bioihbjkbjnl/mcl2 huggingface dataset:
Relief of Migraine Pain Through Electro Stimulation
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      This study will evaluate transcutaneous electro stimulation device developed by Siano for
      adequacy, safety and efficacy for the treatment and/or prevention of migraine pain for
      migraine sufferers.
    

Detailed description: 
      This study will gather information regarding performance of Avital transcutaneous electro
      stimulation device developed by Siano. Electrostimulation in the form of weak electrical
      pulses arranged in specific patterns (programs), is delivered through adhesive electrodes
      attached to patient's skin. A set of stimulation programs, out of which one is placebo, is
      stored in device memory.The device is controlled wirelessly using a dedicated smartphone
      application. Participants will be instructed to attach and activate the device at the onset
      of a migraine attack and manually adjust stimulation intensity to a level where it is
      perceivable but not painful. Upon each activation, a program will be automatically picked for
      execution in random order. Randomization is performed within and between subjects. Subjects
      will not be aware of the executed program. Subjects are requested to refrain from use of
      migraine relief drugs prior to treatment and during the first two hours of the treated
      attack. Throughout the course of electrostimulation, participants will be requested to rate
      their migraine pain level via te same smartphone application, using Visual Analog Scale
      (VAS).

      Overall experimental duration for each participant will be determined by the goal of using
      the Avital device for 10-20 migraine attacks.

      Data containing activation times, executed programs, stimulation intensity and user feedback
      will be transmitted via the smartphone to a central database for analysis. All data are
      completely de-identified and linked to a unique code assigned to each device. The link
      between participant's ID and this code will be securely maintained by the research
      coordinator. Database will be overseen by Siano staff responsible for monitoring the clinical
      study. The electronic database will be used to generate outcome measures.

      In the course of this study the investigators will obtain controlled data on the safety and
      efficacy of transcutaneous electro stimulation for migraine treatment using Siano developed
      transcutaneous electro stimulation device.
    

Intervention name(s): Randomized treatment/placebo delivery of transcutaneous electro stimulation via a dedicated device Avital.
Intervention type(s): Device
Intervention description(s): Transcutaneous electro stimulation
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects
Condition: Clinical Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the bioequivalence of one extended release combination (loratadine 5
      mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG
      Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination
      (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by
      Schering-Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.
    


Intervention name(s): Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG); Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)
Intervention type(s): Drug; Drug
Intervention description(s): Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1); Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)
Intervention MeSH terms: Loratadine; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Upper respiratory allergy symptoms including congestion
Phase 3 Study to Evaluate the Efficacy & Safety of Tralokinumab in Adults & Adolescents With OCS Dependent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to
      Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent
      Asthma.
    

Detailed description: 
      This is a randomized, double-blind, parallel group, placebo-controlled study designed to
      evaluate the efficacy and safety of a fixed 300 mg dose of tralokinumab administered
      subcutaneously every 2 weeks in adult and adolescent subjects with oral corticosteroid
      dependent asthma. Approximately120 subjects will be randomized globally. Subjects will
      receive tralokinumab or placebo, administered via subcutaneous injection at the study site,
      over a 40-week treatment period.
    

Intervention name(s): Tralokinumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Tralokinumab dose; Placebo dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Reactive Airways; Repiratory Tract Disease; Obstructive Lung Disease; Lung Diseases
Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant
Condition: Breast Pumping
Study type: Interventional

Summary: 
      Babies are the best in class in order to get human milk out of a lactating breast. With this
      in mind, Philips has developed the a new electric breast pump, attempting to mimic the babies
      sucking behavior. The new electric breast pump includes a new vacuum profile and 2 new
      expression kits.
    

Detailed description: 
      Breast pumps currently on the market function by applying vacuum directly to the breast. The
      effect of a build-up of pressure within the breast due to the accumulation of milk, combined
      with the external negative pressure introduced by the breast pump, results in the expression
      of milk. However, in order to express sufficient amounts of milk it is important to stimulate
      the Milk Ejection Reflex (MER). The MER, also called letdown, draught ejection, expulsion or
      pumping reflex, is described as a response of the mammary gland to oxytocin. When the nipple
      is stimulated, the mother's posterior pituitary gland releases oxytocin into the bloodstream.
      Upon reaching the breast tissue, oxytocin provokes contraction of cells within the structure
      of the breast causing milk flow. Without the MER successful breastfeeding or breast milk
      expression cannot happen. In order to stimulate the MER, Philips has developed 2 new
      expression kits to better mimic the suckling pattern of an infant.
    

Intervention name(s): Using Eureka Breast Pump with Expression Kit
Intervention type(s): Device
Intervention description(s): Each subject will undergo two expression sessions for single and double electric pumping in randomized order to reduce the variation.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The Investigational Device used for this study, is an electric breast pump, intended to express and collect milk from the breast of a lactating woman. Both the 1K and 2K expression kit will be tested in single and double pumping regime.
Masking: None (Open Label)
Primary purpose: Treatment
A Multiple Ascending Dose Trial of CVL-231 in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) of CVL-231 following multiple-dose oral administration in subjects with
      schizophrenia.
    


Intervention name(s): CVL-231; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CVL-231; Placebo matching CVL-231
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label study to investigate whether HEC74647 and HEC110114 has
      an effect on the pharmacokinetic (PK) profile of midazolam（a cytochrome (CYP) 3A4
      substrate）in healthy subjects
    

Detailed description: 
      This is a single center, open-label study in healthy adult subjects. Total 14 subjects will
      be enrolled into the study and will be receive study drug per the defined treatment.
    

Intervention name(s): Midazolam Syrup; HEC74647PA; HEC110114
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered Midazolam Syrup 5 mg orally once daily in fed state;; Administered HEC74647PA 100 mg orally once daily in fed state;; Administered HEC110114 600 mg orally once daily in fed state;
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparative Pharmacokinetics of YH14659
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare pharmacokinetics after single oral administration
      of 2 capsules of YH14659, a fixed-dose combination of clopidogrel and aspirin developed by
      Yuhan Corporation versus co-administration of Plavix (clopidogrel) and Astrix (aspirin) in
      healthy male volunteers.
    


Intervention name(s): YH14659; clopidogrel & aspirin
Intervention type(s): Drug; Drug
Intervention description(s): YH14659 capsule by oral; clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: YH14659; Aspirin; Clopidogrel; Yuhan
Topical Gel Anti-Fungal Agent for Tinea Unguium
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare, in a controlled fashion, the response to two
      anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations
      in the treatment of subjects with distal subungual tinea unguium of the toenails
      (onychomycosis).

      The formulation used as the vehicle for the active agents has been shown in earlier studies
      to facilitate the penetration of the active agent through fungally-infected nails. This study
      will examine dose-response and agent differences in terms of efficacy and safety.

      Once the subject has qualified for the study, he/she will be randomly assigned to one of five
      study groups, dispensed appropriate study medication and instructed to apply one drop to the
      great toe designated for study.
    


Intervention name(s): Organogel of naftifine, 2%; Organogel of terbinafine, 2%; Organogel of naftifine, 6%; Organogel of terbinafine, 6%
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Terbinafine; Naftifine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: tinea unguium; onychomycosis
The Comparison of Postoperative Pain After Colon Resection in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment
Condition: Colon Cancer
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Colon resection is one of the major surgery, the postoperative pain is so severe that it is
      necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The
      most common pain management of this surgery is the intravenous (IV) PCA. If it is relatively
      insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce
      the pain effectively. Consequently, it may result in the a lot of rescue analgesics use,
      which leads to the adverse effects in patients who are very sensitive to narcotic analgesics.
      And the patient's satisfaction to the PCA may be low.

      For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode
      setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out
      time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a
      new mode, so that the administered rate and amount of drug can be increased or decreased
      according to the patient's use of bolus button. Therefore, this PCA device can be implemented
      to the conventional mode, and added the function of automatically controlling the basal rate
      and administered amount of drug according to the use demand of the patient. However, since
      there are few studies related to this new mode of PCA, more research is needed in patients
      with postoperative pain.
    


Intervention name(s): Optimizing B.I (New) PCA mode; Conventional PCA mode
Intervention type(s): Other; Other
Intervention description(s): In the intervention group, the optimizing B.I PCA mode will be setted. This mode is setted that the amount of administered drug per hour will be increased by 0.3 ml by pressing bolus button (The interval: ~ 6 hr: 1.5 - 3.5 ml, 6-24 hr: 1 - 3 ml, 24 hr ~ : 0.5 - 2.5 ml). Conversely, if the bolus button is not used for 90 minutes, the administered amount of drug per hour is setted to be reduced by 0.1 ml, and the maximum (or minimum) allowable flow rate is 3.5 ml (or 0.5 ml).; (Mode setting; total volume: 150 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 10 minutes)
Other intervention name(s): (Mode setting; total volume: 150 ml, flow rate: changable by patients' requirement, bolus volume: 0.5 ml, and LOT: 10 minutes)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Colon resection; Patient Controlled Analgesia; Optimizing Basal Infusion Mode
Oxytocin and Resting State fMRI
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of the study is to investigate the effects of intranasal oxytocin (OT) or placebo to
      resting state brain activity in healthy males.
    

Detailed description: 
      Although several fMRI studies investigated the neural correlates of OT administration, only
      few have focused on the underlying modulatory effects of OT on baseline brain function. While
      functional MRI examines the neural activity during a certain task, it might be especially
      interesting to assess the main effect of OT on the basic activity of the human brain in rest.
      This resting state activity becomes typically evident in the default mode network (DMN),
      compromising midline structures such as medial frontal cortex, cingulate and precuneus, as
      well as specific resting state networks .

      In fact, a recent study succeeded in demonstrating a modulatory influence of OT. Recent
      studies were able to show an increased functional connectivity at rest of amygdala to the
      medial prefrontal cortex (PFC) in a small sample of 15 subjects.

      However, distinct subregions of the amygdala seem to be involved in different OT effects. To
      goal of the present study is to decipher the modulatory effects of OT to subregions of the
      amygdala in a larger sample using improved anatomical mapping of the seed regions and relate
      these alterations to individual traits of healthy volunteers. We expected to add evidence to
      the increase of amygdala - PFC connectivity under OT as well as detailed anatomical mapping
      of this networks.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Oxytocin
Primary purpose: Basic Science
A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar
      Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will receive
      doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg). Subjects
      will receive 5 consecutive daily doses in Period 1 (Days 1-5) and a single dose on Day 1 of
      Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each
      of the two study periods. In addition, safety assessments will be conducted throughout the
      study.
    


Intervention name(s): Filgrastim Hospira; US-Approved Neupogen
Intervention type(s): Biological; Biological
Intervention description(s): 5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2.; 5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2.
Other intervention name(s): Filgrastim; Filgrastim
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Cannabidiol for Inflammatory Bowel Disease
Condition: Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with
      cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol.
      cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat
      soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side
      effects.

      The aim of the proposed study is to examine in a double blind placebo controlled fashion the
      effect of cannabidiol on disease activity in patients with IBD.
    

Detailed description: 
      Background: Inflammatory bowel diseases (IBD) are relatively common disease with a rising
      incidence. Treatment includes various immunocompromising agents including corticosteroids,
      immunomodulators and biologic agents. Current treatment is not always effective and has many
      side effect.

      Cannabinoids have been known to have anti inflammatory effect, probably via the CB2 receptor.
      There are many anecdotal reports of cannabinoids in inflammatory disease such as rheumatoid
      arthritis, and the impression is that cannabinoids do have an ameliorating effect on IBD and
      that side effects are negligible. However, there are no placebo controled trials in human
      subjects.

      The cannabis plant contains about 600 ingredients, and it is not known which are the active
      ingredients affecting IBD. The most effective anti inflammatory compound known today is
      cannabidiol. Cannabidiol can be extracted from the cannabis plant, it has no central effect
      and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any
      side effects.

      The aim of the proposed study is to examine in a double blind placebo controlled fashion the
      effect of cannabidiol on disease activity in patients with IBD.
    

Intervention name(s): cannabidiol; placebo in drops
Intervention type(s): Drug; Drug
Intervention description(s): cannabidiol given in olive oil drops, 5 mg twice daily; olive oil containing no drug given in drops twice daily
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: crohn's disease; ulcerative colitis; cannabis; cannabidiol
Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen
      Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to
      moderate hypoglycemia, a complication of diabetes.
    


Intervention name(s): G-Pen Mini™ (glucagon injection)
Intervention type(s): Drug
Intervention description(s): stable, pre-mixed, liquid glucagon for subcutaneous injection
Other intervention name(s): mini-dose glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hypoglycemia; Glucagon; Diabetes
Assess Extent of Agreement Between Online 24-hr Dietary Recall and Interviewer-administered 24-hr Dietary Recall on the Same Day for 2 Non-consecutive 2 Days 1 wk Apart to Adults and School Age Children
Condition: Dietary Habits
Study type: Observational

Summary: 
      Hypothesis: The online 24 hour dietary recall will be comparable to interviewer-administered
      24 hour dietary recall considering the limits of agreement in the reporting of energy and
      macronutrient intake. If the two methods of dietary assessment are comparable (i.e., if
      greater than 95% of the data plots will lie within the limits of agreement), the online
      dietary assessment tool could be used in future studies to collect dietary intake data and
      health data in larger sets of Russian populations, in order to investigate the potential
      differences in anthropometric risk factors of non-communicable diseases (cancers, diabetes,
      obesity, hypertension, mortality, etc.) in people with different diet.
    

Detailed description: 
      Baseline assessments include a demographic questionnaire, including anthropometrics (height,
      weight), a heath status questionnaire, supplement intake, eating habits, and a food frequency
      questionnaire, and cardiovascular assessment (blood pressure and heart rate).
    

Intervention name(s): Dietary assessment
Intervention type(s): Other
Intervention description(s): 24-hr dietary recall
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Recruited at 3 locations within a specific area: Saint-Petersbourg Russia
      
Keywords: 24-hr dietary recall