bioihbjkbjnl/mcl2 huggingface dataset:
Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      In recent years, there has been increased focus on cognitive side effects of sleep-inducing
      medications that may contribute to unusual behavior during unexpected awakenings during the
      night. Concerns regarding these side effects have led to a class Food and Drug Administration
      (FDA) warning for all sleep-inducing medications. Almorexant is an experimental
      sleep-inducing medication in a new class of medications that is being extensively developed
      by multiple pharmaceutical companies. Medications in this class block wake/arousal centers in
      the brain that function with proteins called hypocretins. The goal of this study is to
      evaluate the impact on cognitive performance of almorexant vs. zolpidem (an approved sleep
      aid) or placebo.
    

Detailed description: 
      Up to 216 healthy volunteers will be enrolled to participate in the 10 day study. After
      screening procedures have been completed (at SFVAMC), Days 1 - 7 will take place in subjects'
      homes, where their sleep/wake activity will be monitored. Days 8 - 10 will take place at
      Moffitt Hospital. On Day 10, subjects will take one dose of either almorexant 100mg,
      almorexant 200mg, zolpidem 10mg, or placebo. Cognitive tests will be administered to subjects
      throughout Day 10. Subjects will return for follow-up safety labs within 5 - 12 days of
      dosing with study medication. Based on animal studies, it is anticipated that subjects who
      take almorexant will be less cognitively impaired than those who take zolpidem.
    

Intervention name(s): Almorexant; Almorexant; Zolpidem 10mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100mg; 200mg; 10mg; One-time dose of Placebo
Other intervention name(s): Ambien
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Sleep Aid
Study of the Safety, Tolerability and Efficacy of BCT194 in Healthy Volunteers and Patients With Psoriasis.
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the local tolerability of a single topical
      administration of BCT194 in healthy volunteers and, potentially, to evaluate the safety,
      tolerability, and efficacy of a multiple topical administrations in patients with psoriasis.
    


Intervention name(s): BCT194
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Safety, tolerability, pharmacodynamics, single administration, BCT194, healthy volunteers, psoriasis
Sickness Absence Versus Physical, Mental, and Job-related Factors in Patients With Chronic Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease; Asthma
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      People with chronic respiratory disease have shortened work life, their disease is associated
      with greater work disability and they are at greater risk of being unemployed. Lower
      employment rates and higher sickness absence is expensive for the community and leads to
      financial as well as social consequences for the individual.

      There is a lack of data on factors that can predict sickness absence and disability in
      patients with pulmonary disease. We therefore want to study a group of people with COPD and
      asthma referred to our clinic. The study will investigate relationships between sickness
      absence and exercise capacity, job-related factors, disease severity, self-efficacy, health
      related quality of life and subjective health complaints.
    


Intervention name(s): Vocational pulmonary rehabilitation
Intervention type(s): Other
Intervention description(s): Multidisciplinary pulmonary rehabilitation with emphasis on vocational issues
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects
      when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6
      multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.
    


Intervention name(s): AZD1446; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution, oral single and multiple dose; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: MAD; NNR; to investigate safety and tolerability in a multiple ascending dose study in Healthy subjects; AZD1446
Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly HCV Cirrhotic Patients
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The proportion of HCV infected patients over age 65 years in Western countries is increasing.
      This growth and the advent of new antiviral therapy bring into the question the real world
      efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV) plus a flat
      dose of ribavirin (RBV) in elderly patients compared to younger patients.
    

Detailed description: 
      The proportion of HCV infected patients over age 65 years in Western countries is increasing.
      This growth and the advent of new antiviral therapy bring into the question the real world
      efficacy and safety of the combination of Sofosbuvir and Simeprevir (SOF/SMV) plus a flat
      dose of ribavirin (RBV) in elderly patients (Group II) compared to younger patients (Group I)
      Multicenter, real world investigation study of once daily treatment with SOF 400 mg + SMV 150
      mg with a flat dose of RBV 800 mg/day for a duration of 12 weeks in treatment naïve or
      experienced HCV genotype 1-infected patients with compensated cirrhosis.To evaluate efficacy,
      tollerability and safety of SOF/SMV/RBV in two different Group of patients.
    

Intervention name(s): Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks
Intervention type(s): Drug
Intervention description(s): Sofosbuvir 400 mg/day/Simeprevir 150 mg/day /Ribavirin 800/day for 12 weeks
Other intervention name(s): Sovaldi Olysio Copegus
Intervention MeSH terms: Ribavirin; Sofosbuvir; Simeprevir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Functional Impact of Adenotonsilectomy
Condition: Apnea, Obstructive; Tonsillitis; Tonsillar Hypertrophy; Respiratory Function Impaired; Infections; ENT Disorder
MeSH terms: Tonsillitis; Sleep Apnea, Obstructive; Respiratory Insufficiency; Hypertrophy
Study type: Observational

Summary: 
      Spirometric assessment of respiratory function before and after adenotonsillectomy surgery
    

Detailed description: 
      Spirometric assessment of respiratory function before and after adenotonsillectomy surgery
      Study site at CHUPorto: Department of Otorhinolaryngology at CHUPorto, Portugal.

      Study design: Institutional, observational, cohort, prospective. Classification of studies
      according to the law of clinical investigation (Dec. Law No. 21/2014): Clinical study without
      intervention. Main objective of the study: To collect a database referring to pediatric
      patients enrolled for surgery in an outpatient setting, in order to compare vital,
      spirometric and clinical parameters at two different times: pre and post surgical
      intervention.

      Secondary objectives of the study: Based on validated indices, to assess the impact of
      surgical intervention on the child's respiratory and cardiovascular system. Participants:
      Patients undergoing surgery in the field of Pediatric Otorhinolaryngology at CHUPorto, a
      tertiary referral Hospital in Portugal.
    

Intervention name(s): Adenotonsillectomy
Intervention type(s): Procedure
Intervention description(s): adenotonsillectomy by cold dissection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing surgery within the scope of Pediatric Otorhinolaryngology at CHUPorto.
      
Keywords: adenotonsillectomy; children; spirometry; obstructive sleep apnea; adenotonsillar hypertrophy; respiratory function
Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of duloxetine on improvement of brain
      cortical activity in patients suffering from major depressive disorder using near infrared
      spectroscopy.
    


Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): duloxetine 30 to 60 mg tablets by mouth, QD to BID per day,
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: near infrared spectroscopy, NIRS, duloxetine
Prospective Single Center Open Label Study of Shoulder OA Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into
      the shoulder for pain in mild to moderate patients
    

Detailed description: 
      Subjects 19-85 years old will receive a single intra-articular (IA) injection of DUROLANE®
      3mL given for the relief of pain in the treatment of symptomatic osteoarthritis (OA) of the
      shoulder followed over a 26-week time period.
    

Intervention name(s): Durolane
Intervention type(s): Device
Intervention description(s): single injection of 3ml
Other intervention name(s): Hyaluronic Acid
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: degenerative arthritis
A Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interaction and Safety/Tolerability Between RLD2202 and RLD2203
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetic/pharmacodynamic drug-drug
      interactions and safety/tolerability between RLD2202 and RLD2203 in healthy adult subjects
    


Intervention name(s): RLD2202; RLD2203
Intervention type(s): Drug; Drug
Intervention description(s): Take it once a day per period; Take it once a day per period
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Myopia Control With Orthokeratology Contact Lenses in Spain
Condition: Myopia, Progressive; Children, Only; Contact Lens Complication; Perception, Self; Axial Myopia
MeSH terms: Myopia; Myopia, Degenerative
Study type: Interventional

Summary: 
      The purpose of this prospective study is to assess the efficacy, safety and patient-reported
      outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression
      in children.
    

Detailed description: 
      The purpose of this prospective study is to assess the efficacy, safety and patient-reported
      outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression
      in children in comparison with a group of distance, single-vision glasses over a 2-year
      period. Efficacy was evaluated by assessing differences in the axial length between groups.
      Safety was evaluated by comparing the incidence of adverse events between groups. Differences
      between groups in patient-reported outcomes were evaluated using a questionnaire that
      assessed vision-related quality-of-life measures.
    

Intervention name(s): Menicon Z Night; Control
Intervention type(s): Device; Device
Intervention description(s): To assess the use of Menicon Z Night contact lenses for reducing myopia progression in children; Distance, single-vision glasses were used as control
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, controlled, longitudinal
Masking: None (Open Label)
Primary purpose: Treatment
Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
MeSH terms: Fatty Liver; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Sphingolipids are associated with metabolic diseases. Distribution of plasma sphingolipids in
      type 1 and type 2 diabetes has never been studied. The objective of the CERADIAB study is to
      compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.
    

Detailed description: 
      Sphingolipids represent a major class of lipids that are structural and signaling molecules.
      Major bioactive sphingolipids include ceramide, dihydroceramide, sphingosine,
      sphingosine-1-phosphate and sphingomyelin.

      Sphingoliplids are involved in development of various chronic metabolic diseases. Some
      ceramides species are implicated in pancreatic β-cell apoptosis and in insulin resistance in
      muscle, fat and liver. Some studies have shown association between inhibition of ceramide
      synthesis, insulin sensibility and lower hepatic steatosis. The deposition of hepatic lipids,
      especially triacylglycerol, defines the development of hepatic steatosis. However,
      sphingolipids appear to play an important role in non-alcoholic fatty liver disease (NAFLD)
      and in its progression. Changes in plasma shingolipids concentrations may also contribute to
      the pathogenesis in cardiovascular disease and atherosclerosis. Distribution of plasma
      sphingolipids concentrations in type 1 and type 2 diabetes has poorly been studied.

      The objective of the CERADIAB study is to compare plasma sphingoliplids concentrations in
      type 1 and type 2 diabetic patients.
    

Intervention name(s): dosing of sphingolipids
Intervention type(s): Other
Intervention description(s): - Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients suffering of diabetes type 1 or type 2.
      
Biospecimen description: 
      plasma samples and dosing of Sphingolipids
    
Keywords: sphingolipids; hepatic steatosis; non-alcoholic fatty liver disease; macrovascular complications; insulin resistance; microvasclar complications; NAFLD
A Study of Acalabrutinib Suspension to Evaluate Relative Bioavailability and Proton-pump Inhibitor Effect in Healthy Volunteers
Condition: Pharmacokinetics; Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to support the clinical development of acalabrutinib in
      patients who are unable to swallow capsule and require nasogastric (NG) tube placement.
    

Detailed description: 
      This is an open-label, single-center, randomized, 3-period, crossover study of acalabrutinib
      suspension administered via NG tube in healthy subjects to evaluate the relative
      bioavailability and proton-pump inhibitor (rabeprazole) effect.

      The study is divided in 3 periods.

      Period 1 of the study is designed to investigate the effect of proton-pump inhibitor on the
      pharmacokinetics (PK) of acalabrutinib suspension. Period 2 and 3 of the study are designed
      to investigate the bioavailability of acalabrutinib suspension relative to an oral capsule
      formulation.
    

Intervention name(s): Acalabrutinib Treatment A; Acalabrutinib Treatment B; Acalabrutinib Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions. A single dose of 20 mg rabeprazole will be administered with 240 mL water, 2 hours prior to administration of acalabrutinib suspension. Treatment with rabeprazole 20 mg twice daily (with meals) will be started 3 days prior to the receiving the first dose of acalabrutinib suspension.; Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions.; Participants will receive a single dose of 100-mg acalabrutinib capsule, under fasted conditions. The acalabrutinib capsule will be administered with 240 mL of water.
Intervention MeSH terms: Acalabrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Calquence; Acalabrutinib
Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this clinical study is to compare the pharmacokinetic parameters of 3000 IU
      Advate using one 3000 IU potency vial dissolved in 5 mL diluent with that of 3000 IU Advate
      using two vials of 1500 IU potency dissolved in 5 mL diluent each (administered in 10 mL
      diluent in total) in previously treated patients with severe hemophilia A (factor VIII level
      < 1%).
    


Intervention name(s): Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]
Intervention type(s): Biological
Intervention description(s): Participants will receive 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence
Other intervention name(s): ADVATE; Antihemophilic Factor (Recombinant)- Plasma/albumin free method (rAHF-PFM)
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Human Trial to Evaluate the Effects of Chungkookjang on Histamine-induced Wheal Size in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators investigate the effect of Chungkookjang on histamine-induced skin reaction
      in a double-blind, randomized, placebo-controlled, human trial
    

Detailed description: 
      Sixty volunteers (aged 20-80) who gave a written consent before entering the study, were
      randomized in two groups of thirty subjects each. The skin prick test with histamine was
      performed on the ventral forearm, 10 cm from the elbow, before and after supplement
      administration, as well as three times daily for 12 weeks of chungkookjang(35g/day) or
      placebo(35g/day)intake.
    

Intervention name(s): Chungkookjang; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Chungkookjang(35g/say)for 12 weeks; Placebo(35g/day) for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Chungkookjang; histamine; skin reaction; wheal
Dexmedetomidine Versus Propofol for Prolonged Sedation in Poly Traumatized Mechanically Ventilated Patients
Condition: Trauma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Dexmedetomidine, a central and peripheral α2-receptor agonist distinct from GABA receptor for
      benzodiazepines and propofol, has been approved by the US Food and Drug Administration only
      for use up to 24 h in mechanically ventilated patients. The investigators aim to compare
      dexmedetomidine with propofol for sedation >24h in poly traumatized mechanically ventilated
      patients.
    

Detailed description: 
      The importance of optimizing the levels of sedation in critical care has been increasingly
      recognized. Many intensive care experts are focusing on maintaining a targeted ''ideal''
      sedation level according to the individual patient's condition to avoid adverse events such
      as prolonged mechanical ventilation, respiratory depression, pneumonia, delirium,
      psychological problems, and increased treatment costs resulting from over sedation.
      Dexmedetomidine is a selective alpha-2-adrenoceptor agonist. It exerts both sedative and
      analgesic effects via mechanisms different from other sedatives such as midazolam and
      propofol, and provides sedation characterized by prompt response to stimuli with no
      respiratory depression. The investigators aim to compare dexmedetomidine with propofol for
      sedation >24h in poly traumatized mechanically ventilated patients. The investigators will
      perform a prospective, single center trial to investigate the safety and efficacy of
      dexmedetomidine for long-term sedation in poly traumatized mechanically ventilated ICU
      patients, in comparison with propofol.
    

Intervention name(s): Dexmedetomidine; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine sedation at a starting dose of 0.2-7.0 µg/kg/hour.; Propofol sedation at a starting dose of 10-70 µg/kg/hour.
Other intervention name(s): Precedex; Deprivan
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment