cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections

Central venous catheters (CVCs) are used in patient care for such purposes as the administration of medication, fluids, blood products and for functions such as hemodialysis and plasmapheresis. However, the use of CVCs can cause complications such as life-threatening bloodstream infections (BSI).

BSIs are caused by organisms from the skin's surface tracking down the catheter's outer surface. The organisms grow on the catheter surface (catheter colonization) which is followed by seeding into the bloodstream. BSIs can be difficult to treat and the mortality rate is as high as 35% in Intensive Care patients with a catheter-related BSI. It is estimated that up to 70,000 patients in the US die each year from catheter-related BSI.

MBI 226 is a new drug that, when applied to the skin surrounding the catheter insertion site, may prevent organisms on the skin from migrating down the catheter and entering the bloodstream and therefore decrease the incidence of catheter-related BSI in patients with CVCs.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing non-cuffed arterial and/or central venous catheterization.
* Patients able to give signed informed consent.
* Concurrent antibiotic therapy is permitted.

Exclusion Criteria:

* Treatment with an experimental topical, antibacterial, or antifungal drug within the previous 30 days.
* Patients who are scheduled to receive catheters impregnated/bonded with an antimicrobial substance.
* Patients requiring arterial or central venous catheterization for less than 48 hours or longer than 28 days.
* Second or third degree burn patients.
* Patients with a suspected or known bloodstream infection or local catheter insertion site infection.
* Patients with a known allergy to adhesive tape or adhesive bandages.
* Patients with a medical condition that the Investigator believes may interfere with the safety of the patient or the intent or conduct of the study.
* Routine non-complicated post-operative CABG patients.
* The disinfection procedure for catheter insertion did not include povidone-iodine.
Estimating Patient Size From a Single Radiograph

A computational model has been created to estimate the abdominal depth of a patient from a single x-ray image. The model has been tested using phantoms and found to be accurate; this study aims to test the accuracy of the model with patients and in a clinical setting.

This will be achieved by enrolling patient's who have already been referred for an anterior-posterior abdomen x-ray examination to the trial, taking a physical measurement of their anterior-posterior abdominal depth and then comparing this measured value with a value as estimated using the computational model based on the patient's x-ray image.

A non-commercial computational model has been developed in-house to estimate the patient's anterior-posterior or lateral depth using the radiographic image and the known exposure factors with which it was undertaken. This model has been tested using single composition phantoms and found to be accurate. If it was found to be accurate for real clinical examinations, this would automate the measurement of patient size and give institutions the estimate of patient size required for local paediatric patient dose audit. In turn, this would provide the national data required to propose national reference values for paediatric x-ray examinations, which would give all institutions an important comparator for their performance. This would lead to optimisation in those sites most requiring it; nationally, paediatric x-ray imaging would improve in time.

This pilot study is necessary to determine if the computational model is accurate enough to be relied upon. Accuracy will be determined by comparing the estimate made by the computational model for each patient with an actual measurement of the patient's anterior-posterior abdomen depth made at the time of the examination.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Referred to Ninewells Hospital for an anterior-posterior abdomen x-ray examination

Exclusion Criteria:

* Patients unable to give consent
* Patients who have had a contrast injection in the previous 24 hours
* Patients suffering abdominal pain at the time of the examination
Olverembatinib for FGFR1-rearranged Neoplasms

FGFR1-rearranged myeloid/lymphoid neoplasms are a rare hematologic malignancy with very poor outcome despite intensive chemotherapy. The only curative option is thought to be allogeneic hematopoietic stem cell transplantation (HSCT) in remission.

This phase II study is aimed to evaluate the efficacy of Olverembatinib, consolidated with HSCT in the treatment of FGFR1-rearranged myeloid/lymphoid neoplasm.

FGFR1-rearranged myeloid/lymphoid neoplasms are a rare and highly heterogeneous hematological malignancy, mainly manifested as myeloproliferative neoplasms (MPNs) or acute leukemia, including T cells or B cells Cell lymphoblastic leukemia/lymphoma (T-cell or B-cell-ALL/LBL), acute myeloid leukemia (AML) and mixed cell leukemia (MPAL).

To date, there is no standard treatment. Conventional chemotherapy is frequently ineffective. The only curative option is thought to be allogeneic HSCT at present, TKIs may offer a therapeutic alternative in patients not eligible for allogeneic HSCT or to bridge the time between diagnosis and allogeneic HSCT.

Third-generation TKIs Olverembatinib is a pan- FGFR1 kinase inhibitor, and is supposed to be effective to achieve bone marrow remission in FGFR1-rearranged myeloid/lymphoid neoplasms.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed, progressed or relapsed myeloid/lymphoid neoplasms with FGFR1 rearrangement according to the WHO-2016 diagnostic criteria. Patients who have received allogeneic hematopoietic stem cell transplantation or ponatinib should be excluded.
2. ECOG score: MPNs patients, 0-3 points; AL patients, 0-2 points.
3. Expected survival period ≥12 weeks.
4. Willingness and ability to comply with study procedures and follow-up examination.

Exclusion Criteria:

1. Patients who have received allogeneic hematopoietic stem cell or ponatinib.
2. Human immunodeficiency virus (HIV) infection, or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive).
3. Patients who are pregnant, planning to become pregnant or breastfeeding.
4. Patients who may not be able to complete all study visits or procedures required by the study protocol, including follow-up visits, and/or fail to comply with all required study procedures.
5. Patients who suffer from any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the safety of the research drug.
Analysis of Body Composition in Patients With Hepatocellular Carcinoma in Radioablation

Number of shows: 20 patients Track: A month with three visiting Intervention: Nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric Hepatic Encephalopathy Score and Critical Flicker Frequency.

There will be a prospective, longitudinal, comparative. It included 20 patients diagnosed with hepatocellular carcinoma. As there are a finite number of active patients at the institute, and no studies with sample size well established, has seen a sample size of 20 patients.

The duration of individual monitoring shall be one month to three visits (baseline, week 2 and week 4 after receiving the first radiofrequency ablation). Each visit will be a nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF).

Anthropometric measures to be taken are weight, height and arm circumference average.

Bioelectrical impedance will be using a single frequency impedance meter (425 to -50 KHz, Range 0 to 10,000) Bioelectrical Body Composition Analyzer Quantium II RJL Systems. The team measured the subjects' impedance, resistance, reactance and phase angle by Lean Body program provided by the manufacturer.

Hepatic encephalopathy be evaluated by testing PHES and was measured CFF, also also be measured ammonium, tumor necrosis factor, IL-1, IL-6, IL-10, renin angiotensin aldosterone.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of hepatocellular carcinoma, treatment-naive and who are referred to the radiology department for radioablation as first therapy.
* Outpatients.
* Willingness to participate in the project.

Exclusion Criteria:

* Patients with hepato-renal diseases.
* Patients diagnosed with hepatocellular carcinoma undergoing chemoembolization treatment, or who have received more than one session radioablation.
* Patients with depression or psychiatric illnesses
* Patients who do not agree to participate in the project.

Exclusion Criteria:

* incomplete Applied Tests
* disagreement of the person to perform any of the tests
* monitoring Breach
* Hospitalization or death after the first session radioablation.
Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell Non-Hodgkin's Lymphoma in China

This study aimed to analyze the safety of 90-min intravenous rapid infusion of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma and to provide evidence for the applicability of rapid infusion regimens in chemotherapy in China.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of B-cell lymphoma and with indications for obinutuzumab treatment
* No significant organ damage
* ECOG score of 0-2;
* Life expectancy ≥ 6 months
* Informed consent

Exclusion Criteria:

* Pregnant or lactating
* Serologically tested positive for human immunodeficiency virus or hepatitis B virus infection but had not received treatment
* Severe hepatic or renal insufficiency
* Severe cardiovascular disease.
Intravenous Paracetamol for Postoperative Pain

The purpose of this study is to define if intravenous paracetamol may improve analgesia and outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) postoperatively.

Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and adolescents following surgery.

Patients aged 1-18 years undergoing general, plastic or orthopedic surgery with expected moderate to severe pain at least for 24 hours postoperatively, who meet inclusion criteria and does not meet exclusion criteria, are enrolled. At the end of surgical procedure, at skin closure, all patients are given 1,5 mg/kg intravenous ketoprofen and repeated every 8 hours up till 4,5 mg/kg/24 h. Patients in paracetamol group are additionally given the first dose of IV paracetamol 20 mg/kg and repeated 6 and 20 hours postoperatively up till 60 mg/kg/24 h. Patients in the placebo group are given 0.9% sodium chloride 2 ml/kg IV and repeated 6 and 20 hours postoperatively.

After surgery optional rescue analgesia is given on patient request: either tramadol in a dose of 2 mg/kg (up till 4 mg/kg/24h), either patient-controlled analgesia (PCA) with morphine, as indicated according to the standard of care. Patients are evaluated up till 24 hours postoperatively. After that patients are followed up as long as indicated per standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Patients 1-18 years of age, undergoing general, plastic or orthopedic surgery with expected median to severe pain postoperatively.
* physical status of the patient corresponding to American Society of Anesthesiologists (ASA) class 1 or 2
* Signed written informed consent by parents/official caregivers.

Exclusion Criteria:

* Allergy to paracetamol, ketoprofen, tramadol, morphine or any NSAID
* oncologic disease
* central nervous system disease
* renal dysfunction
* hepatic dysfunction
* bronchial asthma
* ulcer(s) in gastrointestinal system
* hemorrhagic diathesis
* chronic use of NSAIDs
* chronic use of opioids
* chronic use of anticoagulants
* female patient is known to be pregnant
ART-3 Pilot - Driving Pressure Limited Ventilation for Patients Without ARDS (ART3pilot)

This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without acute respiratory distress syndrome (ARDS).

Mechanical ventilation has the potential to produce or worsen alveolar injury. Driving pressure is the difference between plateau pressure and PEEP. Evidence from observational studies suggests that elevated driving pressure is the main independent determinant of ventilator-induced lung injury, however clinical trials are needed to establish whether targeting low driving pressures can improve clinical outcomes in patients without acute respiratory distress syndrome (ARDS).

Thus, ART-3 pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without ARDS. Patients considered to this trial are those in mechanical ventilation for less than 72 hours without diagnosis of ARDS. We will exclude patients with less than 18 years old; contraindication to hypercapnia such as intracranial hypertension or recent acute coronary syndrome; patients in which a high probability of death within 24 hours is anticipated and patients under exclusive palliative care. Eligible patients will be randomized to the driving pressure limited ventilation strategy or conventional strategy (tidal volume of 8 mL/kg of predicted body weight). The primary outcome is driving pressure between days 1 and 3.

Eligibility Criteria:
Inclusion Criteria:

* Patients on invasive mechanical ventilation for less than 72 hours and without diagnosis of ARDS, and no perspective of extubation in 24 hours.

Exclusion Criteria:

* Less than 18 years old
* Presence of any contraindication to hypercapnia as suspected or confirmed intracranial hypertension or recent (\<7 days) acute coronary syndrome.
* Patients in which a high probability of death within 24 hours is anticipated.
* Patients under exclusive palliative care.
Evaluation of Patient and Lesion Specific Prognostic Factors for Standard Radioimmunotherapy

MERIT-NHL as an addendum to the International Registry of Radioimmunotherapy (RIT registry) pooling clinical data of patients who suffered from a non-Hodgkin´s lymphoma also includes the documentation of the respective FDG-PET and CT-image files in an online archive.

Based on these documented clinical and imaging data, the MERIT study group centrally performs an intra- as well as interindividual evaluation of follicular CD20+ lymphoma lesions before and after radioimmunotherapy. According to this, the aim of the MERIT-NHL study is to prospectively identify yet unknown patient- and lesion specific prognostic factors predicting patient´s outcome in line with the therapeutic modality radioimmunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* standard radioimmunotherapy with 90-yttrium-labeled anti-CD20-antibodies in treatment of relapsed and/or refractory follicular NHL or partial remission after induction chemotherapy
* finding of at least one image-guided measurable lymphoma lesion
* existence of FDG-PET- and CT-image data of at most 8 weeks before treatment
* signed patient´s agreement for RIT registry and MERIT-NHL

Exclusion Criteria:

* other therapy modalities than standard radioimmunotherapy (e.g. consolidation)
* solely CNS-lymphoma or primary effusion lymphoma
To Determine Effect and Safety of Tadalafil Taken by Men of Different Races and With Different Diseases When Needed for Erections

To compare men of different races and those with diabetes or depression to white men that do not have diabetes or depression but also suffer from the inability to get or keep an erection.


Eligibility Criteria:
Inclusion Criteria:

* At least 3 months history of erectile dysfunction (ED)
* Anticipate a monogamous relationship with a female sexual partner
* Be able to make minimum required sexual intercourse attempts
* Abstain from using any other ED treatment

Exclusion Criteria:

* Other primary sexual disorders
* History of penile implant or clinically significant penile deformity
* History or current nitrate use
* History of certain heart problems
* History of certain kidney problems
Cognitive-driven ADL Impairment as a Predictor for PDD

Mild cognitive impairment in Parkinson's disease (PD-MCI) is the highest risk factor for Parkinson's disease dementia (PDD). The core feature for differentiating PDD from PD-MCI is the loss of the ability to perform activities of daily living (ADL). As Parkinson's Disease (PD) is primarily a movement disorder, the distinction between motor and cognitive contributions to ADL in PD is an obvious challenge, which the investigators aimed to explore in this study. The goal of the study is to evaluate whether PD-MCI patients with more pronounced, cognitive-driven ADL impairment are at higher risk for cognitive worsening and PDD. A longitudinal follow-up assessment of 262 non-demented PD patients will be conducted over the next two years, with a comprehensive clinical assessment as well as biomarker sampling (cerebrospinal fluid and blood markers). Primary longitudinal outcome will be conversion to PDD and PD-MCI. Conversion rates of patients with and without additional mild cognitive-driven ADL impairment at baseline will be compared. Novel scores of the Pfeffer Functional Activities Questionnaire (FAQ) are used to assess instrumental ADL, differentiating between cognitive- and motor-driven ADL impairment in PD-MCI.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the baseline assessment
* Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
* Provide written informed consent to participate in the study and understand their right to withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

* Any disability that may prevent the subject from completing the informed consent form or other study requirements.
* Other neurodegenerative disease which renders the subject unable to communicate well with the investigator or to understand and comply with the requirements of the study.
* Participation in any clinical investigation of a new investigational compound or therapy within 4 weeks prior to baseline visit, and for any other limitation of participation based on local regulations.
* Alcohol, medication or drug dependency or abuse (except for nicotine).
* History of brain disease other than PD, e.g. head trauma, stroke, encephalitis, etc.
M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)

The main purpose of the study was to evaluate the safety and tolerability of M7824 in combination with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants greater than or equals to (\>=) 18 years of age inclusive at the time of signing the informed consent
* Participants who have histologically confirmed diagnosis of Stage IV NSCLC:

  1. Participants in Cohort A, B, and C must not have received prior systemic therapy treatment for their Stage IV NSCLC
  2. Participants who had disease progression on previous treatment with Programmed death-ligand 1 (PD- L1) inhibitors in combination with platinum-based chemotherapy are enrolled in Cohort D, as long as therapy was completed at least 28 days of the first study intervention.
* Have measurable disease based on Response evaluation criteria in solid tumors (RECIST) 1.1
* Have a life expectancy of at least 3 months
* Availability of archived tumor material (less than \[\<\] 6 months old) adequate for biomarker analysis is mandatory at Screening, central laboratory confirmation is required. Fresh biopsies should be collected if archived tumor material is not available
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study entry and date of first dose

Exclusion Criteria:

* The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation,ROS1 rearrangement, or BRAF V600E mutation or anaplastic lymphoma kinase (ALK) positive, if targeted therapy is locally approved
* Mixed small cell with NSCLC cancer histology
* Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy (RT) of \> 30 gray (Gy) within 6 months prior to the first dose of study intervention
* Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks after the end of the RT and, have no evidence of new or enlarging brain metastases evaluated by imaging, preferably brain magnetic resonance imaging (MRI)
* Known severe hypersensitivity to study intervention or any components in their formulations
* For participants in Cohort A, B and C: Has received prior systemic therapy for Stage IV NSCLC, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
* Unable to tolerate computed tomography (CT) or MRI in the opinion of the Investigator and/or allergy to contrast material.
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers

ALX-0171 is a Nanobody directed against the human respiratory syncytial virus (RSV). The purpose of this first-in-man study is to determine the safety, tolerability and pharmacokinetics (PK) of ALX-0171 after single and multiple pulmonary administrations in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking healthy male volunteers, aged 18-55 years
* Good health condition, as determined by medical history, physical examination and clinical laboratory testing
* Forced expiratory volume in 1 second (FEV1) ≥ 90% of predicted value
* Diffusing capacity of the lung for CO (DLCO) ≥ 85% of predicted value
* Normal chest X-Ray (anteroposterior and lateral view)
* Minimum weight of 70.0 kg, minimum height of 1m70, body mass index between 18.0 and 30.0 kg/m²

Exclusion Criteria:

* Current smokers, or ex-smokers abstinent from tobacco for less than one year
* History or presence of atopy or pulmonary non-specific hyperreactivity
* Positive bronchial challenge test
* Symptomatic viral infection, or suspicion thereof (including rhinitis) in last 14 days prior to dosing
* Signs of active pulmonary infection or other inflammatory conditions, even in the absence of febrile episodes, in the last 14 days prior to dosing