cyrilzakka/clinical-trials huggingface dataset:
Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19

The purpose of this study is to provide data on the proportion of seroconverted children and their immune status. It will also provide insight into the number of children currently infected at each time point including healthy carriers. Investigators will provide similar data on their parents in an ancillary study.

The fraction of undiagnosed but likely to transmit the virus is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV2. To adapt the epidemy control, it is essential to study the immunoprotection of the general population. A crucial question is the study of pauci or asymptomatic subjects, and in particular children who make mild forms, because they could act as a real reservoir for the spread of the virus. The serological study is essential in this context.

The serologic test Abbott will be used to study immunoprevalence. Institut Pasteur has validated test using neutralizing Ab. CEA will used a antibodies and antigen test.

Eligibility Criteria:
Inclusion Criteria:

For hospitalized children or consulting at hospital

* any child over 7 days old and under 17 years old in consultation or hospitalized for at most 4 days at AP-HP or CH Cayenne; Or any child over 7 days old and under 17 years old with a positive PCR at home, with an attending physician in a participating centre
* Parent's agreement for blood, saliva and stool samples
* Optional parent's agreement for nasopharynx swab
* Optional parent's agreement for follow-up if PCR+
* With an Health insurance

For children with potential COVID disease during the first wave

* Any child over 7 days old and under 17 years, seropositive during the first wave
* Or any child over 7 days old and under 17 years, with a previous inflammatory clinical disease potentially linked to SARS-cov2
* With an Health insurance

Parent of the enrolled child

* One parent of the enrolled child on ped-covid
* Agreement for blood and saliva samples
* Optional agreement for nasopharynx swab
* Optional parent's agreement for follow-up if PCR+
* With an Health insurance

For children SARS-coV2 positive

* any child less then 18 years old
* infected by SARS-coV2
* Parent's agreement for blood, saliva samples
* Optional parent's agreement for nasopharynx swab
* With health insurance

For people living under the same roof of a child included in the study

* any child or adult living under the same roof of a child SARS-coV2 positive and included in the study
* With health insurance

Exclusion Criteria:

For hospitalized children or consulting at hospital

* child younger than 7 days
* Refusal of parent
* Refusal of child
* No health insurance
Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject has received mechanical ventilation for at least 48h at the time of the randomisation
* Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization
* Presence of new or progressive infiltrate on chest X-ray
* Presence of clinical criteria consistent with VABP
* High probability of VABP caused by Pseudomonas aeriginosa

Key Exclusion Criteria:

* Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia
* Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction
* Severe liver or renal impairment
* Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control
Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection

Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection

Prospective, randomized, open-label, multicenter, international study in a population with an accepted indication for an implantable automatic defibrillator.

The main objective is to know the different values of the rates of inappropriate therapies, of serious cardiac and cerebrovascular adverse events, and of the appropriate detections in single-chamber ICD devices, with optimized programming according to the patient's arrhythmic history, using the three discrimination methods. arrhythmias: Smart, Onset and Stability, and Morphmatch.

The device under investigation is a single chamber with a floating atrial dipole for the detection of atrial signals.

Patients who are included in the study will present an indication for an automatic cardioverter-defibrillator device according to clinical practice guidelines for an ICD and who also do not have an indication for permanent stimulation in the right atrium. For this reason, the indication of patients will be those that require an ICD without the implantation of an electrode in the atrium, that is, single-chamber ICDs or DX ICDs since both, from the therapeutic point of view, are equivalent.

The centers will follow standard clinical practice to diagnose patients

Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication of a single chamber ICD due to high risk of sudden death.
* Patients with and without a prior history of AF.
* Patients with indication for primary and secondary prevention.
* Device optimized for the discrimination of supraventricular events.
* DX device implant with single floating cable.
* Activation of "Home Monitoring" function.
* Over 18 years.
* Signature of informed consent

Exclusion Criteria:

* Indication for permanent atrial pacing according to current pacing guidelines.
* Congestive heart failure grade IV.
* Candidates for Cardiac Resynchronization Therapy.
* Patients with a previous device.
* Permanent Atrial Fibrillation.
* Life expectancy less than 12 months.
* Pregnant or lactating women.
* Patients who are unable to understand the nature of the study.
* Subjects with irreversible brain damage caused by pre-existing brain disease.
* Heart transplant 6 months prior to recruitment or expected in the next 3 months.
* Cardiac surgery 3 months prior to recruitment or planned for the next 3 months.
Echocardiographic Changes After 3-hydroxy Butyrate+Whey Intake

This study evaluates the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during human endotoxemia. Further, this study compares cardiovascular changes during healthy and catabolic conditions.

Participants will receive isocaloric, isonitrogenous beverages of either whey or 3-OHB+whey in a randomized crossover design during either healthy (overnight fast) or catabolic conditions (inflammation/endotoxemia + 36 h fast and bed rest).

Background: A newly published study found beneficial cardiovascular effects of 3-OHB infusion in a population with chronic heart failure, significantly increasing cardiac output. Similar effects on cardiac output were observed in healthy volunteers. These findings pave the way for 3-OHB as a therapeutic nutritional supplement, since it is well-absorbed during oral consumption. However, it is unknown whether the cardiovascular effects of 3-OHB persist during a sepsis-like catabolic state and when administered orally.

Aim: This study aims to investigate the cardiovascular effects of adding the ketone body 3-hydroxy butyrate (3-OHB) to whey protein during a human disease model, comprising endotoxemia + bed rest + fast.

Hypothesis:

1. Adding the ketone body 3-OHB to an oral protein supplement increases cardiac output measures
2. Catabolic stress (endotoxemia/inflammation + 36 h fast and bed rest) induces cardiovascular changes compared with healthy conditions (overnight fast)

   Interventions:

   In a randomized crossover design, eight healthy, lean, young men will undergo either:

   i) Healthy conditions (overnight fast) + whey protein\^

   ii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest\*) + whey protein\^

   iii) Catabolic conditions (Inflammation (LPS) + 36-hour fast and bed rest\*) + 3-OHB/whey protein\^"

   \*LPS will be administered (1 ng/kg) the day prior to the study together with fast and bed rest. On the study day LPS (0.5 ng/kg) will be injected.

   \^Beverages will be isonitrogenous and isocaloric (fat will be added) with 45 g whey protein + 20 g maltodextrin. Bolus/sip administration will be applied (1/3 bolus, 1/2 sip)

   " 50 grams of 3-OHB will be orally administered (1/2 bolus, 1/2 sip)

Eligibility Criteria:
Inclusion Criteria:

* Between 20-40 years of age
* Body mass index between 20-30 kg/m\^2
* Healthy
* Oral and written consent forms obtained prior to study day

Exclusion Criteria:

* Recent immobilization of an extremity that is not fully rehabilitated
* Lactose, lidocain or rubber allergies
* Current disease
* Use of anabolic steroids
* Smoking
* Former major abdominal surgery (Or current problems with the GI tract)

  •\>10 hours of exercise/weak
* Present ketogenic diets or high-protein diets
* Blood doner that does not want to discontinue blood donations until study completion
* Pending MR scan
Multiplex Testing for Evaluation of Breast Cancer Risk, Longitudinal Study

The overall goal of the proposed research is to evaluate the uptake of testing and longitudinal risks and benefits of multiplex testing for cancer susceptibility in BRCA1/2 negative patients. This model will inform the selection of the outcomes and potential mediators and moderators of these outcomes, to inform the debate over utility, risks, and benefits of clinical incorporation of multiplex testing for breast cancer susceptibility.


Eligibility Criteria:
Inclusion Criteria:

* 1. Women and men (at least 18 YO) 2. English speaking AND 3. Negative for BRCA1 and BRCA2 mutations

Exclusion Criteria:

1. Non English speaking patients
Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)

Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. This observational study was designed to evaluate the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding during surgery (perioperative bleeding) in a routine clinical setting.


Eligibility Criteria:
Inclusion Criteria (All):

For all cohorts:

•≥ 16 years of age

* Received treatment with:

  * Beriplex® P/N
  * or FFP and Beriplex® P/N (in subsequent order)
  * or FFP only
* INR and/or PT results available in connection with administration of Beriplex® P/N or FFP:

  * within 3 hours directly before and after administration of Beriplex® P/N or FFP

In case of Beriplex® P/N use subsequent to FFP, additional results of INR and PT between the administration of the two products

Cohort P (Prophylaxis Group):

* Chronic liver disease, acute liver failure, or other conditions requiring correction of coagulopathy
* Coagulopathy (INR \> 1.4 and/or PT ≥ 3 sec of upper limit of normal \[ULN\])
* Any planned major or minimally invasive procedure, except liver transplantation

Cohort T (Treatment Group):

* Acute perioperative bleeding (as assessed by the investigator)

Exclusion Criteria:

* Treatment with prothrombin complex concentrates (PCCs) other than Beriplex® P/N
* Acquired deficiency of the vitamin K-dependent coagulation factors (e.g., as induced by treatment with oral vitamin K antagonists)
Effect of Lacidipine and Losartan on 24 Hour Systolic Blood Pressure Variability in Elderly Hypertensive Patients

The aim of this study is to evaluate the effect of lacidipine and losartan in elderly hypertensive patients on reducing the 24 hour systolic BP variability, which is one of the potential parameter to consider in treating elderly hypertensive patients.

In this study, we investigate the effects of two anti-hypertensive medications on systolic BP variability profile as a pilot study. This is a prospective, randomized, open-label, blinded end point (PROBE), parallel group study with two treatment arms. At the end of an initial 2-week washout period, during which any eventual anti-hypertensive drug is discontinued, patients fulfilling the inclusion criteria are randomly treated with the lacidipine (4 mg) or losartan (50 mg), both given once daily at the same hour in the morning (approximately at 8 AM) for 12 weeks. If the BP goal (SBP \< 140 mmHg and DBP \< 90 mmHg) has not been attained after 4 week's treatment, 12.5 mg hydrochlorothiazide (HCTS) once daily can be added.

Patients are checked 24-h ambulatory BP monitoring (ABPM) at the end of the washout period and after 12 weeks of active treatment. At each visit, seated cuff SBP and DBP, heart rate, use of concomitant medication and spontaneously reported adverse events are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (age \> 65 years)
* Essential hypertension (systolic BP \> 140 mmHg or diastolic BP \> 90 mm Hg)
* Provide written informed content

Exclusion Criteria:

* Secondary hypertension
* Myocardial infarction or cerebrovascular accident within the preceding 6 months
* Clinically significant valvular heart disease, heart failure (Class III, IV), renal insufficiency (serum creatinine \> 2.5mg/dl), hepatic failure, uncontrolled diabetes mellitus
* Known hypersensitivity to the drugs used in the study.
Adoption of Audio Recording in the Outpatient Supportive Care Center

This study evaluates how patients feel about having an audio recording of their visit to help remember information given to them and share that information with family members and/or caregivers not present during a clinic visit. Information from this study may help evaluate the effectiveness of using technology to help improve patient care by recording consultation recommendations.

PRIMARY OBJECTIVE:

I. To assess the patient's perception of the usefulness of the audio recording in helping to recall information given to him/her in the visit along with the perception of usefulness in the dissemination of information to family member(s) and/or caregiver(s) not present at the clinic visit.

SECONDARY OBJECTIVES:

I. To assess the number of times the recording is listened to. II. To assess the ease of use of the technology. III. To assess the ability to share the information with the patient's family member(s) and/or caregiver(s) if he or she chooses to do so.

IV. To assess the patient perception of whether the audio recording caused any disruption to the clinic.

V. To estimate the participation rate of patients. VI. To explore association between patient's perception of the usefulness of the audio recording and patient's demographic/clinical characteristics.

VII. To explore the association between age and sex of the caregiver and frequency of caregiver's use of the audio recording.

VIII. To explore the association of the ease of use of the technology and the type of device and application used.

OUTLINE:

Patients audio record the recommendations and instructions given to them by the doctor record as part of their clinic visit at the Supportive Care Center.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of advanced cancer as defined as locally advanced, recurrent or metastatic cancer. Both solid and liquid tumors are eligible for the study
* Patients who are seen in the outpatient supportive care center at M.D. Anderson Cancer Center
* Patients who have access to a recording device or cellphone with recording technology
* Patients who can be contacted 7 to 11 days from the clinic visit that the recording took place
* Patients who can sign informed consent
* Patients who are able to read and write in English
* Patients 18 years or older

Exclusion Criteria:

* Patients who have been diagnosed with delirium or cognitive impairment. This will be defined by chart review along with review of the MD Anderson Symptom Inventory (MDAS) the day of clinic visit. An MDAS of 7 or greater will be considered to define delirium in this study
* Patients who are unwilling to sign informed consent
* Patients who have used audio recordings before in clinic visits
* Patients who have severe hearing impairments without access to assisted devices or programs to aid in listening to the recorded material
Lidocaine-Ketamine for Management of Chronic Pain

Chronic pain is defined as 'an unpleasant sensory and emotional experience associated with actual or potential tissues damage, or described in terms of such damage". It is estimated that 1 in 5 Canadians experience chronic pain "Chronic pain is associated with the worst quality of life compared with other chronic diseases such as chronic lung or heart disease". Many of these problems are confined to a specific anatomic structure, and can be diagnosed and treated by injections, physical therapy, surgery, etc. Nonetheless, other individuals experience a more generalized pain. This condition has also resulted I depressed mood, bad relations with other people, sleep disturbances and poor quality of life.

The condition is very difficult to manage, and multiple methods have been recommended. Therapeutic intravenous infusion may be considered as one of these methods. Patients come for infusions of non-opioid medications under medical supervision and in a scheduled fashion. Two most commonly used mediation are lidocaine and ketamine.

Even though it is common to use multiple medications with complementary mechanisms of action to treat pain a combined lidocaine-ketamine infusion has never been studied Therefore, the purpose of this research study is to determine whether mixture of two medications (ketamine and lidocaine) infused intravenously 1 time per month for 6 months results in reduction of pain unpleasantness.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-90
* Pain duration: \> 3 months
* Multifocal and/or non-dermatomal neuropathic pain per Pain Diagram
* Failed medical management with at least 2 neuromodulation agents (e.g., gabapentinoids, antidepressants)
* Neuropathic component (\>15 points on S-LANSS)

Exclusion Criteria:

* Non-English speakers
* Refusal to sign informed consent
* Body weight \> 100 kg
* Allergies to ketamine and/or lidocaine
* Known contraindications to ketamine use which include poorly controlled systemic illnesses: arterial hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., history of psychosis, schizophrenia, dissociative state).
* Known contraindication to lidocaine use which include current symptomatic or clinically significant brady- or tachyarrhythmia, systolic blood pressure \<90 or \>180 mmHg.
* Scheduled interventions targeting neuropathic pain: epidural injections, peripheral nerve blocks, Bier block, radiofrequency of dorsal root ganglia and peripheral nerves, additional lidocaine or ketamine infusions
* Newly added analgesic or neuromodulating medications, or recently performed interventions including lidocaine infusions (in the previous 3 months), or previous lidocaine/ketamine infusion in the previous 360 days. -Acute intoxication or active illegal substance abuse (excluding marijuana)
Predictive Value of New AMH Test Method for Ovarian Response

In China, the incidence of infertility is about 15%, and patients need to use assisted reproductive technology (ART) to obtain pregnancy. It is particularly important to accurately predict the patient's ovarian response before initiating controlled ovulation hyperstimulation (COH). At present, the commonly used AMH detection method is enzyme-linked immunoassay (ELISA), and it has obtained the normal reference range for ovarian response. In recent years, with the development of detection technology, chemiluminescence immunoassay（CLIA） detection reagents have been successively used for the detection of AMH. However, there are few studies on the comparison of these two detection methods. The predictive value of the new method on ovarian response was lack. Therefore, by comparing the two methods of ELISA and CLIA detection of AMH levels in this study, the predictive value of poor ovarian response (the number of retrieved oocyte ≤ 3) and high response (the number of retrieved oocyte ≥ 15) in IVF/ICSI stimulation cycle was analyzed. In order to provide more reference basis for individualized COH, the AMH cutoff value of low and high ovarian response by the new method predicts was analyzed. At the same time, the prediction value of the two methods is compared to determine whether the new CLIA is suitable for clinical application.


Eligibility Criteria:
Inclusion Criteria:

* The first IVF/ICSI COH cycle;
* the causes of infertility :fallopian tube factors and/or male factors;

Exclusion Criteria:

* Endometriosis;
* PCOS;
* Adenomyosis;
* PGT cycle because of the female chromosome abnormality or genetic abnormality;
* FET cycle;
* Malignant tumor patient.
Connection Between General Practitioner's (GP's) Estimation of Cardiovascular Risk and Theoretical Calculation in France

The purpose of this study is to evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation.


Eligibility Criteria:
Inclusion Criteria:

* Adults 50 years old and over, visiting their GPs
Study Inflammation During a 100 Miles

To study per and post effort variations of inflammatory biological markers during a 100 miles


Eligibility Criteria:
Inclusion Criteria:

* adults (age\>18years)
* completion of an ultra endurance race (50 miles) during the 2 years before

Exclusion Criteria:

* female
* age\<18years
Appendicoliths in Acute Complicated Appendicitis Patients With Abscess

Complicated appendicitis, characterized by the presence of an abscess or perforation, involves acute inflammation of the peritoneum secondary to an infection of the appendix, presenting additional challenges for management. Traditionally, the standard treatment for complicated appendicitis has been surgical intervention. However, conservative management, involving antibiotics and drainage, has emerged as a viable alternative for selected patients. Recent studies emphasize the importance of selecting appropriate antibiotics based on local resistance patterns and the patient's clinical condition. Broad-spectrum antibiotics, including those targeting anaerobic bacteria, are often preferred. In addition, advances in imaging technology, such as ultrasound-guided drainage, have improved the precision and success rates of percutaneous abscess drainage. This minimally invasive approach helps manage localized infections and can prevent the need for immediate surgery.

One factor that has gained significant attention in determining the success of conservative treatment for acute complicated appendicitis is the presence of appendicoliths-calcified deposits within the appendix. This study aims to investigate the clinical significance of appendicoliths in the conservative management of acute complicated appendicitis with abscesses.


Eligibility Criteria:
Inclusion Criteria:

* Patients who aged ≥18 years, who diagnosed as acute appendicitis clinically, who had peri-appendiceal abscess larger than 2 cm in diameter on CT scan, who agreed conservative treatment first, who refused immediate emergency surgery

Exclusion Criteria:

* Patients younger than 18 years, those with malignancies, those with incomplete clinical or pathological records were excluded from the study