bioihbjkbjnl/mcl2 huggingface dataset:
Pradaxa Tablet Proton Pump Inhibitor (PPI) Bioavailability (BA) Study in Japan
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the relative Bioavailability (BA) of
      tablet formulation of Dabigatran etexilate (DE) with and without co-administration of
      rabeprazole in healthy male subjects.

      The secondary objective is the evaluation and comparison of several pharmacokinetic
      parameters between the treatments.
    


Intervention name(s): Dabigatran Etexilate; Rabeprazol sodium
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, film coated; Tablet
Other intervention name(s): MICARDIS, PRITOR, TELMISARTAN
Intervention MeSH terms: Telmisartan; Dabigatran
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children
Condition: Colloid Osmotic Pressure
Study type: Observational

Summary: 
      The purpose of this study is to identify normal values of colloid osmotic pressure in
      interstitial fluid and plasma in healthy children between 2 and 10 years.
    

Detailed description: 
      Measurements of colloid osmotic pressure (COP) by sampling of interstitial fluid from
      subcutaneous tissue and plasma are well documented in animal models and human adult studies.
      COP plays a major role in transcapillary fluid balance and is valuable in fluid therapy
      planning in critically ill patients. There are no data regarding interstitial fluid COP
      values in neither sick nor healthy children. Sampling of interstitial fluid by the wick
      method in children who is under general anaesthesia (ear-nose-throat operations) gives the
      opportunity to identify normal COP values in this age group.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Secondary care clinic (ENT)
      
Biospecimen description: 
      Interstitial fluid and serum
    
Keywords: Colloid Osmotic pressure in interstitial fluid; Colloid Osmotic pressure in plasma; Protein fractions in interstitial fluid
Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) : Multi-centre, Prospective, Randomized Controlled Study
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Chinese medicinal herbs are effective and
      safe for treating novel influenza A (H1N1) infection.
    

Detailed description: 
      The antiviral agent, oseltamivir, is recommended by the World Health Organization (WHO) to
      treat recent outbreak novel influenza A (H1N1) virus infection around world. But limited
      stock and resistant strain emergence raised increasing concerns. Chinese medicinal herbs, are
      derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat
      the disease. The investigators performed RCT to indicate that Chinese medicinal herbs was
      effective and safe for treating novel influenza A (H1N1) infection.
    

Intervention name(s): oseltamivir; blank; chinese medicinal herbs; oseltamivir and chinese medicinal herbs
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): 75mg,bid,for 5 days; no antiviral therapy; 200ml,p.o,qid,for 5 days; oseltamivir:75mg,p.o,bid,for 5 days; chinese medicinal herbs:200ml,p.o,qid,for 5 days
Other intervention name(s): TamifluTM
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Novel Influenza A(H1N1); Oseltamivir; Chinese Medicinal Herbs
Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Thrombotic event is one of the most serious complications of coronary artery disease, which
      often result in myocardial infarction and even death. Even according to the standard
      guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic
      events, in high-risk patients, the proportion is higher, this phenomenon is called
      anti-platelet drug resistance in clinical practice

      The aim of this multicenter prospective, randomized, controlled study is to observed
      policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after
      Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and
      short-term prognosis to find new ways to the prevention of platelet aggregation .
    

Detailed description: 
      Thrombotic event is one of the most serious complications in coronary artery disease, which
      often result in myocardial infarction and even death. Even according to the standard
      guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic
      events, in high-risk patients, the proportion is higher, this phenomenon is called
      anti-platelet drug resistance in clinical practice
    

Intervention name(s): high maintenance clopidogrel; routine dual antiplatelet; policosanol plus dual antiplatelet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): clopidogrel 150 mg/d for 30 days followed by 75 mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；; clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；; aspirin 300 mg/d for 1 month followed by 100 mg/d chronically； clopidogrel 75 mg/d for at least 1 year policosanol 40mg/d for 6 months
Intervention MeSH terms: Clopidogrel; Policosanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: high on-treatment platelet reactivity; percutaneous coronary intervention; stent thrombosis
[11C]Yohimbine PET Study of alpha2-AR
Condition: Healthy Controls
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to model tissue specific kinetics of [11C]Yohimbine in
      healthy male participants by positron emission tomography (PET) and the appropriate arterial
      input function (part A) ; to determine the reproducibility of measures (classical test-retest
      study, part B1) and to measure the blocking of [11C]Yohimbine uptake in the brain following
      single oral dose administration of clonidine (part B2).
    


Intervention name(s): [11C]Yohimbine; [11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2)
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will receive an intravenous (IV) bolus injection of [11C]Yohimbine at a dose of 370 MegaBecquerel (MBq) ± 10% with concomitant arterial blood sampling. The distribution of [11C]Yohimbine in brain will be measured by dynamic PET scans obtained from the time of injection for up to 90 minutes along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics of [11C]Yohimbine.; Part B1 : Test Retest Variability will be assessed on percent difference in the binding potential following [11C]Yohimbine PET scan (IV bolus injection of [11C]Yohimbine at a dose of 370 MBq ± 10%) obtained at least 1 week after [11C]Yohimbine PET scan of part A.
Part B2 : Occupancy of alpha2-adrenergic receptors in brain by clonidine will be evaluated by comparing the binding potential of [11C]Yohimbine (IV bolus injection of [11C]Yohimbine at a dose of 370 MBq ± 10%) after single oral dose of clonidine (0,15mg) to the binding potential of [11C]Yohimbine obtained at baseline (part A).
Intervention MeSH terms: Clonidine; Yohimbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PET imaging; Noradrenaline; Radiotracer
Effects of C0-C1 Mobilization in the Neutral Position in Subjects With Upper Cervical Rotational Hypomobility
Condition: Upper Cervical Spine Rotational Hypomobility
Study type: Interventional
Phase: Phase 3

Summary: 
      C1-C2 is the most mobile segment of the spine and its dysfunction is frequently associated to
      cervical pain and headache. However, serious neurovascular adverse effects have been
      documented through direct treatment of C1-C2 segment. Although indirect treatment via
      adjacent segments and avoidance of end range of rotation and extension have been recommended
      for a safer and effective cervical treatment, there is no scientific evidence of the
      effectiveness of the indirect treatment approach in the cervical neutral position for C1-C2
      hypomobility.

      Due to that, the investigators designed a randomized controlled trial to compare the
      short-term effects in the Flexion Rotation Test (FRT) of a translatoric mobilization of
      C0-C1, a translatoric mobilization of C7-T1 and a control group in subjects with C1-C2
      hypomobility.The primary hypothesis is that C0-C1 dorsal glide mobilization applied in the
      neutral cervical position can recover the C1-C2 rotational range of movement in subjects with
      upper cervical hypomobility.
    


Intervention name(s): C0-C1 dorsal glide manual mobilization; C7-T1 ventral cranial glide manual mobilization
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: manual therapy; cervical; range of movement
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of this study is to determine if chronic pain subjects on around-the-clock
      opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely
      transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose
      without inducing opioid withdrawal or reversing analgesic effects.
    


Intervention name(s): Buprenorphine; Placebo film; Oxycodone; Morphine sulfate; Placebo capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Matching placebo buccal film; Oxycodone extended-release (ER) or immediate-release (IR) 5, 10, 15, 20, and 30 mg over-encapsulated oral tablets; Morphine sulfate 15, 30, and 60 mg ER or 15 and 30 mg IR over-encapsulated oral tablets; Oral placebo capsules matching the over-encapsulated morphine sulfate and oxycodone tablets
Other intervention name(s): Buprenorphine buccal film; Buprenorphine HCl buccal film; EN3409; BEMA Buprenorphine; BELBUCA; Placebo buccal film; BEMA placebo; Oxycodone tablets; OxyContin; Oxycodone IR; Morphine sulfate tablets; MS Contin; Morphine sulfate IR; Matching placebo capsules
Intervention MeSH terms: Morphine; Oxycodone; Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: ATC, Opioid, withdrawal, switch
Effect of Camel Milk on Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this
      study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon
      Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .
    

Detailed description: 
      The investigators enrolled 40 patients into the study. Group 1(Intervention ) : received
      PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg
      per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and
      ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily and 250 ml of raw camel milk will be
      consumed in 10 minutes orally twice daily for 12 weeks.

      Group 2 ( control ): received PEGASYS( Peginterferon ) One subcutaneous injection containing
      0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted
      dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12
      weeks.

      Follow up period is 1,2,3 months after treatment. The patients are visited every 4 weeks with
      biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid)
      on the first months after initiation of the treatment to assess early virologic response and
      at the end of the study for complete response rate and on the third month after treatment
      completion for sustained response rate. The patients with undetectable HCV RNA are considered
      as responders.
    

Intervention name(s): Peginterferon, Ribavirin, camel milk; Peginterferon, Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks .
camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.; Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks.
Other intervention name(s): PEGASYS® COPEGUS®. Dromedary milk (camel milk ); PEGASYS® (Peginterferon ) , COPEGUS® (Ribavirin)
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C ,Chronic Hepatitis C ,camel milk
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Condition: Restless Legs Syndrome (RLS)
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to assess the efficacy of once-daily oral administration of
      gabapentin enacarbil versus placebo, based on the change in International Restless Legs
      Syndrome Rating Scale (IRLS) score in participants with moderate-to-severe idiopathic
      restless legs syndrome. This study also assessed the safety of Gabapentin enacarbil.
    

Detailed description: 
      After 1 week run in period with single-blind placebo, participants meeting the inclusion and
      none of the exclusion criteria were randomized to receive double-blind treatment with either
      gabapentin enacarbil 600 mg or placebo for 12 weeks treatment period. After then,
      single-blind placebo was given for 1 week for follow-up observation.
    

Intervention name(s): Placebo; Gabapentin enacarbil
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Other intervention name(s): Regnite
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Restless Legs Syndrome; ASP8825; Gabapentin enacarbil
BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate
      the comparative reduction of Propionibacterium acnes in-vivo following once daily topical
      administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.
    

Detailed description: 
      The objective of this study is to evaluate the comparative reduction of Propionibacterium
      acnes (P. acnes) in-vivo following once daily topical administration of BPX-01 Minocycline 1%
      Topical Gel or BPX-01 Vehicle control Gel.

      A secondary objective is to assess the tolerance of the treatment regimen versus a vehicle
      control. Safety laboratory data (chemistry and hematology) and plasma levels of minocycline
      are also of significant interest to the sponsor.

      This is a single center, randomized, double blind, two-cell, vehicle controlled P. acnes
      study. All subjects will be randomized 2:1 to 1% BPX-01 or vehicle control to be applied as a
      topical gel once daily for four (4) weeks.

      This is a six (6) week study with a four (4) week treatment period and a two (2) week post
      treatment follow up visit. The clinical endpoint is in-vivo quantification of P.acnes. The
      safety/tolerance endpoints are; observer reported: erythema, scaling-peeling, edema, and
      subject reported: tightness, burning-stinging, and itching. Plasma levels of minocycline and
      basic hematology and chemistry laboratory values will be collected.
    

Intervention name(s): BPX-01, 1% Topical Gel; BPX-01 Vehicle Gel
Intervention type(s): Drug; Drug
Intervention description(s): topical gel, applied to the forehead, cheeks, nose and chin; topical gel, applied to the forehead, cheeks, nose and chin
Other intervention name(s): BPX-01 Topical Gel; BPX-01 Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pivotal Study of the Bioequivalence of Oral Viagra® and a Test Sublingual Sildenafil Wafer
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      A comparative bioequivalence study in 48 healthy male volunteers of oral Viagra and a test
      sublingual sildenafil wafer.
    

Detailed description: 
      Healthy volunteers will complete two inpatient study periods and receive either sublingual
      wafer sildenafil or oral sildenafil. Plasma samples and adverse events will be collected.
    

Intervention name(s): Sublingual Sildenafil; Oral Sildenafil
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg sildenafil sublingual wafer.; 50 mg oral sildenafil (Viagra)
Other intervention name(s): Pheonix; Viagra
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
Condition: Non-infectious Anterior Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, multi-center, investigator masked, comparator controlled study. The
      purpose of this study is to determine the efficacy and safety of NS2 in patients with
      non-infectious acute anterior uveitis. Subjects will be randomized 1:1:1 to receive multiple
      doses of NS2 0.5%, NS2 0.5% and Pred Forte® 1%, or Pred Forte® 1%.

      Free aldehydes are thought to be related to inflammatory diseases such as uveitis. NS2, a
      small molecule aldehyde trap, may decrease inflammation by lowering aldehyde levels.
    


Intervention name(s): NS2; Prednisolone acetate ophthalmic suspension (1%)
Intervention type(s): Drug; Drug
Intervention description(s): NS2 ophthalmic drops (0.5%)
Other intervention name(s): Pred Forte
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: uveitis; acute uveitis; anterior uveitis; NS2; Aldeyra; prednisolone acetate
Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and
      the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of
      the World Trade Center (WTC) attacks.
    

Detailed description: 
      Selective serotonin reuptake inhibitor (SSRI) medication is often recommended in combination
      with cognitive behavioral therapies for PTSD, but combined initial treatment of PTSD has not
      been studied under controlled conditions. Also, there are few studies of either treatment in
      survivors of terrorism. This randomized controlled trial evaluates efficacy of combined
      prolonged exposure (PE) and the SSRI paroxetine in the treatment of survivors of the World
      Trade Center (WTC) attacks.
    

Intervention name(s): Paroxetine; Prolonged Exposure Therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks; Weekly for 10 weeks
Other intervention name(s): Paxil controlled release (CR); Cognitive Behavioral Therapy
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; anxiety disorders; trauma