bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a
      reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus
      (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis,
      kidney problems, and anemia, among other problems).
    

Detailed description: 
      A multicenter (more than one medical research center involved in study), randomized (study
      drug assigned by chance), double-blind (neither the Investigator nor the participant know
      about the study drug), placebo-controlled, proof-of-concept study of ustekinumab in
      participants with active systemic lupus erythematosus. Participants will be screened to
      achieve all inclusion criteria and none exclusion criteria and will then receive either
      ustekinumab or placebo along with concomitant background medicine. Participants will be
      primarily assessed for response using the Systemic Lupus Erythematosus Response Index 2000
      (SRI-4). Participants' safety will be assessed throughout the study.
    

Intervention name(s): Ustekinumab IV; Placebo Infusion; Placebo SC; Ustekinumab SC; Concomitant Medication
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0.; Placebo intravenously at Week 0.; Placebo subcutaneously at Weeks 8 and 16.; Ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40 and up to Week 104 in study extension (for eligible participants); Concomitant treatment (mycophenolate, azathioprine/6-mercaptopurine, methotrexate, hydroxychloroquine and/or chloroquine, oral corticosteroids, NSAIDs, antihypertensive medications, and topical medications) through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48.
Other intervention name(s): STELARA
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus; Ustekinumab
A Study Comparing Four Different Rivoceranib Tablets in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this trial is to compare a single dose of 4 different rivoceranib tablets
      in healthy adult participants.
    

Detailed description: 
      Participants will be randomized to 1 of 4 treatment sequences (1-4). Each participant will
      participate in 4 treatment periods. One formulation of rivoceranib will be administered per
      treatment period. Blood samples will be collected predose and up to 120 hours postdose to
      evaluate the pharmacokinetics (PK) of rivoceranib and its major metabolites.
    

Intervention name(s): Rivoceranib
Intervention type(s): Drug
Intervention description(s): Rivoceranib will be supplied as film-coated tablets for oral administration as 4 different formulations: Formulation 1, 3, and 4 = 250 milligrams; Formulation 2 = 200 milligrams.
Other intervention name(s): Rivoceranib Mesylate; Apatinib Mesylate
Intervention MeSH terms: Apatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Promoting Healthy Weight Gain During Pregnancy
Condition: Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional
Phase: Phase 3

Summary: 
      Study goal is to determine whether behavioral lifestyle intervention during pregnancy can
      reduce the number of women who exceed the Institute of Medicine recommendations for weight
      gain during pregnancy.

      It is hypothesized that the intervention will reduce the number of women who exceed weight
      gain guidelines relative to standard care. The investigators also expect the intervention to
      reduce the proportion of women exceeding weight gain guidelines in both normal weight and
      overweight groups.
    


Intervention name(s): Lifestyle
Intervention type(s): Behavioral
Intervention description(s): Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Excessive gestational weight gain
A Study for Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients
      with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet
      and exercise alone, or in combination with metformin, will be enrolled. The primary objective
      of this study is to test the hypothesis that LY2428757 given to patients with T2DM
      inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a
      significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks
      as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week
      safety follow-up.
    


Intervention name(s): LY2428757; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once weekly for 12 weeks as a subcutaneous injection.; 1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis
Condition: Bronchiolitis; Bronchiolitis, Viral; RSV Infection; Respiratory Failure
MeSH terms: Bronchiolitis; Respiratory Syncytial Virus Infections; Bronchiolitis, Viral; Respiratory Insufficiency
Study type: Interventional

Summary: 
      This study will compare the novel methods of NS and BS with the standard technique of
      nasophayngeal aspiration (NPA) and routine ETT suction. We shall assess the samples for
      diagnosis of RSV, viral load and immune responses in the airways of babies with RSV
      infection. We shall also assess the genetics of babies included in this study, to see if they
      may be vulnerable to RSV infection.
    

Detailed description: 
      In conjunction with a specialist medical device manufacturing company (Hunt Developments
      (Midhurst, West Sussex) we have produced novel nasosorption and bronchosorption kits that
      have CE marking. Both nasosorption and bronchosorption methods use synthetic absorptive
      matrix (SAM) strips: that look and feel like blotting paper, and will be placed onto the
      mucosal surface. These are comfortable to use and can be used at frequent intervals over
      extended periods of time. This non-invasive technique is ideal for infants and children, and
      it is possible to obtain neat mucosal lining fluid (MLF) even from normal healthy noses. The
      eluates contain cytokines and chemokines at high detectable levels on multiplex immunoassay.

      We would like to use these SAMs to take MLF samples from the nasal and bronchial mucosal
      surfaces to see if these novel techniques can overcome the problems with current sampling
      methods. We plan to use these absorption techniques to measure RSV viral load. We also aim to
      look at the immune response in terms of the anti-viral interferon response (IFN-γ, IFN-λ,
      IFN-α2a, IP10, ITAC). In therapeutic studies in the future, it may be possible to document
      levels of drug (pharmacokinetics) in nasal MLF.
    

Intervention name(s): Nasal and Bronchial Sampling
Intervention type(s): Diagnostic Test
Intervention description(s): Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol-Midazolam Versus Sevoflurane Anesthesia
Condition: Ophthalmic
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Ocular alignment will be studied in children having cataract surgery that will be divided
      into two groups, one group will be anesthetized using sevoflurane anesthesia (group A), and
      the other will be anesthetized by midazolam bolus and propofol infusion (total intravenous
      anesthesia, TIVA) (group B). in both groups depth of anesthesia will be monitored by
      bispectral index monitor.
    

Detailed description: 
      After signing the informed consent by children parent, child will be transferred to the
      operating room and will be connected to pulse oximetry, non invasive blood pressure and
      electrocardiogram(ECG), child will be anesthetized by sevoflurane 8% for cannula insertion,
      then in Group A, sevoflurane will be continued with 2%, and iv atracurium 0.25mg/kg, and
      paracetamol 15mg/kg iv will be given. In group B, sevoflurane will be discontinued and
      propofol bolus1mg/kg iv, midazolam 0.05 mg/kg iv, atracurium 0.25 iv, and paracetamol 15mg/kg
      iv then propofol infusion will start immediately according to McFarlan protocol for manual
      syringe pump for pediatrics. For first 10 minutes 15mg/kg, second 10 minutes 13mg/kg, third
      10 minutes 13mg/kg, fourth 10 minutes 11mg/kg, fifth 10 minutes 11mg/kg, and will be
      continued on this rate for the end of surgery. Bispectral index monitor(Covidien, Germany)
      will be attached to child forehead after cleansing it with alcohol 70%. after adequate jaw
      relaxation , trachea will be intubated with adequate size endotracheal tube and attached to
      anesthesia machine ( General electric, Carestation 650).Volume controlled ventilation (VCV)
      will start with tidal volume(VT) 6-8 ml/kg, respiratory rate (RR)16-20 according to end-tidal
      carbon dioxide (CO2)35-40mmhg. Flow of fresh gas rate 2 l/minute. standard circuit system
      connection for pediatric will be used. Heart rate ,peripheral oxygen saturation (SPO2), non
      invasive blood pressure, end-tidal carbon dioxide (ETCO2), and bispectral index monitor will
      be measured every 5 minutes. 6 ml/kg of ringer will be given infusion slowly.
    

Intervention name(s): measuring depth of anesthesia and its relation to the globe
Intervention type(s): Other
Intervention description(s): measuring feasibility of BIS monitor in detecting depth of anesthesia in pediatric population and whether it will be beneficial as a tool for helping anesthesiologist in maintaining central globe alignment
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups, each is 50 child randomly allocated.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: propofol; ocular alignment; TIVA
Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing
Condition: Thoracic Diseases; Parathyroid Diseases
MeSH terms: Thoracic Diseases; Parathyroid Diseases
Study type: Interventional

Summary: 
      The B vitamin biotin is widely available as an over the counter supplement, often advertised
      and used to promote health of hair, skin and nails. Commercially available over the counter
      biotin supplements contain dose ranges up to 10 mg/day (ie 333 times higher than the
      recommended dietary allowance). The biotin molecule is also sometimes used as part of the lab
      technology to measure hormone and protein levels in the blood. It is possible that high doses
      of ingested biotin may interfere with accurate hormone or protein measurement using biotin
      related in vitro measurement systems. Such interference, if present, could lead to
      misdiagnosis. The study will analyze laboratory levels obtained with streptavidin-biotin
      assay systems while ingesting biotin in currently available high dose supplements. The data
      will be compared to measurements obtained prior to and one week after stopping the biotin
      supplement.
    

Detailed description: 
      Specimens will be collected by venipuncture at 3 time points, including baseline (time 0),
      after one week of biotin supplementation (time 1, day 7), and then one week later (time 2,
      day 14). The time 1 specimen will be drawn approximately 2 hours after the last ingested dose
      of biotin on day 7. Specimen collection will include three 10 ml red top (no gel) tubes at
      each timepoint.

      Specimens will be separated for isolation of serum using routine methods of the clinical
      chemistry laboratory. Serum will be stored at -80 degrees C until batch measurements as
      described Measurements Biotin levels will be measured on each sample. Hormone measurements
      will be performed using specific commercially available streptavidin-biotin assays and using
      different analyzers as indicated below. Immunoassay methods, not employing
      biotin-streptavidin methodology, will be used for negative assay controls.
    

Intervention name(s): biotin
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Biotin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: biotin pharmacokinetic; biotinylated assay; hormone measurement; thyroid; parathyroid; prolactin
The Effect of the Serratus Block on Pain Control After Breast Surgery
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Surgery for breast cancer is associated with significant pain. The serratus nerve block
      targets the interfascial plane either below or above the serratus muscle, blocking thereby
      the lateral cutaneous branches of the intercostal nerves. The purpose of this randomized
      controlled double-blinded study is to see whether the addition of a serratus nerve block to a
      general anesthesia results in a better postoperative pain control in patients undergoing
      surgery for breast cancer.
    

Detailed description: 
      The prevalence of severe acute postoperative pain after breast surgery is high. Regional
      anesthesia has the potential to provide superior pain relief with fewer side effects compared
      to standard systemic opioid therapy. The search for a regional anesthesia technique for
      breast surgery has been ongoing as this technique needs to be time efficient, relatively
      risk-free and also practicable in an out-patient setting. The serratus block is a promising
      technique that may combine these advantages.
    

Intervention name(s): Serratus Block; Placebo Block; ropivacaine; epinephrine; sterile saline
Intervention type(s): Procedure; Procedure; Drug; Drug; Other
Intervention description(s): Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles; Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line; Drug indicated for regional anesthesia; Drug indicated to prolong the action of regional anesthesia; Neutral injection (no drug involved)
Other intervention name(s): Control Group - Placebo Comparator; Naropin HCL; Adrenaline Chloride; Sodium Chloride
Intervention MeSH terms: Epinephrine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Serratus Block; Breast Surgery
Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of LY2623091 after
      multiple oral dosing in healthy men and women of non-childbearing potential. Two cohorts of
      16 subjects will participate in 2 dosing periods. Treatment assignment will be double-blind
      for LY2623091 and placebo (negative control), and open label for eplerenone (positive
      control).
    


Intervention name(s): LY2623091; Placebo; Eplerenone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Kidney; Renal
Meditation and Decision Making Study III
Condition: Meditation
Study type: Interventional

Summary: 
      The overarching goal of the proposed research is to investigate the role of emotions in
      facilitating successful lifestyle change, defined as healthy behavioral decisions repeated
      daily, or near daily.

      Participants are asked to make two lab visits during the course of four weeks to complete
      electronic questionnaires, be monitored for psychophysiological activity (e.g. heart rate,
      blood pressure, respiration), and listen to a guided meditation audio track. Additionally,
      between the two visits participants will be asked to complete weekly surveys that ask about
      daily meditation practice (outside of the lab) and general emotions.
    


Intervention name(s): Lovingkindness Meditation (LKM); Mindfulness Meditation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Compassionate behavior training (REVISE)
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of Hesperidin on Bone Mineral Density and Bone Metabolism of Postmenopausal Women
Condition: Osteoporosis, Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      Fruits and vegetables are rich in a variety of flavonoids with antioxidant properties. These
      compounds may be partially responsible for some of the positive links found between fruits
      and vegetables intake and higher bone mineral density in adults and children. Several animal
      studies have shown that consumption of onions (which are rich in quercetin), rutin (a
      quercetin glycoside) and resvatrol (found in red wine) inhibits ovariectomy induced bone loss
      in rats. One of the most studied flavonoids with respect to bone health is the soy
      isoflavones. However, consumption of soy products is relatively low in Western countries. One
      the other hand, a flavonoid such as hesperidin, found mostly in oranges is much more abundant
      in the Western diet. Citrus juice consumption has been demonstrated to prevent bone loss in
      male orchidectomized rats while specifically feeding hesperidin has been shown to prevent
      bone loss in ovariectomized mice and rats. However, to date no clinical prove has been
      obtained for these benefits.Therefore the aim of this study is to investigate the effect of
      hesperidin in preventing bone loss in postmenopausal women. This study is designed as a
      2-year, double blind, placebo-controlled, two arm, and parallel group study. The primary
      outcome measure is change in bone mineral density (BMD) while the secondary outcome measures
      are changes in bone resorption and formation markers as well as body composition. The women
      are randomised to consume 2 servings of hesperidin-rich food or food without hesperidin but
      with the same taste & appearance (placebo). Subjects will undergo medical screening,
      anthropometry, physical activity, dietary assessments and BMD before randomisation into
      placebo or active group. Follow-up measurements are made at 3-month intervals (for blood and
      urine collection) and 6-month intervals for bone mineral density. Side effects are also being
      monitored during each visit.
    


Intervention name(s): Hesperidin; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: bone loss, osteoporosis, prevention, hesperidin
Evaluation of Tear Film Lipid Layer Thickness Change After Cataract Surgery
Condition: Cataract Patients
MeSH terms: Cataract; Capsule Opacification
Study type: Observational [Patient Registry]

Summary: 
      This study will compare cataract patients before and after phacoemulsification. Evaluations
      will be performed before and 1 and 3 months following cataract surgery, including measurement
      of tear film lipid layer thickness, tear film break up time, Schirmer test, corneal and
      conjunctival fluorescein staining, examination of lid margins and meibomian glands, and the
      Ocular Surface Disease Index.
    


Intervention name(s): LipiView
Intervention type(s): Other
Intervention description(s): tear film lipid layer thickness measured by LipiView interferometer (TearScience Inc, Morrisville, NC)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cataract patients with lens opacities classification higher than grade III
Inspiratory Muscle Training and Low Back Pain
Condition: Inspiratory Muscle Training; Low Back Pain; Respiratory Disorders
MeSH terms: Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Proprioceptive weighting changes may explain differences in postural control performance. In
      addition, the respiratory movement has a disturbing effect on postural balance. Postural
      balance seems to be impaired in individuals with respiratory disorders. Besides the essential
      role of respiration, the diaphragm may also play an important role in the control of the
      trunk and postural balance. Deficits in proprioception are found in a subgroup of patients
      with low back pain. In addition, disorders of respiration have been identified as strongly
      related to low back pain.

      The aim of the study is to clarify whether inspiratory muscle training has a positive effect
      on proprioceptive postural control in individuals with recurrent low back pain.
    


Intervention name(s): Inspiratory muscle training; Sham inspiratory muscle training
Intervention type(s): Other; Other
Intervention description(s): Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 60% Pi,max; Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max
Other intervention name(s): Powerbreathe Classic; Powerbreathe Classic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment