cyrilzakka/clinical-trials huggingface dataset:
Effect of Probiotics on Amino Acid Absorption

The goal of this clinical trial is to test effects of consuming probiotics in healthy adults. The main question it aims to answer is:

• Do consuming probiotics affect a healthy adult's ability to absorb amino acids from plant proteins?

Participants will

* Consume one dose of probiotic pills per day after meals for two weeks
* Consume one dose of plant-based plant protein beverage after an overnight fast and collection of one 5 ml fasting blood sample
* Undergo blood draw of 6 more 5 ml blood samples for the next 3 hours after consuming plant-based protein beverage

There is increasing evidence that the gut microbiota contributes to a range of immune, inflammatory, and metabolic responses. Numerous studies have shown that administrating probiotics - strains of bacteria that benefits intestinal function - confer benefits to the host's immune system. Except for soy protein, plant proteins are incomplete proteins lacking in one or more essential amino acids. The incomplete amino acid profile of most plant proteins is compounded by their lower rate of absorption as compared to animal protein. Hence, the investigators aim to investigate the administration of probiotics as a potential strategy to overcome compositional shortcomings of plant proteins by improving the gastrointestinal absorption of plant-based proteins.

The aim of Stage 1 is to formulate a plant-based protein beverage with optimized amino acid profile with consumer acceptance.

Stage 2 of this study will be to conduct a randomized, double-blind, placebo-controlled, crossover trial using the formulation developed in Stage 1, together with probiotics supplementation to evaluate the effect of probiotics on the absorption of amino acids from plant proteins.

The probiotics to be studied will be provided by the Asian Microbiome Library (AMILI) with the plant protein beverage to be developed within SIT. Findings from this mutually beneficial collaborative project with AMILI will pave the way to further understand the role of probiotics in human health, particularly its effect in nutrient absorption of plant protein.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to comply with study procedures and give written informed consent
* Self-reported to be healthy
* Within healthy BMI weight range (18.5-23kg/m2)

Exclusion Criteria:

* Any chronic medical condition
* Individuals who were treated for or diagnosed with a gastrointestinal, cardiac, respiratory, circulatory, musculoskeletal, metabolic, immune, autoimmune, haematological, neurological or endocrinological disorder
* Antibiotic use
* Prebiotics, probiotics, synbiotics, and/or digestive enzymes use
* Food allergy/intolerances/avoidances towards eggs, soya, peanuts, tree nuts, crustaceans, and gluten
* Smoking
* Alcohol consumption
Resection of the Primary Tumor vs. Systemic Treatment Alone for Patients With Small Intestinal Neuroendocrine Tumors and Unresectable Metastases: a Europe-wide Study

When possible, surgery to completely remove small intestinal neuroendocrine tumors (siNETs) is always recommended. However, in cases where the tumor has spread and cannot be cured completely, it is unclear whether a surgical removal of the primary tumor only is reasonable. In this situation, current guidelines from the European Neuroendocrine Tumor Society (ENETS) recommend surgery only for patients who have symptoms like intestinal blockage or bleeding, or are at risk of such complications. For patients without symptoms, it is still unclear whether removing the main tumor improves overall outcomes and prevents future problems.

Studies evaluating this type of surgery on survival show conflicting results. These studies often do not separate patients with symptoms from those without, and they overlook other important factors like the amount of cancer in the liver and nearby tissues. Due to these uncertainties, the rarity of siNETs and many factors that can affect outcomes, like age, overall health, or other current treatments, conducting a high-quality study to answer this question is challenging. To address this, the present Europe-wide study is being planned.

This study aims to determine if resecting the main tumor improves the 10-year overall survival and reduces risks like intestinal blockages or blood flow issues compared to no surgery in patients without symptoms. The study will also assess other outcomes, such as how long patients stay free from disease progression, the risks of surgery, and prognostic factors for long-term survival. This international collaboration among neuroendocrine tumor referral centers will provide robust evidence to guide clinical practice and update treatment guidelines for siNETs.


Eligibility Criteria:
Inclusion Criteria:

- All patients with siNET and non-curative metastatic disease between 01.01.2005 and 31.12.2019 will be included.

Exclusion Criteria:

- All patients with siNET G3, resectable metastatic disease and/or non-resectable primary tumor at initial diagnosis will be excluded. Furthermore, symptomatic patients (small intestinal obstruction, bleeding) or when imaging suggests that obstruction will probably occur (bowel dilatation, mesenteric fibrosis) at initial diagnosis will be excluded. Patients with diarrhea, flushing, or abdominal pain will not be excluded.

Patients with a documented rejection for a further use of their data for scientific purposes will also be excluded.
A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers

In this study, PP-001 eye drops are assessed for safety and tolerability in healthy, adult volunteers. PP-001 is a novel, anti-inflammatory small molecule that inhibits a specific enzyme (Dihydroorotate Dehydrogenase).

The study was amended and now includes patients with ocular surface inflammation.

In this prospective, single-centre, double blind (within each cohort), placebo controlled, randomised study, safety and tolerability of PP-001 eye drops is assessed in healthy, adult volunteers (cohorts 1-3) and in patients with ocular surface inflammation (cohort 4). PP-001 is a novel small molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH) with anti-inflammatory properties.

Eligibility Criteria:
Inclusion Criteria (excerpt):

Cohorts 1-3:

* male or female healthy volunteers 18 - 64 years of age
* good general state of health and participants must not have a diagnosis of any eye disease that could effect the pharmacokinetics of PP-001

Cohort 4:

* male or female subjects 18-64 years of age with ocular surface inflammation in both eyes
* ocular surface inflammation as defined per protocol
* good general state of health

Exclusion Criteria (excerpt):

Cohorts 1-4:

* participation in other clinical trials within 30 days prior to dosing start (ocular and non-ocular clinical trials)
* pregnant or nursing patients
* regular use of any ocular agents within 60 days prior to start dosing
Pilot Study of a Brief Behavioural Activation Intervention for Depressed Patients in Primary Care

This study will explore the effectiveness of a brief psychological intervention for depressed outpatients in primary care. Participants will attend two intervention sessions with a psychologist and use a mobile activity/goal setting application for 6 weeks.

This study will evaluate the feasibility and effectiveness of a two-session psychologist-led behavioural activation intervention, with adjunctive use of a free activity/goal setting app, for depressed patients in primary care. Outpatients in primary care with Major Depressive Disorder will be recruited to complete two intervention sessions with the primary care psychologist, as well as use the mobile activity scheduling app for 6 weeks. Symptom measures will be administered prior to both intervention sessions and 6-weeks after the first intervention session.

Eligibility Criteria:
Inclusion Criteria:

* Depression is the primary concern;
* Score of 10 or greater on a depression screening tool;
* Have access to an iPhone or iPad.

Exclusion Criteria:

* Another psychological disorder is the primary concern (e.g., anxiety disorder, personality disorder);
* Concurrent alcohol or drug use disorder;
* Unstable dose of psychotropic medication (i.e., any psychotropic medication doses will need to be stable for at least four weeks prior to enrolment);
* Current participation in other regular psychological treatment (e.g., cognitive behavioral therapy, counselling);
* At a high risk/emergent risk for suicide.
Ph 2 Trial of ADI PEG 20 Plus Concurrent Transarterial Chemoembolization (TACE) Vs TACE Alone in Patients With Unresectable Hepatocellular Carcinoma

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of HCC confirmed clinically or histologically or cytologically. A clinical diagnosis of HCC, using the 2010 Guideline of the American Association for the Study of Liver Diseases requires the presence of hepatic tumor(s) with image findings (e.g. sonography, CT or MRI) compatible with HCC, and no evidence of other gastrointestinal tumors (Bruix \[2011\] - Guideline, 2010).
2. Solitary hepatic tumor \<8 cm in diameter or multifocal disease as evidenced by CT or MRI scan. Tumor volume ≥50% of liver organ or infiltrating HCC should be excluded.
3. Not a candidate for surgical resection or ablation of the tumor.
4. The target lesion must not have been treated previously with local therapy, including TACE. Prior local therapy (radiofrequency ablation, percutaneous ethanol injection, cryoablation, or surgery) to nontarget lesions is acceptable.
5. The subject must have received no more than 2 TACE (n≤ 2) or the previous TACE was performed longer than 2 months before enrollment.
6. Local therapy must have been completed at least 4 weeks before baseline scan.
7. Measurable disease using mRECIST criteria (Appendix A) and RECIST1.1 (Appendix B) criteria. At least 1 measurable lesion must be present.
8. Barcelona Clinic Liver Cancer (BCLC) staging classification B (intermediate stage) (Appendix C).

Exclusion Criteria:

1. 1. Candidate for potential curative therapies (i.e., resection or transplantation).
2. Prior allograft transplantation including liver transplantation.
3. Significant cardiac disease (New York Heart Association Class III or IV; Appendix F).
4. Serious infection requiring treatment with systemically administered antibiotics.
5. Pregnancy or lactation.
6. Expected non-compliance.
7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
8. Subjects who have had any anticancer treatment within 2 weeks prior to week 1 visit.
Integration of Palliative Care in an Oncology and Hematology Unit

The main goal of this study is to assess retrospectively the integration of Palliative Care in an oncology and hematology unit. The investigators will study the last six month of life on advanced cancer patients and retrieve data from their medical file to obtain criterias of quality of care and integration of palliative care in this population.

Those criterias have been used before in other setting (Earle Criterias, ESMO Recommendations) and The investigators will compare our data to existing publications.

They also hope to see if it is retrospectively possible to assess the probability of death using the Pronopall score. This will help them asses if aggressive end of life care could have been avoided using the Pronopall Score


Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 years old
* Patient who has been followed in the oncohematology Unit of the University Hospital of Strasbourg for a solid tumor or haematological cancer
* Died within the 1rst of January 2017 and the 31st of December 2018
* The patient has not expressed an opposition to the use of his medical data during his lifetime.

Exclusion Criteria:

* Patient receiving allogeneic stem cell transplant
* Patient expressed during his lifetime an opposition regarding the use of his medical data
Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer.

This study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with gastric cancer.


Eligibility Criteria:
Primary Inclusion Criteria:

* At least 20 years of age
* Histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma.
* Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
* Previously untreated, unresectable advanced (M0) or unresectable metastatic (M1) disease except for prior adjuvant (or neo-adjuvant) chemotherapy.
* ECOG performance status 0 or 1
* At least 4 weeks and recovery from effects of prior major surgery
* Adequate bone marrow, hepatic, and renal function

Primary Exclusion Criteria:

* Operable gastric or gastroesophageal-junction cancer
* Known brain metastasis
* Second cancer
* Previous adjuvant or neo-adjuvant chemotherapy with capecitabine and cisplatin in combination. (Previous adjuvant or neo-adjuvant monotherapy with capecitabine or S-1 or therapy with S-1 and cisplatin in combination or 5-FU and cisplatin in combination is allowed.)
* Uncontrolled diarrhea
* Nausea or vomiting for at least 3 consecutive days within the 14 days prior to registration despite the administration of standard antiemetic therapy
* Symptomatic peripheral neuropathy ≥ Grade 2
* Malabsorption syndrome or other disease that significantly affects gastrointestinal function
* Other uncontrolled systemic illness
Prehospital Study at the Universitair Ziekenhuis Brussel II

Interventional prospective randomized open blinded end-point (PROBE) single-center clinical trial on the evaluation of the efficacy, safety, feasibility, reliability, and cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.

The purpose of PreSSUB II is to evaluate the efficacy, safety, feasibility, reliability and cost-effectiveness of in-ambulance telemedicine during Paramedic Intervention Team transportation of patients with suspicion of acute stroke.

The implementation of expert stroke support in the pre-hospital arena using in-ambulance telemedicine is an innovative approach that opens up new perspectives and allows continuous guidance by a stroke specialist throughout the acute stroke care continuum.

Eligibility Criteria:
Inclusion Criteria:

* Emergency transportation by the Paramedic Intervention Team of the Universitair Ziekenhuis Brussel
* Age \>= 18 years
* Suspicion of acute stroke with symptom onset \< 12 h or unknown, based on any of the symptoms mentioned in the Belgian manual for medical regulation of pre-hospital care: Hemiparesis, Facial asymmetry, Speech disturbance, Sudden, severe headache, or Confusion.

Exclusion Criteria:

* Patients for whom in-ambulance telemedicine consultation would delay any diagnostic or therapeutic intervention.
Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention

To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS) before and after sinus surgery.

Rhinosinusitis (RS) is a heterogenous disease, with variable etiologies, manifestations, and progression. Generally, RS can be divided into acute, subacute, and chronic RS, depending on the symptoms and duration of the disease. Most commonly, acute RS is caused by a viral infection (viral RS), which starts in the nasal passages and progresses to inflammation of the sinuses. When this inflammation of the paranasal sinuses does not resolve and lasts for at least 12 weeks, the disorder is broadly defined as chronic RS (CRS), which is usually accompanied by bacterial infections. This inflammatory disease pathophysiology is further subdivided into CRS with (CRSwNP) and without (CRSsNP) nasal polyps. Recently, several studies aimed at phenotyping the diverse pathophysiology among patients suffering from CRS characterized subgroups based on the presence of inflammatory clusters. CRSsNP is marked by pro-inflammatory neutrophilic inflammation of the nasal mucosa and a nasal cytokine profile that is characterized by increased levels of TGFβ1 and IFNγ and low or undetectable levels of IL-5. In contrast, patients with CRSwNP demonstrate eosinophilic inflammation of the nasal mucosa, low levels of TGFβ1, but high levels of Th2/Th17-type cytokines such as IL-17 and IL-5, higher levels of eosinophil cationic protein (ECP) and mast cell tryptase, and lower levels of IL-10.

Currently biomarkers associated with physician diagnosed disease severity and patient-perceived quality of life impairments are lacking. Analysis of markers of inflammation in the nasal mucosa and peripheral blood leukocytes in combination with quality of life symptom scoring will enable us to identify biomarkers associated with CRS disease severity. This study will determine if biomarkers identified in the nasal mucosa and peripheral blood leukocytes correlate with physician diagnosed and patient-perceived disease severity.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed CRS with surgical requirement for treatment

Exclusion Criteria:

* Subjects with physician-diagnosed:
* cystic fibrosis,
* vasculitis,
* any type of nasal tumor
* receiving ongoing immunosuppressant therapy
Examining the Individual Response to a Restricted Sodium Diet in Hypertensive Patients

Excessive dietary sodium intake is an independent risk factor for hypertension and cardiovascular disease. A vast array of efforts have tried to reduce sodium consumption based on evidence indicating a public health benefit. Yet this benefit has been questioned, mainly based on studies showing variability in individual responses to a sodium-restricted diet (SRD). The effects of an SRD on blood pressure vary, and adherence to an SRD is not optimal. The original Sodium Watchers Program (R01NR012967) was developed and implemented by Dr. Misook Chung (University of Kentucky). In this pilot study, the modified Sodium Watchers Program will propose improving adherence to an SRD through education and digital self-monitoring for daily sodium intake and blood pressure.

In addition, few studies have examined individuals' metabolic responses to the SRD. In a secondary analysis, we further will examine genetic variants associated with salt sensitivity and whether such a genetic component is associated with sodium excretion and BP control.

A total of 40 hypertensive patients will be randomly assigned to the intervention (n=20) or control group (n=20). The intervention group will receive 8-week education sessions remotely using a video conferencing program. All participants will collect a 24-hour urine specimen for sodium excretion and a total of 4.0ml of peripheral blood will be drawn for salt sensitivity during baseline visit. All participants will be asked to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg, whether or not taking blood pressure medications.
* Smartphone with a data plan
* Valid email address
* Willing and able to participate in online study videoconferencing visits (Zoom)
* Reads and writes in English

Exclusion Criteria:

* Participating in another related research study
* Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
* Active cancer
* Recent hospitalization due to psychiatric condition or event
* Pregnancy or breastfeeding - current or planned during the study period
* Documented dementia
* Prisoners
* Diabetes Diagnosis
* Heart Failure Diagnosis
Formative Research for an HIV Videogame for Young Black Women

As part of Yale's Play2Prevent (www.Play2Prevent.org) program to develop videogame-based interventions targeting risk reduction and prevention in youth and young adults, this study is designed to develop a paper prototype and intervention design manual of an online social-network game, One Night Stan, with the goal of risk reduction and HIV/STI prevention in young black women. The ultimate plan is to incorporate focus group participants input and feedback into the development of a conceptual model, intervention manual, and videogame intervention prototype. This prototype will then be tested using 20 participants and will utilize a pre-post design to evaluate the effectiveness of the program.

The specific aims of this study are to:

Develop an online social network game for HIV/STI risk reduction and prevention by conducting a first set of focus groups with a total of 25 participants (5 focus groups with 5 participants each) in order to better understand preferences for online social network and gaming platforms, characteristics and design.

These collected data, established theoretical constructs, and the literature will be harnessed to develop a conceptual model for HIV/STI risk reduction and prevention in this specific population of women.

From the data collected and the new conceptual model, an intervention manual will be created that will incorporate a culturally and socially-tailored online social network game intervention paper prototype and design manual. In an iterative fashion, a second series of focus groups will be conducted (5 groups with 5 participants each for a total of 25 participants) to refine the intervention.

To pilot test the prototype intervention we will determine, in a pre-post design: (a) the intervention's acceptability and feasibility based on self-report data on the game experience and (b) preliminary evidence of the efficacy of the intervention collecting data on 1) HIV/STI knowledge 2) intentions/attitudes regarding condom use and HIV/STI partner testing 3) self-efficacy to insist on condom use and HIV/STI partner testing 4) self-efficacy and beliefs related to sexual risk behaviors, 4) perceived social norms, and 5) behaviors related to condom use and partner HIV/STI testing.

The focus of this registration record will be the participants and collected outcomes used to assess the prototype of the social network game. Assessments will be conducted at baseline, 2 weeks after playing the game and at 4 weeks post follow up.

Eligibility Criteria:
Inclusion Criteria:

* African-American race
* Female
* Ages 18 to 24 yeats

Exclusion Criteria:

* Failure to meet all inclusion criteria will exclude individuals from participation in the study