bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Investigation of UDCA in Bile and Serum
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bile acid composition of cystic bile and serum pharmaco¬kinetics after a 3-week
      treatment with UDCA and to correlate pharmacokinetic parameters of UDCA in bile and serum
      during steady state.
    

Detailed description: 
      see protocol
    

Intervention name(s): UDCA
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: PK analysis
Efficacy and Safety Study of Combination Therapy to Treat Uncomplicated Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of 3 combinations of
      naltrexone and bupropion SR compared to naltrexone alone, bupropion SR alone or placebo.
    

Detailed description: 
      A completed proof of concept study, OT-101 (Data on File, Orexigen Therapeutics, 2005),
      demonstrated that a combination of 300 mg bupropion SR and 50 mg naltrexone was associated
      with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects
      with uncomplicated obesity.

      The hypothesis for the current trial is that by adjusting the doses and titration schedules
      of bupropion SR and naltrexone greater efficacy and improved tolerability can be achieved. In
      this trial, a higher dose of bupropion and 2 lower doses of naltrexone than utilized in the
      previous trial (OT-101) will be evaluated. The doses of both drugs will be titrated over 4
      weeks and administered twice a day. There are 2 cohorts. At each site, cohort 2 recruitment
      began as soon as cohort 1 enrollment was completed. Cohort 1 treatment groups are (60 per
      group):

        -  Group 1: Bupropion SR (400 mg/day) plus Naltrexone (48 mg/day)

        -  Group 2: Bupropion SR (400 mg/day) plus Naltrexone (16 mg/day)

        -  Group 3: Bupropion SR (400 mg/day) plus N-Placebo

        -  Group 4: B-placebo plus Naltrexone (48 mg/day)

        -  Group 5: B-Placebo plus N-Placebo

      Cohort treatment 2 Groups are:

        -  Group 6: B-Placebo plus N-Placebo (n=20)

        -  Group 7: Bupropion SR (400 mg/day) plus Naltrexone (32 mg/day)(n=60)
    

Intervention name(s): naltrexone and bupropion SR
Intervention type(s): Drug
Intervention description(s): naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity
BPN14770 Single Ascending Dose Study in Healthy Male and Female Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized double-blind (investigator and subject blinded), placebo controlled
      ascending single dose study to evaluate the safety, tolerability, and pharmacokinetic profile
      of BPN14770 in healthy male and female subjects. Each subject will be randomized to receive
      either a single dose of BPN14770 or placebo.
    

Detailed description: 
      Objectives:

        1. To evaluate the safety and tolerability profile of single oral ascending dose levels of
           BPN14770 in healthy subjects.

        2. To characterize the BPN14770 plasma pharmacokinetic profile following oral
           administration.
    

Intervention name(s): BPN14770; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BPN14770 is an investigational new drug being developed for the treatment of Alzheimer's disease and other cognitive disorders. BPN14770 is a small molecule, subtype selective, negative allosteric modulator of phosphodiesterase 4D.
Intervention MeSH terms: BPN14770
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture
Condition: Leukemia; Non Hodgkin Lymphoma
MeSH terms: Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomised controlled study the investigators intended to compare the analgesic
      effects of EMLA and\or nitrous oxide in children submitted to lumbar puncture.
    

Detailed description: 
      It is a randomized controlled clinical trial, double blinded, with the purpose to compare the
      use of EMLA - local anesthetic (lidocaine and prilocaine), and or nitrous oxide at 50% in
      oxygen (Livopan®) to prevent and treat pain in pediatric patients aged four to 16 years old
      submitted to lumbar puncture for intrathecal chemotherapy. Pain was assessed using the Wong
      Baker faces scale and the visual numeric scale during six observational periods: baseline;
      three minutes after gas administration and before the first attempt of lumbar puncture;
      during the first lumbar puncture attempt; during the chemotherapy administration; during
      needle remove and three minutes after gas interruption. All the studied procedures will have
      clinical indication and will not be held by the researcher. The children was random divided
      within three groups A, B and C as follow: Group A (n=16)EMLA + Livopan; Group B (n=19)EMLA +
      gas placebo (oxygen); Group C (n=17) Livopan® + placebo cream.

      Primary outcome was the detection of a difference of 20% or more in the visual numeric scale
      between the three treatment groups during the first attempt of lumbar puncture.
    

Intervention name(s): Livopan; Livopan; EMLA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhalation of oxygen and nitrous oxide 50%; equimolar mixture of N2O/O2; Lidocaine-prilocain cream
Other intervention name(s): equimolar mixture of nitrous oxide/oxygen; equimolar mixture of nitrous oxide/oxygen; Eutetic mixture of local anesthetics lidocaine/prilocaine
Intervention MeSH terms: Lidocaine; Nitrous Oxide; Anesthetics, Local; Prilocaine; Lidocaine, Prilocaine Drug Combination; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: lumbar punction; myelogram; pain assessment; nitrous oxide and EMLA; Leukemia and non Hodgkin lymphoma
Sinecort Pilot Efficacy Study
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The study shall prove whether treatment of atopic dermatitis is equally effective with
      Sinecort cream as compared to standard therapy (Hydrocortisone cream).
    


Intervention name(s): Sinecort cream; Hydrocortison cream; Untreated skin
Intervention type(s): Device; Drug; Other
Intervention description(s): Application over 29 days; Application over 29 days
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Sinecort; Hydrocortison; Mild atopic dermatitis; Efficacy, safety
Protein Supplementation and Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This randomized control trial of diet with protein supplementation is being conducted to test
      the hypothesis that in overweight/obese subjects high protein diet may lead to weight loss
      and improvement in cardio-metabolic profile.
    


Intervention name(s): herbalife protein shake
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia
Condition: Behavioral and Psychological Symptoms in Alzheimer's Disease; Behavioral and Psychological Symptoms in Vascular Dementia
MeSH terms: Alzheimer Disease; Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 2

Summary: 
      The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral
      and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA activation
      is critical for learning and memory. Individuals with Alzheimer's disease (AD) have fewer
      NMDA receptors in the frontal cortex and hippocampus than controls. This study is a
      randomized, double-blind, placebo-controlled drug trial. All patients will be allocated
      randomly to two groups: (1) NMDA enhancer: DAOIB (starting dosage: 250-500 mg/day), (2)
      placebo, for 6 weeks. The investigators hypothesize that DAOIB may yield better efficacy than
      placebo for cognitive function and clinical symptoms in patients with BPSD.
    


Intervention name(s): DAOIB; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks; Intervention drug: placebo by mouth. Duration: 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline
      ester chloride) ophthalmic solution on near visual function in presbyopic subjects.
    

Detailed description: 
      This was a multi-center, double-masked, placebo-controlled, randomized, parallel-group study.
      The total duration of the study was approximately 3 months. Approximately 120 presbyopic
      subjects were to be enrolled into the study.

      Presbyopic subjects aged 45 to 55 years were the primary age group in this study.

      Screening and Baseline: Subjects were screened for eligibility followed by a baseline visit
      after which they were randomized to receive either UNR844-Cl (1.5%, equivalent to 1.3%
      freebase) or Placebo, dosed one drop in each eye twice daily, for 3 months.

      Randomized subjects attended the following study visits after baseline: at Week 2, Month 1,
      Month 2 and Month 3.

      The primary objective of this study was to assess the efficacy of UNR844-Cl on binocular
      distance corrected near visual acuity (DCNVA) in presbyopic subjects aged 45 to 55 years with
      the primary endpoint being the change from baseline in binocular DCNVA in subjects aged 45 to
      55 years at Month 3 after UNR844-Cl or Placebo treatment.

      There were two secondary endpoints:

        1. To assess the efficacy of UNR844-Cl on achieving 75 or more Early Treatment Diabetic
           Retinopathy Study (ETDRS) letters in binocular DCNVA in presbyopic subjects aged 45 to
           55 years with endpoint being the proportion of subjects aged 45 to 55 years achieving 75
           or more ETDRS letters in binocular DCNVA at Month 3 after UNR844-Cl or Placebo
           treatment.

        2. To assess the safety of UNR844-Cl in presbyopic subjects by the frequency of treatment
           emergent adverse events (AEs) and treatment emergent serious adverse events (SAEs) in
           all subjects after UNR844-Cl or Placebo treatment.
    

Intervention name(s): UNR844-Cl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.5% Ophthalmic solution for topical ocular administration; placebo
Other intervention name(s): Lipoic acid choline ester chloride, EV06; Vehicle
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Presbyopia, adults, randomized study, placebo
Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD
      in children and adolescents (aged 6-17 years). The primary objective of this study is to
      evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in
      the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.
    


Intervention name(s): SHP465; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12.5mg and 25mg capsules (one capsule daily); Matching placebo capsule that appear identical in size, weight, shape, color
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Biomarker Analysis in Post-COVID Patients
Condition: Post-COVID-19 Syndrome
Study type: Observational

Summary: 
      Headache is one of the most common neurological manifestations of COVID-19. However, it is
      unclear whether chronic headache after the initial diagnosis, is associated with ongoing
      damage of the central nervous system. We investigate cpost-COVID-19 patients with persistent
      headache lasting longer than 3 weeks, to hospitalized acute COVID-19 patients with
      neurological symptoms and to other non-COVID-19 disease-controls. Readout are neurologial and
      glial biomarkers in CSF.
    

Detailed description: 
      Measurements of neuronal and glial markers in CSF were performed on a SIMOA analyzer
      (Quanterix) using the Neurology 4-Plex A (Nf-L, Tau, GFAP, UCH-L1) kit.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        General population
      
Biospecimen description: 
      CSF
    
Keywords: persistent headache
Yoga for Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit
      of a hatha yoga intervention for patients with irritable bowel syndrome (IBS) compared to
      nutrition counselling. Further, the potential of both interventions to influence the gut
      microbiome will be inquired.
    


Intervention name(s): Yoga; Nutrition Counselling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation; Evidence-based Nutrition Counselling, 3 appointments within 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Antisepsis Regimen in the Surgical Treatment of Human Papilloma Virus Generated Cervical Lesions: Polyhexamethylene Biguanide Versus Chlorhexidine
Condition: Antisepsis Regimen After Surgical Treatment of HPV Infected Lesions
Study type: Interventional
Phase: Phase 4

Summary: 
      Treatments for the macroscopic or pathologic lesions caused by HPV infection can be
      classified as topical, surgical, destructive, or immunomodulatory. Post surgical treatments
      generally consist of analgesic, anti-inflammatory and topical antimicrobial agents to reduce
      the risk of local infections.

      The aim of this study is to compare the efficacy and safety of polyhexamethylene
      biguanide-based vaginal suppositories to a similar chlorhexidine-based treatment, in the post
      recovery regimen after surgical treatment of cervical lesions.

      Women who underwent to CO2 laser therapy for cervical lesions are randomly assigned to
      receive 10 days of antiseptic treatment with chlorhexidine digluconate vaginal suppositories,
      or polyhexamethylene biguanide vaginal suppositories (Monogin® / BiguanelleTM vaginal
      suppositories, Lo.Li.Pharma, Italy). A weekly follow-up check was performed for 6 weeks.
    


Intervention name(s): Chlorhexidine vaginal suppositories; Polyhexamethylene biguanide vaginal suppositories
Intervention type(s): Device; Device
Intervention MeSH terms: Biguanides; Chlorhexidine; Polihexanide
Keywords: Laser therapy; Cervical lesions; Polyhexamethylene biguanide; Chlorhexidine
Whole Muscle Exercise Training (WHOLEi+12) in Pulmonary Hypertension
Condition: Exercise Therapy
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional

Summary: 
      The purpose of this RCT is to study the effects of whole muscle training (inspiratory muscle
      training + aerobic training + muscle resistance training) on muscle power, VO2peak and
      gas-exchange variables obtained during cardiopulmonary exercise testing, QoL, functional
      capacity (eg, 6-min walking distance), and maximal inspiratory pressure in patients with
      pulmonary artery hypertension.
    


Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): Exercise training for 8 weeks (aerobic exercise, resistance training and inspiratory muscle training thrice a week)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection
Condition: Musculoskeletal Diseases
MeSH terms: Bacterial Infections; Musculoskeletal Diseases
Study type: Observational

Summary: 
      The purpose of this study is to assess the long-term safety of levofloxacin administered to
      children as therapy for acute bacterial infection.
    

Detailed description: 
      This is a prospective (look forward using periodic observations collected predominantly
      following participant enrollment), long-term, comparative, multicenter, observational study
      (study in which the investigators/physicians observe the participants and measure their
      outcomes) to monitor long-term the incidence of musculoskeletal (MS) disorders in children
      who have received levofloxacin or a standard therapy for acute bacterial infection.
      Approximately 2500 participants who were enrolled in prior Phase 3 clinical studies of the
      use of levofloxacin for the treatment of acute infectious disease will be observed in this
      study. The study consists of 3 phases: a screening phase; a surveillance phase; and a
      musculoskeletal disorder follow-up phase. Safety evaluations will include assessment of an
      overall incidence of musculoskeletal disorders that occur during the first 60 days after the
      first dose of anti-microbial therapy. The specific musculoskeletal disorders to be reported
      are: tendinopathy (inflammation or rupture of a tendon); arthritis (inflammation of a joint
      as shown by redness or swelling); arthralgia (pain in a joint); gait abnormality (limping or
      refusal to walk). Other assessments of safety will include interviews using standardized
      questionnaires to assess the occurrence of musculoskeletal adverse events, physical
      examinations, and measurement of participants height over the course of 1 year.
    

Intervention name(s): No intervention
Intervention type(s): Drug
Intervention description(s): This is an observational study. Participants rceiving dosing regimen from the respective Phase 3 levofloxacin clinical studies will be observed in this study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children who have received levofloxacin or a standard non-fluoroquinone therapy for acute
        bacterial infection in one of the Phase 3 interventional studies will be enrolled in this
        study.
      
Keywords: Musculoskeletal Diseases; Musculoskeletal Disorders; Childhood Disease; Bone Diseases; Joint Diseases; Levofloxacin; Quinolones; Bacterial infections
Early Treatment of Cytokine Storm Syndrome in Covid-19
Condition: Cytokine Storm; COVID-19
MeSH terms: COVID-19; Cytokine Release Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This proposal addresses the problem of preventing the very high mortality and morbidity
      associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory
      failure in Covid-19 infection.
    

Detailed description: 
      The first aim of this project is to determine whether rapidly assayed early clinical
      laboratory markers of CSS (eCSS: leucopenia, lymphopenia, and elevated ferritin, d-dimer,
      LDH, CRP, and AST/ALT) in patients admitted to the hospital with respiratory compromise in
      the setting of Covid-19 infection can accurately identify patients with CSS as defined by
      validated CSS case definitions (H-Score, aHLH-2004). Confirmation of eCSS predictive of
      evolving CSS will identify patients at risk for rapid deterioration of lung function and
      inform early initiation of treatment for CSS. Genotyping studies will also be performed on
      patients with confirmed CSS to determine whether perforin pathway mutations commonly present
      in CSS associated with other disorders are present. The second aim is to determine whether
      early treatment with rhIL-1Ra (anakinra) in patients admitted to the hospital with markers of
      CSS improves or prevents deterioration of respiratory dysfunction and prevents the
      development of respiratory failure requiring mechanical ventilation.
    

Intervention name(s): Anakinra; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): The active treatment group will receive anakinra 100 mg subcutaneously every 6-12 hours for a period of 10 days; The control group will receive normal saline placebo subcutaneously every 6-12 hours for period of 10 days
Other intervention name(s): recombinant human IL-ra (rhIL-1ra); NS
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two parallel treatment arms
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment