including tacrolimus once-daily, among Italian kidney transplant recipients receiving. Along with non-adherence evaluation, possible factors related to NA will be investigated (patient-related, condition/disease-related, therapy/treatment-related, etc.).


Eligibility Criteria:
Inclusion criteria:

1. Adult (≥ 18 years) recipients of a deceased- or living-donor kidney transplant since maximum 12 months.
2. Recipients with a functioning graft
3. Patients receiving tacrolimus once-daily as part of their IS therapy since minimum 2 months.
4. Patients who have signed informed consent form and privacy form.
5. Patients capable of discernment and able to read and write in Italian language.

Exclusion criteria:

1. Patients received or planned to receive, a non-renal solid organ transplant, a simultaneous pancreas-kidney transplant, or a bone narrow transplant.
2. Patients who already received a kidney transplant (re-transplant).
3. Patients enrolled or planned to be enrolled in any clinical study.
4. Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.
Yoga on Arrhythmia Burden and Quality of Life in Paroxysmal Atrial Fibrillation

Studies in the past have shown that yoga could relieve stress which is the most common trigger for recurrent episodes of atrial fibrillation. Breathing exercises in yoga are found to influence the autonomic nervous system (particularly parasympathetic) and thus reduce palpitations. This study hypothesizes that patients with atrial fibrillation might benefit by practicing yoga. Yoga may also help to better control heart rate and rhythm when used in combination with usual medical management.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with paroxysmal atrial fibrillation ages 25-80

Exclusion Criteria:

* Advanced malignancy or severe co-morbid conditions such as severe heart failure and with life expectancy less than 1 year
* Pregnant women
* Unmedicated or uncontrolled high blood pressure
* A past history of pneumothorax
* Severe cervical spondylitis and cervical, thoracic or lumbar disc prolapse
* Carotid stenosis
* History of psychosis or substance abuse
* History of epilepsy
* Glaucoma
* History of total hip replacement
* Ablation within 3 months of the start date of study
* Patients who have not seen a cardiovascular physician in the last year
Effect of Manual Massage Technique on Swelling, Pain and Mouth Opening After Bilateral Lower Third Molar Surgery

The aim of this study was to evaluate the effect of manual lymphatic drainage on pain, edema and trismus after impacted mandibular third molar surgery.

This study is a randomized controlled split-mouth trial. A total of 46 healthy patients who presented to our department for the extraction of impacted mandibular third molars were included in this study.The inclusion criteria were as follows: presence of pericoronal infection, no recent use of anti-inflammatory medications, symmetrical impactions on both sides, asymptomatic cases, and class 2, position B or C, vertical and mesioangular impactions. Impactions were classified using the Pell and Gregory classification system.

Exclusion criteria included patients who declined participation, pregnant or lactating individuals, patients with penicillin allergies, those with chronic diseases that could affect healing, uncooperative patients. Following the surgery, manual lymphatic drainage therapy was administered in the afternoon of the same day by a professional physiotherapist using the "Vodder" technique. In this study, measurements were conducted by two researchers. Swelling and trismus values were recorded preoperatively (T0), on the 3rd postoperative day (T1), and on the 7th postoperative day (T2). To assess pain, the VAS was used and values were recorded 1, 2, 3 and 7 days postoperatively. In this study, edema was evaluated using the 3dMD FACE SYSTEM (3dMD, Atlanta, GA), which virtually transfers the patient's face into 3D, allowing for the calculation of volume changes.To assess pain, the Visual Analog Scale (VAS) was used.To determine the effect of MLD therapy on postoperative trismus, the distance between the upper and lower incisors was measured using a digital caliper immediately before the operation, as well as on the 3rd and 7th postoperative days

Eligibility Criteria:
Inclusion Criteria:

* good general health conditions;
* presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);

Exclusion Criteria:

* no clinical evidence of major facial asymmetry;
* use of medication that would influence or alter wound healing;
* temporomandibular joint disorder history;
* smoking
Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet

Low Carbohydrate Diet (LCD) (\< 130 g of carbohydrate per day) and ketogenic diet (\< 50 g of carbohydrate per day) are popular among patients with type 1 diabetes (T1D). In most cases, LCD allow a better glycemic control and a important decrease of insulin requirements that cannot, however, be the sole result of low carbohydrate intake. However, due to the increase production of ketone bodies and the decrease of the insulin/glucagon rate, this diet is not without risk in T1D patients and some of them develop ketoacidosis.

Type 1 diabetes is a autoimmune disease defined by the destruction of the pancreatic beta cells by the effector T cells, in condition of low regulatory T cells (Tregs). Indeed, some nutrients could regulate the plasticity and the function of Tregs, and be involved in the control of some autoimmune diseases in animals models thanks to a direct effect on immune cells of the digestive tract or an indirect effect by microbiota modulation.

The study hypothesises that LCD may be able to restore residual insulin secretion in some patients by modulating immunity. The metabolic mechanisms leading to the effects described in patients with T1D patients under LCD have not been studied : in particular, there is no data on the evolution of the residual insulin secretion and no immunological parameter has been studied on these patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* type 1 diabetes for less than 20 years
* willing to start a low carbohydrate diet of less than 75 g per day
* under continuous glucose monitoring
* having been informed about the study and having given their written and informed consent

Exclusion Criteria:

* already on a low carbohydrate diet of less than 100 g per day
* history of ketoacidosis within the last 5 years, except during diabetes diagnosis
* autoimmune disease, except thyroiditis
* immunosuppressive treatment
* hepatitis B virus, hepatitis C virus or human immunodeficiency virus infection
* ongoing cancer or history of cancer within the past 5 years, except in situ cervical cancer or basal cell cancer with early treatment
* participation to another interventional study within the past 3 months
* pregnancy or breast feeding
* no affiliation to a social security scheme
* patients subject to legal protection measures
* unability to give consent for the study
The Impact of Soft Contact Lenses on the Corneal Neuromediators and Optical Quality in High Myopia Prior to SMILE

To investigate the influence of Neuromediators expression in corneal stromal lenticules and corneal injury repair after small incision extraction

This study included 160 eyes from high myopia patients who underwent Small Incision Lenticule Extraction. Patients were devided into three groups based on duration of wearing SCLs: \> 10 years group, ≤ 10 years group, and NW group (not SCLs). Corneal higher-order aberrations and densitometry were evaluated using a Pentacam system. Neuromediator levels in corneal stromal lenticules were analyzed using ELISA and immunofluorescence

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years with stable refraction for at least two years;
* spherical equivalent (SE) \< -6.00 D;
* corrected distance visual acuity of 20/20 or better;
* no history of using rigid gas permeable lenses or orthokeratology (OK) lenses prior to examination

Exclusion Criteria:

- a history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery.