bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      Increased computational power has made it possible to implement complex image recognition
      tasks and machine learning to be implemented in every day usage. The computer vision and
      machine learning based solution used in this project (Nelli) is an automatic seizure
      detection and reporting method that has a CE mark for this specific use.

      The present study will provide data to expand the utility and detection capability of NELLI
      and enhance the accuracy and clinical utility of automated computer vision and machine
      learning based seizure detection.
    

Detailed description: 
      This is a prospective, blind comparison to the clinical gold standard for seizure
      characterization. This study is intended to compare the Nelli Software's ability to identify
      seizure events to vEEG review in adults with suspected nighttime seizures. Simultaneously,
      Nelli will continuously record audio and video while video-electroencephalography (vEEG) is
      recorded per typical standard of care. Events with positive motor manifestations will be
      independently identified, following standard clinical practice, by three epileptologists
      using clinical vEEG data. Nelli Software will review the audio and video data and
      independently identify events with positive motor manifestations. The outcomes of event
      identification will be compared between Epileptologists and the Nelli Software. For each
      category of event captured the positive percent agreement will be calculated using the exact
      binomial method. The primary endpoint of this study is to demonstrate that Nelli is able to
      identify seizures that have a positive motor component with a sensitivity of > 70%.
    

Intervention name(s): Nelli
Intervention type(s): Device
Intervention description(s): Nelli detects and registers activity that is indicative of seizure events. Nelli captures, stores, and processes video and audio recordings from each patient. Biomarker data is collected during periods of rest for the length of an examination period, which may span several days or months (when used inside and outside of a hospital setting, respectively), as prescribed by a treating physician.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with suspected motor seizures that are undergoing video-EEG monitoring for routine
        clinical care.
Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg /25 mg Tablet Under Fed Conditions
Condition: Hypertension
MeSH terms: Hypertension; Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of losartan
      potassium/hydrochlorothiazide 100/25 mg tablet under fed conditions.
    


Intervention name(s): losartan potassium hydrochlorothiazide
Intervention type(s): Drug
Intervention description(s): 100 mg / 25 mg tablet
Other intervention name(s): Hyzaar
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Ingestion of Sugary Drinks on Thirst Sensation
Condition: Thirst
Study type: Interventional

Summary: 
      The purpose of this study is to determine if regular soft drinks (with sugar) have the same
      effect on thirst as diet soft drinks(with sweeteners).
    

Detailed description: 
      Participants should be in the laboratory at 8.00 in order to collect the values of weight,
      height, total body water, intracellular water and extracellular water in a Segmental Multi
      Frequency Body Composition Monitor (TANITA MC 180 MA®). Then, a blood sample will be
      collected for analysis of blood glucose and osmolality. They will sit at individual tables
      for the duration of the session and were allowed to read, listen to music with earphones, or
      use their portable computers with the exception of internet access to minimize visual cues
      (e.g., unwanted publicity for beverages or visiting Web sites showing pictures of food and
      drinks), which may have effect on thirst. Breakfast will be served at 9.30 on every occasion
      and preload stimuli will be offered exactly 60 minutes after breakfast (at 10.30). Lunch will
      be provided at 13.00. Motivational ratings will be first obtained at the end of collection of
      blood sample (baseline or time 0) and every 30 minutes thereafter until the lunch time (times
      1 through 7). After lunch (time 8), participants will complete the last set of ratings and
      will bring a food diary to record all food and fluid intake until 00.00 that day.
    

Intervention name(s): Effect of ingestion sugary and sweetened drinks on thirst
Intervention type(s): Behavioral
Intervention description(s): The participants will drink Water (control group), Decarbonized Pineapple Soda (11% sugar)and Decarbonized Pineapple Diet Soda (1% Sugar and Sucralose). The beverages will be presented chilled but without ice in 500 ml portions in opaque plastic containers and participants will be asked to consume the entire amount within 15 min. The beverages will be tested previously in laboratory in order to obtain their pH and osmolality.
Other intervention name(s): Effect of ingestion of water, soda and diet soda on thirst; Diferences between sweeteners and sugar on thirst
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Evaluation of the Food Effect on the Safety, Tolerability, PK of EC-18 After Oral Administration in Healthy Volunteers
Condition: Chemotherapy-Induced Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open-Label, Single -Dose, Crossover, Phase I Clinical Trial to Evaluate the
      Effect of Food on the Safety, Tolerability and Pharmacokinetics of EC-18 after Oral
      Administration in Healthy Volunteers
    

Detailed description: 
      In vitro and in vivo efficacy studies and clinical trials have shown that EC-18 has a mode of
      action of improving neutropenia by promoting neutrophil production from hematopoietic stem
      cells and at the same time, efficiently controlling STAT6/Complement 3(C 3), suggesting its
      potential to be developed as an orally administered new drug for treatment of neutropenia
      resulting from decreased neutrophils caused by administration of an anticancer agent.

      This study is a randomized, open-Label, single -dose, crossover, phase I clinical trial to
      evaluate the effect of food on the safety, tolerability and pharmacokinetics of EC-18 after
      oral administration in healthy volunteers
    

Intervention name(s): high-fat diet; EC-18
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): This trial is conducted as a randomized, open-label, single -dose, crossover, phase I to evaluate the effect of food on the safety, tolerability and pharmacokinetics of EC-18. EC-18 is given at an oral, once daily in condition of empty stomach and a high fat diet(900~1,000 kcal, contains 50~60%lipid).This trial is divided into Part 1(1,000mg dose) and Part 2(500mg dose and 2,000mg dose), 12 subjects are included in each dose and cross-over period is 7 days. After Part 1 study, If primary PK parameters of EC-18 is affected by food and AEs meeting study discontinuation criteria are not reported, Part 2 will proceed in consecutive order with registering new subjects.; This trial is conducted as a randomized, open-label, single -dose, crossover, phase I to evaluate the effect of food on the safety, tolerability and pharmacokinetics of EC-18. EC-18 is given at an oral, once daily in condition of empty stomach and a high fat diet(900~1,000 kcal, contains 50~60%lipid).This trial is divided into Part 1(1,000mg dose) and Part 2(500mg dose and 2,000mg dose), 12 subjects are included in each dose and cross-over period is 7 days. After Part 1 study, If primary PK parameters of EC-18 is affected by food and AEs meeting study discontinuation criteria are not reported, Part 2 will proceed in consecutive order with registering new subjects
Other intervention name(s): EC18 Soft-capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: EC-18; Hematology; Cancer; Neutropenia
A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to compare the pharmacokinetic characteristics of
      GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.

      GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.

      GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption
      by Extending the Absorption Site.

      To overcome the shortcomings of the currently existing sustained release drug delivery
      technologies the investigators have recently developed a novel drug delivery system to enable
      a drug to be dissolved irrespective of the surrounding environment and further absorbed up to
      colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
    

Detailed description: 
      Basically, this system is a triple-layered tablet, comprised of upper and lower layers that
      swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that
      rapidly draw water into the tablet core simultaneously.

      The water drawn into the tablet (about 3 to 4 times the weight of the tablet itself)
      functions as an additional media which enables additional and later drug release out of the
      dosage form. This serves to overcome the shortage of surrounding media that has been reported
      to be one of the key reasons for mal-absorption of a drug in colon.

      As the middle layer induces a rapid water draw into the tablet core, the penetrated water
      also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and
      controls drug release.

      At virtually the same time, the swollen upper and lower layers form to surround a lateral
      side of the middle layer, which can, in turn, further control drug release.

      This relatively rigid swollen matrix structure makes drug release not affected by surrounding
      mechanical flux, which can provide relatively consistent in vivo drug release irrespective of
      degree of gastrointestinal motility.
    

Intervention name(s): Pregabalin 150mg; Pregabalin 300mg
Intervention type(s): Drug; Drug
Intervention description(s): GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day); GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day)
Other intervention name(s): GLA5PR GLARS-NF1 tablet 150mg; GLA5PR GLARS-NF1 tablet 300mg
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Growth Hormone Deficiency in Adults (GHDA)
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Japan. The aim of this trial is to demonstrate superiority of the
      effect of NN-220 compared with that of placebo as assessed by the change in percent in
      truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with
      Growth Hormone Deficiency in Adults (GHDA).
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
Condition: Hyperlipidemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously
      once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from
      baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial
      hypercholesterolemia (HeFH).
    


Intervention name(s): Evolocumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Postpartum Immediate Contraception in Cesarean Deliveries-Comparison of Two Intrauterine Systems
Condition: Intrauterine Systems; Postpartum Immediate Contraception
Study type: Interventional

Summary: 
      To compare two intrauterine systems in order to avoid complications originating from short
      pregnancy interval and undesired pregnancies in the early postpartum period.
    

Detailed description: 
      The patients admitting to Zeynep Kamil Research and Training Hospital for caesarean delivery
      will be included in the study. There will be two computer based randomized groups. The
      investigators expect that both groups will have 100 cases. First group will be treated with
      conventional intrauterine devices (Cu T380 A) while the second group will be treated with
      frameless intrauterine devices (GyneFix). The participants will be informed about postpartum
      unplanned pregnancies and the complications of short pregnancy interval. Participants will
      also be informed about possible complications of having an intrauterine device and that there
      may be a possibility of failure.The participants who choose to participate in the study will
      be divided into two groups by computer based randomization and one of the systems will be
      applied. After the participants read and sign the informed consent form, the intrauterine
      device will be applied postplacental up to 10 minutes.
    

Intervention name(s): GyneFix; Cu T380 A
Intervention type(s): Device; Device
Intervention description(s): The fiber is fixed to the anchoring thread by means of a stainless steel clip 1 cm from the upper part of the anchoring knot. The anchoring knot is implanted into the myometrium of the uterus thus permanently securing the implant in the uterine cavity; Cu T380 A will be inserted into the uterus
Other intervention name(s): Gynefix(frameless intrauterine devices); Copper T 380a
Intervention MeSH terms: Copper
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will have two parts as follows:

      The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and
      confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric
      participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days
      of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.

      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF
      dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the
      Treatment Phase with no interruption of study drug administration. The Treatment Phase will
      evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in
      pediatric participants with genotype 2 or 3 HCV infection, respectively.
    


Intervention name(s): SOF; RBV
Intervention type(s): Drug; Drug
Intervention description(s): SOF administered orally once daily; RBV oral solution or capsules will be administered orally in a divided daily dose based on weight
Other intervention name(s): Sovaldi®; GS-7977; REBETOL®
Intervention MeSH terms: Ribavirin; Sofosbuvir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pedobarographic Assessments of Clubfoot Treated Patients
Condition: Clubfoot
MeSH terms: Clubfoot; Talipes; Equinus Deformity; Foot Deformities
Study type: Observational

Summary: 
      The purpose of this study is to determine the utility of pedobarographs in evaluating
      clubfoot post-treatment.
    

Detailed description: 
      Detailed Description: Using Tekscan's HRMat Pressure assessment system or EMED pedobarography
      system the distribution of force will be measured across the plantar surface of the subject'
      foot. The Tekscan system is comprised of a 50 cm square pressure sensor connected to a
      computer interface. The data collection will be made up of two parts:

      Part I: Static Profile: The child will be asked to stand on the mat for 6 seconds for five
      trials. During this time the data collection software will collect force data across the foot
      60 times per second. The software will then calculate centre of force as well as changes in
      pressure during the static trial. The foot will be assessed into the distribution of forces
      across the hindfoot, midfoot, forefoot, and the big toe. In addition, the centre of gravity
      will also be determined.

      Part II: Dynamic Profile: The dynamic test will involve the child walking across the mat for
      a total of 5 passes per foot. Measurements of force will again be taken at 60 Hz.

      The EMED-x400 sensor is rectangular and its dimensions are 47.5 cm by 32 cm. Measurements of
      force will be recorded at up to rates of 400 Hz. Foam pieces (included with the EMED
      platform) are constructed around the platform to establish a levelled and safe runway for the
      patient to walk along. The EMED platform is connected to a computer interface which operates
      on the Novel analysis software. The subject will be asked to walk across the mat
      independently at their ordinary pace. The foot is required to land in the centre of the mat,
      at a minimum of three trials per foot10. Plantar pressure recording takes 10-20 minutes for
      each subject.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Clubfoot patients seen at BC Children's Hospital in Vancouver.
      
Keywords: Evaluation of an outcome tool; clubfoot; foot pressure profiles; pedobarographs
Comparative Study of Anaconda System Use Versus Conventional Sedation in COVID-19 Patients.
Condition: COVID-19; Respiratory Failure
MeSH terms: COVID-19; Respiratory Insufficiency
Study type: Observational [Patient Registry]

Summary: 
      At the beginning of 2020, a global alert emerged which saturated intensive care units due to
      COVID-19 worldwide. This caused a need for mechanical ventilation due to atypical pneumonias
      that had a rapid evolution and respiratory failure; therefore the consumption of sedative
      agents in the intensive care units escalated. Suboptimal sedation in the intensive care unit,
      increases the adverse effects, costs, and morbidity. For the time being, they focus on the
      use of intravenous agents such as propofol or dexmedetomidine, which are associated with
      tolerance, withdrawal, delirium, and hemodynamic effects. Consequently, the need arises to
      maximize availability and effectiveness, which is why the intervention of the ANACONDA
      conservation device is carried out, which works with a heat and humidity exchange filter
      capable of administering isoflurane or sevoflurane with an efficiency of 90%.
    

Detailed description: 
      Analyze the difference in intravenous sedation requirements in patients with COVID-19.
      Patients who were assisted by a mechanical ventilator with sevoflurane versus conventional
      sedation.
    

Intervention name(s): Sevoflurane with AnaConDa
Intervention type(s): Device
Intervention description(s): Sevoflurane administered with AnaConDa device
Intervention MeSH terms: Sevoflurane
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with confired COVID-19 infection assited with mechanical ventilation that required
        sedation.
      
Keywords: sedatives; acute kidney injury; SARS-CoV-2; mechanical ventilation
Effect of Eltrombopag Plus G-CSF on Human CD34+ Cell Mobilization in Multiple Myeloma Patients Undergoing ASCT
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Eltrombopag may improve the cell collection available for Autologous Stem Cell
      Transplant(ASCT). The overall goal is to determine if adding Eltrombopag to the standard ASCT
      will increase the number of blood cells collected and reduce the number of times blood needs
      to be collected. This study will also determine the highest dose of Eltrombopag that can be
      used without causing serious side effects.
    

Detailed description: 
      Subjects will receive standard treatment for autologous stem cell transplant. Subjects will
      be assigned to receive no Eltrombopag or one of three dose levels of Eltrombopag. Subjects
      will receive oral Eltrombopag on days 2-15 of treatment.
    

Intervention name(s): Eltrombopag
Intervention type(s): Drug
Intervention description(s): oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15
Other intervention name(s): SB-497-115-GR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ASCT; G-CSF