bioihbjkbjnl/mcl2 huggingface dataset:
First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome in Premature Infants
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate the safety and tolerability of intratracheal
      administration of two different single doses of CHF 5633 in preterm neonates with RDS in
      terms of adverse events, adverse drug reactions, hematology and biochemistry values, the
      incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and
      mortality.
    

Detailed description: 
      The study will be a multicentre, open-label, single escalating dose, per-cohort design.
    

Intervention name(s): synthetic surfactant (CHF5633)
Intervention type(s): Drug
Intervention description(s): CHF5633 100 mg/kg; CHF5633 200 mg/kg synthetic surfactant sterile suspension in 3.0 ml glass vials with a total concentration of 80 mg/ml for intratracheal administration. Single administration
Intervention MeSH terms: Pulmonary Surfactants
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Respiratory Distress syndrome; Complications of prematurity
Cognitive Function of Alcoholic Compensated Liver Cirrhosis
Condition: Alcoholic Liver Disease
MeSH terms: Liver Diseases; Liver Cirrhosis; Liver Diseases, Alcoholic
Study type: Observational

Summary: 
      Differences in cognitive function between patients with viral and alcoholic compensated liver
      cirrhosis
    

Detailed description: 
      Hepatic encephalopathy (HE) is one of the important complications of liver cirrhosis (LC). HE
      exhibits alterations in cognitive, psychomotor-intellectual, emotional, behavioral, or
      fine-motor functions. Approximately 22-74 % of patients with non-fulminant HE have MHE with a
      frequency proportional to the patient age and the severity of the liver disease. Patients
      with MHE exhibit disability in most functional behaviors such as social connection,
      alertness, emotional behavior, sleep, work, and leisure.

      Alcohol consumption itself has a toxic effect on the brain. It has been documented that there
      is a neuronal loss in the cerebral cortex, hypothalamus, hippocampus, septal region, and
      cerebellum of an alcoholic brain.

      The major causes of LC are hepatitis B/C viral infection and chronic alcohol consumption. The
      most widely accepted theory of HE pathogenesis is that toxic substances derived from the gut
      affect cerebral function after liver dysfunction or portosystemic shunting. This proposed
      pathogenetic mechanism could apply to viral compensated LC. However, it is difficult to
      explain the development of MHE in patients with alcoholic LC in this manner.

      Therefore, patients with alcoholic LC may have different cognitive dysfunction as compared to
      patients with viral LC.
    

Intervention name(s): Cognitive function test
Intervention type(s): Other
Intervention description(s): Laboratory and imaging test
Biochemical serum test: total bilirubin, alanine aminotransferase (ALT), haptoglobin, aspartate aminotransferase (AST), gamma glutamyltranspeptidase (GGT), alkaline phosphatase (ALP), albumin, blood urea nitrogen, creatinine, α-fetoprotein (AFP), prothrombin time, blood glucose, triglycerides, and total cholesterol.
Baseline evaluations: family and alcohol history, X-ray, electrocardiography, blood tests for electrolyte, liver function, and viral markers
Neuropsychological test
-Attention, Language, Visuospatial, Memory, Frontal/executive
Other intervention name(s): Laboratory, imaging, neuropsychological tests
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All of them are agree to provide it to investigation.
      
Keywords: Hepatic encephalopathy; Liver cirrhosis; Cognition; Alcohol; BMI
Automatic Segmentation Ultrasound-based Radiomics Technology in Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Observational

Summary: 
      Diabetic kidney disease is a common complication of diabetes and the main cause of end-stage
      renal disease. In this study, the investigator plan to enroll nearly 500 participant
      with/without DKD and to develop an automatic segmentation ultrasound based radiomics
      technology to differentiating participant with a non-invasive and an available way.
    

Detailed description: 
      Ultrasound examination is a convenient, cheap and non-invasive method for kidney examination.
      However, the ability of conventional ultrasound to distinguish diabetic kidney disease from
      normal kidney is limited, and it is difficult to accurately distinguish between diabetic
      kidney disease and normal kidney only with the naked eye. In recent years, computer science
      has developed rapidly and artificial intelligence has been developing continuously. Much
      progress has been made in applying artificial intelligence in data analysis. Machine learning
      is a direction of generalized artificial intelligence, its main characteristic is to make the
      machine autonomous prediction and create algorithm, so as to achieve autonomous learning.
      kidney disease and deep learning are two different approaches in the field of machine
      learning. In this study, image omics and deep learning were used to analyze the images. Image
      omics extracts traditional image features, including shape, gray scale, texture, etc., and
      uses machine learning (pattern recognition) models to classify and predict, such as support
      vector machine, random forest, XGBoost, etc. Deep learning directly uses the convolutional
      network CNN to extract features, and completes classification and prediction in combination
      with the full connection layer, etc.

      This study aims to explore the detection of diabetic kidney disease and its pathological
      degree based on automatic segmentation ultraound-based radiomics technology, mining of
      internal information of ultrasound images, and form a set of non-invasive monitoring of
      diabetic kidney disease complications development system, especially in primary medical
      institutions, has a broad clinical application prospect.
    

Intervention name(s): ultrasonic imaging
Intervention type(s): Diagnostic Test
Intervention description(s): Two-dimensional ultrasound images of the patient's kidneys were obtained by ultrasound imaging.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        1. patients with diabetes

          2. patients with or without DKD
      
Keywords: diabetic kidney disease; ultrasound; radiomics; deep learning; multi-center
CH14.18 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed Neuroblastoma
Condition: Neuroblastoma Recurrent
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      A six courses regimen consisting of a 8 hour infusion (ch14.18/CHOmAb 20 mg/m²) for five
      consecutive days will be administered every 4 weeks, starting 60-180 days after previous
      haploidentical stem cell transplantation.

      Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants
      will be premedicated with an intravenous antihistamine and ranitidine within approximately 30
      minutes prior and during the infusion of the study agent Pain as an anticipated side effect
      is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be
      evaluated after 3 and 6 courses and after 1 year
    


Intervention name(s): ch14.18/CHO
Intervention type(s): Drug
Intervention description(s): A six courses regimen consisting of a 8 hour infusion (ch14.18/CHOmAb 20 mg/m² ) for five consecutive days will be administered every 4 weeks.
Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants will be premedicated with an intravenous antihistamine and ranitidine within approximately 30 minutes prior and during the infusion of the study agent Pain as an anticipated side effect is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be evaluated after 3 and 6 courses and after 1 year.
Other intervention name(s): ch14.18; anti GD2 antibody
Intervention MeSH terms: Dinutuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; haploidentical; stem cell transplantation
Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis
Condition: Neonatal Sepsis
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Interventional
Phase: Phase 3

Summary: 
      Majority of healthcare authorities believe that due to the methodological weakness and small
      number of patients in conducted therapeutic trials, the evidences are insufficient to support
      the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis.
      The objective of this research is to determine the effect of intravenous immunoglobulin in
      prevention of preterm neonatal sepsis.
    


Intervention name(s): IVIG
Intervention type(s): Drug
Intervention description(s): IVIG at a dose of 500mg/kg within 12 h and 3 days of birth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Aortic Calcium: Epidemiology and Progression -- Ancillary to MESA
Condition: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Arteriosclerosis
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      To study the epidemiology of aortic calcium.
    

Detailed description: 
      BACKGROUND:

      Aortic calcium measured by computed tomography occurs earlier in life than other subclinical
      (that is, asymptomatic) markers of cardiovascular disease (CVD), shows a wide range, and is
      common in women. The large size of the aorta and relative lack of image artifact from motion
      make it ideal for radiographic quantitative imaging. This study is ancillary to and
      coordinated with the Multi-Ethnic Study of Atherosclerosis (MESA), a large prospective
      epidemiologic study investigating multiple subclinical CVD measures and CVD risk factors.
      Subclinical measures in MESA include coronary calcium, carotid ultrasound, cardiac magnetic
      resonance imaging, and the ankle/brachial blood pressure index. The extensive CVD risk factor
      measurements include both traditional risk factors and newer measures such as inflammatory
      and genetic markers.

      DESIGN NARRATIVE:

      This ancillary study will determine the epidemiology of aortic calcium in 2000 randomly
      selected (from 6500 total) MESA participants. Questions to be addressed include predictors of
      aortic calcium progression; associations of aortic calcium and aortic calcium progression
      with other subclinical CVD measures, CVD risk factors, and demographics; and the prognostic
      significance of aortic calcium. The project has three primary specific aims: 1) to predict
      the cross-sectional aortic calcium burden as a function of other subclinical CVD measures and
      CVD risk factors; 2) to predict aortic calcium progression as a function of other subclinical
      CVD measures and CVD risk factors, and 3) to predict aortic calcium progression as a function
      of progression of selected subclinical CVD measures and CVD risk factors. The two secondary
      specific aims are 1) to contrast the results of the three primary specific aims for men vs.
      women, and for four major ethnic groups (White, Hispanic, Black, and Asian); and 2) to
      provide a database for future evaluation of whether aortic calcium and/or aortic calcium
      progression independently predict subsequent myocardial infarction, stroke, and other CVD
      events.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A random selection of approximately 1/3 of the original MESA participants.
Combination Pharmacological Interventions for Multiple Mechanisms of Obstructive Sleep Apnea
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Currently, there is no pharmacological intervention for OSA that targets multiple
      pathophysiological deficits in combination. Here the investigators study the effect on sleep
      apnea severity of combinations of pharmacological agents that stimulate the pharyngeal
      muscles, stabilize ventilatory control, and increase the arousal threshold.
    

Detailed description: 
      The primary goal of the current study is to determine the effect of combination therapy
      targeting phenotypic traits on OSA severity. Specifically, the investigators will assess the
      effect of combination pharmacological therapy on OSA severity as measured by the
      apnea-hypopnea index and the arousal index (co-primary outcome variables).

      The investigators will also estimate the effects of the interventions on the physiological
      traits responsible for OSA using polysomnography, namely:

        -  Pharyngeal anatomy and its propensity towards collapse

        -  The ability of the upper airway dilator muscles to activate and reopen the airway during
           sleep (i.e. neuromuscular compensation)

        -  Arousal threshold from sleep (i.e. the propensity for hypopneas/apneas to lead to
           arousal and fragmented sleep).

        -  Stability of the ventilatory control system feedback loop (i.e. loop gain). Baseline
           traits will be used to examine whether patient characteristics influence the responses
           to each combination of interventions (i.e. muscles, muscles plus loop gain, muscles plus
           arousal threshold).
    

Intervention name(s): SAS0421a; SAS0421b; SAS0421c; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): treatment will be given for 3 days; treatment will be given for 3 days; treatment will be given for 3 days; placebo will be given for 3 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to first evaluate the effect of food on E7050's pharmacokinetic
      parameters following the administration of single 100 mg oral doses of E7050 tablet to each
      normal healthy participant in the study (Part A), and second to characterize E7050
      pharmacokinetics after single doses at 200 mg and 400 mg under fasted conditions (Part B).
      Part A will be a randomized, single-dose, open-label, three-treatment period crossover study.
      Part B is a nonrandomized, open-label, two-treatment sequential study design. Twelve
      participants in Treatment Period 1 will receive a single dose of 200 mg of E7050 under fasted
      conditions. Following review of safety data of the 200 mg dose level, an additional 12
      subjects will then receive a single dose of 400 mg of E7050 in Treatment Period 2.
    


Intervention name(s): E7050
Intervention type(s): Drug
Intervention description(s): 100 mg tablet administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; E7050; Healthy Subjects
The Simultaneous Use of Supraclavicular and Distal Blocks
Condition: Orthopaedic Disorders; Nerve Block; Anaesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the combined ultrasound-guided supraclavicular brachial
      plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block
      alone.

      Sixty two patients undergoing upper extremity surgery will be randomized to supraclavicular
      only (Group S, n=31) or supraclavicular + distal (Group SD, n=31) group. Patients in group S
      will receive 32 mL of lidocaine 1.5% + epinephrine 5µg/mL and in group SD receive 20 mL of
      lidocaine 1.5% + epinephrine 5µg/mL followed by a distal median, radial, and ulnar nerve
      blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Sensory and
      motor block of the ulnar, median, radial and musculocutaneous nerves will be assessed every 5
      minutes starting at the 10th minutes. The imaging, needling and performance times will be
      recorded. Also the onset and anesthesia related times, need for analgesic and first analgesic
      time will be noted.
    


Intervention name(s): intravenous cannulation.; Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks.; Intravenous cannulation.; Routine ASA monitoring; Premedication midazolam; Lidocaine; Epinephrine; Levobupivacaine
Intervention type(s): Procedure; Procedure; Device; Device; Drug; Drug; Drug; Drug
Intervention description(s): A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site; Supraclavicular block with 20 mL of lidocaine 1.5% + epinephrine 5µg/mL and the addition of ultrasound-guided ulnar, median and radial nerve blocks. For that 12 mL of local anesthetic solution of a 50:50 mixture of lidocaine 2% and levobupivacaine 0.5% (4 mL/nerve) was used.; A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site; Monitorization with ECG, noninvasive blood pressure and spO2.; Premedication with 0.03 mg/kg midazolam iv
Intervention MeSH terms: Lidocaine; Epinephrine; Midazolam; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: ultrasound; peripheral nerves; anesthetics; local
Cough-Generated Aerosols of NTM in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Non-tuberculous mycobacteria (NTM) are opportunistic pathogens normally found in soil and
      water that are being cultured from Cystic Fibrosis (CF) airways at an increasing frequency.
      They have been demonstrated to cause clinically significant lung disease in some cases and
      the transmission of NTM, from person to person has been proposed. There are currently no
      standardized guidelines for isolation of those colonized or infected with NTM.

      The investigators will measure particle droplet size from patients with CF who have positive
      sputum cultures for NTM with the hypothesis that they will be in a range that can spread
      infection.
    

Detailed description: 
      Patients with a positive NTM sputum culture will be asked to participate in the study. If
      they agree to participate they will sign an informed consent and will be scheduled to come to
      the University of Florida Clinical Research Center for the testing.

      The test will consist of the following: pulmonary function test, collecting a sputum culture
      if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline
      and albuterol will be given after the 5 minutes of coughing and then they would repeat with
      another 5 minutes of coughing. There can be a break inbetween the coughing if needed.

      Patients maybe asked to come back a second time if they develop a different type of NTM or
      start treatment for NTM.
    

Intervention name(s): CF with culturable NTM
Intervention type(s): Procedure
Intervention description(s): CF patients who produce culturable aerosols of NTM will receive the following test: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Specialialty Clinics, Pulmonary
      
Biospecimen description: 
      Sputum cultures
    
Keywords: Positive Nontuberculous Mycobacteria
Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators will examine the balance between IVF success in terms of outcome
      parameters, using a mild ovarian stimulation protocol, opposing it to the conventional
      stimulation regimens in poor responders undergoing IVF.
    


Intervention name(s): mild ovarian stimulation; conventional ovarian stimulation
Intervention type(s): Procedure; Procedure
Intervention description(s): 100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery; 300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses with GnRH agonist long protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ovarian stimulation; climiphene citrate; Gonadotropin-Releasing Hormone agonists/antagonists; Follicle Stimulating Hormone
A Safety, Tolerability, and Pharmacokinetic Study of Tucatinib in Healthy Japanese and Caucasian Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to compare the pharmacokinetics (PK) and safety/tolerability of
      tucatinib in healthy Japanese and Caucasian participants.

      Three cohorts of healthy Japanese and Caucasian men and women will be admitted to the
      Clinical Research Unit (CRU) and receive multiple oral doses of tucatinib over 14 days with
      and without food.

      Subjects will be in the study for up to 45 days, including the screening period.

      Due to practical considerations, each cohort will be dosed sequentially (this is not a dose
      escalation study).
    


Intervention name(s): Tucatinib
Intervention type(s): Drug
Intervention description(s): Administered via oral tablet
Intervention MeSH terms: Tucatinib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment