cyrilzakka/clinical-trials huggingface dataset:
Existence in the Human Digestive Flora of Phages Able to Prevent the Acquisition of Multiresistant Enterobacteria

This research focuses on antibiotic resistant bacteria that may reside in the digestive tract (intestinal flora) of everyone.

When we develop an infection, the bacteria in question is, often, already present in our flora. Face to the growing phenomenon of multi-resistance, which is a public health problem, it is essential to follow the frequency of these bacteria but also to find new strategies and effective means to fight against their spread.

It has been discovered long time ago that it exists viruses able of destroying bacteria: they have been called bacteriophages .They was used before the arrival of antibiotics for the treatment of various infections (phagotherapy). Today, with the problems of resistance, phagotherapy could become a good way to fight against infections with bacteria very resistant but also a way to remove the resistant bacteria that are present in our digestive flora.

Moreover, it is known that these viruses of bacteria are present everywhere in the environment (waters, soils, human digestive tract and animal), it is important to check their presence in our digestive tract. Our objective is to study if the presence of these phages prevents resistant bacteria from set up in our digestive flora.

To answer the question, it is planned to include 460 people hospitalized in intensive care unit (resuscitation). The choice of this unit is linked to the fact that the monitoring of resistant bacteria is carried out regularly during the hospitalization. Three resuscitation services were recruited: 2 in Saint Antoine Hospital and 1 in Tenon Hospital. On stool samples collected at different times of the stay (admission and then during the stay), we will look for 2 types of bacteria and viruses capable of destroying them.

Evaluate the association between the presence of phage (s) in patients not carrying E. coli or K. pneumoniae ESBL or carbapenemase (EPC) (Ec-ESBL / EPC or Kp-ESBL / EPC) and subsequent acquisition Of carrying Ec-BLSE / EPC or Kp-BLSE / EPC during their stay in intensive care.

Collection of stools of the patients included at the admission then in a successive way. On the first stool, search for multiresistant bacteria. If positive research: search for bacteriophage directed against the strain of the patient bearing. Continued screening of stools from non-carriers at baseline.

In patients defined as non-carriers at the end of the inclusions and collection, selection of 8 stools for the detection of bacteriophages directed against all BMR strains which were isolated during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Admission in reanimation
* Duration of stay \> 72 h.

Exclusion Criteria:

* Absence of at least 2 consecutive faeces.
A Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response.

This is a mechanistic, randomized, investigator-blinded, placebo-controlled, single-center, crossover study designed to evaluate the effects of premeal administration of whey protein microgels compared to placebo on postprandial glycemia in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to sign written informed consent prior to study entry.
* Male or female, \>18 years of age.
* Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a history of type 2 diabetes diagnosis).
* Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
* Patients must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
* Patients must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.

Exclusion Criteria:

* Fasting plasma glucose \>220mg/dl at screening.
* Impaired kidney function, epidermal growth factor receptor of \<60mL/min/1.73m2 at screening.
* BMI \>40kg/m2.
* Elevated liver transaminase \> 3 upper limit of normal at screening.
* Ongoing or recent (i.e. \< 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
* Ongoing or recent (i.e. \< 3month) injectable insulin therapy.
* Ongoing or recent (i.e. \< 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss \>5% within previous 6 months.
* Ongoing or recent (i.e. \< 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
* Major medical/surgical event requiring hospitalization in the last 3 months.
* Known allergy and intolerance to product components or acetaminophen.
* Alcohol intake higher than 2 servings per day. A serving is 0.4dl of strong alcohols, 1dl of red or white wine, or 3dl of beer.
* Are unable to comply with protocol procedures in the opinion of the investigator.
* Have a hierarchical link with the research team members.
* Positive pregnancy test at screening.
* Patients who have been dosed in another clinical trial with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening, or patients currently participating in any investigational trial.
* Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Patients must also agree to not donate blood within 8 weeks after their last visit.
Cost-effectiveness of In-shoe Pressure Measurement for Therapeutic Shoes

The purpose of this study is determine whether the use of plantar pressure measurements in the production of customized therapeutic footwear for patients with diabetes and a history of foot ulceration results in lower production costs and more pressure relief, compared to the standard production. A secondary objective is to explore if a difference in durability can be observed in pressure reduction and development of (pre-) ulcerative lesions between the shoes produced with and without plantar pressure measurements.

For each patient two pairs of shoes will be produced by two shoemakers, one using plantar pressure measurements and one according current standard production procedures. The patient will wear one of these two pairs of shoes during a period of 3 months.

Eligibility Criteria:
Inclusion Criteria:

* diabetes
* neuropathy
* prescription of therapeutic footwear
* diabetic foot ulcer in the last 5 years
* receiving regular preventive foot care
* written informed consent

Exclusion Criteria:

* peripheral arterial disease
* not motivated to wear therapeutic footwear
* active foot ulcer
* recent vascular intervention
* severe mobility impairment
* amputation more proximal than toes, except a single ray amputation is allowed.
* severe visual impairment
* active cancer
* severe cardiac/ pulmonary failure
* severe oedema
* chronic drug abuse
* severe psychiatric illness
* hospital admission at the time of inclusion
* any condition that may interfere with follow-up visits.
A Study of Imlunestrant (LY3484356) in Female Healthy Participants

The main purpose of this study is to evaluate the effect of imlunestrant on repaglinide, omeprazole and dextromethorphan, and rosuvastatin and digoxin. The study will also investigate the effect of quinidine on imlunestrant in female healthy participants of non-childbearing potential. The safety and tolerability of imlunestrant will be investigated in female healthy participants of non-childbearing potential. The study will last approximately up to 32 days for each participant excluding the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical assessment
* Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)
* Female participants of non childbearing potential.

Exclusion Criteria:

* Have known allergies to imlunestrant, related compounds or any components of the formulation, repaglinide, omeprazole, dextromethorphan, quinidine, rosuvastatin, or digoxin, as appropriate, or history of significant atopy.
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing
* Use or intend to use any prescription medications/products within 14 days prior to first dose until completion of the follow-up visit, unless deemed acceptable by the investigator (or designee), including but not limited to medications that inhibit or induce cytochrome P450 (CYP) 2C8, CYP2C19, CYP2D6, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP).
Minocycline in Acute Spinal Cord Injury (MASC)

The objective of this study is to assess the efficacy of IV minocycline in improving neurological and functional outcome after acute non-penetrating traumatic spinal cord injury (SCI).

The primary hypothesis is that intravenous minocycline twice daily (800 mg initial dose tapered to 400 mg by 100 mg at each dose then administered to the end of day 7) administered to subjects with acute traumatic non-penetrating cervical SCI starting within 12 hours of injury will improve motor recovery as assessed by the International Standards for Neurologic Classification of Spinal Cord Injury - ISNCSCI (a.k.a. ASIA) neurological examination measured between 3 months and 1 year post-injury, compared to placebo.

The secondary hypotheses are that the above minocycline treatment will also results in improvement in ASIA sensory improvement, in ASIA grade and in functional outcome as assessed by Spinal Cord Independence Measure (SCIM) and Short Form 36 (SF-36), compared to placebo. In addition the effect of minocycline on neurological and functional outcome after SCI is expected to be more pronounced in those subjects with motor incomplete SCI compared to those with motor compete SCI. A subgroup analysis will be undertaken to examine this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 or over
* Acute traumatic non-penetrating cervical SCI involving neurological levels as defined by the ASIA neurological examination between C0 and C8 and resulting in a detectable change in the ASIA motor assessment
* Patient English speaking and able to provide informed consent
* Randomization and administration of first dose (drug or placebo) within 12 hours of injury.

Exclusion Criteria:

* History of systemic lupus erythematosus (SLE)
* Pre-existing hepatic or renal disease
* Tetracycline hypersensitivity
* Pregnancy or breast feeding
* Isolated radicular motor deficit
* Significant leucopenia (white blood cell count \< 1⁄2 times the lower limit of normal) at screening
* Elevated liver function tests (AST, ALT, alkaline phosphatase, or total bilirubin \> 2 times the upper limit of normal) at screening
* Presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, HIV, HTLV-1)
* Associated traumatic conditions interfering with informed consent or outcome assessment (e.g. closed head injury, liver contusion)
* Known uncorrected severe coronary artery disease or evidence of active coronary ischemia (ECG changes, positive Troponin) will be excluded, as they may not tolerate the standardized protocol for hemodynamic management
BREATHE: An Efficacy-implementation With Listening Sessions

Listening sessions: The research team will collect qualitative data from the listening sessions (focus groups) using a semi-structured iterative focus group guide.

The trial will be informed by 4-8 listening sessions (research focus groups) with 4-8 adults with asthma at each of four sites (N=32). The trial will also include interviews with approximately 1-2 providers and 1-2 administrators at each site (N=8-16).

Adults with asthma and providers/administrators will participate in pre-trial listening sessions (focus groups) prior to recruiting for other phases in this project. They will share their experience with asthma and clinical research. This will aid in gaining the identification of possible barriers to participation and will provide the opportunity for the patients and providers/administrators to identify which of the planned outcomes they consider to be most meaningful. After obtaining informed consent from participants, the research team will collect demographic and diagnosis information, administer surveys and conduct listening sessions.

The research team will collect demographic information and administer questionnaires to characterize the participants. These include: Demographic form, Asthma history (patient), Asthma history (family), Asthma Control Questionnaire, Shared Decision Making Questionnaire, Medication Adherence Record Scale (preventer), Conventional and Alternative Management for Asthma (patient), Conventional and Alternative Management for Asthma (family), Asthma Quality of Life Questionnaire, Newest Vital Sign, and Short Assessment of Health Literacy. Pre-trial listening sessions: one 2-hour session.

Providers/administrators will participate in one 30-minute session interview.

This pre-trial is an informative research that will help design an RCT with masking and allocation in the future.

Eligibility Criteria:
Inclusion Criteria:

1. be adults (\> 18 years of age or emancipated)
2. self-report 'black' race (African American, African, Caribbean, West Indian, multi-racial \[black AND one or more additional races\]); identify their ethnicity as Hispanic OR non-Hispanic
3. have clinician-diagnosed asthma
4. receive asthma care at a partner federally-qualified health center (FQHC)

Exclusion Criteria:

1. non-English speaking
2. serious mental health conditions that preclude completion of study procedures or confound analyses
3. participation in a listening session

Inclusion Criteria (provider/administrator): Providers who manage a panel of adult asthma patients (i.e., eligible for randomization in the trial) and administrators at that site will be recruited to participate in the interviews.
Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old)

The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.


Eligibility Criteria:
Inclusion Criteria:

1. Whose blood and bone marrow explorations have been completed before the steroids prephase
2. aged 18-59 years old with a not previously treated (including IT injection) T-ALL newly-diagnosed according to the WHO 2008 definition with \> 20% bone marrow blasts
3. With Eastern Cooperative Oncology Group (ECOG) performance status \< 3
4. With or without central nervous system (CNS) involvement or testis
5. Without other evolving cancer (except basal cell carcinoma of the skin and "in situ" carcinoma of the cervix) or its chemo or radio-therapy treatment finished at least since 6 months
6. Having signed a written informed consent
7. With efficient contraception for women of childbearing age (excluding estrogens and IUD)
8. Having received or being receiving steroid prephase
9. With health insurance coverage

Exclusion Criteria:

1. With lymphoblastic lymphoma and bone marrow blasts \< 20%, Burkitt-type ALL or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm
2. With contra-indication to anthracyclines or any other general or visceral contra-indication to intensive therapy except if considered related to the ALL:

   * Aspartate transaminase (AST) and/or alanine transaminase (ALT) \> 5 x upper limit of normal range (ULN)
   * Total bilirubin ≥ 2.5 x upper limit of normal range (ULN)
   * Creatinine \> 1.5 x upper limit of normal range (ULN) or creatinine clearance \<50 mL/mn
3. Myocardial infarction within 6 months prior to inclusion in the trial, cardiomyopathy (NYHA grade III or IV), left ejection ventricle fraction (LEVF) \< 50% and/or RF \< 30%,
4. Active severe infection or known seropositivity for HIV or Human T cell leukemia/lymphoma virus type 1 (HTLV-1) or active hepatitis B or C
5. Other active malignancy
6. Pregnant (beta-Human Chorionic Gonadotropin (hCG) positive) or nursing woman
7. Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least three months thereafter. Patients not willing to ensure not to beget a child during participation in the study and at least three months thereafter
8. Treated with any other investigational agent or participation in another trial within 30 days prior to entering this study
9. Not able to bear with the procedures or the frequency of visits planned in the trial
10. Unable to consent, under tutelage or curators, or judiciary safeguard
Mesenchymal Stem Cells Treat Liver Cirrhosis

The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) transfusion in the treatment of liver cirrhosis. Liver function will be monitored by serum analysis. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 3 days to 2 years post-transfusion. Child-Pugh scores, Model for End-Stage Liver Disease scores and clinical symptoms will be assessed simultaneously.

Patients with liver cirrhosis will be randomly divided into three groups. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group. The catheter will be inserted to proper hepatic artery. After the catheter placement confirmed by angiography, umbilical cord MSCs will be infused slowly in 20-30 minutes. Umbilical cord MSCs will be infused intravenously slowly in 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA)and albumin (ALB) will be examined at re-transplantation, and 3 days to 2 years post-transplantation. The efficacy of umbilical cord MSCs transfusion will be investigated. The efficacy of different interventional therapies will also be compared.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years.
* Imaging evidences of liver cirrhosis.
* Child-Plough score of 8 or more.
* Model for End-Stage Liver Disease score of 20 or more.

Exclusion Criteria:

* Liver tumor on ultrasonography, CT or MRI examination.
* Problems in organs other than liver (e.g. heart or lungs).
* History of moderate to severe hepatic encephalopathy or variceal bleeding.
* Imaging evidences of vascular thromboses.
* Coma.
A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)

This study is being done to compare the safety and efficacy of PEG-Intron™ to that of PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen \[HBeAg\] positive or negative) who have not previously been treated with interferon.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to adhere to dose and visit schedules
* ≥ 40 kg
* Hepatitis B surface antigen (HBsAg) positive for at least 6 months
* Anti-HBs negative
* Female participants of childbearing potential must agree to use an acceptable

method of contraception from at least 2 weeks prior to Day 1 and continue until at least 1 month after last dose of study drug

Inclusion Criteria for HBeAg(+) participants:

* HBeAg(+)
* Anti-HBe(-)

Inclusion Criteria for HBeAg(-) participants:

* HBeAg(-)
* Anti-HBe(+)

Exclusion Criteria:

* Co-infection with the human immunodeficiency virus (HIV) or hepatitis C or hepatitis D virus
* Prior treatment with interferon for hepatitis B
* Use of nucleoside/nucleotide analogues within 6 months of the screening visit or at any time during the study
* Use of any investigational drug within 30 days of the screening visit
* Prior treatment with herbal remedies with known hepatotoxicity. All herbal remedies used for hepatitis B treatment must be discontinued before Day 1
* Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
* Diabetic and/or hypertensive with clinically significant ocular examination findings
* History of stroke or transient ischemic attack
* Immunologically mediated disease (e.g., inflammatory bowel disease \[Crohn's disease, ulcerative colitis\], celiac disease, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, sarcoidosis, severe psoriasis requiring oral or injected treatment, or symptomatic thyroid disorder)
* Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis)
* Current or history of any clinically significant cardiac abnormalities/dysfunction
* Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
* Myelodysplastic syndromes
* Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
* Pregnant or nursing, or intending to become pregnant during the trial period
Reducing Test Anxiety in High School Students

School-age test anxiety is an important risk factor for school performance. Notwithstanding, few studies seek to identify which strategies are effective in improving test anxiety. This study aimed to test whether a cognitive-behavioural intervention for high school students could significantly reduce test anxiety.

A two-arm, cluster-randomized controlled, unblinded, parallel, trial was conducted. Participants were students of the 10th year of the Alves Martins High School in Viseu, Portugal. Students were randomized at class level to receive a cognitive-behavioural-based intervention combined with mindfulness, psychoeducation, and relaxation techniques, or to a control group with no intervention. Participants' anxiety levels were measured using the Test Anxiety Questionnaire. The analysis of the effect of the intervention was carried out on an intention-to-treat basis at the class level, using multilevel mixed effects models and Bayesian modelling.


Eligibility Criteria:
Inclusion Criteria:

* 10th grade students; both students and parents provide written informed consent

Exclusion Criteria:

* cognitive inability to answer the questionnaire and/or to participate in the intervention