cyrilzakka/clinical-trials huggingface dataset:
Analysis of Circulating Tumor Markers in Blood

The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.

The new major challenge in the research concerns the circulating biomarkers, which aim at replacing the molecular analyses on tumour tissue obtained by biopsy (for example the search for somatic mutations of cancer) by a simple blood test (liquid biopsy). The other current important challenge is to have an idea of the interest to analyse the kinetics of blood markers, in particular in answer to a clinical "event", either through the chemotherapy, a biopsy and / or surgery. There is almost no data in the literature on this aspect. It is very likely that the liberation in the blood of the blood tumoral markers is strongly dependent on medical interventions on the tumour.

The study ALCINA 2 rests exactly on the principle of small cohorts, which correspond each to a clinical situation and/or a technique of different implemented detection, so as to generate data of feasibility and proof of concept. In case of success, statistical hypotheses will be necessary for the implementation of wider studies (being then the object of a specific approval by competent authorities).

Eligibility Criteria:
Inclusion Criteria:

1. Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
2. Man or woman ≥ 18 years,
3. Obtaining of the informed consent signed before any procedure of specific preselection on approval.

Exclusion Criteria:

1. Private persons of freedom or under guardianship,
2. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
3. Pregnant woman and/or breast-feeding,
4. Unaffiliated patient to Social Protection System,
Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research

In normal patients, blood and cerebrospinal fluid (CSF) contain circulating cells and other molecules such as proteins and nucleic acids. In patients with central nervous system (CNS) and other conditions, the levels of these molecules may be altered. In several other studies at our institution, the investigators are investigating such molecules in tumor specimens as well as the blood and cerebrospinal fluid of pediatric patients with CNS tumors. However, these levels are difficult to interpret without comparing them to levels in patients without CNS tumors. The investigators propose a study to collect small amounts of blood and cerebrospinal fluid from pediatric patients without CNS tumors who are undergoing a diagnostic or therapeutic neurosurgical procedure aimed at addressing altered CSF dynamics.


Eligibility Criteria:
Inclusion Criteria:

* Children without central nervous system tumors who are undergoing a neurosurgical procedure to address hydrocephalus during which CSF will be obtained
* Between the ages of 1 year and 21 years
* Patients must be having blood draws, lumbar punctures or CSF sampling from Ommaya reservoirs or VPS as part of routine clinical care.

Exclusion Criteria:

* Patients who do not require routine blood draws and/or CSF collection as part of their routine clinical care
* Patients who are considered too ill to participate as determined by their treating physician
* Patients with documented bacterial of viral infections of the CSF, brain parenchyma and/or neurosurgical devices and/or
* Patients with suspected de-myelinating conditions
* Patients who are pregnant or lactating.
Enterobius Vermicularis Infestation of the Appendix

This study identifies the incidence of appendiceal Enterobius vermicularis (E.v) infestation in all the patients undergoing appendectomy and evaluates the relationship between E.v infestation of the appendix and the acute appendicitis.

All the patients undergoing appendectomy surgical procedure for clinical picture of acute appendicitis in 3-years period at our referral hospital were evaluated to pick up the Enterobius vermicularis infestation of the appendix. These cases were evaluated for clinico-laboratory characterization to define the incidence in our country and the relationship between the E.v and initiation of the the inflammatory process to study the possibility of limitation of surgical intervention in acute abdomen conditions.

Eligibility Criteria:
Inclusion Criteria:

All routine examined appendectomy specimens

Exclusion Criteria:

Cases with clinical suspicion of tumor Cases attached to the colectomy specimens
Prevalence of COVID-19 (Coronavirus Disease 19) in Pregnant Women on Labor in a Public Hospital in Chile (COroNavirus diSease Covid-19 pandEmic iN ChilE)

This study aim is to assess the prevalence of SARS-COV-2 in unselected pregnant women on labour (or a predictable delivery during next 24 hours), their outcome and sociodemographic conditions.

This is a cross sectional study conducted in Hospital San Juan de Dios, Santiago of Chile. This Hospital attends nearly 4500 births every year. When the COVID-19 pandemia came to Chile, there was no possibility to assess the seroconversion for SARS-Cov2. Currently, it remains unclear the seroprevalence of SARS-Cov-2 in pregnant near to delivery in our country, also its correlation with clinical, perinatal outcomes and sociodemographic characteristics. The project will evaluate these features, collecting nasopharyngeal swab serology in a systematic manner in unselected pregnant women on labor (or a predictable delivery during next 24 hours). Maternal information including clinical data, obstetric history, comorbidities and sociodemographic characteristics acquired from medical records will be correlated to the seroconversion.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women on labor or preterm labor.
* Pregnant women who underwent programmed or emergence cesarean

Exclusion Criteria:

* Stillbirth
* Refusal to participate in the study
Clinical Study of Partially Hydrolysed Protein Infant Formula on Trans-epidermal Water Loss (TEWL)

This is a single-centre, prospective, randomized, open-label, controlled trial of 200 infants 42±7 days of age. Subjects will be randomized to one of two open label feeding intervention group:

* Intact Cow's Milk Protein Formula Group (CMFG) (n = 100) or
* Partially Hydrolysed Whey Formula Group (pHFG) (n = 100).

Atopic dermatitis (AD) affects 15 - 30% of children. Approximately 45% of these cases have an onset within the first 6 months of life and 60% develop within the first year (Bieber 2010). Besides environmental factors, the aetiology of AD has been found to be associated with genetic variants involved in skin barrier function defect and inflammation, leading to dry skin with increases in susceptibility to environmental exposures (Bieber 2008).

Partially hydrolysed cow's milk (whey) protein infant formula (pHF) has been shown to be effective in prevention of AD, both among at-risk and healthy infants (Exl, Deland et al. 2000, von Berg, Koletzko et al. 2003, Jingrana and Dunjina 2015). However, to date there are no published pediatric data to document the relationship between partially hydrolysed protein formulas and skin barrier function, specifically evaluating the effect of pHF on Trans-epidermal Water Loss (TEWL) among infants. Therefore, this study aims to evaluate the effect on skin barrier function as measured by TEWL and we hypothesize that infants consuming partially hydrolysed starter formula will have lower TEWL when compared infants consuming intact cow's milk protein starter formula.

Eligibility Criteria:
Inclusion Criteria:

* Infants 42± 7 days of age at enrolment (date of birth = age 0).
* Infants who have been born full-term gestational birth (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.
* Parents /caregivers must agree to follow study procedures and recommended skincare routines, such as avoidance of moisturizers or other skincare products on the primary sites of interest.
* Parent(s) must have already independently elected before enrolment to formula feed and less than 30% of intake will be from breastmilk.

Exclusion Criteria:

* Known and diagnosed cow's milk protein allergy/intolerance.
* Infants currently using or have ever used partially hydrolysed protein formulas.
* Infants who have ever used topical corticosteroids, calcineurin inhibitors and/or any other physician-recommended treatments for skin conditions after birth.
* Infants who have been introduced to complementary foods.
Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure

The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.

The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.

The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. Noninvasive ventilation (NIV) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (COPD) and nonCOPD patients.

The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.

Patients over the age of 18 admitted to Royal Brompton Hospital respiratory ward will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. After 24 hours on the first NIV the patient will be swapped to the alternative NIV for a further 24 hours of treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 \< pH \< 7.35, PaCO2 \> 6.0kPa, and respiratory rate \> 20bpm

Exclusion Criteria:

* \< 18 years old
* pH \< 7.25
* need for immediate intubation
* uncontrolled cardiac failure
* hypotensive (systolic blood pressure \< 90mmHg)
* acute myocardial infarction
* acute dysrhythmia
* other system failure (e.g. acute renal failure, liver failure)
* moderate or severe bulbar weakness
* inability to understand rationale and/or consent form for study
Nitrous Oxide and Neuraxial Labor Analgesia Use on Maternal Fetal Outcomes

The purpose of this study is to evaluate maternal and neonatal outcomes in parturients who used nitrous oxide and neuraxial labor analgesia during labor.

The use of nitrous oxide during labor is common in several countries including the United Kingdom, Finland, Canada, Australia and New Zealand.1, 2 The use of nitrous oxide during labor has undergone a resurgence in popularity recently in the United States and became available at Brigham and Women's hospital in August 2014.

Inhaled nitrous oxide has a rapid onset (30-50 seconds) and clearance with a half-life of about 5 minutes.3 It can be used for analgesia during the first, second and third stages of labor, as well as during post-delivery procedures such as laceration repair, manual removal of the placenta, and uterine curettage. It is also commonly used to facilitate the initiation of epidural analgesia.4 At the Brigham and Women's Hospital, a pneumatically driven gas mixer is designed to deliver a 50% oxygen and 50% nitrous oxide mixture to patients. Nitrous oxide passes readily across the placenta, and reaches equilibrium within a few minutes; the fetal maternal concentration ratio after 2 minutes of inhalation is 0.64.5 Hence, when administered at 50% concentration to the mother, the fetal concentration approximates at 32%.

Despite its long track record of maternal safety reported in numerous countries, the effect of nitrous oxide on the fetus is less well-studied. A number of studies have published data on the use of nitrous oxide for labor analgesia, including the effectiveness in labor analgesia, maternal satisfaction and maternal fetal adverse effects. Most of these studies have not identified adverse neonatal outcomes. However, these studies used Apgar scores or neonatal behavior scores as outcome measures and the quality of these studies was predominately poor.

The purpose of this study is to evaluate maternal and neonatal outcomes in parturients who used nitrous oxide and neuraxial labor analgesia during labor.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients requesting for pain relief with neuraxial analgesia and/or nitrous oxide
* health patients with no comorbidities
* singleton, vertex gestation at term

Exclusion Criteria:

* Refuse informed consent
* evidence of anticipated fetal anomalies
* significant medical or pregnancy-related diseases
Comparison of Pericapsular Nerve Group Block and Quadratus Lumborum Block

Adequate pain management following total hip arthroplasty (THA) is a key component for patient satisfaction and early ambulation. However, due to the complexity of the innervation of the hip joint, the most appropriate anaesthetic and analgesic technique for THA remains unclear. A femoral nerve block is commonly performed and well established but is associated with motor weakness. Recently, the pericapsular nerve group (PENG) block has been introduced as an effective choice which targets the articular branches of the hip. The quadratus lumborum block (QLB) is a relatively new regional block that has been reported to provide effective analgesia for THA.

The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to QLB block in terms of efficacy of pain control and the safety profile after total hip arthroplasty under spinal anesthesia.

The patients will be randomly classified into two equal groups (40 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and outcomes assessor will be blinded to group assignment.

Patients will be randomized to one of three equal groups:

Group I (n= 40 patients): Patients in this group will receive an ipsilateral single shot of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

Group II(n= 40 patients): patients in this group will receive an ipsilateral single-shot of PENG block (25 ml of plain bupivacaine 0.25%) and LFCN block (5 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

Eligibility Criteria:
Inclusion Criteria:

Physical status according to American Society of Anesthesiologists (ASA ) I-III

Exclusion Criteria:

* Younger than 40 years old and older than 85
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* Infection of the skin at the site of the needle puncture,
* Patients who do not accept the procedure
* History of bleeding diathesis
* ASA IV,
* Chronic gabapentin/pregabalin,opioid use
* Hepatic or renal insufficiency
* Previous operation on the same hip
* BMI \>40
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

This study evaluates the use of Targretin capsules (bexarotene) in combination with Cisplatin and Vinorelbine for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Eligibility Criteria:
Patients must have:

* Pathologic (histologic or cytologic) confirmation of NSCLC
* Stage IIIB with malignant pleural effusion or Stage IV disease
* At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy
* ECOG performance status 0 or 1
* Adequate organ system function
* Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).

Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)

Patients must not have had:

* Brain metastasis
* Prior chemotherapy for NSCLC
* Prior platinum-based chemotherapy for any indication
The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 2) (OPAL-Aim 2)

This study will evaluate the effect of a brief alcohol counseling intervention on PrEP and PEP adherence among adults with heavy alcohol use at high risk for HIV, while gaining insights into the facilitators, barriers, and cost-effectiveness of this approach.

The investigators have developed a mobilization strategy of integrating HIV testing within multi-disease screening to recruit \>2,000 people from drinking venues in Kenya and Uganda and invite them to begin biomedical HIV prevention if eligible (OPAL Aim 1; NCT05862857)

Following uptake of biomedical HIV prevention, persons with heavy alcohol use face challenges with retention in care and adherence to PrEP/PEP. The investigators have adapted a brief alcohol counseling intervention (Health Living Intervention) to reduce alcohol use and promote antiretroviral therapy (ART) adherence and HIV viral suppression among persons with HIV in Kenya and Uganda. The investigators now need to determine whether this intervention can promote retention in biomedical prevention and PrEP/PEP adherence among adults with heavy alcohol use.

Specific Aims:

* Determine the efficacy of the Healthy Living Intervention (HLI) to reduce heavy alcohol use vs. standard care (control) on retention in biomedical HIV prevention in a randomized trial among adults with heavy alcohol use.
* Determine the cost-effectiveness of interventions that increase biomedical HIV prevention retention among adults at high-risk for HIV who attend drinking venues.

The proposed research will address the critical intersection of alcohol use and HIV risk in SSA, by promoting retention of biomedical HIV prevention and exploring associated facilitators and barriers.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years)
* HIV-uninfected (by rapid HIV antibody test)
* AUDIT-C score of \>=4 for men and \>=3 for women
* Attending a clinical visit for initiation of biomedical HIV prevention with oral or injectable PrEP or oral PEP (or the dapivirine vaginal ring, if available)
* Has access to a mobile phone

Exclusion Criteria:

* Ineligible for PrEP based on MoH guidelines
* Intention to move away from the study community in the coming year
* Gross inebriation or inability to provide informed consent
An Observational Study of Cisatracurium 0.15 mg/kg in Young and Elderly (≥ 80 Years) Patients.

The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years.

The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years. The hypothesis of this study is that cisatracurium administered in elderly patients (\>80 years) has a longer onset time and duration of action compared to younger patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 80 or ≥18 - ≤40 years of age
2. Informed consent
3. Scheduled for elective surgery under general anaesthesia (expected duration of anaesthesia \> 1 hour) with intubation and use of cisatracurium
4. American Society of Anaesthesiologists (ASA) physical status classification I to III
5. Can read and understand Danish

Exclusion Criteria:

1. Known allergy to cisatracurium
2. Neuromuscular disease
3. Indication for rapid sequence induction
4. Surgery in the prone position
Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)

The purpose of the study is to evaluate the safety of sodium phenylbutyrate (NaPB) treatment in subjects with amyotrophic lateral sclerosis (ALS) and the ability to take this medication without major side effects.

Although it is known that nerve cells die in the brains and spinal cords of patients who have ALS, the cause of the cell death is unknown. There is evidence that this cell death may be caused by changes in DNA, the body's genetic material. Drugs such as sodium phenylbutyrate (NaPB) can increase the expression of genes, block how the motor nerve cells in ALS die, and may prove to be an effective therapy for ALS. NaPB has shown an improvement in survival in mice with conditions similar to ALS.

STUDY DESIGN:

All research participants will take sodium phenylbutyrate for a total of 20 weeks. The dose of medication will be increased every 2 to 4 weeks until a maximum, easily tolerated dose is achieved (study maximum is 21 g/day).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ALS
* At least 18 years of age
* Women, who can become pregnant, must actively use effective birth control measures

Exclusion Criteria:

* Must not have any other neurological (nervous system) disease

Veterans only are eligible to participate at VA sites.