cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes

This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 diabetes for at least 4 weeks
* Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks
* HbA1c: 7.5-13.5%
* Body Mass Index (BMI): 18-35 kg/m2

Exclusion Criteria:

* Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation
* History of drug abuse or alcohol dependence
Driving Pressure-guided Positive End-expiratory Pressure to Prevent Postoperative Atelectasis in Obese Children: a Prospective, Randomized Controlled Clinical Trial

At present, the use of lung protective ventilation strategies in children is mainly based on adult and intensive care unit data. Although obese children may benefit more from lung protective ventilation, there are few studies on the use of lung protective ventilation strategies in obese children during surgery. Therefore, the investigators hypothesized that intraoperative use of LPV strategies in obese pediatric surgery patients can reduce atelectasis and improve the incidence of postoperative pulmonary complications.

In the lung protective ventilation group, PEEP was titrated individually in a sequential manner after mechanical ventilation. According to previous studies, PEEP was 5 cmH2O, inspiratory pressure was 20 cmH2O, and respiratory rate was set according to patient age. PEEP and inspiratory pressure were increased by 5 cmH2O every 30 seconds until PEEP was 15 cmH2O and inspiratory pressure 30 cmH2O. This was followed by a decreasing amplitude of 2 cmH2O to 3 cmH2O starting from 15 cmH2O, and each PEEP level was maintained for 4 to 5 respiratory cycles.The PEEP was at the lowest driving pressure was applied throughout the procedure. The PEEP level resulting in the lowest driving pressure was applied during surgery. In the traditional mechanical ventilation group, a fixed PEEP of 5 cm H2O was applied. The investigators compared the incidence of postoperative atelectasis between the two groups using lung ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Age 3-18 years old;
* According to the People's Republic of China health industry standard "Overweight and Obesity Screening threshold for school-age children and adolescents WS_T586-2018" defined as obesity;
* American Society of Anesthesiologists (ASA) grades I - II;
* Children with healthy lungs and hearts;
* Patients with general anesthesia under tracheal intubation;
* Clear mind and able to cooperate with the anesthesiologist to receive treatment;
* Patients who plan to have elective surgery under general anesthesia and the estimated operation duration is ≥2 hours.

Exclusion Criteria:

* PEEP contraindications: (a) bronchopleural fistula; (b) hypovolemic shock; (c) right ventricular failure;
* American Society of Anesthesiologists (ASA) grade greater than II;
* Pulmonary dysfunction, congenital heart disease children;
* Refusal to participate in the study and/or use personal data, preoperative intubation or ventilation of children;
* Children with upper respiratory tract infection within 2 weeks.
A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)

The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.


Eligibility Criteria:
Inclusion Criteria:

* Has relapsed or refractory (rr) DLBCL; has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent. anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
* Has histologically confirmed diagnosis of DLBCL.
* Has radiographically measurable DLBCL per the Lugano Response Criteria.
* Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason).
* Life expectancy of at least 3 months.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment.
* Has adequate organ function.

Exclusion Criteria:

* Has received a diagnosis of Primary mediastinal B-cell lymphoma (PMBCL).
* Has undergone solid organ transplant at any time.
* Has a history of any clinically significant cardiovascular conditions within 6 months of screening or serious cardiac arrhythmia requiring medication.
* Has known history of liver cirrhosis.
* Has pericardial effusion or clinically significant pleural effusion.
* Has ongoing Grade \>1 peripheral neuropathy.
* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
* Transformed DLBCL from indolent lymphoma.
* In participants with prior allo-SCT, acute graft versus host disease (GVHD) or ongoing evidence of chronic GVHD.
* Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
* Has received prior radiotherapy within 28 days of start of study intervention. Participants.

must have recovered from all radiation-related toxicities.

* Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent).
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
* Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.
* Has an active infection requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of hepatitis B or known active hepatitis C virus (HCV).
Bioavailability of Human Milk Oligosaccharides in Healthy Adults

Human milk oligosaccharides (HMOs) have been associated with beneficial health outcomes in breastfed infants, therefore they were investigated intensively within recent years. HMOs support the establishment of a "balanced" intestinal microbiome by acting as both a prebiotic and as a specific antimicrobial. In vitro work has demonstrated that HMOs are resistant to hydrolysis by salivary, pancreatic, and brush-border enzymes, as well as to low gastric pH values enzymes. Consequently, HMOs are mostly resistant to digestion and reach the colon unmodified, where they are available for selective utilisation by certain bacteria. Microbial utilisation results in the formation of microbial metabolites, which are associated with local and systemic effects. Simultaneously, HMOs have bacteriostatic effects and directly limit the growth of potential pathogens. Moreover, they serve as antiadhesives, mimicking intestinal epithelial cell surface receptors to which pathogenic microbes attach, thus acting as a decoy receptor. Additionally, it is suggested that HMOs exert effects independent of the microbiome, by modulating cell recognition and cell signalling. These include interactions with immune cells, thereby modulating the development and responses of the immune system, the maturation of the intestinal glycocalyx, and the promotion of neurodevelopment and cognitive functions. A prerequisite for systemic effects is that HMOs are absorbed and can enter the blood circulation, thus making them potentially available at the systemic level. In order to understand the underlying mechanisms for HMO-mediated, microbe-independent effects, information regarding absorption, metabolisation, and excretion is needed and will be investigated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40 Years
* Non-smoker
* Normal weight (BMI 18.5-25.0 kg/m²)

Exclusion Criteria:

* Impaired insulin sensitivity/glucose tolerance
* Underweight or overweight/obesity
* Regular intake of nutritional supplements
* Alcohol, drug or medication abuse
* Pregnancy and breastfeeding
* Hypo- and hypertension
* Epilepsy
* known hepatitis B, hepatitis C, HIV infection
* Malabsorption and maldigestion syndrome
* Type 1 or type 2 diabetes mellitus
* Other metabolic diseases
* Chronic inflammatory diseases
* Other chronic diseases
* Psychiatric illnesses
* Participation in another study
Prognostic Value of Proadrenomedullin in Intra-abdominal Sepsis

An observational, prospective study whose main objective is to measure the value of Pro-adrenomedullin as a prognostic marker and predictor of mortality in patients with intra-abdominal sepsis after damage control surgery.

Proadrenomedullin as a Severity Score and Prognostic Marker in Intra-abdominal Sepsis

Research Type:

Prospective, observational study.

Duration:

October 2016 - October 2017

Associated Medical Centers:

La Paz University Hospital (Madrid), La Princesa Hospital (Madrid), Hospital del Mar (Barcelona), Hospital Clínico de Valladolid and Hospital Clínico de Valencia.

Main Goal:

To measure the value of Pro-adrenomedullin as a prognostic marker and predictor of mortality in patients with intra-abdominal sepsis after damage control surgery.

Secondary Goals:

Make a comparison with other biomarkers (procalcitonin, lactic acid, CRP) and clinical severity scales used in standard critical practice (SAPSII, SOFA).

To establish a correlation between the levels of Pro-Adrenomedullin, the time of stay in critical care units, days of mechanical ventilation and mortality.

Variables:

A. Demographics

B. Date of admission to hospital and date of admission to critical care unit unit

C. Clinical data:

* Associated diseases
* SAPS II
* SOFA

D. Intra-abdominal infection episode data

* Systemic response: sepsis / septic shock
* Isolated microorganisms in blood cultures and intra-abdominal fluid
* Complications related to the infectious process (ARDS, need for mechanical ventilation, vasopressors, disseminated intravascular coagulation, acute renal failure, renal replacement techniques)

E. Follow-up

* Critical unit registration date
* Date of discharge from hospital
* Critical unit mortality, in-hospital mortality and 30 days mortality (assessed by telephone contact if the patient had been discharged).

F. Pro-adrenomedullin levels at admission, 24 and 72 hours. As well as procalcitonin (PCT), lactic acid and polymerase Chain Reaction (PCR) levels.

Eligibility Criteria:
Inclusion Criteria:

* All patients consecutively collected, adults over 18, who are admitted to critical care unit with the diagnosis of localized or generalized intraabdominal infection after damage control surgery.

Exclusion Criteria:

* Pregnant or lactating women.
* Patients with neutropenia induced by bone marrow transplant or by chemotherapy (\<500 neutrophils / ml).
Outpatient Registry Trial of Respiratory Tract Infections in Adults

To measure the speed of bacterial eradication from the respiratory tract after administration of azithromycin or telithromycin.

To Evaluate the relationship between rate of S. pneumoniae killing in sputum, PK/PD, and clinical response of oral telithromycin and azithromycin in patients with AECB or CAP and to determine if there is a difference in the rates of infection site bacterial killing (as described above) between these 3 antibiotics against penicillin- and erythromycin-resistant S.pneumoniae

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, either males or non-pregnant females, aged 18 to 75 years of age with clinical findings of CAP or AECB who are amenable to serial nasopharyngeal and oropharyngeal sampling and having positive Binax-NOW tests indicating infection with Streptococcus pneumoniae
* Patients with a medical history and clinical findings consistent with a respiratory tract infection. A patient with advanced COPD, repeated exacerbations by history, a BINAX-NOW test consistent with S. pneumoniae and/or proven culture positivity for S. pneumoniae may be enrolled
* All patients (CAP or AECB) must produce purulent sputum and be positive on the Urinary BINAX-NOW assay.
* The female patient of child bearing potential must agree to use an accepted method of contraception (i.e., oral or implanted contraceptive with a barrier method, spermicide and barrier methods, or IUD). The patient must agree to continue with the same method throughout the study.

Exclusion Criteria:

* Baseline sputum cultures known to be negative for S. pneumoniae, or negative urinary BINAX-NOW.
* Patients with a microbiologically documented pathogen known prior to inclusion to be resistant to any of the study medications.
* History of hypersensitivity to macrolides, azalides, ketolide antibiotics or history of serious hypersensitivity reaction to any drug.
* Pre-existing impaired hepatic function or impaired renal function CCL \<20ml/min
* Patients who will require on-study treatment with medications known to have contraindicated drug interactions with telithromycin
* Treatment with more than one dose of an antimicrobial prior to entry into the study

Others as per protocol
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea

The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.

Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female aged 18 years or older.
2. Subject has a clinical diagnosis of facial rosacea.
3. Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
4. Subject has a self assessment score of moderate to severe redness prior to enrollment.
5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Exclusion Criteria:

1. Female subjects who are pregnant, nursing or planning a pregnancy during the study.
2. Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.
3. Subjects with conditions causing facial erythema which would confound the assessment of treatment.
4. Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
5. Subjects with known allergies or sensitivities to one of the components of the investigational products.
Amylase and Hypersomnia

Hypersomnia is defined as a reduced ability to remain awake during the day. There are basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia. Currently, the diagnosis of these sleep disorders is based on polysomnographic recordings which is difficult to access. Tests of sleepiness (Epworth, Karolinska) are subjective.

A biological marker of sleepiness, easily accessible and measurable, would be very useful for the diagnosis and therapeutic follow up of excessive diurnal sleepiness. Salivary secretions appear as good physiological markers. Studies have shown for healthy subjects, that the expression and activity of salivary amylase are increased when subjects are deprived of sleep.

The investigators propose to explore the usefulness of salivary biomarkers (including amylase) as a new non-invasive and simple technique for the assessment of excessive daytime sleepiness.


Eligibility Criteria:
Inclusion Criteria:

Subjects with hypersomnia (narcolepsy or idiopathic):

* Children and adolescents with hypersomnia (according to ICSD diagnostic criteria 2); narcolepsy or idiopathic hypersomnia (with or without lengthening of sleep),
* aged \> 6 years and \<18 years,
* no treatment,
* Parent consent

Control subjects:

* healthy children and adolescents without any known pathology,
* aged \> 6 years and \<18 years,
* matched on sex and age\> 6 years - \<12 years,\> 12 - \<18 years)
* Parent Consent

Exclusion Criteria:

* Subjects with hypersomnia (narcolepsy or idiopathic):
* Secondary narcolepsy,
* Symptomatic hypersomnia,
* Restless legs syndrome,
* Sleep apnea syndrome,
* Severe neurological, psychiatric, cognitive or endocrinological concomitant disease.

Control subjects:

* Hypersomnia,
* Restless legs syndrome,
* Sleep apnea syndrome,
* Severe neurological, psychiatric, cognitive or endocrinological concomitant disease,
* Sleep disorder evaluated by a score \> 70 on the Sleep Disturbance Scale for Children19,
* Excessive daytime sleepiness according to Epworth scales (score \> 10),
* Abnormal sleep time according to the age (sleep diary).
Effects of Low Power Laser Therapy on Muscle Performance Isokinetic Pre-exercise in Individuals With Diabetes Mellitus Type II

The low level laser therapy is able to improve immediately and long term (after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy) isokinetic muscle performance of the quadriceps femoris muscle (peak torque, total muscular work , maximum power and fatigue index - normalized by body weight) pre-exercise concentric isokinetic quadriceps femoris muscle in subjects with diabetes mellitus non-insulin-dependent.

The low level laser therapy is able to improve after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy, the indicators: The low level laser therapy is able to improve immediately and long term (after 4 weeks of treatment, 3 days per week resulting in 12 applications of low level laser therapy), the indirect blood markers for muscle damage that evaluate the enzymatic activity of creatine Kinase (CK) and Lactate Dehydrogenase (LDH) and the visual analog scale (VAS-F) for fatigue, improves indicators F 2.2 point of the WHOQOL-100 for fatigue, improvement in functional indicators of the lower lower Extremity functional regarding Scale, functional improvement in performance in the execution of the test stand and sit and walk test six minutes, the indicators for quality improvement of life questionnaire for the Diabetes Quality of Life Measure and emotional states through the questionnaire Problems Areas in Diabetes Scale. Eligibility criteria: Diagnosis for Diabetes mellitus non-insulin-dependent confirmed by the individual physician, presenting between 30 to 70 years.Exclusion criteria: Diagnosis of cardiovascular disorders, diagnosis of diabetic neuropathy, which have a skin lesion or local infection (quadriceps), history of musculoskeletal injuries in the last 6 months or during the study, individuals unable to perform the assessment protocols / exercise so satisfactory, those who are doing some kind of regular physical activity and who underwent alcohol intake in the 24 hours before any of the stages of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis for Diabetes mellitus non-insulin-dependent
* Age between 30 to 70 years

Exclusion Criteria:

* Diagnosis of cardiovascular disorders
* Diagnosis of diabetic neuropathy,
* Skin lesion or local infection (quadriceps)
* History of musculoskeletal injuries in the last 6 months or during the study
* Individuals unable to perform the assessment protocols or exercise
* Regular physical activity
* Underwent alcohol intake in the 24 hours before any of the stages of the study
Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA)

The goal of this observational study is to learn about the functioning of the abdominal wall in patients who underwent hybrid (open- and laparoscopic) incisional hernia repair. The main objective is to assess the anatomical restoration and function of the linea alba one year after surgery by ultrasonography and mean peak torque during trunk flexion using a BioDex machine.

Rationale: Abdominal wall functioning has been reported to be higher in patients that underwent open incisional hernia repair compared to laparoscopic incisional hernia repair. With the use of a recently developed hybrid approach, we aim for a functional anatomical restoration of the linea alba while also achieving the technical advantages of the hybrid approach.

Objective: The main objective is to asses functional anatomical restoration of the linea alba through functioning in mean peak torque, and ultrasound examination.

Study design: Multicentre prospective cohort study. Study population: Adult patients with a midline incisional hernia ≥4 cm and ≤10 cm.

Intervention: Not applicable. Main study parameters/endpoints: The primary objective of this study is to assess anatomical restoration and function of the linea alba one year after surgery by ultrasonography and measuring the mean peak torque during trunk flexion using a BioDex(trademark) machine.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risk is associated with participation other than known complications for incisional hernia repair. HYDRA is part of standard care in the Alrijne Hospital, and the technique has previously been published. The mesh used in this study is being used on a world-wide scale. We do not expect additional risks with this study. As participants have to visit the Erasmus Medical Center (Erasmus MC) an additional three times and have to fill in additional questionnaires, there is a burden for enrolled patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Scheduled for elective HYDRA-surgery
* Midline incisional hernia larger than 4 centimetres in mean width
* Sufficient knowledge of the Dutch language to be able to understand and fill in the questionnaires
* Signed informed consent form by patient

Exclusion Criteria:

* Pregnant at inclusion
* Inclusion in other trials with interference of the primary and secondary endpoints
* American Society of Anesthesiologists Classification (ASA Classification) \> 3
* Hernia defect larger than 10 centimetres in mean width
* Incarcerated hernias or emergency procedure
* Unable to perform a trunk flexion
* Incapacitated patients