cyrilzakka/clinical-trials huggingface dataset:
Potential Predictive Biomarkers in Patients Undergoing First-line Chemotherapy for Metastatic Colorectal Cancer

Chemoresistance remains an obstacle in treating people with metastatic colorectal cancer (mCRC). Studying samples of blood and tumor tissue in the laboratory from patients with mCRC receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. It may also help doctors predict how patients will respond to treatment. In this study, we aimed to evaluate biomarkers in chemotherapy regimens for first-line chemotherapy for mCRC.


Eligibility Criteria:
Inclusion Criteria Histologically confirmed metastatic colorectal cancer Unresectable metastatic disease must be confirmed histologically if \> 2 years since primary diagnosis Measurable metastatic disease \> 1 cm by spiral CT scan or \> 2 cm by other methods Scheduled to receive first-line chemotherapy for metastatic disease Chemotherapy must include fluorouracil, capecitabine, irinotecan hydrochloride, or oxaliplatin Exclusion Criteria Inadequate or unusable tissue as the only tissue available Brain metastases or meningeal disease Contraindication to chemotherapy Pregnant or nursing Other severe pathology that is likely to worsen during therapy Dementia or severely impaired mental condition Geographical or psychological reasons that would preclude treatment
Evaluation Of The Pan-microbiome and Host Immune Response in CF

Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic Fibrosis patients to explore microbiome features that are associated with an inflammatory phenotype. Investigators hypothesize that temporal and spatial differences in lung microbiome are associated with host inflammatory responses.

While chronic and polymicrobial airway colonization are commonly recognized in cystic fibrosis (CF), it is unclear what factors of the microbial environment lead to infection with pathogenic microorganism. This is a multi center, longitudinal cohort of adult Cystic Fibrosis subjects recruit4ed from NYU and Columbia to understand how changes in the airway microbiome may affect the host inflammatory responses in Cystic Fibrosis (CF). There will be three approaches to understanding inflammatory responses; 1) a longitudinal assessment of temporal changes in the microbiome over a 6-month period of clinical stability; 2) comparison of the regional differences in airway microbiome between lung segments with more versus less disease; 3) evaluation of functional aspects of the lung microbiome.


Eligibility Criteria:
Inclusion Criteria:

* CF diagnosis
* able to produce sputum
* no recent (one month) exacerbation defined as physician treatment with antibiotics for ≥ 7days
* FEV1 ≥ 30% of predicted.

Exclusion Criteria:

* Initiation of any new chronic therapy (e.g., ibuprofen, aerosolized rhDNase, hypertonic saline, azithromycin, tobramycin inhalation solution, aztreonam inhalation solution, ivacaftor) within 8 weeks prior to enrolment
* introduction of vitamins or proton pump inhibitors within 8 weeks prior to enrolment
* use of new investigational therapy within 4 weeks
* current smoker; use of oral corticosteroids
* Initiation of treatment or change in regimen for allergic bronchopulmonary aspergillosis or nontuberculous mycobacteria within 8 weeks.
* liver enzymes \> 3 times the upper limit
* pregnancy

Additional Exclusion Criteria for Bronchoscopy Subgroup (Aims 2 and 3):

* FEV1 \< 50% of predicted.
* Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
* Significant renal disease (Creatinine Clearance \< 30%).
* Severe malnutrition (BMI \<18kg/m2)
Infants Fed a Hydrolyzed Infant Formula

The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.


Eligibility Criteria:
Inclusion Criteria:

* Infant is 0 to 90 days of age at enrollment.
* Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional
* Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
* Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
* Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study

Exclusion Criteria:

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development
* Awareness of a positive drug screen in the mother or participant
* Suspected maternal substance abuse including alcohol
* Participation in another study that has not been approved as a concomitant study by AN
* Participant is receiving oral or inhaled steroids
* Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
* Participant has received an amino acid-based formula
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis

This study is to evaluate the efficacy and safety of SHR0302 in subjects with active non-radiographic axial spondyloarthritis.


Eligibility Criteria:
Inclusion Criteria:

1. Provide signed informed consent.
2. BMI ≥18 kg/m2.
3. Participant has the clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on magnetic resonance imaging (MRI) or based on high sensitivity C-reactive protein (CRP).
4. Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 and a Patient's Assessment of Total Back Pain score \>= 4 based on a 0 - 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits.
5. Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
6. If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline, the stable doses should have lasted for more than 4 weeks already.

Exclusion Criteria:

1. Pregnant women or refuse to receive contraception during the study.
2. Lab abnormality within 4 weeks of randomization as follows: WBC count \<3.0×10\^9/L；neutrophil count\<1.5×10\^9/L;hemoglobin level\<90.0 g/L ; platelet count \<100×10\^9/L; AST or ALT levels greater than the 1.5 times the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
3. History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
Study Assessing Pain Relief After Replacement of the Knee

The goal of the ATX101-TKA-004 clinical trial aims to evaluate the efficacy and safety of ATX101 1,500 mg in participants undergoing primary unilateral total knee arthroplasty. The study will compare the effectiveness of ATX101 with a saline placebo and bupivacaine, an active comparator. Additionally, it will assess opioid consumption among participants receiving ATX101 versus those given the saline placebo and bupivacaine. The trial will also focus on the safety and tolerability of ATX101 in the participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Primary indication of TKA is knee pain due to osteoarthritis or post-traumatic arthritis
* Scheduled to undergo primary unilateral TKA with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted)
* American Society of Anesthesiology (ASA) Physical Classification System of class 1, 2, or 3
* Capable, able, and willing to comply with all trial visits and procedures. Participant must also be able to use trial required e-diary and demonstrate completion compliance during the screening period
* English or Spanish speaking, willing, and capable of providing written informed consent

Key Exclusion Criteria:

* Has a planned concurrent surgical procedure (e.g. bilateral TKA) at the time of surgery or a planned surgical procedure before the last trial visit
* Has had any previous open surgery, (e.g., ORIF for fracture, osteotomy, arthroplasty, unicompartmental knee arthroplasty, or TKA), in the trial knee at any time in the past or arthroscopic surgery within 12 months. Has had any previous surgery in the contralateral knee within 6 months prior to screening
* Has been administered any type of intra-articular injection within 3 months of surgery in the trial knee
* Unable to abstain from opioid use for knee pain (including codeine) within 2 weeks (14 days) of surgery
* Has a Body Mass Index (BMI) ≥45 kg/m²
* Is unwilling or unable to discontinue use of medications or products that can impact pain control from the Screening Visit until the last trial visit (e.g. cannabidiol (CBD) oil, Kratom)
* Has a medical condition or receiving medication such that, in the opinion of the Investigator, participating in the trial would pose a health risk to the participant or confound the postsurgical assessments or might confound or interfere with the outcome of the trial
* Has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. COVID-19 vaccines (approved or under emergency use authorization locally) are permitted if the participant is not in a clinical trial for the vaccine
* Has a positive drug screen at the Screening Visit or on the day of surgery
* Has participated in an ATX101 clinical trial
* Pregnant, breastfeeding, or planning to become pregnant during the trial or before the last trial visit

Other protocol defined Inclusion/Exclusion criteria may apply
Early Application of Continuous Positive Airway Pressure in Coronavirus Patients at Risk of Obstructive Sleep Apnea

This was an experimental clinical trial, Aim: To evaluate the role of early use of Continuous Positive Airway Pressure (CPAP) in management of moderate to severe Coronavirus disease 2019 patients at risk of Obstructive Sleep Apnea, enrolled patients are randomized into two equal groups;Non- CPAP group and CPAP group. Non-CPAP group will receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 and CPAP group as in Non-CPAP group plus using CPAP.

steps included

1. Clinical Assessment:

   Full history taking were taken from the enrolled Coronavirus disease 2019patients including age, occupation, medical history and special habits), Coronavirus disease 2019 symptoms (e.g., fever, dyspnea, fatigue, loss of smell or taste, (gastrointestinal tract) symptoms....) as well as all obstructive sleep apnea symptoms (e.g., Snoring, Insomnia, Excessive day time sleepiness, witnessed apnea, ...).
2. II. Scales \& Questionnaires:

   * Epworth Sleepiness Scale (ESS) It's designed to assess the degree of daytime sleepiness.
   * - Berlin Questionnaire
   * - (Snoring, Tiredness, observed apnea, high blood pressure, body mass Index, age, neck circumference and male Gender questionnaire: This scoring system composed of 8 items that are graded from 0 to 8 according to Yes/No responses (score: 1/0).
3. III. Radiological investigations
4. IV. Laboratory Investigations Blood gases, complete blood picture, etc
5. . CPAP application Auto-CPAP with continuous nocturnal administration or at least4- 6hours /night and during day naps, for more than 70% of nights from the first night of admission to isolation center

Eligibility Criteria:
Inclusion Criteria:

* patients age above 18 years, diagnosed with moderate to severe (Coronavirus disease 2019) and at risk of Obstructive Sleep Apnea as well as confirmed nasopharyngeal swab positive for (Severe acute respiratory syndrome coronavirus 2) ( by (polymerase chain reaction).

Exclusion Criteria:

* patients were excluded from the study if their age \<18 years, hypercapnic, unstable cardiorespiratory (shock) status or respiratory arrest and if there are any contraindications for ( Continuous Positive Airway Pressure (CPAP) mask use
Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management

We designed a study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.

We designed a prospective, single-blinded, randomized, and controlled study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* lung surgery
* one-lung ventilation.

Exclusion Criteria:

* body mass index exceeding 30 kg/m2,
* autonomic dysfunction,
* cardiovascular disease,
* neurological or psychiatric diseases
Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study

This is a pilot feasibility study to evaluate if patients with ST depression Acute Coronary Syndrome who are taken directly to the catheter laboratory for angiogram and angioplasty +/- stents will fare better that patients who are taken to the ward area and managed with drug therapy and stabilised for 24 hours before being taken to the catheter laboratory.


Eligibility Criteria:
Inclusion Criteria Patients presenting with symptoms (onset of symptoms ≤ 12 hours) of a suspected acute coronary syndrome (unstable angina or MI without persistent ST elevation) characterised as follows

* Clinical history consistent with ongoing ischaemic chest pain and/or symptoms AND
* \>1mm ST depression AND/OR ≥2mm T wave inversion in at least two adjacent ECG leads Pathological T wave inversion in leads 1+4 suggesting 'LAD Syndrome' Or Ischaemic ST depression/T wave inversion not fulfilling the above criteria that is felt in the opinion of the attending physician to represent an acute coronary syndrome. AND
* Written informed consent Main exclusion criteria

  1. ≤ 18 years of age
  2. Previous Coronary Artery Bypass Grafting surgery
  3. ST elevation myocardial infarction
  4. Left bundle branch block (LBBB)
  5. ST depression seen in patients during paced mode only
  6. Heart rate ≥ 150bpm
  7. Cardiogenic shock or other catastrophic state
  8. If in the opinion of the physician the patient is not suitable for revascularisation due to co-morbidity
  9. Patient participating in another clinical trial such that randomisation to DANCE would result in deviation from the protocol stipulations of either trial.
Prolonged Infusion Cefepime and Nosocomial Infections

It is advocated that prolonged infusion of beta-lactamic antibiotics provides better bactericidal effect. The aim of the present study is to randomize patients a to extended cefepime infusion regimen (lasting four hours) or to a usual infusion regimen (not lasting more than thirty minutes) and evaluate the clinical efficacy of this theoretical pharmacokinetic advantage.

Introduction: it has been proved that the main determinant for microbiological cure gram-negative infections treated with cefepime is the time above minimal inhibitory concentration (T\>MIC). Although this particular pharmacokinetic property have never been proved in clinical trials utilizing cefepime, intervention studies with other betalactamic antibiotics, such as pipercillin-tazobactam, showed clinical benefit.

Objective: to evaluate if prolonged infusion (lasting 4 hours) with cefepime translate into better clinical outcomes.

Methods: the investigators aim to conduct an open-label, unique-centered, randomized controlled trial using cefepime in prolonged infusions in patients being treated for urinary or respiratory tract infections. Patients developing these infections after 72 hours of hospital admission, requiring the use of broader spectrum antibiotics after clinical failure or isolating gram-negative bacteria from adequate sample sensible to cefepime will be enrolled. The use of a second antibiotic such as clindamycin, vancomycin or metronidazole will be allowed.

Interventions: the investigators aim to randomize 134 patients to two different treatment arms, the intervention arm who will receive the medication in a four hour lasting infusion, and the active control arm who will receive the medication in a 30 minutes lasting infusion. The randomization will be conducted in blocks of ten patients each, and it will be balance according to the patients age (older or younger than 65 years old) and presence of SIRS criteria.

Eligibility Criteria:
Inclusion Criteria:

* Urinary tract infection after 48-72 hours of hospital stay
* Respiratory tract infection after 48-72 hours of hospital stay
* Catheter related urinary tract infection after 48-72 hours of hospital stay
* Urinary or respiratory infections not responding to a narrower spectrum antibiotic
* Isolation of bacteria sensible to cefepime in blood, urine or sputum in a clinical context of infection

Exclusion Criteria:

* Glomerular filtration rate lower than 30 ml.min/1,73m²
* ICU admission for at least 72 hours before randomization
* Neutrophil count lower than 1000 cels per mm³
* Hematologic malignancy, bronchiectasis and cystic fibrosis
* Patients allergic to cefepime
* Concomitant treatment to another infectious disease
* Central nervous system, cutaneous or intrabdominal infections
* Solid organ transplantation
* HIV with a cluster differentiation 4 (CD4) lower than 100 cels per mm³
Tranexamic Acid and Spontaneous Chronic Urticaria

Spontaneous chronic urticaria (UCS) is a disease that affects 1% of the general population with a potentially severe impact on quality of life. Most patients respond favorably to long-term antihistamine treatment, but sometimes it is necessary to give a high dose (4 times the formal dose, Berlin consensus 2016). These high doses are often accompanied by side effects requiring cessation of treatment. The therapeutic alternative is then omalizumab, an expensive biotherapy. UCS is secondary to non-specific mast cell activation. It has been shown to be associated with activation of fibrinolysis that correlates with the severity of symptoms. Patients with UCS resistant to levocetirizine were shown to have higher D-dimer levels than patients who responded to antihistamines. Tranexamic acid is a molecule with antifibrinolytic propertiesSeveral cases of severe chronic urticaria responding favorably to treatment with tranexamic acid have been reported. In our department, Investigators also noticed the improvement of some of their patients on tranexamic acid. The combination of these two treatments appears to be synergistic: action on histamine receptors and control of fibrinolysis.

The investigators propose to evaluate the association of tranexamic acid and levocetirizine for the treatment of chronic spontaneous urticaria.

Multicentric controlled randomized crossover study, double-blind To evaluate the efficacy and safety of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine 20mg / day alone in the chronic treatment of chronic urticaria evaluated at 4 weeks.

A hierarchical analysis will be implemented in the following order:

1. Non-inferiority of the combination levocetirizine 10 mg / day + tranexamic acid (TA) 2 g / day versus levocetirizine alone 20 mg / day in terms of effectiveness
2. Superiority of the combination levocetirizine 10 mg / day + tranexamic acid (AT) 2 g / day versus levocetirizine alone 20 mg / day in terms of tolerance
3. Superiority of levocetirizine 10mg / day + tranexamic acid (AT) 2g / day versus levocetirizine alone 20mg / day in terms of effectiveness Each objective will be tested sequentially if and only if the previous objective is validated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with spontaneous chronic urticaria, according to the criteria of the European Academy of Allergology and Clinical Immunology (EAACI) in agreement with the European Dermatology Forum (EDF), and the World Allergy Organization (WAO), corresponding to an association of the following symptoms : urticarial eruptions and / or recurrent angioedema for at least 6 weeks

Exclusion Criteria:

* Urticaria associated with a specific systemic disease including cutaneous and systemic mastocytosis, urticarial vasculitis, autoinflammatory diseases associated with cryopyrin
* Bradykinin angioedema and isolated angioedema whose origin is not clearly attributable to spontaneous chronic urticaria.
* Presence of a contraindication to tranexamic acid and to levocetirizine
Attitudes of General Practitioners in Lorraine Towards Prediabetes

Screening for the risk factors of type 2 diabetes is a part of the primary prevention approach. Pre-diabetes is one of the modifiable risk factors; however, it remains under-diagnosed. Our aim was to analyse the attitudes of general practitioners in Lorraine towards prediabetes


Eligibility Criteria:
Inclusion Criteria:

* General practitioner
* Practice in Lorraine
* Installed or substitute
* Exclusively private practice or mixed activity

Exclusion Criteria:

* Retired physicians
* General practitioners working exclusively in hospital