cyrilzakka/clinical-trials huggingface dataset:
Immune Benefits of Coffee

This study will assess whether coffee consumption:

* increases immune responses
* decreases inflammatory status

Epidemiological studies suggest that coffee consumption is associated with protective effects against several types of chronic diseases. Recent data have shown that certain coffee components may possess anti-inflammatory and immune-enhancing properties. Low-grade inflammation and poor capacity of immune response is highly prevalent in elderly subjects.

The purpose of this study is to evaluate whether coffee consumption improves immune and inflammatory status in healthy elderly subjects. To sort out the role of antioxidants, we will test 2 different soluble coffee, i.e. fully torrefied coffee and partially torrefied coffee.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, self-sufficient, free-living Chilean elderly
* Having the ability to comprehend the procedures of the study
* Having obtained his/her informed consent after verbal and written information

Exclusion Criteria:

* Subjects drinking more than 2 cups of coffee per day
* Subjects with rapidly deteriorating health status at enrolment in the study
* Subjects with terminal or acute disease, or unstable health status
* Subjects with chronic disease: chronic respiratory illness; chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic disease (diabetes); chronic renal disease, organ failure
* Subjects with serious neurological disorder, including dementia (MMSE \< 20) or Alzheimer's disease
* Subjects who have experienced rapid weight loss, chronic diarrhea (loose stools, 3 times daily), or Crohn's (IBD)
* Subjects with gastrointestinal problems
* Subjects with a hospitalization planned during this study
* Subjects who have received any antibiotic treatment during the last 3 months prior to the beginning of this study
* Subjects who had a colonoscopy performed during the last 3 months prior to the beginning of this study
* Subjects with immune deficiency diseases (e.g. HIV infection)
* Subjects with a history of allergy - especially to egg protein, egg, shellfish or the antibiotics polymyxin or neomycin
* Subjects receiving medication that may influence the immune system (i.e. corticosteroids, immuno-suppressors and immuno-modulators, antimicrobials)
* Subjects who have received any vaccination during the last 15 days prior to baseline
* Subjects who are expected to be non-compliant
* Subjects currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
* Subjects participating in another research study involving any type of medication related to the study
Effect of PEFLOW on PFM Function Recovery of Postpartum Women

The purpose of this study is to explore the correlation between women's pelvic floor function with their overall state of bodily functions, including body composition, physical activity levels, trunk muscle endurance, body posture, vaginal and gut microbes. The main intervention of this study is a set of global training which Includes the strength, endurance, flexibility, stability and flexibility training on the diaphragm, abdominal, lower back, as well as pelvic floor muscles, on the basis Kegel training. The primary destination of global training is to shorten the cycle of postpartum pelvic floor functional recovery, improve the effect of maternal training, and convenient in clinical promotion.

Training for 2 times a week, for 12 weeks leading by a specific physiotherapist.The training intensity was evaluated by RPE self-induced fatigue scale.

Eligibility Criteria:
Inclusion Criteria:

* Newly born women within 42 days to 3 months after delivery, after the end of puerperium, initial postpartum review and pelvic floor professional outpatient screening, found that pelvic floor muscle strength decreased (Oxford Oxford muscle strength ≤ grade 3);
* Healthy before pregnancy without pregnancy complications;
* Convenient transportation, familiar with the Internet;
* Be in good condition and be able to complete the exercise program;
* Complete clinical baseline data;
* Agreed to conduct the study and signed the informed consent.

Exclusion Criteria:

* Patients with stage Ⅲ and Ⅳ pelvic organ prolapse;
* Severe urinary incontinence;
* lochia, vaginal bleeding and pregnancy;
* Serious medical diseases, such as cardiac dysfunction who wear pacemakers, neurological diseases, cognitive impairment and other pathological conditions;
* Cannot complete the intervention program;
Phase III Study of ASP2151 in Herpes Zoster Patients

To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.

A double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster. The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving cessation of new lesion formation by Day 4 of study treatment" to demonstrate the non-inferiority of ASP2151 to VACV. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

Eligibility Criteria:
Inclusion Criteria:

(1) Patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash

Exclusion Criteria:

1. Patients who are not expected to have an adequate response to oral antiviral medication
2. An extreme decline in immune function
3. Presence of serious complications
4. Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:

   * AST or ALT ≥ 2.5 x upper limit of normal
   * Platelet count \< lower limit of normal
   * Serum creatinine ≥ 1.5 mg/dL
   * Creatinine clearance \< 50 mL/min
5. Current or previous history of malignant tumor within 5 years before informed consent
6. Diagnosis of autoimmune disease
7. Evidence of bone marrow suppression
Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not

This is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up.

Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study.

The main objective of this study is to evaluate the feasibility for the determination of Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of treatment (ie, at D0 before and D28 after beginning of treatment).


Eligibility Criteria:
Inclusion Criteria:

1. Women of more than 18 years old (menopause or not).
2. Women with invasive breast cancer metastatic or non-metastatic, for which treatment with tamoxifen or anti-aromatase is retained.
3. Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (≥ 10% of tumor cells in Technical HIC).
4. Any previous hormonal therapy, stopped for progression, should be discontinued for at least 21 days prior to study entry.
5. WHO ≤ 2.
6. Women of childbearing age must use effective contraception for the duration of the study.
7. Informed consent obtained and signed before any specific procedure in the study.
8. Patient member in a national insurance scheme.

Exclusion Criteria:

1. Patient with breast cancer HER2 positive (IHC and / or FISH-CISH)
2. Patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days.
3. Patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer.
4. Any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator.
5. Patient unable to follow procedures, visits, examinations described in the study.
6. Pregnant women or nursing mothers can not participate in the study.
7. Patients under legal guardianship.
Non-interventional Study on Time to Response and Quality of Life in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide in Second Line

The purpose of this study is to quantify the burden of treatment in relapsed or refractory multiple myeloma in patients receiving lenalidomide after one prior treatment for myeloma.


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age
2. Have a confirmed diagnosis of MM
3. Starting lenalidomide treatment for MM (due to relapsed or refractory disease) after one prior treatment.
4. Have personally signed and dated a legally effective written informed consent form prior to admission to the study.
5. Must be willing and able to understand and comply with the study requirements.

Exclusion Criteria:

1. Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.
2. Individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them.
Radiomic Signature as Predictive Marker of Response to Chemoradiation and Durvalumab in Stage III NSCLC.

The introduction of maintenance immunotherapy with the anti PD-L1 inhibitor durvalumab opened a new therapeutic window for stage III NSCLC patients who achieve at least stable disease after chemo-radiation, as shown by the randomized phase 3 PACIFIC study. However, still half of the patients do progress at 12 months (up to 70% at 18 months). In this study, the investigators aim to test a non-invasive image-based approach, namely a "radiomics" platform, as a tool to define a higher or lower likelihood of response to chemo-radiation and durvalumab. For this purpose, we will retrospectively and prospectively collect and analyze a cohort of at least 70 stage III NSCLC patients treated with CT-RT followed by maintenance durvalumab.

Specific aim (one):

To collect and analyze CT scans at diagnosis and after chemoradiation, and assign them to a specific radiomic signature (blind assessment).

Specific aim (two):

- To correlate the radiomics signatures to clinical outcome: the main measure will be progression-free survival at 6 months, the second will be overall survival at 24 months.

This is an observational longitudinal retrospective/prospective study.

Criteria for study entry:

* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
* Age 18-80
* Stage IIIA-C disease judged to be unresectable by a multidisciplinary team including pulmonologists, thoracic surgeons, medical and radiation oncologists.
* Signed informed consent

Exclusion criteria:

* Inability to sign the informed consent
* Absence of analyzed CT images

Treatment:

As per indication, patients should have received a thoracic radiation dose of at least 54 Gy to the primary tumor and lymph nodes; all techniques are allowed. Conventional fractionation or mild hypofractionation is also allowed. All different platinum-based chemotherapy regimens are admitted for the present study in combination with radiotherapy, given either concomitantly or sequentially, according to International Guidelines for combination therapy in locally advanced NSCLC.

Radiomic data extraction: after a pilot harmonization study phase, all CT scans will be analyzed using two different pre-defined signatures. The first one was developed by the Institut Gustave Roussy, Paris, and the second one by Radiomics (Liegi, Belgium). These two signatures have been either linked to response to anti PD1 or to chemoradiation alone.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
* Age 18-80
* Stage IIIA-IIIB-IIIC disease judged to be unresectable by a multidisciplinary team including pulmonologists, thoracic surgeons, medical and radiation oncologists.
* Signed informed consent

Exclusion Criteria:

* Inability to sign the informed consent
* Absence of analyzed CT images
Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections

Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years of age)
* managed within a study center for high-grade cephalosporinase-producing bacteremia
* Not objecting to the reuse of their health data for scientific research purposes.

Exclusion Criteria:

* Patient who has expressed opposition to the reuse of their data for scientific research purposes.
* Resistance to Cefepime or carbapenems
* Multiple bacteremia
* Treatment with a molecule other than Cefepime or carbapenem.
Epidural Analgesia vs Adductor Canal Block in Bilateral TKA

This study evaluates postoperative analgesic efficacy within 48 hours between epidural analgesia and single-shot bilateral adductor canal blocks in bilateral total knee arthroplasty. Half of participants will be received continuous epidural analgesia, while other half of participants will be received single-shot bilateral adductor canal blocks.

Continuous epidural analgesia is effective postoperative pain control but it has some limitations in patients with hypotension, concurrent anticoagulants, technical difficulty, urinary retention.

Adductor canal block is less invasive than continuous epidural analgesia. It provides effective analgesia for total knee arthroplasty and preserves quadriceps muscle strength.

Eligibility Criteria:
Inclusion Criteria:

* Aged more than 18 years old undergoing bilateral total knee arthroplasty
* American Society of Anesthesiologists physical status classification 1-3

Exclusion Criteria:

* Participants deny to enroll the study
* Allergy to bupivacaine
* Weight less than 50 kilograms
* Hepatic disease
* Contraincation for neuraxial block or adductor canal block
* Uncontrolled cardiovascular disease
* Creatinine clearance less than 50 ml/min
Assessment of Infection Activity in Travelers and Migrants Diagnosed With Chronic Schistosomiasis

The primary objective of this clinical investigation is to determine the percentage of travelers and migrants diagnosed with chronic schistosomiasis according to site-specific diagnostic practice who have active infection at the time of evaluation (as assessed and classified by composite reference standards that integrate clinical, laboratory, and diagnostic features, such as microscopy, PCR (where available), POC-CCA (where available), and serum CAA results).

All subjects with chronic schistosomiasis according to site-specific diagnostic practice will have a standardized baseline clinical and laboratory evaluation at the time of evaluation that will include blood sampling for hematology, schistosome serology available at each site, and schistosome PCR where available; urine sampling for microscopy, determination of hematuria as an indirect marker of morbidity for schistosomiasis, and Schistosome PCR (where available), and urine strip testing POC-CCA (where available); and stool sampling for microscopy and PCR, where available, and fecal occult blood as indirect markers of schistosomiasis morbidity.

Composite reference standards will be used to assess and classify the activity of the infection. Organ-specific ultrasound and other tests will be left to the physician's decision, but results will also be collected.

Serum (at least 1 ml remaining from routine diagnostics) will be sent to LUMC, the Netherlands, where CAA will be determined with the UCP-LF CAA test designed for routine use.

Participants will be asked to sign an additional consent form, which is optional and not precluding enrollment in the study, to allow the remaining serum to be stored at LUMC for 15 years, to allow secondary research.


Eligibility Criteria:
Inclusion criteria

1. diagnosis of chronic schistosomiasis (\>3 months after last potential exposure) according to site-specific diagnostic practice
2. signed informed consent (and assent for minors).

Exclusion criteria

1. age below 5 years;
2. exposure to praziquantel after the last potential exposure to schistosomes
3. acute infection, i.e. likely infection \<3 months before presentation
Genotype-related Molecular Targets in the Vitamin D Pathway for Spinal Disc Diseases

The objective of our study will be to analyze the interplay between particular VDR variants and its ligand in cells obtained from intervertebral disc and cartilage endplate and their action on cell proliferation and phenotype maintenance. The identification of novel molecular targets in the vitamin D pathway, potentially promoting pathological alterations of the tissues involved in spinal disc diseases, will allow to develop innovative and more personalized preventive and pharmacological/nutritional therapies.


Eligibility Criteria:
Inclusion Criteria:

patients with spinal disc diseases

* males and females
* 18≤age ≤ 70 years old
* Italian white
* patients with spinal disc diseases that will be surgically treated

Exclusion criteria:

- age \< 18 or \> 70 years old
Clinical Observation During Anaesthetic Induction: Which Difference Between Novice and Expert ?

The study aims to show a difference of observation and data integration between novice and expert during anaesthetic induction, in a population of nurse anesthetists.


Eligibility Criteria:
Inclusion Criteria:

* Groupe "novice" : nurse anesthetist students, in 1st or 2nd years at Besançon nursing school OR nurse anesthetists with less than 1 year experience at Besançon University Hospital
* Group "expert" : full-time employed nurse anesthetists, with at least 5 years experience at Besançon University Hospital
* Correct vision with or without correction
A Study of Repeat-Dose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects

The purpose of this study is to evaluate the single dose pharmacokinetics (PK) of subcutaneous (SC) darbepoetin alfa in subjects with congestive heart failure (CHF) and anemia.


Eligibility Criteria:
Inclusion Criteria: - Symptomatic CHF despite optimized therapy for at least the previous 3 months (treatment included a diuretic, angiotensin converting enzyme \[ACE\] inhibitor, and/or an A2 antagonist, unless not tolerated) - Hemoglobin greater than or equal to 12.5 g/dL at the time of screening
COVID-19: The Effectiveness of Free Face Mask Distribution

The investigators will carry out a randomised trial of free face mask distribution in Stovner District, Oslo, Norway. Ten grocery stores will serve as study sites. Over three weeks the stores will be randomised daily to having "corona hosts" outside their entrance, handing out face masks to customers. The investigators will compare the proportion of customers who wear face masks as they enter the store in stores with or without face mask distribution.


Eligibility Criteria:
All grocery stores in the Stovner district are eligible as long as they have not, or only sporadically, had free distribution of face masks previously.

At the customer level, we will only include those 12 years or older (age based on the outcome assessor's judgement).
The Effect of Calcium β-hydroxy-β-methylbutyrate (CaHMB) Supplementation in Sarcopenia in Liver Cirrhosis

This study is to evaluate the effect of CaHMB in the treatment of sarcopenia in liver cirrhosis.

The study is a randomized double-blind controlled trial. Patients randomly enter into two treatment groups: 1) the CaHMB group and 2) the placebo group. Treatment allocation is by block randomization, with an one-to-one ratio for CaHMB and placebo. The results are concealed in opaque envelopes. Patients will report their daily diets with an online software. Patients will come for clinic after 4 weeks and 12 weeks, receiving laboratory tests and sarcopenia evaluation, and events of primary and secondary outcomes will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed of cirrhosis with imaging or liver biopsy;
2. diagnosis of portal hypertension with endoscopy or radiography；
3. assessed total muscle mass at the level of L3 (\<42 cm2/m2 for male and \<38 cm2/m2 for female)
4. has signed an informed consent form.

Exclusion Criteria:

1. diagnosed as hepatic cell cancer;
2. complicated with malignancy, renal failure, diabetes mellitus;
3. comorbidities including heart failure or pulmonary disease;
4. current use of drugs that affect skeletal muscle metabolism;
5. be allergic to the experimental food;
6. participated other clinical trials in the past 3 months;
7. other conditions that researchers consider not suitable for this study
On the PhonE Respiratory rAte Study (OPERA)

Introduction. The increasing use of telephone medical advice requires the development of telemedicine tools to assess the patient's severity. Respiratory rate (RR) is a simple vital parameter and is often associated with morbidity and mortality of patients. There is no standardized measure of RR by telephone.

Objective: The investigators wanted to evaluate the RR measurement by phone using a smartphone application called RRate.

Methods. Adults who have been admitted for less than 6 hours to the emergency department after calling Center 15 and whose main reason for consultation is dyspnea will be included. Patients with non-invasive or tracheotomized ventilation will be excluded. The main objective will be to compare by Bland-Altman method the accuracy of the RRate measurement by phone to a one-minute RR measurement at patient's bedside. Secondary endpoints will evaluate the length of RR measurement according to the different methods used; measurement failure criteria; the accuracy of different measurement techniques (RRate at patient's bedside, impedancemetry, traditional measurement during 15s or 30s).

Expected Results. The accuracy of the RR measurement by RRate over the telephone should be within the limits of agreement. The measurement time should be shorter with the RRate application than with traditional methods. However, the measurement by telephone should not always be feasible in patients with mild dyspnea or with poorly audible breathing.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18yo
* Dyspnea as main reason for consultation
* Regulated by "Centre 15"
* Admitted for less than 6hours at emergency department

Exclusion Criteria:

* Non invasive or tracheotomized ventilation
* Cognitive impairment
* Pregnancy