bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Efficacy and Safety of Autologous Lung Stem Cell Transplantation in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Idiopathic pulmonary fibrosis (IPF) is a chronic and ultimately fatal disease characterized
      by a progressive damage of lung structure and decline in lung function.This study intends to
      carry out an open, single-center, non-randomized, self control phase I clinical trial. During
      the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in
      vitro. Cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy
      after lavage. After 24-week observation, the investigators will evaluate the safety and
      efficacy of the treatment by measuring the key clinical indicators.
    


Intervention name(s): Lung stem cells
Intervention type(s): Biological
Intervention description(s): Patients will receive 0.5-5x10^6 (0.5-5 million) /Kg/person cells of clinical grade lung stem cells (LSCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Volume Kinetics for Starch Solution and Acetated Ringers
Condition: Blood Volume; Blood Coagulation
Study type: Interventional

Summary: 
      Volume kinetics is a method mostly used, so far, to study the distribution and elimination of
      crystalloid solutions. Voluven (in Sweden the most commonly used colloid for replacement of
      bleeding during surgery) is poorly studied, though. Also, a recent study showed unexpected
      volume kinetics for a crystalloid solution when it was given after a colloid solution. The
      investigators aim to study the volume kinetics of crystalloids and colloids and also the
      combination of the two in more detail. The investigators will also compare the invasive
      hemoglobin measurements with measurements from a new non-invasive tool (Radical 7, from
      Masimo Inc.) which could help to make volume kinetics more practical for everyday use.
      Finally the investigators will also study the concentrations of a few coagulation factors to
      see if they can explain the variations in coagulability that has been described in earlier
      studies of infusion solutions.
    

Detailed description: 
      We will study ten volunteers, each one on three occasions. Each volunteer will receive only
      crystalloid one time, only colloid another time, and on the third occasion first a colloid
      and then a crystalloid one hour later. The different protocols will be in random order in the
      different volunteers. During all these tests we will sample the hemoglobin (both invasive and
      non-invasive) every fifth minute in the beginning (every tenth minute later) after the
      infusion. On six to nine occasions during each test we will analyse Albumin, Cystatin-C,
      Ig-G, Ig-M as markers of hemodilution and D-Dimer, Fibrinogen, Factor VII, PK-INR
      (prothrombin complex international normalized ratio), and aPTT (activated partial
      thromboplastin time) as markers of coagulation. The volunteers are also monitored regarding
      non-invasive blood pressure and pulse rate.
    

Intervention name(s): acetated Ringers; colloid; colloid+acetated Ringer; Non-invasive hemoglobin with pulse-oximeter (SpHb)
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): Infusion of Ringer acetate 20 ml/kg over 30 min; Infusion of starch 10 ml/kg over 30 min; Infusion of combined colloid+acetated Ringer; 10 ml/kg of starch was infused between 0 and 30 min, followed by 20 ml/kg of Ringers acetate between 105 and 135 min.; Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
Other intervention name(s): Voluven; Voluven; acetated Ringers; Radical 7, Masimo
Intervention MeSH terms: Chrysarobin; Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood volume; blood coagulation; volume kinetics
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      Recombinant human angotensin-converting enzyme 2 (rhACE2) as a treatment for patients with
      COVID-19 to block viral entry and decrease viral replication.
    


Intervention name(s): RhACE2 APN01; Physiological saline solution
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be treated with APN01 intravenously twice daily (BID).; Patients will be treated with placebo intravenously twice daily (BID).
Other intervention name(s): APN01; Recombinant human angiotensin-converting enzyme 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Measures Taken to Contain COVID-19 on Hospital Surgical Care Services and Clinical Outcomes
Condition: Surgery
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This study aims to look at the impact on patient outcomes arising from measures implemented
      during the COVID-19 pandemic. The information and knowledge from this study will be useful
      for the management and allocation of hospital resources and patients in tne event of a
      disease outbreak.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study seeks to assess the effect of the measures taken to contain COVID 19 on patients
        who need surgical services measured by patient outcomes, such as, length of hospital stay
        (LOS), ICU stay, APACHE score, and stage of cancer at surgery.
      
Keywords: Covid-19 pandemic; emergency; cancer; elective surgery; postponement
Improvement of Sensibility in the Foot in Diabetic Patients Induced by EMLA-application to the Lower Leg
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Sensory input from the foot as well as all other body parts results in activation of sensory
      cortex.

      It is well known that the cortical body map is experienced-dependant and can rapidly change
      in response to changes in activity and sensory input from the periphery [10-12]. Increased
      activity and sensory input from the hand results in expansion of the cortical hand
      representation [13-15], while decreased sensory input, for instance by anaesthesia,
      amputation or nerve injury, results in shrinkage of the cortical hand representation [16-21].
      Due to the constant ongoing "cortical competition" between body parts the adjacent cortical
      areas expand and take over the silent area, deprived of sensory input.

      The investigators have recently described striking examples of such rapid cortical
      re-organisations induced by selective cutaneous anaesthesia of the forearm: application of
      EMLA cream to the volar aspect of the forearm results in improved sensory functions of the
      hand [18] linked to expansion of the hand representational area in sensory cortex . In
      analogy, EMLA application to the lower leg in healthy controls results in improved sensory
      functions in the sole of the foot linked to expansion of the foot representational area in
      sensory cortex.

      To test the hypothesis that EMLA application to the lower leg of diabetic patients will
      result in improved sensory functions in the sole of the foot as well as expansion of the foot
      representation in sensory cortex. The investigators hypothesize that repeated applications of
      EMLA will result in a long lasting sensibility improvement.
    


Intervention name(s): EMLA cream; EMLA cream
Intervention type(s): Drug; Drug
Intervention description(s): The study subjects are treated either by 50 g of a local anesthetic agent containing 2.5% Lidocaine and 2.5% Prilocaine (EMLA®, AstraZeneca - Södertälje, Sweden) or a placebo cream, applied to the lower leg. The cream is applied under occlusive bandage (plastic foam and a tube) for 1.5 hours circumferential to the lower leg 10-12 cm distally of the tibial tuberosity and the malleolus at ankle level. Administration of the treatment cream as well as removal after 1,5 hour and at sensory assessment after 1.5 hour and 24 hours, and interviewing the patient about subjective experience from the treatment are performed by an independent research nurse, not involved in the sensory assessment.; 50g applied according to description of intervention
Intervention MeSH terms: Lidocaine, Prilocaine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus; neuropathy; foot; sensibility; brain plasticity
Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy (Vestibular Neuronitis)
Condition: Acute Peripheral Vestibulopathy
MeSH terms: Vestibular Neuronitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The vestibular system is a part of the inner ear and functions as a motion sensor. It
      provides the central nervous system with information about changes of the head position. This
      information is essential for the proper functioning of the balance system. In particular, it
      ensures effective postural control and gaze stabilization. Abrupt vestibular deficit is
      defined as a sudden loss of the vestibular function. In the acute phase the patient presents
      mainly with intense rotatory vertigo and instability, most often accompanied by nausea. The
      symptoms are exacerbated by head movements. The diagnosis is made by observation of a
      spontaneous nystagmus, measurement of a pathological head impulse test and an asymmetric
      response to caloric tests, in the absence of other neurological symptoms. Although the
      etiology is unknown, it could be of viral or vascular origin. Symptoms usually regress within
      a few days or weeks. Vestibular function recovers in about half of the cases, in the other
      half a central compensation process is set up. The benefit of a 3-week course of
      corticosteroids has been demonstrated in one study. The dosage has been debated. The aim of
      this study is to demonstrate the benefit of a 10-day course of oral corticosteroids. The
      primary objective is to demonstrate a significant reduction in the rate of asymmetry of
      caloric response and the secondary objective is to demonstrate a significant reduction in the
      impact of symptoms assessed with the Dizziness Handicap Inventory (DHI) score at 1 year.
    


Intervention name(s): Prednisone
Intervention type(s): Drug
Intervention description(s): oral administration, 60mg/d for 10d
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of
      Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin
      requiring diabetes,18-75 years of age.
    

Detailed description: 
      The study is a multi-center, prospective single-arm design without controls. All subjects
      will be assigned to treatment for 11 days of sensor wear. Each subject will wear 4 Guardian
      Sensor (3)s, and each will be connected to a Guardian Link (3) Transmitter and/or Guardian
      Connect Transmitter. Subjects will not use sensor glucose values for diabetes management.

      On days 1, 3, 5, and 6, subjects will be asked to measure blood glucose (BG) using a home
      glucose meter approximately every 20 minutes for 5 hours. Subjects will be asked to take one
      gram of acetaminophen orally on days 3, 5, and 6 of sensor wear.

      On day 11, devices will be removed, data uploaded from the study meter and transmitter or
      recorder, skin assessment will be performed, and the subject's participation in the study
      will be completed.
    

Intervention name(s): Guardian Sensor (3)
Intervention type(s): Device
Intervention description(s): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Acetaminophen
A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY 1142524 in Patients After Acute Myocardial Infarction With Left-ventricular Dysfunction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor
      BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period
      in patients with left-ventricular (LV) dysfunction after myocardial infarction (MI).
      BAY1142524 or placebo will be given on top of evidence-based standard of care for
      left-ventricular dysfunction after myocardial infarction. Primary objective is the analysis
      of first signs of efficacy as determined by favourable changes in functional parameters of
      adverse cardiac remodelling (i.e. endsystolic and enddiastolic volume index, ejection
      fraction). Secondary objective is the analysis of safety and tolerability as evidenced by the
      incidence and severity of adverse events. 30 patients have to complete treatment with verum
      and 30 patients have to complete treatment with placebo.
    


Intervention name(s): Fulacimstat (BAY1142524); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg BAY 1142524 are given twice daily over a treatment period of 6 months; Matching placebo tablets are given twice daily over a treatment period of 6 months
Intervention MeSH terms: Fulacimstat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of food on the pharmacokinetics
      (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male
      participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center,
      2-way crossover (method used to switch participants from one treatment arm to another in a
      clinical trial) and randomized (the study drug is assigned by chance) study to assess the
      effect of food on the pharmacokinetics of TMC435 after a single dose in Japanese healthy
      adult male participants. The study duration will be of 44 days per participant, which is
      divided into 3 parts: Screening (from Day -28 to Day -2); Treatment (consists of 2 treatment
      periods of 5 days each [that is, Day -1 to 4, in-patient period], wherein all participants
      will receive TMC435 in the respective period, and the period will be separated by washout
      period of 9 days); and Follow-up (on Day 7 of Period 2). Participants will keep upright
      position from the time of study drug administration until 4 hours after study drug
      administration. Participants will not be allowed to ingest meal until 4 hours post-dose.
      Participants will have standardized lunch and dinner at 4 hours and 10 hours post-dose,
      respectively. Drinking water will not be allowed from 1 hour before the administration up to
      1 hour after administration except for the water served with the study drug and meal.
      Pharmacokinetics will be assessed in blood samples which will be collected up to 72 hours
      after administration of study drug. Participants' safety will be monitored throughout the
      study.
    

Intervention name(s): TMC435
Intervention type(s): Drug
Intervention description(s): TMC435, 100 milligram oral capsule will be administered on Day 1 of each treatment period, separated by washout period of 9 days.
Other intervention name(s): G008
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; TMC435; G008
Assessment of Contact Lens Wettability Using Wavefront Aberrometry
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This study will test the feasibility that differences in contact lens wettability can be
      measured with a wavefront sensor.
    


Intervention name(s): senofilcon A; lotrafilcon B
Intervention type(s): Device; Device
Intervention description(s): A soft spherical contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Exercise for Women With Peripheral Arterial Disease
Condition: Peripheral Artery Disease; Claudication; Women
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in
      exercise performance, peripheral vascular function, and health-related quality of life than
      compared to the attention-control group.

      Hypothesis #2. The change in peripheral vascular function will be predictive of improved
      exercise performance following the supervised exercise program.
    


Intervention name(s): Walking Exercise; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3 times per week for 3 months; Resistance training 3 times per week for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Relative Bioavailability and Tolerability of Bimekizumab in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study to determine the relative bioavailability of bimekizumab in healthy
      subjects
    


Intervention name(s): Bimekizumab
Intervention type(s): Drug
Intervention description(s): Subjects will be receiving bimekizumab at pre-specified time-points.
Other intervention name(s): UCB4940; BKZ
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bimekizumab; Phase 1
Effect of Phototherapy Incorporated Into an Exercise Program on Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of the proposed study is to analyze the effect of the incorporation of phototherapy
      into a therapeutic exercise program on pain, functional capacity, range of motion, muscle
      strength in individuals with osteoarthritis of the knees. The participants will be allocated
      to different groups through a randomization process using opaque envelopes containing cards
      stipulating one of the three following groups: Group A (exercise protocol); Group B (exercise
      protocol + phototherapy protocol); and Group C (exercise protocol + placebo phototherapy
      protocol). Phototherapy will be performed on the knees diagnosed with osteoarthritis.
    


Intervention name(s): exercise; Phototherapy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Physical Therapy Modalities; osteoarthritis
A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children
Condition: Malaria; Respiratory Infections
MeSH terms: Malaria; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine whether addition of azithromycin (AZ) to
      Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine
      (AQ) will provide an additional reduction in deaths and severe illness in young African
      children. The secondary objectives include an assessment of the safety and cost-effectiveness
      of the addition of AZ to SMC with SP+AQ.

      This a double blind, randomised, placebo controlled trial. The unit of randomisation will be
      the household. Children aged 3 - 59 months will be randomised to receive four cycles of
      either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission
      season.

      Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59
      months of age at the start of each period of drug administration will be eligible for
      inclusion in the trial provided that parental consent is obtained. Children with a severe,
      chronic illness or known allergy to one of the study drugs will be excluded.

      Primary endpoint: Incidence of the combination of death or hospital admission for at least 24
      hours, not due to trauma or elective surgery during the intervention period

      Secondary endpoints:

        1. incidence of the primary endpoint during the whole study period

        2. attendance at a study health centre with a nonmalaria febrile illness

        3. attendance at a study health centre with malaria,

        4. the prevalence of moderate anaemia at the end of each malaria transmission season,

        5. nutritional status at the end of each malaria transmission season,

        6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant
           pneumococci before and at the end of each malaria transmissions season,

        7. prevalence of resistance markers to SP at the end of the study,

      Sample size: 19,200 children (9600 in each country) will be enrolled.
    


Intervention name(s): Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin; Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin 4 rounds during malaria transmission season; Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin 4 rounds during malaria transmission season
Intervention MeSH terms: Azithromycin; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention