cyrilzakka/clinical-trials huggingface dataset:
Impact of Helminth Infections During Pregnancy on Humoral Vaccine Immunogenicity in Infants

Helminth infection is associated with low vaccine immunogenicity. Pregnant women are particularly sensitive to helminth infection.

Since most vaccines are given shortly after birth, an effect of parasites on infant immunogenicity is of particular concern. Therefore, within this study the investigators aim to investigate if maternal infection influences vaccine immunogenicity in the newborn.

There is evidence that helminth infections during pregnancy affect the immune system of the mother and the unborn child. As a consequence, the antimicrobial- immune and vaccine- response of the infant may be deficient. The aim of the present study is to measure the influence of maternal helminth infection (schistosomal, filarial and intestinal helminth infection) on vaccine immunogenicity of their infants. The main focus is on immune responses of infants to vaccine antigens given as part of the expanded program on immunization (EPI) in Gabon at an age when infants are unlikely to be infected with helminths and are immunologically primed by their intrauterine life. The objective is to investigate if and which species of helminths during pregnancy have an effect on any of the EPI vaccine-induced immune responses.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form (ICF) by the participant aged 18 years or older or by a legal major representative and the participant
* Willingness to deliver in one of the two maternities in the study area
* Willingness and ability to comply with study protocol for the duration of the trial
* Willingness to give blood for the examinations and to provide samples for helminth assessment (stool, urine, blood)

Exclusion Criteria:

* Known chronic diseases (diabetes, TB, HIV, HCV or HBV infection); these will be assessed on a regular basis at given examinations during pregnancy
* Withdrawal of consent
* Poor general health (including a hemoglobin level out of local reference range)
* Signs of symptoms of helminth infection which needs immediate treatment of the mother
* Planned migration from the area
Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

* The aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected patients treated with protease inhibitors.
* Single-centre, open, randomized, controlled, prospective pilot study.
* 60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. The patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.The visit will be every month.


Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years
* documented positive HIV antibodies test
* on stable therapy with PIs for at least 12 months
* LDL-cholesterol \>130 mg/dl or triglycerides 200 - 500 mg/dl with non-HDL cholesterol \>160 mg/dl
* unresponsive to dietary measures and regular physical exercise of at

Exclusion Criteria:

* history of dyslipidemia before antiretroviral therapy
* cardiovascular and cerebrovascular diseases
* Cushing's syndrome
* concurrent therapy with lipid-lowering agents, oral anticoagulant, estrogens, thiazidic diuretics, beta-blockers
* hypothyroidism
* Type 1 diabetes mellitus
* renal failure
Popliteal Sciatic Nerve Block and Adductor Canal Block

The goal of this observational study is to determine the effect of adding adductor canal block to popliteal sciatic nerve block on patient-surgeon satisfaction, intraoperative sedation need, tourniquet pain, return time of motor block, and postoperative pain in patients undergoing hallux valgus correction surgery. The main question it aims to answer are:

* Does peroperative pain decrease?
* Do patient-surgeon satisfaction increase? The patients were divided into two groups, the Popliteal Sciatic Block (PSB) group, and the Popliteal Sciatic Block + Adductor Canal Block (PSB + ACB) group.

Patients were randomly assigned into 2 groups as popliteal sciatic nerve block (Group PSB), popliteal sciatic nerve + adductor canal block (Group PSB + ACB). In this study, 52 patients scheduled for hallux valgus correction operations, in the American Society of Anesthesiologists I-III groups, between the ages of 18-80, were enrolled. Study was planned as a prospective, randomized and controlled trial. All patients were perfomed PSB with 10 ml 0.5% bupivacaine and 10 ml 2% prilocaine in the prone position, using ultrasonography and nerve stimulator. 10 ml of 0.5% bupivacaine and 10 ml of 2% prilocaine were administered to the patients in the ACB + PSB group in the supine position, in addition to PSB. Patients with coagulopathy, infection at the region site of regional blockade, allergy of local anesthetic drugs, peripheral neuropathy and neurogenic disorders affecting the lower extremities, peripheral artery disease, mental retardation and those who did not give consent to study were excluded. All patients were sedated with 1-2 mg midazolam and 50 µg fentanyl. After the blocks were performed , sensory -motor block onset time, surgery-tourniquet time, tourniquet pain, motor block time, pain onset time, first analgesic administration time (NPRS≥4) and analgesic administered were recorded. Anesthesiologists evaluating these data were blinded to group distribution .

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 80
* American Society of Anesthesiologists ASA I-III

Exclusion Criteria:

* Patients with coagulopathy
* Patient with wounds or infections in the region
* Patient with allergies to local anesthetic drugs
* Patient with significantly impaired peripheral neuropathy and neurogenic disorders affecting the lower extremity
* Patient with peripheral arterial disease
* Patient with mental retardation
Goal-directed Low Oxygen During Anesthesia

The study aims at investigate whether low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery. 200 patients scheduled for abdominal surgery will be randomized (1:1) to goal directed low oxygen concentration during and after anesthesia vs. fixed high oxygen concentration. Arterial oxygen partial pressure is the primary outcome and lung function a secondary explanatory outcome.

Postoperative hypoxia is a most common complication after major abdominal surgery. This study aims at investigate whether goal-directed low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery.

200 adult patients scheduled for major abdominal cancer surgery lasting for more than 2 hours will be included after signed informed consent. Patients will then be randomized to either goal directed low oxygen or high oxygen during anesthesia and in the postoperative period.

Patients who are randomized to goal directed low oxygen will be given oxygen before the induction of anesthesia, with increasing fraction of inspired oxygen (FiO2) from 0.25 to 0.30 to 0.35 and so on. After intubation, the FiO2 is set to 0.25 to achieve a target saturation of 94-96%. Supplementary oxygen after surgery will be given with the same targets and with as little oxygen as necessary, Patients who are randomized to high oxygen will be given FiO2 of 1.0 before induction until end-tidal oxygen concentrations of 0.80 occur. The FiO2 will be reduced to 0.35 during anesthesia, followed by an increase in FiO2 to 0.80 during 5 minutes before extubating the patient, followed by FiO2 0.40 for at least thirty minutes after anesthesia. Oxgen will then be given at 3 liters a minute with a oxygen saturation goal of 98%.

Arterial blood gases, lung function measurements including diffusion capacity will be taken on the day before surgery. Blood gases will be taken during the first and second day after surgery and lung function tests during the second day after surgery. Blood gases and lung function will also be obtained at three months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Being scheduled for a major abdominal cancer surgery lasting for more than 2 hours.
* Having a condition within American Society of Anesthesia Class 1-3.

Exclusion Criteria:

* Being at risk for a difficult intubation during anesthesia in the form of Mallampati score 3-4, or having a previous documentation of difficult intubation.
* Decline participation
Recurrence of Thromboembolic Venous Disease of Atypical Location (RUSE)

RUSE is a retrospective data-based study designed to assess the frequency, characteristics and phenotype of documented recurrences of thromboembolic venous disease in atypical locations.


Eligibility Criteria:
Inclusion Criteria:

* All patients over 18,
* Affiliated to "sécurité sociale"
* Having at least one episode of atypical localisation of VTE at Brest University Hospital

Exclusion Criteria:

* Patients under legal protection
* Minors
* Refusal to participate
Low-frequency Repetitive Nerve Stimulation in Myotonic Dystrophy Type 1

The study design is a prospective cohort study. It aims to evaluate the neuromuscular junction in dystrophic myotonia 1 (DM 1) using low-frequency repetitive nerve stimulation (RNS) on several nerve-muscle pairs of the one side including proximal and distal muscles of upper and lower extremities. First, it will be investigated whether a decrement with 3 Hz stimulation, as described in literature, is reproducible in our patient population. If this is the case, it will be examined whether it is the consequence of a dysfunction of the neuromuscular junction or rather linked to a hypo-excitability of some muscle fibers due to myotonia. For this purpose, additional tests including short exercise test (to observe any decrement resulting from an inexcitability in myotonic muscle fibers) and needle EMG (for mapping myotonic discharges in the muscles tested with repetitive nerve stimulation) will be performed. Single fiber-EMG will not be provided in this study as an abnormal result does not necessarily indicate a dysfunction of the neuromuscular junction but could just as well be due to the muscular dystrophy in the context of DM1. Finally, it will be investigated if there is a correlation between the decrement

with 3 Hz stimulation and clinical signs as fixed muscle weakness (via Medical Research Counsil (MRC) scale, DM-activ scale \[30\]) and fatigue (via MG-ADL scale).


Eligibility Criteria:
Inclusion Criteria:

\* genetically confirmed DM1

Exclusion Criteria:

* minor age
* auto-immune diseases
* medical conditions involving the neuromuscular junction: (myasthenia gravis, Lambert-Eaton myasthenic syndrome, congenital myasthenia syndromes).
Skin Efficacy Testing of Astrion Products

This project aims to conduct safety and efficacy tests on the skin for the ingestion of Astrion Vitality Capsules, containing A. membranaceus and C. Asiatica roots, and the topical application of Astrion Vitality Cream. The goal is to develop health and skincare products that regulate physiological functions, promote overall wellness, and enhance skin beauty.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged ≥18 years.

Exclusion Criteria:

* Non-voluntary participants.
* Subjects diagnosed with skin diseases, cirrhosis, or chronic renal failure by a -physician.
* Individuals with known allergies to cosmetics, drugs, or food.
* Pregnant or breastfeeding women.
* Individuals taking medication for chronic diseases.
* Subjects who, within 12 weeks prior to the test, have undergone laser facial treatments, chemical peels, or experienced prolonged sun exposure (more than 3 hours of direct sunlight in a week).
* Students taught by the investigator.
* Individuals unwilling to allow the publication of photos of the experimental results.
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.

CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
2. Men and women ≥18 years of age at the time of signing the informed consent form
3. Confirmed infection with SARS-CoV-2 confirmed per World Health Organization (WHO) criteria (including positive RT-PCR nucleic acid test of any specimen \[eg, respiratory, blood, urine, stool, or other bodily fluid\]) within 4 days of randomization
4. COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation \<94% on room air or requires supplemental oxygen
5. Able to swallow pills
6. Willing to follow contraception guidelines

Exclusion Criteria:

1. Respiratory failure at time of screening due to COVID-19
2. Known medical resuscitation within 14 days of randomization
3. Pregnant or breast feeding
4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin ≥ 3x upper limit of normal (ULN) and/or severe hepatic impairment detected within 24 hours at screening (per local lab)
6. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll
7. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug).
8. Requires treatment with proton-pump inhibitors (PPIs; eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study
9. Received oral antirejection or immunomodulatory drugs (eg, anticytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
Trial of Autism Parent Navigator Program

To address the dual needs of parents for support in navigating Autistic Spectrum Disorder (ASD) services and maintaining positive family functioning, the investigators propose to test Autism Parent Navigators (APN), an innovative in-home, peer support model for parents with a young child recently diagnosed with ASD.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children who have been newly diagnosed with Autism Spectrum Disorder (ASD).
* The child will be age 2-6 years and been diagnosed with ASD in the past four months.
* The child is the first child in the family to be diagnosed with ASD.
* Parents are not already involved in a parent mentoring relationship.
* Parents are currently involved in a couple relationship, including same-sex partners, dating couples, adoptive parents and step-parent families.

Exclusion Criteria:

None
Disseminated Tumour Cells (DTC) in Left Sided Colorectal Cancer (LSCC).

Two metaanalyses of studies on the prognostic significance of circulating cancer cells in colorectal cancer indicated, that the presence of circulating tumour cells (CTC) in the peripheral blood is the negative prognostic factor. However there is no sufficient evidence that disseminated tumour cells (DTC) in the bone marrow of the colorectal cancer patients influence the prognosis. There is the evidence that right-sided and left- sided cancers may have different biology and different prognosis. Therefore in this study the investigators concentrated on the left colon and rectum locations with the locally advanced cancer being the main area of interest.

The aim of this study was to analyse the relation of DTC with the tumor characteristics, cancer progression and survival in left sided colorectal cancer.

A group of 91 colorectal patients treated in a single institution was involved into the study. Only the patients with tumors located in the rectum or left side colon were included. The term left colon was defined as the left 1/3 of transverse colon and all the colon parts distally from this point. None of the colon cancer patients received preoperative chemotherapy, while 5 of the rectal cancer patients received preoperative radiotherapy and two preoperative radiochemotherapy. There were 42 women and 49 men, the mean age 64,7 (SD - standard deviation 10,2). The bone marrow biopsy was performed on the day of surgery after the induction of general anesthesia from posterior superior iliac spine. The 5ml sample of the bone marrow was collected to plastic tubes containing EthyleneDiamineTetraacetic (EDTA). Patients received postoperative chemotherapy if indicated, regardless of their DTC status. All the patients were followed up at least for 5 years or until death.

The incidence of DTC was not related to the depth of infiltration (T feature) being similar in T1-2 and T4 patients. There was no statistically significant difference between the incidence of DTC in N- and N+ patients. The 5 years survival rate for the DTC patients was 59,5% while for the DTC negative patients was 53%.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* histologically proven left-sided colorectal cancer
* signed informed consent

Exclusion Criteria:

* synchronous right sided colon cancer
* history of other neoplasm
* inability to understand and sign informed consent
Study of Treatment's Echocardiographic Mechanisms

This ancillary study determines whether the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) \[ClinicalTrials.gov Identifier: NCT03434028\] treatment arms (restrictive fluids strategy vs. liberal fluid strategy) for early sepsis-induced hypotension are associated with differences in cardiac structure and function based on an echocardiogram at 24 hours after randomization. Secondarily, this ancillary study explores possible heterogeneity of treatment effect based on an echocardiogram performed shortly after randomization in CLOVERS.

The Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM) study is an ancillary study to CLOVERS, a parent multi-center, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The CLOVERS trial attempts to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension. This ancillary study obtains echocardiograms among CLOVERS-enrolled patients who consent to CLOVERS-STEM at baseline and 24 hours later (secondarily, this study also measures serum troponin levels at baseline and 24 hours) to pursue three aims: 1. Evaluate for differences in left ventricular global longitudinal strain at 24 hours after randomization between treatment arms; 2. Evaluate for differences in right ventricular end diastolic area to left ventricular end diastolic area ratio at 24 hours after randomization between treatment arms; 3. Explore possible heterogeneity of treatment effect based on baseline echocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial

Exclusion Criteria:

* Lack of Informed Consent for this Ancillary Study
* Allergy to Ultrasound-Enhancing Agents
Preschool Children Motor Development

The preschool age period is crucial for motor and cognitive development, which retention primary reflexes can negatively influence. Primary reflexes are fixed motor patterns controlled from developmentally lower areas of CNS and are necessary for delivery, survival or rudimentary movement activation during infancy and should be progressively inhibited. Primary reflexes' retention increases the risk of blocks for further cognitive and motor development in higher, mainly cortical areas. Children in preschool and school age with non-inhibited primary reflexes displayed a poor level of fundamental movement skills and worse attention, self-regulation or working memory capacity. Children with the problems above usually pass a movement program based on developmental kinesiology, like Neurodevelopmental stimulation (NVS). NVS contains exercises that simulate situations for adequate processing of the primary reflex and allow the brain to correct and inhibit this reflex. Even though in the Czech preschool environment, almost 13% of children with neurotypical development have significant positive responses to at least one primary reflex, there are no methods to inhibit primary reflexes to improve motor and cognitive development positively. Therefore, this project aims to find how the NVS intervention will influence the performance in the selected area of motor and cognitive development, with the follow-up three-month retesting. Population for this project are preschool children aged 4-6 years old.


Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* strong ADHD/learning disorders diagnosed
Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell Transplant

The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9 mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms of the number of patients attaining a complete (CR) or morphological (CRp) remission.


Eligibility Criteria:
Inclusion Criteria

* Patients with CD33+ AML who have experienced relapse after autologous or allogeneic HSCT. Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33 positive, based on local laboratory criteria (Patients with history of MDS pretransplant will be eligible if their proportion of myeloblasts by marrow aspirate exceeds 5% at time of evaluation for Gemtuzumab Ozogamicin treatment)
* The patient must be greater than or equal to 60 days post-HCST
* Patients of all ages may be entered in this study

Exclusion Criteria

* Peripheral white blood count (WBC) greater than or equal to 30,000/uL at the time of initial Gemtuzumab Ozogamicin administration. (In order to reduce the peripheral blood count, patients may be treated with Hydroxyurea. Hydroxyurea must be discontinued 24 hours prior to Gemtuzumab Ozogamicin administration.)
* Known active central nervous system (CNS) or testicular leukemia at time of study entry.
* Prior therapy with anti-CD33 antibodies.