bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioavailability and the bioequivalence between
      two active pharmaceutical ingredient (API) sources of opicapone (OPC) at two different dosage
      strengths (25 mg and 50 mg) after a single oral dose administration under fasting conditions
      in healthy male and female subjects.
    

Detailed description: 
      Single-center, fasted, open-label, randomized, gender-balanced, single-dose, laboratory
      blinded, two-periods, two-sequence, crossover study in 2 groups of subjects.

      In Group 1, subjects will receive randomly in Period 1 and 2, either a single 25 mg dose of
      OPC approved formulation [AF] or a single 25 mg dose of OPC formulation to be submitted for
      approval [NF].

      In Group 2, subjects will receive randomly on Period 1 and 2, either a single 50 mg dose of
      OPC (AF), or a single 50 mg dose of OPC (NF
    

Intervention name(s): Opicapone (OPC)
Intervention type(s): Drug
Intervention description(s): Test treatment: 25 mg or 50 mg of OPC hard capsule (new API source NF) Reference treatment: Ongentys® 25 mg or 50 mg of OPC hard capsule (current API source - AF).
Other intervention name(s): Ongentys; BIA 9-1067
Intervention MeSH terms: Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Investigate the Efficacy and Safety of DWJ1351
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetic characteristics of
      combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers
    

Detailed description: 
      The purpose of this study is to compare the safety and pharmacokinetic characteristics of
      combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male
      volunteers.
    

Intervention name(s): DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin); Sevikar and Crestor
Intervention type(s): Drug; Drug
Intervention description(s): DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) X 1 tablet followed by Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet (after washout period); Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period)
Other intervention name(s): DWJ1351; Amlodipine/Olmesartan and Rosuvastatin
Intervention MeSH terms: Amlodipine; Olmesartan; Olmesartan Medoxomil; Amlodipine Besylate, Olmesartan Medoxomil Drug Combination; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers (HV)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the safety, tolerability and pharmacokinetics of
      inhaled CHF 6001 after single and multiple doses in healthy volunteers.
    

Detailed description: 
      The study will be conducted in a single centre and will consist of a single dose part and a
      multiple dose part.

      Seven single doses of CHF 6001 will be administered according to an escalation, alternate
      cross over scheme. Five multiple doses of CHF 6001 will be administered for 7 days according
      to a sequential escalation scheme.
    

Intervention name(s): CHF 6001 SD or placebo; CHF 6001 MD or placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dry Powder Inhaler; Dry Powder Inhaler
Other intervention name(s): CHF 6001 DPI; CHF 6001 DPI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase I Study to Evaluate the Safety and Immunogenicity of Heterologous Boost Immunizations With MVA-CMDR
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are
      safe and whether they will boost immune responses generated by immunizations with a dendritic
      cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected
      volunteers.
    

Detailed description: 
      This trial will investigate whether immunizations with an MVA recombinant HIV vaccine are
      safe and whether they will boost immune responses generated by immunizations with a dendritic
      cell (DC) targeted protein vaccine, DCVax-001, plus poly ICLC in healthy HIV-uninfected
      volunteers. Investigators propose to assess the quality of immunity elicited by immunizations
      with MVA-CMDR only or by booster immunizations with MVA-CMDR in volunteers previously
      immunized with a DC-targeted HIV vaccine. This vaccination regimen can provide the
      proof-of-concept that DC targeted protein vaccines can prime strong immune responses and
      therefore be valuable in combination with other vaccine modalities against HIV or other
      diseases.
    

Intervention name(s): MVA-CMDR
Intervention type(s): Biological
Intervention description(s): injections of MVA-CMDR vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV Prevention
Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to investigate the pharmacokinetic (PK) and safety of M2951 (Bruton's tyrosine
      kinase [BTK] inhibitor) in participants with different degrees of hepatic impairment compared
      to participants with normal hepatic function.
    


Intervention name(s): M2951 (BTK inhibitor)
Intervention type(s): Drug
Intervention description(s): Participants will receive a single oral dose of M2951 (BTK inhibitor).
Other intervention name(s): Evobrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; Pharmacokinetics
Understanding Oxytocin's Neural and Behavioral Effects in Adolescents Diagnosed With Autism
Condition: Autism Spectrum Disorder; Oxytocin
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The investigators explored the neural and behavioral effect of oxytocin on youth with Autism
      spectrum disorder using magnetoencephalography (MEG). The investigators hypothesize that
      oxytocin will modulate neural activity to resemble patterns observed in the age-matched
      control group.

      Thirty-two adolescents with autism and 26 typically developing adolescents participated in
      this randomized, double-blind MEG study. Individuals with autism arrived at the lab twice and
      received an acute dose of intranasal oxytocin or placebo in each session. During the scans,
      participants were asked to complete several tasks related to social perception - such as
      identification of social and non-social stimuli.
    

Detailed description: 
      In the current study, the investigators aimed to explore oxytocin's influences on neural
      components that relate to social processing. Namely, we focused on M100, M170, and M250,
      which tend to show atypical patterns in individuals with autism.

      The investigators also examined the effects of oxytocin on time dynamics - the change in
      specific oscillation over time and its effects on neural connectivity patterns.
    

Intervention name(s): Oxytocin: Including placebo
Intervention type(s): Drug
Intervention description(s): Individual received age-dependent dosing of oxytocin and placebo. Participants aged 13-18 years received a dose of 24 IU (3 puffs to each nostril), and younger participants (aged 12 years) received 16 IU.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Youth with autism participated in a randomized, double-blind placebo-controlled trial. Participants visited the lab for two sessions. In one of the sessions, they received oxytocin, and in the other, they received the placebo. Intranasal doses of 40 international units of oxytocin (IU)/mL were prepared by the "Maayan-Haim" pharmacy, Israel. We used age-dependent dosing such that participants aged 13-18 years received a dose of 24 IU (3 puffs to each nostril), and younger participants (aged 12 years) received 16 IU. Typically-developing youth underwent the same experimental procedure but did not receive oxytocin or placebo due to ethical constraints in Israel.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Autism; MEG; Social perception
Sleep and Cytokines During Acute Diverticulitis
Condition: Acute Diverticulitis
MeSH terms: Diverticulitis
Study type: Observational

Summary: 
      The purpose of this study is to investigate sleep disturbances during Acute uncomplicated
      diverticulitis by polysomnography. The investigators hypothesis is the inflammation causes
      REM(rapid eye movement)-sleep reduction and this is correlated with plasma cytokine levels.
    

Detailed description: 
      An increasing number of experimental studies have showed that inflammation can induce
      disturbances in sleep architecture, mediated by cytokines. Sleep is important both in health
      and disease processes and can affect recovery, morbidity and mortality.

      Studies have been done on sleep disturbances after major and minor GI-surgery but never in
      relation to none surgical inflammatory diseases, namely acute diverticulitis.

      This study will investigate sleep architecture by Polysomnography and inflammation by levels
      of pro inflammatory cytokines in plasma.

      Following methods will be applied

      Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)

      Procedure: Plasma cytokines (IL-2, IL-6 and TNF(tumor necrosis factor-alfa)

      Procedure: Plasma CRP(C reactive protein) and leukocytes
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        16 x Acute uncomplicated diverticulitis (Hansen and stock stage 1) patients aged 18-75
        years managed by antibiotic treatment at Herlev Hospital.
      
Biospecimen description: 
      plasma
Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fasting Condition
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence,
      two-period, crossover pivotal study. The purpose of this study is to assess the
      bioequivalence between Test Product and the corresponding Reference Product under fasting
      condition in healthy, adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Etodolac Capsules USP 300 mg of Ipca Laboratories Limited, India and the corresponding
      Reference Product: Etodolac Capsules USP 300mg of Taro Pharmaceutical Industries Ltd., USA,
      under fasting condition in healthy, adult, human subjects in a randomized crossover study.

      The study was conducted with 36 healthy adult subjects. In each study period, a single 300 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 15 days including washout period of 12
      days between administrations of study drug in each study period.
    

Intervention name(s): Etodolac Capsules USP 300 mg; Etodolac
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg capsule once a day; 500 mg tablet once a day
Other intervention name(s): Test Product; Reference product
Intervention MeSH terms: Etodolac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I BP Interferon (IFN) Beta-001
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study aiming at:

        -  assessing the absolute bioavailability, pharmacokinetic profile, and dose
           proportionality of interferon beta-1a (HSA-free solution in pre-filled syringes) after
           i.v. and s.c. administration as well as the pharmacodynamic profile to create the link
           with available surrogate markers investigated with both formulations used clinically,
           lyophilisate with HSA (HSA+) and solution without HSA (HSA-);

        -  gathering further information on safety and tolerability of interferon beta-1a over dose
           range,including local and systemic tolerance, body temperature, vital signs, and a
           battery of exploratory sickness behavior tests.
    


Intervention name(s): Interferon beta-1a
Intervention type(s): Drug
Intervention description(s): 6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution
Other intervention name(s): Bioferon®
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
TRIP-Patch vs the Rigiscan
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      In men without erectile problems, night time erections occur during the REM-sleep. For this
      study the current diagnostic test, the Rigiscan is compared, with the data from the
      TRIP-Patch during the night. To validate discriminating sensor-readings between flaccid state
      and full rigidity of the penis. Eventually, to have a validated device, a patch in the size
      of a postage stamp, that easily measures erectile function at home. Furthermore the
      temperature on the outside of the thigh will be measured.
    

Detailed description: 
      Background of the study: Erectile dysfunction (ED) is defined as the persistent or recurrent
      inability to attain and maintain an erection sufficient to perform sexual activity. ED has an
      effect on physical and psychosocial well-being. The current diagnostic test, the Rigiscan to
      measure night time erections, has a lot of disadvantages.

      When an erection occurs and there is no inflow and outflow in the corpora cavernosa it is
      expected that the saturation will drop. As known with low flow priapism. From a study from
      Solnick, the mean skin temperature in younger male (19-33 years old) increases from 33,8°C to
      36.2°C during arousal. A penile oximeter and temperature sensor was developed, to measure
      saturation and temperature of the penis during the night. The TRIP-Patch (Transdermal
      Rigidity assessment via Ischemia of the Penis) is expected to continuously measure saturation
      levels in the corpora cavernosa by real time monitoring with a photodiodes and LEDs and the
      sensor has a temperature logger.

      Objective of the study: see above Study design: Observational study Study population: Healthy
      volunteers are asked to participate after informed consent. Age between 18 and 40 years. Both
      sensors and the Rigiscan will be placed at the same time, when 10 patients have night time
      erections with the Rigiscan, the study is complete.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Residents and medical students in the St Antonius Hospital and other volunteers
      
Keywords: Rigiscan; Nocturnal erection; Temperature; Saturation
Optimized Diagnostics for Improved Therapy Stratification in Invasive Fungal Infections
Condition: Systemic Mycosis
MeSH terms: Mycoses; Invasive Fungal Infections
Study type: Observational

Summary: 
      Invasive fungal infections (IFI) in immunocompromised patients pose a major challenge for
      diagnostics designed to permit timely onset of appropriate treatment. The aim of the current
      clinical-diagnostic studies, one in in pediatric and one in adult patients at high risk of
      IFI, is to test newly developed diagnostic approaches to invasive fungal infections in
      relation to established procedures. The studies will be performed in a prospective, blinded
      fashion, and represent a work package within the FUNGITECT grant supported by the European
      Commission. The studies will focus on analyses of blood-samples from patients with febrile
      neutropenia during treatment of acute leukaemia and other tumour entities, and patients
      undergoing allogeneic stem cell transplantation treated with intensive chemotherapy.
    

Detailed description: 
      Samples from immunosuppressed patients with febrile neutropenia (NP - defined as fever ≥
      38.5ºC and <500 ANC) will be taken:

        -  at the start of neutropenic fever

        -  after 24 hours

        -  after 48 hours

        -  before the start of antimycotic therapy, if pertinent

        -  at the end of antimycotic therapy, if pertinent

      The results ot analyses by a panfungal PCR screening assay developed at our institution
      (European patent No 1960536) and methods newly developed during the FUNGITECT project will be
      compared with conventional methods for fungal diagnostics such as HR (High Resolution)-CT,
      serological testing, histology and fungal culture. Additionally, genomic approaches will be
      employed to investigate host- and pathogen-related factors of susceptibility, pathogenicity
      and antimycotic resistance.
    

Intervention name(s): Peripheral blood sampling
Intervention type(s): Other
Intervention description(s): Peripheral blood samples will be taken at 3-5 defined timepoints during febrile neutropenia:
at the start of neutropenic fever
after 24 hours
after 48 hours
before the start of antimycotic therapy, if pertinent
at the end of antimycotic therapy, if pertinent
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Adult Patients between 18-90 years of age with high risk of invasive fungal infections
             (patients suffering from acute leukaemia and other tumour entities treated with
             intensive chemotherapy with neutropenic fever

          2. Pediatric patients between 0-18 years of age with high risk of invasive fungal
             infections ((patients suffering from acute leukaemia, patients undergoing allogeneic
             stem cell transplantation treated with intensive chemotherapy with neutropenic fever.
      
Biospecimen description: 
      Material that is not analyzed immediately will be stored until end of the study.
Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents
Condition: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, double-blinded, placebo-controlled, phase Ⅱb clinical trial of an
      inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co. ,
      Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine
      in healthy children and adolescents aged 3-17 years.
    

Detailed description: 
      This study is a randomized, double-blinded, placebo-controlled,phase Ⅱb clinical trial in
      children and adolescents aged 3-17 years. The experimental vaccine and placebo were both
      manufactured by Sinovac Life Sciences Co. , Ltd. A total of 500 subjects will be enrolled,
      including 100 children aged 3-5 years, 200 children aged 6-11 years and 200 adolescents aged
      12-17 years. Each age group will be randomly divided into two groups in a 3:1 ratio and
      received two doses of experimental vaccine or placebo on on day 0 and day 28.
    

Intervention name(s): SARS-CoV-2 Inactivated Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection; aluminium hydroxide solution only
Other intervention name(s): CoronaVac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Bioavailability of Potassium From Potatoes and Potassium Gluconate
Condition: Potassium Bioavailability; Blood Pressure
Study type: Interventional

Summary: 
      This study is designed to compare the effect of sources of potassium on uptake and the effect
      of potassium on blood pressure.
    

Detailed description: 
      The study will compare uptake of potassium from three different doses and sources;
      supplements (720, 1440 and 2160 mg) potatoes (720, 1440 and 2160 mg) or French fries (2160
      mg).

      During 9 phases, participants will consume a controlled diet with the supplements, potato or
      french fries (every other week for 5 days). On the 4th day, blood and urine samples will be
      taken to monitor potassium uptake and excretion. Measures of blood pressure will be analyzed
      at defined time points throughout the intervention.
    

Intervention name(s): Placebo control; Low dose potassium gluconate; Medium dose potassium gluconate; High dose potassium gluconate; Low dose potato; Medium dose potato; High dose potato; High dose French fries; Basal diet control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Potassium; Potato; French Fries; Bioavailability; Blood Pressure