bioihbjkbjnl/mcl2 huggingface dataset:
PK/PD Modeling of Magnesium in the Mother and Neonate
Condition: Magnesium Sulfate Pharmacokinetics and Pharmacodynamics
Study type: Observational

Summary: 
      Determine significant correlations between maternal serum magnesium levels, and maternal and
      neonatal outcomes.
    

Detailed description: 
      We will construct a pharmacokinetic and pharmacodynamic model of intravenous magnesium
      sulfate administered antenatally to expectant mothers and exposed fetuses with the aim of
      optimizing maternal and fetal outcomes while preventing maternal and neonatal overdosing and
      morbidity associated with current magnesium treatment protocols. Once we have developed a
      PK/PD model in our own hospital cohort, we will apply this model to a large existing NICHD
      database to mathematically calculate optimal dosing protocols.
    

Intervention name(s): Magnesium sulfate infusion
Intervention type(s): Drug
Intervention description(s): Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.
Intervention MeSH terms: Magnesium Sulfate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women and neonates exposed to magnesium sulfate infusion around the time of
        delivery for one of three reasons: 1.) preeclampsia 2.) tocolysis 3.) neuroprotection.
      
Biospecimen description: 
      Blood specimens will be obtained to test magnesium levels in the mother and neonate.
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Branch Retinal Vein Occlusion
Condition: Macular Degeneration; Macular Edema; Branch Retinal Vein Occlusion
MeSH terms: Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone
      for the treatment of macular edema associated with branch retinal vein occlusion.
    


Intervention name(s): dexamethasone
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eye diseases
Study of [14C]CS0159 in China Healthy Subjects
Condition: Primary Biliary Cholangitis
MeSH terms: Cholangitis; Liver Cirrhosis, Biliary
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of [14C]CS0159 in China Healthy Subjects.
    

Detailed description: 
      A phase I study to quantify the total mass balance in healthy subjects after a single dose of
      [14C]CS0159.
    

Intervention name(s): [14C]CS0159
Intervention type(s): Drug
Intervention description(s): Single oral administration of 4mg [14C]CS0159
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Antipsychotic Medication Extended Dosing Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      In patients stabilized on their antipsychotic and demonstrating evidence of good clinical
      response, there will not be a significant change in symptoms if their medication is decreased
      to every 2 days rather than daily. This decrease in antipsychotic exposure will lead to a
      reduction in side effects, as well as improved subjective response to treatment.
    

Detailed description: 
      The present study is a 6-month, double-blind study of patients with schizophrenia stabilized
      on their current antipsychotic (monotherapy) for a period of at least 3 months. After
      providing informed consent, individuals will be randomly assigned to 1 of 2 treatment arms:
      regular daily antipsychotic dosing or active medication at the same daily dose every 2nd day.
      Various scales to measure clinical response and side effects will be administered at
      baseline, as well as every 2 weeks thereafter. Subjective scales will also be employed, and
      lab evaluations will include plasma antipsychotic levels at baseline and endpoint, as well as
      prolactin. Our sample size will be 20/group.
    

Intervention name(s): dosing
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective; antipsychotic; randomized control trial
Innovative Ultrasound Technology in Neuromuscular Disease
Condition: Amyotrophic Lateral Sclerosis; Muscular Dystrophy; Radiculopathy; Myopathy; Polyneuropathy and Mononeuropathies; Trauma Injury; Orthopedic Disorder
MeSH terms: Muscular Dystrophies; Musculoskeletal Diseases; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Radiculopathy; Polyneuropathies; Mononeuropathies
Study type: Observational

Summary: 
      This study is utilizing ultrasound measurement to measure neuromuscular disease status in
      adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that
      ultrasound can be utilized as a tool to determine if a disease is responding to therapy or
      progressing.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with any neuromuscular disorder (i.e. primary nerve or muscle disease), both
        localized and generalized, producing some degree of weakness or disability.
An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects
Condition: Spasmodic Torticollis
MeSH terms: Torticollis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate inter-ethnic similarity in pharmacodynamics between Japanese and Caucasian
      healthy adult male subjects by comparing electrophysiological reactions after administering
      E2014 to extensor digitorum brevis muscle (EDB).
    


Intervention name(s): E2014 (Botulinum toxin type B); E2014 (Botulinum toxin type B) Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single-dose injection solution containing 20 units (U), 100 U, or 500 U/ 0.2 milliliters (mL) of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12.; A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participants were hospitalized from a day before study treatment to Day 8 for 9 nights and 10 days, and visited at the medical institution on Days 10 and 14, and Weeks 4 and 12.
Intervention MeSH terms: rimabotulinumtoxinB; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Dispensing Study for a New Study Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study investigated the performance criteria over one week of daily wear to determine if
      the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere
      (control) in terms of measurement and subjective ratings of visual performance.
    

Detailed description: 
      This study was a prospective, single site, daily wear, double masked, randomized bilateral
      cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and
      comfilcon A sphere lens (control) over 1 week of daily wear.
    

Intervention name(s): Phenacite; comfilcon A
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Direct Pulp Capping
Condition: Patients With Deep Carious Lesions
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Comparative study between Biodentine and MTA in direct pulp capping of deeply carious teeth.
    


Intervention name(s): Biodentine; MTA
Intervention type(s): Drug; Drug
Intervention description(s): Biodentine is going to be used as the direct pulp capping material; MTA is going to be used as the direct pulp capping material in the second group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
Condition: Migraine; Cluster Headache
MeSH terms: Migraine Disorders; Cluster Headache; Headache
Study type: Interventional

Summary: 
      This study collects data from migraine and cluster headache patients during a three-month
      study. Contextual data (e.g. location or smartphone usage) and physiological variables will
      be used to assist machine learning algorithms in making predictions on activity, stress and
      sleep in patients with migraine or cluster headache.
    

Detailed description: 
      Migraine and cluster headache are brain disorders with disabling headache attacks and
      assoicated symptoms. Attacks have multiple phases such as the premonitory phase, aura phase,
      headache phase and postdromal phase. During those phases, symptoms of homeostatic disturbance
      or sensory alterations may occur.

      The goal of the study is to observe activity, stress and sleep parameters in relation to
      registered headache attacks.

      Participation in the mBrain-21 study will last maximum 90 days. Participants are patients
      with migraine or cluster heacache recruited within the headache clinic of Ghent University
      Hospital. Physiological variables such as heart rate, movement and galvanic skin resonse will
      be measured by the Empatica E4 wrist sensor. Patient-specific experiences during headache
      attacks and activities of daily life will be registered with a custom-made headache
      smartphone applications. Contextual data (e.g. smartphone usage or location) can be
      autonomously collected through smartphone applications.
    

Intervention name(s): Wearable sensor and smartphone application
Intervention type(s): Device
Intervention description(s): Empatica E4 wearable sensor and custom-made headache smartphone application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Migraine; Cluster Headache; Smartphone application; Machine Learning; Wearable sensor
Caloric Restriction and Body Weight in Adults
Condition: Overweight
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      The purpose of this study is to determine the role of

        1. dietary calcium in fecal fat loss and the association between lactose maldigestion,
           dietary calcium level and source, and weight loss induced by caloric restriction.

        2. caloric restriction on biomarkers of inflammation and oxidative stress
    


Intervention name(s): Dietary calcium
Intervention type(s): Dietary Supplement
Intervention description(s): Dairy and non-dairy calcium provided as a part of diet in the amounts of 500 mg/day and 1500 mg/day. Diet contained 70% of daily caloric requirements.
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dietary calcium; weight loss
Blood Loss at the Time of First Trimester Surgical Abortion in Anticoagulated Women
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      The primary objective of this study is to compare blood loss resulting from surgical
      termination of pregnancy up to 12 weeks gestation between women who are anticoagulated to
      therapeutic levels and those who are not anticoagulated. This study is based on the
      hypothesis that anticoagulant therapy does not increase intraoperative blood loss in women
      receiving surgical abortions up to 12 weeks gestation.
    

Detailed description: 
      We intend to conduct a prospective cohort study at Oregon Health and Science University and
      the University of Hawaii. This study will not be blinded and subjects will not be randomized.
      Women will be approached about this study after they have made a decision to terminate the
      pregnancy and have completed the preoperative history and physical examination and surgical
      consenting process. For patients who are receiving anticoagulant medications, the decision to
      continue anticoagulant therapy or interrupt it will be made by the patient's physician,
      independently of this study.

      We will recruit women who continue on anticoagulant therapy (heparin, low molecular weight
      heparin, or warfarin) without interruption for the surgical procedure. Our control group will
      consist of women who are not on anticoagulant treatment. This is a matched study and our
      control group will be matched for gestational age, parity, and cesarean section history.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women will be approached about this study after they have made a decision to terminate the
        pregnancy and have completed the preoperative history and physical examination and surgical
        consenting process. We will recruit women who continue on anticoagulant therapy (heparin,
        low molecular weight heparin, or warfarin) without interruption for the surgical procedure.
        Our control group will consist of women who are not on anticoagulant treatment.
      
Biospecimen description: 
      Whole blood
    
Keywords: anticoagulation; surgical abortion
Assessment of Reward Responses to Erythritol Using Flavor Preference Learning
Condition: Reward Responses; Gastrointestinal Hormones; Glycemic Control; Appetite; Satiation; Emotional State
Study type: Interventional

Summary: 
      The aim of this project is to investigate the reward responses to oral erythritol compared to
      sucrose and sucralose using flavor preference learning in healthy participants. In addition,
      the release of GI hormones, glycemic control, appetite-related sensations, and emotional
      state in response to erythritol will be investigated.
    

Detailed description: 
      This trial is a randomized, double-blind, cross-over study; the project set-up will be
      single-centre, national. The study is composed of six visits: one screening visit, one
      pre-test visit, three conditioning visits, and one post-test visit. The screening and
      pre-test will last about two hours, the conditioning days and the post-test day about 4 hours
      each. During the screening participants take part in a 6-n-propylthiouracil (PROP)
      sensitivity test to exclude potential supertasters. Moreover, the participants will rate
      explicit liking and explicit wanting of 10 non-caloric flavored and colored beverages in a
      randomized order (flavor preference learning). The pre-test visit consists of two parts.
      First, a chemosensory sweetness matching will be performed, during which we will establish
      dose-response relationships for perceived sweetness of sucrose, erythritol, and sucralose
      using equisweet watery solutions across a range of concentrations. Second, the participants
      will perform a triangle test to ensure that they cannot distinguish the matched erythritol
      and sucralose solutions from a 10% sucrose solution.

      During the 3 conditioning visits, participants will be presented with three conditioning
      trials (at t = 0, 45, and 90min), each consisting of drinking 100mL of the flavored drink
      (CS) paired with one of the sweet substances (US = erythritol, sucrose, or sucralose).

      In post-test visit, preference for each of the 3 flavored CS drinks will be assessed and a
      computerized forced choice task will be completed by the participants.
    

Intervention name(s): Erythritol; Sucrose; Sucralose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subject specific dose of erythritol dissolved in 300 mL tap water.; 30 g sucrose dissolved in 300 mL tap water.; Subject specific dose of sucralose dissolved in 300 mL tap water.
Other intervention name(s): E968-Erythritol; Saccharose; E955-Sucralose
Intervention MeSH terms: Erythritol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the effect of the
      Daclatasvir/Asunaprevir/BMS-791325 fixed dose combination (FDC) tablet on the
      pharmacokinetics of the cocktail CYP and transporter probe substrates and to assess the
      effect of the DCV 3DAA FDC [DCV 3DAA FDC = fixed dose combination formulation of 3
      direct-acting antivirals (3DAA) (DCV 30 mg, ASV 200 mg, and BMS-791325 75 mg)] + BMS-791325
      75-mg single-agent tablet on the Pharmacokinetic (PK) of the cocktail CYP and transporter
      probe substrates.
    

Detailed description: 
      IND number: 79,599 and 101,943

      Primary purpose: Other: study is being conducted to investigate the potential drug-drug
      interactions (DDIs) when the Daclatasvir/Asunaprevir/BMS-791325 FDC formulation is
      coadministered with a cocktail of cytochrome P450 (CYP) probe substrates (Caffeine,
      Metoprolol, Montelukast, Flurbiprofen, Omeprazole, and Midazolam) and transporter probe
      substrates (Digoxin and Pravastatin) in healthy subjects. It is also intended to characterize
      the PK of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325, and its major metabolite,
      BMS-794712, at steady state.
    

Intervention name(s): Cocktail; DCV 3DAA FDC; BMS-791325
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cocktail = Caffeine 200 mg, Metoprolol 50 mg, Montelukast 10 mg, Flurbiprofen 50 mg, Omeprazole 40 mg, Midazolam 5 mg, Digoxin 0.25 mg, and Pravastatin 40 mg; DCV 30 mg + ASV 200 mg + BMS-791325 75 mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study Comparing Conventional, Burst and High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation
Condition: Failed Back Surgery Syndrome
MeSH terms: Syndrome; Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly
      labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after a
      spine surgery. Treatment of this chronic condition by further operation or medical management
      has a heavy financial impact on health care systems.

      Many studies have demonstrated the efficacy and economic value of Spinal Cord Stimulation
      (SCS) for chronic neuropathic pain, and randomized controlled trials (RCTs) have shown SCS to
      be a clinically effective adjunct to medical management. SCS has the advantages of being
      reversible and less invasive than surgery and may cause fewer issues over time than long-term
      pharmacological treatments.

      Despite variable levels of success in the literature, approximately 30-55% of the patients
      treated with traditional SCS for neuropathic pain disorders will not receive adequate long
      term pain relief. Therefore, technical SCS system refinements, as well as new techniques have
      emerged.

      Two new stimulation waveforms based on traditional SCS technology have appeared to further
      optimize the outcome for specific painful conditions;

        -  Burst stimulation mode: which generates constant-current stimuli with 5 spikes at 500 Hz
           per burst and pulse width and interspike intervals of 1 ms.

        -  High-frequency stimulation (from 1 to 10 kHz) mode.

      Several studies have demonstrated the potential interest of these 2 new waveforms to treat
      FBSS patients compared to traditional SCS.

      The Precision Spectra™ system allows MultiWave Technology by offering a broad spectrum of
      waveform options (from Tonic Conventional Stimulation (TCS), BURST stimulation to High
      Frequency stimulation (HF)).

      To date, literature data comparing these 3 stimulation patterns is lacking but it is
      suggested the pain relief in some of non-responsive patients can be "recaptured" by
      increasing the SCS frequency to 500 Hz by BURST stimulation or beyond by HF stimulation. It
      seems important to conduct RCT in crossover, thanks to the new Precision SCS Stimulator, to
      compare the effects of these 3 different SCS modalities in FBSS patients and to determine
      which concept is the most effective in terms of pain reduction and energy consumption.
    


Intervention name(s): Precision Spectra™ system
Intervention type(s): Device
Intervention description(s): Neurostimulation procedures
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of IQP-VV-102 in Weight Management
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the
      subjects' body weight, body fat and safety parameters are monitored
    


Intervention name(s): IQP-VV-102; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The purpose of this study is to compare preference of the patients, efficacy of preparation,
      and safety between 4 L polyethylene glycol and 2 L of polyethylene glycol with ascorbic acid
      in patients with inactive ulcerative colitis.
    


Intervention name(s): polyethylene glycol; Ascorbic Acid
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: ulcerative colitis; bowel preparation