cyrilzakka/clinical-trials huggingface dataset:
The Role of Skin Microbiota in Hepatic or Renal Pruritus

* Various neurotransmitters may share in the pathogenesis of hepatic and renal itching.
* Skin microbiota may share in the pathogenesis of pruritus.

Uremic pruritus (UP) is a frequent phenomenon and it is regarded as one of the most bothersome symptoms in patients with chronic renal disease. The prevalence of UP is still high and reported in around 40% to 50%. UP has an important impact on patients' quality of life and sleep, depression, and increased mortality. The pathogenesis of UP remains blurry, although many different factors have been indicated in the etiology of this symptom, including increased systemic inflammation, abnormal serum parathyroid hormone, calcium, and phosphorus levels, an imbalance in opiate receptors, a neuropathic process, or even skin dryness. This is why until now there is no specific treatment for patients with UP and many of the available therapeutic modalities are not satisfactory Pruritus in liver diseases can often be a debilitating symptom causing significant impairment in quality of life. Not all patients with liver disease develop pruritus and its prevalence varies depending on the underlying cause of liver disease. It is more common in conditions characterized by bile duct inflammatory destruction than in those characterized by hepatocellular injury.

Cutaneous microbiota delivers a diverse and far-reaching influence on our physiology by calling upon the host nervous system. Bacteria make metabolites, toxins, and structural components that are recognized by peripheral and central neurons via matching receptors. Microbiota also indirectly affects neural function by causing endocrine (i.e., keratinocytes) and immune cells to transmit signals (i.e., cytokines, proteases). Itch is a prototypic sensory neural function, and the microbiota propels the itch-scratch cycle.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes. Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) or Patients with renal failure Willing to sign an informed consent.
A Pilot Study on Effect of add-on Sulforaphane to SSRIs and Application of Niacin Skin Flush Response Test in Major Depressive Disorder

A 12-week, randomized controlled trial (RCT) will be conducted to explore the effect of add-on sulforaphane (SFN) to selective serotonin reuptake inhibitors (SSRIs) for major depressive disorder (MDD). This study also aims to explore the value of niacin skin flush response test in MDD. One hundred adults diagnosed with MDD will be recruited. Then all the patients will be randomly assigned to SSRI only group and SSRI plus SFN group. Clinical symptoms and side-effects will be evaluated using the 17-Hamilton Depression Rating Scale (17-HDRS), the Hamilton Anxiety Scale (HAMA), Treatment Emergent Symptom Scale (TESS), and Asberg's Rating Scale for Side Effects (SERS) at baseline and weeks 2, 4, 8 and 12 after treatment. Fifty healthy subjects will be recruited as control group. For all subjects, testing of niacin skin flush response and serum levels of nuclear factor erythroid-2-related factor 2(Nrf-2), p-Nrf2, Heme Oxygenase-1 (HO-1), malondialdehyde (MDA) and erythrocyte glutathion peroxidase (GPX) will be performed at baseline and endpoint. The primary outcome is the reduction rate in 17-HDRS total score from baseline to the end of the study. The secondary outcomes include changes in niacin skin flush response test and levels of serum markers. All the data will be analyzed by SPSS software.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18-60 years;
2. diagnosed with moderate or severe depressive disorder according to the criteria of the DSM-5;
3. total score of 17-HDRS≥17;
4. never receiving electroconvulsive therapy (ECT)/modified ECT (MECT)/rTMS or other treatments in the past month;
5. having sufficient audio-visual ability and comprehension;
6. signed informed consent statements.

Exclusion Criteria:

1. serious or active somatic illness (abnormal index values were more than twice the limit of normal);
2. a history of mania/hypomania;
3. current high risk of suicide (score of item 3 of 17-HDRS ≥ 3);
4. pregnant or lactating women, or planning pregnant women;
5. taking immunosuppressants or vitamins recently.
Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion to ICU Patients

The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine total and free flucloxacillin concentrations in 30 ICU patients, who will get continuous (n=10) or intermittent infusion (n=20) of flucloxacillin as standard care.

Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing regimen and limited sampling will be taken for individual patients on the continuous dosing regimen on day 2 and 4.

The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared to non-ICU patients. There is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU. To prevent the risk of inadequate dosing in critically ill patients, it is important to optimize dosing regimens in ICU patients.

With this study the investigators will define pharmacokinetics of flucloxacillin in ICU patients and search for variables influencing pharmacokinetics. By using population modeling the investigators will simulate different dosing regimens, intermittent and continuous, and compare probability of target attainment between continuous and intermittent infusion.

To be able to include 30 patients within the study duration, a multi-centre approach is necessary.

Patients will receive standard care, as stated in the product characteristics or according to local protocols. Minimally invasive blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter or an arterial line. Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing regimen and limited sampling will be taken for individual patients on the continuous dosing regimen on day 2 and 4.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is admitted to an ICU
2. Subject is at least 18 years old on the day of the first dosing
3. Is managed with a central venous catheter or arterial line
4. Patient is treated with flucloxacillin

Exclusion Criteria:

1. Has previously participated in this trial
Influence of Central Obesity on the Esophageal Epithelial Barrier

This study is being done to help understand why some people with an increased amount of central obesity, without gastroesophageal reflux, develop changes to the lining of their esophagus that can potentially lead to esophageal adenocarcinoma (cancer).


Eligibility Criteria:
Inclusion Criteria:

Participants who are undergoing clinically indicated upper endoscopy with Bravo ambulatory pH capsule (off reflux medications for 7 days), in the Esophageal Clinic at Mayo Clinic.

Exclusion Criteria:

1. Pre-existing or suspected Barrett's Esophagus (\> 1cm of columnar mucosa in esophagus on endoscopy
2. Oral anticoagulation precluding endoscopic biopsies
3. Patients with known hypersensitivity to fluorescein sodium.
Compartmental Inflammation in Mechanically Ventilated Patients With COVID-19

The aim of the present study is to examine the inflammatory response in the pulmonary compartment and blood of critically ill patients admitted to the ICU with COVID-19.

The mechanisms of the ARDS-like respiratory failure observed in patients with COVID-19 are currently unknown, but may be related to a distinct local immune response within the lung. In the present study, we will examine the cellular and humoral pulmonary immune response in mechanically ventilated patients admitted to the ICU with COVID-19 by examining immune cell profiles, cytokine patterns, and the complement pathway in bronchoalveolar lavage fluid, and relate it to the concomitant systemic inflammatory response. We will examine the patients on day 1-3 and 7-9 after ICU admission.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18y
* Mechanical ventilation
* Verified COVID-19 (throat swab or tracheal aspirate positive for SARS-CoV-2)
* ARDS according to the Berlin definition

Exclusion Criteria:

* Untreated malignant tachycardia or bradycardia
* Suspected or verified intracranial hypertension (ICP \> 15 mmHg)
* Unilateral lung ventilation
* Severe non-correctable coagulopathy
Investigation of the Acute Calming Effects of Drinks Containing Herbal Extracts in Healthy Adults

The primary objectives of this study are to assess the effects of three investigational drinks containing three botanicals in differing combinations versus a placebo control, on mood, psychological state, physical response, and cognitive performance during and after exposure to an observed multi-tasking stressor.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 49 years
* Self-report of good health
* Are not excluded on the basis of the following exclusion criteria

Exclusion Criteria:

* Are a smoker
* Have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff
* Currently take medication except the contraceptive pill
* Have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
* Have sleep disturbances and/or are taking sleep aid medication Are employed in a job that includes night shift work
* Have a Body Mass Index (BMI) outside of the range 18-35 kg/m2or weigh less than 50kg or more than 85kg.
* Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg)
* Have a history of neurological, vascular or psychiatric illness including epilepsy or seizures (excluding depressive illness and anxiety)
* Have a history of anxiety or a current diagnosis of anxiety or depression
* Are pregnant, trying to get pregnant or breast feeding
* Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units)
* Have learning difficulties or dyslexia
* Have visual impairment that cannot be corrected with glasses or contact lenses
* Have frequent migraines that require medication (more than or equal to 1 per month)
* Have disorders of the blood (e.g. anaemia, hemophilia, thrombocytosis)
* Have a heart disorder or a history of vascular illness
* Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)
* Have a diagnosis of type I or type II diabetes
* Have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation
* Have any health condition that would prevent fulfillment of the study requirements
* Are currently or have in the past 8weeks participated in other clinical or nutrition intervention studies
* Have participated in the BPNRC's recent stress study
* Do not have a bank account (required for payment)
Safety, Feasibility and Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Pilot Study

Gastric cancer is a major health issue and one of the most common malignance in Korea. With the popularization of cancer screenings and increasing the average lifespan, the number of gastric cancer patients is increased. In the past, most of the research were concerned with survival and recovery after cancer surgery. However, as the medical technology had been developed and recovery rate and survival rate of cancer patients had risen, the patients wanted to return to a daily life and desire for participation for leisure. In other words, the patients who underwent surgery wants to maintain a high quality of life(QOL) level as like prior to cancer surgery.

There are many reports on the effect of the exercise program after cancer surgery. In addition, exercise program was associated with improving the QOL and functional recovery, decreasing a mood of depression, maintaining a muscle mass and improving the survival rate.

However, the subject patients of previous studies were Western people. Therefore, The results were not disclosed whether the exercise program suited to the body characteristics of Korean people. Furthermore there was no exercise program studies for the gastric cancer patients.

Medical service for cancer patients care should include not only diagnosis, treatment as like surgery but efforts on enhancing the quality of life. In other words, post-management education and management program as like exercise program are necessary for the cancer patients after surgery. So, the research about how to practice the exercise program and how to evaluate the effect on the recovery is needed.


Eligibility Criteria:
Inclusion Criteria:

1. Early gastric cancer patients
2. Undergoing minimally invasive surgery
3. AGE: 20-70
4. ECOG: 0-1
5. A patient who did not exercise regularly for the last 6 months
6. A patient who signed the informed consent

Exclusion Criteria:

1. Pregnancy or plans to become pregnant
2. Cognitive disabilities
3. Other primary cancer history
4. History of major abdominal surgery except current surgery
5. Cardiopulmonary medical comorbidity
6. Living \> 60 km from the hospital
Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors

The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity. This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden. The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Stage I-III breast cancer within the last 5 years
2. Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
3. English speaking
4. Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
5. Own a smartphone
6. Have access to a computer with Internet
7. Participants may be using adjuvant endocrine therapies.
8. Willing to be waitlisted for future wave if current wave reaches capacity

Exclusion Criteria:

-Women will be excluded if they report any of the following:

1. Respiratory, joint or cardiovascular problems precluding physical activity
2. Metastatic disease
3. Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).

ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION:

1. A prior cardiovascular event (i.e. stroke, myocardial infarction)
2. Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)
Effect of Rituximab on Immunological Recall Response to Specific Antigens in the Treatment of Non-Hodgkin's Lymphoma

The purpose of this study is to provide treatment for patients who have relapsed Non-Hodgkin's lymphoma (NHL) or refractory NHL, and to test the immunity of study subjects after receiving four treatments with rituximab.


Eligibility Criteria:
Inclusion Criteria:

* Signed IRB-approved informed consent.
* Age \>/=40 years.
* Men and women of reproductive potential who are following accepted birth control methods.
* Histologic confirmation of low-grade or follicular, B-cell NHL prior to study entry.
* Relapsed (maximum of 5 relapses) or refractory, low-grade or follicular, CD20+,B-cell NHL.
* WHO performance status \</= 2.
* Expected survival \>/= 1 year.
* Acceptable hematologic status, liver function, renal function, and pulmonary function.
* Patients must be recovered from all nonhematological toxicities associated with prior surgery, radiation treatments, chemotherapy, biological therapy, bone marrow transplant, investigational drugs, or immunotherapy.
* Known history of tetanus toxoid immunization or positive tetanus titer at the screening visit.

Exclusion Criteria:

* Active autoimmune disease.
* Exposure to rituximab within 12 months prior to Day 1.
* Chemotherapy within 3 months prior to Day 1.
* Previous immunization with tetanus toxoid within 2 years prior to Day 1.
* Previous exposure to KLH.
* Receipt of intravenous or intramuscular immunoglobulin (IVIG or IMIG) within 30 days of Day 1.
* Known history of hepatitis or other hepatic disease, HIV infection, or AIDS.
* Current use (including "recreational use") of any illicit drugs or history of drug or alcohol abuse within the 5 years prior to Day 1.
* Prior diagnosis of aggressive NHL or mantle-cell lymphoma.
* Chronic lymphocytic leukemia (CLL).
* Small lymphocytic lymphoma (IWF A) with peripheral blood lymphocyte count \> 5,000 cells/mm3.
* History of other primary malignancy, with the exception of squamous cell carcinoma or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer for which the subject has not been disease free for at least 3 years.
* Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active, uncontrolled bacterial, viral, or fungal infection; or any other condition that would compromise protocol objectives in the opinion of the investigator and/or sponsor.
* Known allergies or contraindications to tetanus toxoid or KLH.
* Known allergy to shellfish.
* Presence of protein-losing enteropathy.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.
* Participation in another clinical study with an investigational agent or device within the last year. The subject cannot participate in any other clinical study with an investigational agent or device during the course of this study.
* Pregnant or lactating female subjects
Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer

The purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells. The tumor DNA fragments are referred to as circulating tumor DNA, or ctDNA for short.

Rectal cancer tissue samples that were collected from participants' previous biopsies will be sent to Natera for Signatera assay creation after enrollment onto the study.

One 6 mL tube of blood will be obtained at baseline prior to initiation of treatment. Blood will also be obtained in two 6 tubes at the following points: 3-4 weeks into chemoradiation therapy (CRT), after CRT, after chemotherapy, after surgery for those who undergo resection, and during surveillance 3 months after surgery or at the end of treatment for one year after completion of TNT (total neoadjuvant therapy).

The primary objective of the study is to estimate the percentage of patients with positive ctDNA at the end of TNT .

The secondary objectives of the study include:

1. Estimating the change in ctDNA after chemoradiation and chemotherapy
2. Characterize the correlation of complete response to TNT with presence or absence of ctDNA
3. Describe the recurrence rate in participants with and without ctDNA after TNT
4. Characterize the correlation of ctDNA at end of TNT with recurrence free survival at 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Newly histologically documented rectal adenocarcinoma or biopsy-proven adenoma with MRI rectum and CT chest/abdomen or PET/CT imaging consistent with stage II or III disease
* Plan is for participant to undergo standard TNT with induction chemoradiation
* Age ≥ 18 years of age

Exclusion Criteria:

* Stage I, recurrent, or metastatic rectal cancer
* Received prior therapy for this rectal cancer
* No baseline tumor biopsies with adenocarcinoma or adequate amount of tissue from biopsies available to send for SignateraTM assay development
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

18\~75 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,SD OR PR,the CR patients should accept 6 course of combination chemotherapy.

3\~8 weeks after patients complete first line chemotherapy(include radiotherapy) Ecog0-2 Expected life time longer than 3 monthes

Normal laboratory values:

* leucocyte ≥ 4×109/L
* neutrophil ≥ 1.5×109/L
* platelet ≥ 100×109/L
* Hemoglobin ≥ 10g/L
* ALT and
* AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) Signed written informed consent

Exclusion Criteria:

* Patients have used drugs according to protocol
* Uncontrolled infection of Bacterial or virus or fungal
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Female patients during their pregnant and lactation period, or patients without contracep
Compliant Analysis of Patient Samples and Data

Patients of scientific interest who have provided a commercial sample to LabCorp or one of its' affiliates will have their de-identified remnant samples and/or data used for research and development. Other commercial patients will be followed up on after informed consent is obtained.

Arm 1 - Remnant commercial samples and data that has been de-identified of personal health information in compliance with HIPAA may be used for R\&D studies or population-based analysis by LabCorp or affiliates.

Arm 2 - Collection of samples and/or data from commercial test patients requiring follow-up or from subjects of scientific interest after informed consent is obtained.

Eligibility Criteria:
Inclusion Criteria:

* Arm 1
* All samples and data are de-identified and HIPAA compliant
* Arm 2
* Subject is of scientific interest to the Sponsor or treating physician
* Subject provides written informed consent and has a clinical sample and/or supporting clinical data collected.

Exclusion Criteria:

* Arm 1
* Subject is from a US state or a country where local law restricts the use of de-identified data and/or remnants of specimens for research and/or development
* Arm 2
* Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent