bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of D-Fagomine on Glycaemic Response to Sucrose in Men
Condition: Glycaemic Response; Insulinemic Response
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to
      sucrose in men.
    

Detailed description: 
      To determine and compare glycaemic response to sucrose of D-Fagomine and control in the
      timeframe of 180 minutes.
    

Intervention name(s): D-Fagomine; D-Fagomine
Intervention type(s): Other; Other
Intervention description(s): 30 mg (initial dose), with 50 grams of sucrose in 200 ml of water.; 0 mg (control) blended with 50 grams of sucrose in 200 ml of water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects
Condition: Type 2 Diabetes Mellitus; Healthy Subjects
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the absolute bioavailability of sotagliflozin via administration of an intravenous
      (IV) microdose of a 14C-sotagliflozin tracer on top of a single oral dose of unlabeled
      sotagliflozin without charcoal administration

      Secondary Objectives:

        -  To assess the PK of sotagliflozin and its main metabolite sotagliflozin-3-O-glucuronide
           (M19) after a single oral dose of sotagliflozin and an IV microdose of a
           14C-sotagliflozin tracer without charcoal administration

        -  To assess the safety and tolerability of single doses of sotagliflozin when administered
           with and without charcoal
    

Detailed description: 
      Study duration per participant is up to 54 days including a screening period of up to 28
      days, period 1 of 8 days, period 2 of 8 days, a washout period of at least 10 days, and a
      follow up period of 12-16 days.

      The oral drug Sotagliflozin is metabolized by the liver and released in the bile juice into
      the intestine. Ingestion of charcoal a few hours after the drug administration circumvents
      the re-uptake of the drug from the intestine back into the blood circulation; instead,
      Sotagliflozin is eliminated with the feces. By comparison of Sotagliflozin drug
      administration with and without charcoal, the extent of this so-called enterohepatic
      circulation can be assessed.
    

Intervention name(s): Sotagliflozin (SAR439954); 14C-microtracer; Charcoal
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: Tablet
Route of administration: Oral; Pharmaceutical form: Solution for injection
Route of administration: Intravenous; Pharmaceutical form: Granules for suspension
Route of administration: Oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Charcoal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Posterior Assisted Levitation of Dropped Nucleus
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      Dropping of nucleus is a common complication during cataract extraction by
      phacoemulsification. The investigators describe a new technique to retrieve the dropped
      nucleus by using an instrument called Pars Plana Levitator (ASICO-LLC, USA).
    

Detailed description: 
      Upon recognition of posterior capsular rupture and dropping of nucleus phaco prob will be
      withdrawn, status of the nucleus will be visualized by posterior segment non contact lens and
      if the nucleus found floating, pars plana levitator will be introduced through temporal pars
      plana, its prongs will be opened and nucleus will be grasped between prongs. Nucleus will be
      lifted up till the anterior chamber where phacoemulsification will be performed in a usual
      manner and a posterior chamber intraocular lens will be implanted if possible in the
      remaining bag.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had dropped nucleus during phacoemulsification
      
Keywords: posterior assisted levitation; Pars Plana; Dropped nucleus; cataract; complication of; surgery
Post-licensure Safety Study of IMOJEV® in Thailand
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to further characterize the safety profile of IMOJEV®.

      Primary Objective:

        -  To describe serious adverse events (SAEs, including adverse events of special interest
           [AESIs]) up to 60 days after administration of one dose of IMOJEV®.

      Secondary Objective:

        -  To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after
           administration of one dose of IMOJEV®.
    

Detailed description: 
      Participants aged 1 year to less than 5 years will be randomized to receive one injection of
      IMOJEV® either as a primary vaccination or as a booster. Safety data will be collected for 60
      days after IMOJEV® vaccination. The duration of each subject's participation in the trial
      will be 60 days.
    

Intervention name(s): IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine; IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous.; 0.5 mL, Subcutaneous.
Other intervention name(s): IMOJEV®; IMOJEV®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Japanese encephalitis; IMOJEV®; Japanese encephalitis chimeric virus vaccine
A Dose Escalation Study of Intranasal Neuropeptide Y in Post Traumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the safety of intranasal administration of NPY using a
      dose escalation, randomized, double-blinded, placebo-controlled crossover design in a
      medication-free, symptomatic PTSD group.
    


Intervention name(s): Neuropeptide Y
Intervention type(s): Drug
Intervention description(s): Intranasal administration will be administered with a nasal drug delivery device.
Other intervention name(s): NPY
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Neuropeptide Y; Intranasal Administration; PTSD; Trauma
TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness, safety, and tolerability (how
      well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114
      given with low dose ritonavir.
    

Detailed description: 
      A phase II randomized, controlled, partially blinded, trial to investigate dose response of
      TMC114/RTV in HIV-1 infected patients who have previously received all three licensed classes
      of HIV antiviral drugs (known as nucleoside reverse transcriptase inhibitors (NRTI),
      nonnucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI)), and who
      are on a stable PI-containing regimen not including an NNRTI may be eligible to participate.
      Four doses of TMC-114/ritonavir will be studied. 300 patients in the United States and Puerto
      Rico will participate. The duration of the study is 96 weeks. Randomize to one of 4 treatment
      groups (TMC114/RTV: 400/100 mg qd; 800/100mg qd; 400/100mg bid; 600/100 bid) or control arm
      for 24 to 48 wks. Optimal dose (TMC114/RTV 600/100mg bid) open label portion of the study.
      The trial was extended to include 144Wks of treatment.
    

Intervention name(s): TMC114/rtv; TMC114/rtv; TMC114/rtv; TMC114/rtv
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 800mg TMC114/100mg rtv once daily; 400mg TMC114/100mg rtv both twice daily; 400mg TMC114/100mg rtv once daily; 600mg TMC114/100mg rtv twice daily
Intervention MeSH terms: Darunavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; TMC114; Ritonavir; Tolerability; Safety and efficacy; TMC114-C211
Safety and Efficacy Study of rAAV2-ND4 Treatment of Leber Hereditary Optic Neuropathy (LHON)
Condition: Leber Hereditary Optic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber
Study type: Interventional

Summary: 
      This study is meant to assess the safety and efficacy of rAAV2-ND4 treatment of Leber
      hereditary optic neuropathy with 11778 LHON mutation.
    

Detailed description: 
      Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular disorder
      associated with a mutation in mtDNA . The common manifestation is visual loss which caused by
      the respiratory chain enzymes complex dysfunction resulting in increased oxidative stress
      enzymes production.

      Material and Method Seven patients with 11778 LHON mutation were randomly treated with a
      Single IVT Injection of recombinant Adeno-Associated Virus-NADH dehydrogenase, subunit 4
      (complex I)（rAAV2-ND4)（0.05ml).The dose was 5 × 10^9 vg/0.05 mL for patients younger than 12
      years old, and 1 × 10^10 vg/0.05 mL for patients older than 12 years old. The visual acuity,
      visual evoked potential （VEP）,optical coherence tomography（ OCT）, computerized visual field,
      electroretinograms(ERG), retinal nerve fiber layer(RNFL)and Liver and kidney function in
      plasma were compared before and after treatment at 1,3,and 6, months interval.
    

Intervention name(s): rAAV2-ND4
Intervention type(s): Drug
Intervention description(s): injection
Other intervention name(s): rAAV2-ND4 gene therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leber's Hereditary Optic Neuropathy,11778 LHON mutation,; rAAV2-ND4,triamcinolone acetonide
An Evaluation of Zinc Status Biomarkers
Condition: Inflammation; Oxidative Stress
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of a moderate decrease in dietary zinc
      on DNA strand breaks and other cellular zinc biomarkers.
    

Detailed description: 
      Assessing the zinc status of humans has proven to be difficult because of the unique
      physiological features of zinc homeostasis. Animal and human studies show that a small,
      vulnerable pool of cellular zinc is sensitive to changes in dietary zinc. The protein,
      Metallothionein (MT), is made within cells to stabilize this transient zinc pool and to
      provide a means to 'park' a small zinc reserve. The overall goal is to develop a new method
      for measuring MT in cells and to assess other cellular responses to changes in small changes
      in dietary zinc. Culture models of zinc deficiency and excess have been developed and used to
      test the response of cellular MT levels and mineralization to changes in zinc availability.
      In Phase II, the changes in the expression of leukocytic zinc transporters and the cellular
      in vitro uptake of isotopic zinc will be measured. Healthy men will be recruited to
      participate in a 6-week feeding trial to be followed by a 3-week recovery period. The results
      of this study will determine if potential new cellular zinc biomarkers respond to changes in
      zinc status when the men are fed an additional 4 mg zinc/d incorporated into a rice-based
      meal. These findings will provide essential, new information for designing an efficacy trial
      of biofortified rice and the zinc status of infants and young children.
    

Intervention name(s): Diet zinc
Intervention type(s): Other
Intervention description(s): 4 mg zinc, as zinc sulfate, was added to a controlled diet; 25 mg supplemental zinc was given during the final recovery period when an ad lib diet was consumed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Zinc; DNA Integrity; Gene Expression; diet zinc; nutrition requirements
Transcranial Near-Infrared Light in Healthy Subjects: a Cerebral Blood Flow Study With Diffuse Correlation Spectroscopy
Condition: Cognitive Change
Study type: Interventional

Summary: 
      Transcranial Light Therapy involves non-invasive and invisible beams of light that increase
      energy metabolism in the brain. Transcranial light therapy has been found to promote brain
      metabolism. The purpose of the study is:

      To asses the change in cerebral blood flow induced by the Transcranial Continuous and Pulse
      Near-Infrared Light Therapy in healthy subjects.

      To correlate with cognitive performance the change in cerebral blood flow induced by the
      Transcranial Continuous and Pulse Near-Infrared Light Therapy in healthy subjects.

      To correlate with skin pigmentation the change in cerebral blood flow induced by the
      Transcranial Continuous and Pulse Near-Infrared Light Therapy in healthy subjects.

      To assess the safety and tolerability of the Transcranial Continuous and Pulse Near-Infrared
      Light Therapy in healthy subjects
    

Detailed description: 
      During study visits a clinician applies transcranial light therapy to both sides of a
      participant's forehead for about 30 minutes. The study involves, 1 screening visit which may
      last up to 3 hours, 3 transcranial light therapy treatment visits, and 1 posttreatment visit
      (5 total visits to the Massachusetts General Hospital).

      All eligible participants will have 1 visit with continuous light, 1 visit with pulsed light,
      and 1 visit with sham light. Cerebral blood flow will be measured before and after each light
      session using DCS-spectroscopy. During sham transcranial light therapy visits, the
      transcranial light therapy device will not produce near infrared waves (e.g., light energy
      that cannot penetrate the skin and cranium). The participant will not know which treatment is
      received at each visit.
    

Intervention name(s): Transcranial Light Therapy
Intervention type(s): Device
Intervention description(s): Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24
      weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1
      hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
    


Intervention name(s): BI 201335 high dose; BI 201335 low dose; BI 201335 high dose; BI 201335 high dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BI 201335 high dose with PegIFN/RBV; BI 201335 low dose with PegIFN/RBV; BI 201335 high dose with PegIFN/RBV; BI 201335 high dose with PegIFN/RBV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Evaluating Acupuncture Relationship With the Catecholaminergic Pathway
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Activation of the sympathetic nervous system attenuates inflammation via catecholamines,
      recent advances in electroacupuncture allow activating critical neuronal networks with the
      release of catecholamines the aim of this research was to evaluate de effect of
      electroacupuncture in the activation of sympathetic nervous system and the control of low
      back pain in athletes
    

Detailed description: 
      Activation of the sympathetic nervous system attenuates inflammation via activation of
      β2-adrenoreceptors by catecholamines, Electrical stimulation of vagus nerve limits the
      inflammatory response in several animal models of inflammatory diseases, In addition,
      voluntary activation of the sympathetic nervous system by meditation, training or breathing
      techniques limits production of proinflammatory cytokines in vivo during experimental
      endotoxemia in healthy human volunteers.

      Currently there are therapies that effectively antagonize proinflammatory cytokines and
      control pain, as non-steroidal anti-inflammatory drugs and opioid analgesics, but had serious
      side effects if used chronically. Therefore, alternative therapies as electroacupuncture,
      which may limit inflammatory cytokine production more physiologically, are warranted. The aim
      of this study was to evaluate de effect of electroacupuncture used for attenuation of low
      back pain in the activation of sympathetic nervous system and leukocyte inflammatory
      potential.
    

Intervention name(s): Electroacupuncture; Diclofenac sodium; Sham electroacupuncture
Intervention type(s): Device; Drug; Other
Intervention description(s): The acupuncture points selected were ST36, BL25, GB30, BL40, GB34 the needles were inserted into acupoints and the depth of needle insertion depended of the acupoints selected to achieve Deqi sensation, which is characterized as a numb, heavy, sore and/or distending sensation.
Electrical stimulation was delivered at 4 Hz. The stimulator (ITO EST-160) was then switched on, and the intensity was gradually increased to reach a strong but comfortable level the sensation of EA which is characterized for numbness, tingling and a light muscle cramp. For 15 minutes; 100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days.; The investigators use 1.0 cm outside point of the real electroacupuncture, the depth of needle insertion was superficial to avoid Deqi sensation, the cables wasn't connected to the electro stimulator and was then switched on for 15 minutes. The participants were threaded separately to avoid sharing experiences about the electroacupuncture sessions
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
Condition: Hyperuricemia; Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of the study are to evaluate the safety and the efficacy in patients
      with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days
      in two dosage groups.

      Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to
      assess anti-SR29142 antibody production in patients with malignant lymphoma and acute
      leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the
      results of efficacy and safety evaluations.
    


Intervention name(s): Rasburicase (SR29142)
Intervention type(s): Drug
Intervention MeSH terms: Rasburicase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      Severe psoriasis has been demonstrated to be associated with decreased endothelial function
      and an increase risk of future coronary events. Although systemic therapy with
      immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic
      inflammation and endothelial function are unknown.

      In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and
      inflammatory markers before and after treatment of moderate to severe psoriasis with an
      FDA-approved biologic agent, adalimumab (Humira).
    


Intervention name(s): Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]
Intervention type(s): Drug
Intervention description(s): 40mg subcutaneously, every other week for 6 months
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Moderate to Severe Chronic plaque type psoriasis
Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour
Condition: Pain Relief During Labour
Study type: Interventional
Phase: Phase 4

Summary: 
      Combined spinal-epidural (CSE) analgesia has become a widely accepted approach to provide
      analgesia for labour pain. Despite the increasingly widespread use of this technique, an
      optimal intrathecal drug regimen has not been established yet.

      Several investigations using local anesthetics such as Bupivacaine, Levobupivacaine and
      Ropivacaine in CSE during labour have been published. But despite the reintroduction of
      Chloroprocaine recently there haven't been any investigations about spinal chloroprocaine.
      Chloroprocaine is already a long-know drug with a beneficial pharmacodynamic/kinetic profile.
      It is known for a very quick onset of action (2 - 3 minutes), high efficacy, rapid metabolism
      by plasma cholinesterases and short half-life both in mother and fetus.

      Because of this beneficial profile, Chloroprocaine is widely used intrathecally for surgical
      anesthesia. Several investigations demonstrate that for surgical anesthesia doses
      Chloroprocaine ranging from 30 - 60 mg are used and that they have an effective surgical
      duration of 40 - 90 minutes.

      Despite these "standards" for surgical anesthesia, little is known about spinal
      Chloroprocaine dose regimens. Therefore the primary goal of this study is to determine the
      minimum adequate dose of Chloroprocaine that is to be given spinally to a woman in labour
      using a CSE procedure. We will use the up-down sequential allocation to identify the median
      effective dose (ED50) or concentration (EC50).

      The Effective dose in 95% of the population (ED95) can be estimated also from an up-down
      sequential allocation and will become an important valuable approximation of the clinical
      dose.
    


Intervention name(s): Spinal administration of chloroprocaine.
Intervention type(s): Drug
Intervention description(s): In order to determine the minimum effective dose that is to be given spinally, an up-down sequential allocation will be used.
Efficacy of the analgesia will be evaluated by a 100mm visual analogue pain score (VAPS). There are two possible outcomes here:
effective: the VAPS is 10mm or lower after the 15 minutes of monitoring. An effective result will decrease the test dose of chloroprocaine with 2mg for the next patient in this study.
Ineffective: the VAPS is more than 10mm after 15 minutes of monitoring. An ineffective result will increase the test dose of chloroprocaine with 2mg for the next patient in this study. Patients who indicate an ineffective result will receive a rescue treatment by the administration of 12ml levobupivacaine epidurally.
Intervention MeSH terms: Chloroprocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment