bioihbjkbjnl/mcl2 huggingface dataset:
Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the effects of co-administration of SPD489 and the antidepressant
      EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In
      addition, serial blood pressure and pulse measures will be obtained and examined to ensure
      that there are no unexpected changes in vital signs following co administration of SPD489 and
      EFFEXOR XR that would impact the further study of this drug combination. The hypothesis is
      that a drug drug interaction could possibly exist.
    


Intervention name(s): LDX + Venlafaxine XR; Venlafaxine XR + LDX
Intervention type(s): Drug; Drug
Intervention description(s): Day 1-5 LDX 30mg
Day 6-10 LDX 50mg
Day 11-15 LDX 70mg
Day 16-20 LDX 70mg and Venlafaxine XR 75mg daily
Day 21-25 LDX 70mg and Venlafaxine XR 150mg daily
Day 26-30 LDX 70mg and Venlafaxine XR 225mg daily
Day 31-34 Venlafaxine XR 150mg daily
Day 35-38 Venlafaxine XR 75mg daily.; Day 1-5 Venlafaxine XR 75mg
Day 6-10 Venlafaxine XR 150mg
Day 11-15 Venlafaxine XR 225mg
Day 16-20 Venlafaxine XR 225mg and LDX 30mg daily
Day 21-25 Venlafaxine XR and LDX 50mg daily
Day 26-30 Venlafaxine XR 225mg and LDX 70mg daily
Day 31-34 Venlafaxine XR 150mg
Day 35-38 Venlafaxine XR 75mg.
Other intervention name(s): Lisdexamfetamine dimesylate, LDX, Vyvanse, SPD489; Venlafaxine hydrochloride extended-release, Effexor XR,; Venlafaxine hydrochloride extended-release, Effexor XR; Lisdexamfetamine dimesylate, LDX, Vyvanse, SPD489
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics of single doses of
      PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male
      volunteers.
    

Detailed description: 
      The purpose of this study is to investigate the pharmacokinetics of single doses of
      PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male
      volunteers.
    

Intervention name(s): PF-02341066; PF-02341066; PF-02341066
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cohort 1: a 150 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 1 x 100 mg IRT.; Cohort 2: a 250 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 2 x 100 mg IRTs.; Cohort 3: a 400 mg single dose of PF-02341066 administered as 4 x 100 mg IRTs.
Intervention MeSH terms: Crizotinib
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: PK profile in Japanese healthy male volunteers
BTRX-246040 Study in Subjects With Parkinson's Disease With Motor Fluctuations
Condition: Parkinson Disease; Motor Disorder
MeSH terms: Parkinson Disease; Motor Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics and
      efficacy of BTRX-246040 in subjects with PD who have motor fluctuations and predictable early
      morning off periods.
    

Detailed description: 
      Study treatment is 1 day and total duration of the study is up to 36 days, including an
      approximate 28-day screening period. The study will consist of 4 sequential, ascending dose
      cohorts of 8 subjects each with a 6:2 randomization to BTRX-246040 or placebo. The planned
      dosing for each cohort will be 40, 80,120 and 160 mg. After enrollment of the first cohort
      has been completed, doses for subsequent cohorts may be modified based on review of the
      available data (safety, tolerability, efficacy, and PK) by an unblinded Dosing Review
      Committee (DRC). A similar review and determination of dosing for the subsequent cohort will
      be performed after completion of each cohort and based on all data available from previous
      cohorts.

      Subjects who meet entry criteria assessed at the screening visit (up to 28 days prior to Day
      1) will present to the clinic on the morning of Day 1 (treatment day) in the practically
      defined OFF state (having withheld anti-parkinsonian medications after 10:00 PM the evening
      prior). Subjects will be dosed with study drug and remain on site for an 8-hour observation
      period with UPDRS Part III motor response, dyskinesia rating and ON/OFF status assessed
      pre-dose, every 30 minutes for 4 hours post-dose, and then hourly for 4 additional post-dose
      hours (i.e., 8 hours total post-dose) prior to being discharged. Blood for pharmacokinetics
      will be collected 6 times at scheduled intervals within the 8-hour observation period. A
      follow-up safety visit is scheduled 7 days later.
    

Intervention name(s): BTRX-246040; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral capsule 40 mg; oral capsule matching BTRX-246040 40 mg capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study will consist of 3 sequential, single ascending dose cohorts of 8 subjects each with a 6:2 randomization to BTRX-246040 or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon
      alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a
      safe and effective treatment for patients with chronic hepatitis C infection as compared to
      patients who receive standard treatment.
    

Detailed description: 
      The study will include patients who are diagnosed with chronic hepatitis C genotype 1
      infection and who have received no previous interferon or other anti-HCV treatment.
    

Intervention name(s): interferon alfa-2b; peginterferon alfa-2b; ribavirin, USP; external drug infusion pump
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): subcutaneous continuous infusion at one of three doses for 48 weeks; 1.5 μg/kg subcutaneous weekly for 48 weeks; All patients will receive oral ribavirin; pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Other intervention name(s): INTRON® A; PEGINTRON™; Rebetol®; Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: hepatitis C; HCV; genotype; sustained virological response; rapid virological response; interferon
A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function
Condition: Renal Insufficiency; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess how fast tirzepatide gets into the blood stream and
      how long it takes the body to remove it in participants with impaired kidney function
      compared to healthy participants.
    


Intervention name(s): Tirzepatide
Intervention type(s): Drug
Intervention description(s): Administered SC.
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Oral Glucose in Pain Alleviation Among Term Neonates
Condition: Pain
Study type: Interventional

Summary: 
      Background: It was long believed that newborns could not experience pain. As it is now
      documented that newborns have all the necessary systems to perceive pain, pain management can
      no longer be ignored.

      Pharmacologic agents are not recommended in neonates for pain relief in minor procedures and
      still there is debate regarding the efficacy of oral glucose, in different strengths, on
      alleviation of pain among neonates.

      Aim: The objective of this study is to assess the efficacy and safety oral administration of
      glucose, in different concentrations, on pain relief in full term neonates undergoing heel
      prick test.

      Methods: The investigators will conduct a prospective, randomized, double blind placebo
      controlled trial to investigate the effect of glucose solution on alleviating the pain of
      heel prick test in 244 healthy full term newborns who will be randomly allocated to one of
      three groups: First group will receive 5% glucose, second group will receive 30% glucose and
      third group will receive sterile water as a placebo, 2 minutes prior to the procedure.

      Specially trained nurses will take turns to carry out blood sampling. Neonatal pain will be
      assessed by the Neonatal Infant Pain (NIPS) as well as by duration of crying, changes in
      heart rate, respiratory rate and oxygen saturation.
    

Detailed description: 
      The investigators will conduct a prospective, randomized, double blind, placebo controlled
      study of healthy full term newborns delivered by normal vaginal delivery, undergoing heel
      prick test. They will be randomized to receive either 5% glucose, 30% glucose or sterile
      water as a placebo, 2 minutes prior to the procedure. The investigators will study the
      efficacy and safety of oral glucose, in different strengths, compared to placebo (sterile
      water) in pain alleviation.

      All parents will receive an explanation of the study before participation, and informed
      written consent will be signed by the parents for voluntary participation
    

Intervention name(s): 5% glucose; 30% glucose; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Neonates will receive 5% glucose, then heel prick wil be performed during which pain will be assessed; Neonates will receive 30% glucose, then heel prick wil be performed during which pain will be assessed; Neonates will receive sterile water, then heel prick wil be performed during which pain will be assessed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
MEDI-573 in Combination With SOC in Unresectable or Metastatic HCC.
Condition: Unresectable or Metastatic Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard
      of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).
    


Intervention name(s): MEDI-573 (1 of 3 doses); Sorafenib
Intervention type(s): Drug; Drug
Intervention description(s): MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands; Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCC, liver cancer, hepatocellular carcinoma, MEDI-573, anti-IGF
Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study
Condition: Microcirculation
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Changes in tissue microcirculation during ischemic conditioning (4 cycles of 5-min ischemia
      and 5-min reperfusion) has not been well documented. In previous studies, there was
      difference in changes in microcirculation, such as recovery slope and occlusion slope,
      between healthy subjects and cardiac surgery patients. Moreover, the occlusion slope, which
      reflects local tissue oxygen consumption during ischemic period, is anticipated to decrease
      during repeated ischemia-reperfusion cycle by its protecting effect, however there has not
      been well-conducted study. The purpose of the study is to evaluate the changes in
      microcirculation measured by tissue oxygen saturation during ischemic conditioning between
      healthy volunteers and cardiac surgery patients.
    

Detailed description: 
      Subjects who are male healthy volunteers (aged 20-45) or who are scheduled to receive cardiac
      surgery (aged 20-80) will undergo ischemic conditioning, consisting of 4 cycles of 5-min
      ischemia with pressure of 200 mmHg on upper extremity followed by 5-min reperfusion with no
      pressure. During ischemic conditioning, changes in tissue microcirculation (baseline tissue
      saturation, occlusion slope during ischemia, and recovery slope during reperfusion) will be
      observed using tissue oxygen saturation sensor attached to the thenar muscle of the hand. For
      cardiac surgery patients, the study will be conducted before anesthesia induction on the
      surgery day to exclude any potential effect of anesthetics.
    

Intervention name(s): ischemic conditioning
Intervention type(s): Procedure
Intervention description(s): Four cycles of 5-min inflation of pneumatic cuff on upper extremity up to 200 mmHg, followed by 5-min deflation with no pressure.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: tissue oxygen saturation, ischemic conditioning
A Double-blind, Group-comparison Study Using Zolpidem (Myslee) as a Comparative Drug in Patients With Insomnia
Condition: Sleep Initiation and Maintenance Disorders; Sleep Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of FK199B (Zolpidem MR
      Tablet) in patients with insomnia by a randomized, double-blind, group-comparison study using
      zolpidem (Myslee) as a comparative drug
    


Intervention name(s): Zolpidem MR; Zolpidem
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Myslee
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: zolpidem; sleep initiation and maintenance disorders Hypnotics and sedatives; double-blind study; comparative study
Intensive Faciltiation of Swallowing in Patients With Severe Dysphagia After Acquired Brain Injury
Condition: Deglutition Disorders
MeSH terms: Deglutition Disorders; Brain Injuries
Study type: Interventional

Summary: 
      This study is a randomized controlled trial (RCT). Patients after severe acquired brain
      injury (ABI) were randomised in addition to the individual daily rehabilitation program to
      intensive Facial Oral Tract Therapy (F.O.T.T.®) (intervention group) or unspecific treatment:
      washing face, brushing teeth, without facilitating swallowing (control group).

      The duration of the intervention period was 15 working days (3 weeks). The intervention in
      both groups was twice a day.
    

Detailed description: 
      The F.O.T.T.® approach uses structured tactile input and facilitation techniques in
      meaningful everyday life context, aiming for improving function in the face and oral tract
      that is as normal as possible. The goal is maximum participation in daily life. The treatment
      encourages learning of helpful functional movements or patterns of movement for safe
      swallowing, protection of airway, oral hygiene, eating, drinking, breathing, voice and
      articulation.
    

Intervention name(s): Intensive F.O.T.T.®; Unspecific Stimulation of face and mouth
Intervention type(s): Other; Other
Intervention description(s): Therapeutic F.O.T.T.® intervention provided by Occupational Therapists (OTs). The intervention consists of positioning the patient, and giving sensory input to the hands and face in order to stimulate and facilitate swallowing of saliva or small amounts of food and drink, if considered safe.; The intervention consists of positioning the patient and either washing his face, the hands, or brushing teeth, apply lipbalm, with no specific stimulation or facilitation of swallowing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess Bioequivalence of a New Tapentadol Extended-Release 250-mg Tablet With Respect to a Tapentadol Extended-Release 250-mg Tablet in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate bioequivalence (scientific basis on which drugs with
      the same active ingredient(s) are compared) of a new tapentadol extended-release (ER) 250-mg
      tamper-resistant formulation (TRF) tablet to the current tapentadol ER 250-mg
      prolonged-release formulation 2 (PR2) tablet in healthy participants under fasted conditions.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center,
      randomized (the study medication is assigned by chance), 2-way crossover (method used to
      switch participants from one treatment arm to another in a clinical study) study of a single
      dose of 250-mg tapentadol. All participants will receive in randomized order the TRF tablet
      and PR2 tablet, both as a single dose of 250 mg tapentadol. Approximately 64 participants
      will be enrolled in the study. The study consists of 3 phases: a screening phase (within 2 to
      21 days before the first study drug administration on Day 1 of Period 1), an open-label
      treatment phase consisting of 2 single-dose treatment periods. Treatment administrations will
      be separated by a washout period of 7 to 14 days. All participants will be randomly assigned
      to 1 of 2 possible treatment sequences and receive both of the following treatments, 1 in
      each period: Treatment A: tapentadol ER 250-mg TRF tablet, administered as a single oral dose
      under fasted condition and Treatment B: tapentadol ER 250-mg PR2 tablet, administered as a
      single oral dose under fasted condition. Safety will be evaluated by the assessment of
      adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical
      laboratory tests which will be monitored throughout the study. The duration of participation
      in the study for an individual participant will be up to 5.5 weeks.
    

Intervention name(s): Tapentadol ER 250-mg TRF tablet; Tapentadol ER 250-mg PR2 tablet
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single oral dose of tapentadol ER 250-mg TRF tablet on Day 1 of each treatment period.; Participants will receive single oral dose of tapentadol PR2 250-mg tablet on Day 1 of each treatment period.
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Tapentadol; Bioequivalence; Fasted
Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects
Condition: Hepatitis C; HCV
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment
      experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not
      complete the prescribed duration due to adverse event or any reason other than for non/poor
      compliance. Subjects will be randomized to 12 or 16 weeks of treatment.
    

Detailed description: 
      The primary purpose of this study is to compare the efficacy and safety of glecaprevir and
      pibrentasvir (G/P) for 12 weeks to G/P for 16 weeks in non-cirrhotic NS5A (non-structural
      protein 5a)-inhibitor plus sofosbuvir ± RBV (Ribavirin) treatment-experienced adults with HCV
      genotype 1 (GT1) infection, and to compare the efficacy and safety of G/P with RBV for 12
      weeks to G/P without RBV for 16 weeks in NS5A-inhibitor plus sofosbuvir (SOF) ± RBV
      treatment-experienced adults with compensated cirrhosis and GT1 infection.
    

Intervention name(s): Glecaprevir/Pibrentasvir (G/P) 300mg/120mg; Ribavirin 200Mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): daily; Weight-based 1000-1200 mg
Other intervention name(s): Glecaprevir/Pibrentasvir; GLE/PIB (Glecaprevir/Pibrentasvir); Ribasphere 200Mg Tablet
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Main Study Up to 225 subjects will be enrolled into 4 study arms A, B, C and D with Glecaprevir/Pibrentasvir (G/P) with or without Ribavirin (RBV).
About 75-90 non-cirrhotic subjects will be randomized in a 2:1 ratio to Arms A and B, and about 110-135 compensated cirrhotic subjects will be randomized in a 1:1 ratio to Arms C and D.
Non-cirrhotic subjects will be randomized 2:1 to:
Arm A: G/P 300 mg/120 mg Once a day for 12 weeks
Arm B: G/P 300 mg/120mg Once a day for 16 weeks
Subjects with compensated cirrhosis will be randomized 1:1 to:
Arm C: G/P 300 mg/120 mg QD + weight-based RBV (Ribavirin) Twice a day (1000 mg or 1200 mg total daily dose) for 12 weeks
Arm D: G/P 300 mg/120 mg QD for 16 weeks Retreatment sub-study Up to 11 subjects who still have hepatitis C virus after being treated in the Main study will have the option to enter the Retreatment sub-study and receive G/P plus Sofosbuvir and with or without RBV.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV; Previously treated