bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability of ASKP1240 in Healthy Subjects After Intravenous and Subcutaneous Administration of ASKP1240
Condition: Pharmacokinetics of ASKP1240; Pharmacodynamics of ASKP1240; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess levels of ASKP1240 in the blood after a single dose
      given intravenously (IV) or as a subcutaneous (SC) injection. The study will determine how
      the drug behaves inside the body and how it is eliminated from the body by looking at the
      pharmacokinetics of ASP1240.

      In addition, the study will determine the effects of ASKP1240 on the body by looking at its
      pharmacodynamics (PD) and at the safety and tolerability of ASKP1240 when given by IV or as
      SC injection.
    


Intervention name(s): ASKP1240
Intervention type(s): Drug
Intervention description(s): intravenous(IV) infusion and subcutaneous (SC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers; CD40 receptor occupancy; Co-stimulation blockade; CD40 antigen; Anti-CD40; ASKP1240
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck
Condition: Musculoskeletal Disorders
MeSH terms: Musculoskeletal Pain; Musculoskeletal Diseases; Shoulder Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Musculoskeletal disorders are frequent among office workers especially in the neck/shoulder
      area.

      The hypothesis is, that specific strength training of the neck/shoulder muscles will
      alleviate the pain.

      The two sub-hypotheses are

        1. Alleviation of pain is independent of training frequency

        2. Alleviation of pain is higher following supervised training vs training with initial
           instruction only
    

Detailed description: 
      Recent studies have shown a positive effect of work site physical exercise intervention,
      however, there is a lack of evidence regarding: 1) extend of instruction and supervision, and
      2) frequency of training session during the wek.

      Questionnaires will be send to around 2000 office workers inviting them to participate in
      work site training for 1 hr per week for 20 weeks. Those accepting the invitation will be
      randomized into 5 different groups:

        1. training 1 hr one time per week supervized 50% of the time

        2. training 3 x 20 min per week supervised 50 % of the time

        3. training 3 x 20 min per week supervised only initially with careful instructions

        4. training 10 x 6 min per week supervised 50 % of the time

        5. no training serving as reference control group At termination of the training period
           there will be a follow-up questionnaire survey
    

Intervention name(s): physical training exercise
Intervention type(s): Behavioral
Intervention description(s): physical exercise training at the work site during work time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: neck/shoulder
Pharmacokinetics And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To estimate the pharmacokinetics and relative bioavailability of oxycodone after
      administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions
      and after chewing under fasted conditions in healthy volunteers
    

Detailed description: 
      This study will estimate the pharmacokinetics and relative bioavailability of oxycodone
      following oral administration of single 40 mg doses of PF-00345439 Formulations J and K
      compared with the reference PF-00345439 Formulation A, all taken whole and under fed
      conditions in healthy volunteers.

      In addition, the study will estimate the pharmacokinetics and relative bioavailability of
      oxycodone followingoral administration of single 40 mg doses of PF-00345439 Formulation J or
      K (to beselected based on Periods 1-3) after chewing under fasted conditions compared to that
      taken whole in the fed state in healthy volunteers, and assess the single-dose safety and
      tolerability of oxycodone inPF-00345439 formulations in healthy volunteers when administered
      under a naltrexone block.
    

Intervention name(s): Oxycodone; Oxycodone; Oxycodone; Oxycodone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One capsule of 40 mg PF-00345439 Formulation A, single dose, taken whole and under fed conditions; One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions; One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions; One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted conditions
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; bioavailability; oxycodone; management of moderate to severe pain
Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions
Condition: Breast Cancer
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Letrozole Tablet under fed
      conditions.
    


Intervention name(s): letrozole; letrozole
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 mg tablet; 2.5 mg tablet
Other intervention name(s): Femara; Femara
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ventilator-driven Alveolar Recruitment Maneuver
Condition: Postoperative Atelectasis; Ventilator Lung; Atelectasis; Recruitment
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      During laparoscopic surgery, gas infiltration and head down position cause pulmonary
      atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and
      improving lung mechanics. Ventilator-driven Alveolar recruitment maneuvers may restore lung
      volume but it remains unknown which method is most effective. The primary aim was to compare
      the efficacy of two ventilator-driven ARMs method using incremental tidal volume or positive
      end expiratory pressure(PEEP) until plateau pressure 30 cmH20 (within driving pressure 20
      cmH20).
    

Detailed description: 
      General anesthesia promotes the formation of atelectasis, which negatively impacts
      respiratory function and may be associated with subsequent pulmonary complications.
      Especially, during laparoscopic surgery, gas infiltration and head down position cause
      pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed
      alveoli and improving lung mechanics, suggesting that performing an Alveolar recruitment
      maneuvers after intubation, circuit disconnection, position change, intraabdominal gas
      infiltration.

      Conventional manual ARM is performed by sustained lung inflation using the reservoir bag on
      the anaesthesia machine with the adjustable pressure-limiting valve set to the desired
      inflation pressure. However, the manual ARM can lead to brief loss of positive pressure when
      switching back to the ventilator circuit, which results in re-collapse of alveoli. For this
      reason, investigators try to compare the methods of the ventilator-driven ARM.
    

Intervention name(s): Alveolar recruitment maneuver
Intervention type(s): Other
Intervention description(s): The two methods for performing an alveolar recruitment maneuver. Alveolar recruitment maneuvers consisted of a stepwise increase in tidal volume to a plateau pressure of 30 cm H2O versus a stepwise increase in PEEP H2O to a plateau pressure of 30 cm H2O.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCM
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine whether treatment with valsartan will have
      beneficial effect in early hypertrophic cardiomyopathy (HCM) by assessing many domains that
      reflect myocardial structure, function and biochemistry.
    

Detailed description: 
      This is a multicenter, double-blind, placebo-controlled Phase II, randomized clinical trial
      to assess the safety and efficacy of valsartan in attenuating disease evolution in early HCM.
      Sarcomere mutation carriers with asymptomatic or mildly symptomatic overt disease (NYHA class
      I-II), and mutation carriers without left ventricular hypertrophy (LVH) will be studied.
    

Intervention name(s): Valsartan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40, 80 and 160 mg tablets of Valsartan; During Active Run-In, all patients take Valsartan. During maintenance, all patients are randomized to valsartan or placebo
Other intervention name(s): Diovan; Matching Placebo pills
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sarcomere Mutations
Effect of Solution-Focused Support Program on Anxiety Levels of Parents During the COVID-19 Pandemic
Condition: Anxiety; Parents; Covid19
MeSH terms: COVID-19; Anxiety Disorders
Study type: Interventional

Summary: 
      In this research, it was aimed to determine the anxiety levels of parents in the Covid-19
      pandemic and to examine the effects of the Solution-Focused Support Program, which is planned
      to be given to parents with high anxiety levels.
    

Detailed description: 
      The study is conducted with parents whose children aged 3-6 years, and have high anxiety
      levels. In collecting research data; an introductory information form prepared by researchers
      and the State-Trait Anxiety Inventory will be used.
    

Intervention name(s): Solution-Focused Support Program
Intervention type(s): Other
Intervention description(s): All participants will be given a program of 4 sessions for 4 weeks. Each session is planned to last approximately 50 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: anxiety; child; nursing practice; parents; Solution-Focused Support Program
Renal Impairment Study of PF-06700841
Condition: Healthy Volunteer; Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the effect of kidney impairment on the blood
      concentrations of PF-06700841 and its major metabolite. Findings from this study will be used
      to develop dosing recommendations so that the dose and/or dosing interval may be adjusted
      appropriately in the presence of kidney disease.
    

Detailed description: 
      This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to
      investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability
      of PF-06700841 after a single oral dose of 30 mg. Subjects will be selected and categorized
      into normal renal function or renal impairment groups based on their estimated glomerular
      filtration rate. Part 1: A total of approximately 16 subjects will be enrolled; approximately
      8 subjects with severe renal impairment and approximately 8 with normal renal function. After
      statistical evaluation of results from Part 1, Part 2 may be conducted with approximately 8
      subjects each with moderate and mild renal impairment. The total duration of participation
      from Screening visit to Day 4 will be a maximum of 32 days and from Screening visit to
      Follow-up/Contact Visit will a maximum of 67 days.
    

Intervention name(s): PF-06700841
Intervention type(s): Drug
Intervention description(s): A single dose of 30 mg PF-06700841 will be administered on Day 1
Intervention MeSH terms: PF-06700841
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single group
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics
Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The purpose of this study is to collect and analyze electrical measurements, timing, and
      signals from a CRT-D device in heart failure patients who either already have an implanted
      left atrial pressure sensor or will undergo a simultaneous implantation of a left atrial
      pressure sensor and a CRT-D device. These devices may be placed at the same time or
      separately (staged procedure) at the discretion of the investigator. A comparison will be
      made between the information gathered from the CRT-D system and the information gathered by
      the left atrial pressure sensor.
    

Detailed description: 
      This is a multi-center feasibility study.

      .
    

Intervention name(s): Cardiac Resynchronization Therapy; HeartPOD™ System
Intervention type(s): Device; Device
Intervention description(s): Pacing of the left ventricle to resynchronize ventricular contraction.; Left atrial pressure monitoring.
Other intervention name(s): CRT-D
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with class III heart failure and a CRT-D device implanted.
Assessing Dopamine Transporter Occupancy in the Healthy Adult Brain With Toludivenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a single-arm, non-randomized, open-label clinical study to assess dopamine
      transporter occupancy in the brain of healthy adults using 11C-CFT positron emission
      tomography (PET)
    


Intervention name(s): Toludivenlafaxine hydrochloride sustained-release tablets
Intervention type(s): Drug
Intervention description(s): 80 mg/tablet, 2 tablets each time, once a day, for 4 days, orally at 30 min after the start of meals, 200 mL water to take
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label study with 30-day run in phase to establish baseline parameters, 90-day
      treatment phase, and a 90-day withdrawal phase to determine long-term effects, duration of
      treatment response, and potential effects of EPI-589 therapy on known trajectory.
    


Intervention name(s): EPI-589
Intervention type(s): Drug
Intervention description(s): An immediate release film-coated table at a 250 mg dosage strength will be administered per dose and schedule specified in arm.
Other intervention name(s): (R)-troloxamide quinone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
Condition: Labor Pain; Pregnancy
MeSH terms: Labor Pain
Study type: Observational

Summary: 
      The objective of this study will be to compare epidural infusion management, specifically
      looking at infusion rate changes, in patients who receive forceps deliveries versus normal
      spontaneous vaginal deliveries. We will match patients based on time and date of delivery, as
      well as parity, in order to eliminate these variables as potential con-founders.

      We hypothesize patients who require a decrease in their basal labor analgesia epidural
      infusion rate will have an increased incidence of forceps delivery.
    

Detailed description: 
      The obstetrical anesthesia database will be queried for all forceps deliveries between the
      dates of January 2004-October 2005. To minimize the influence of different anesthetic and
      obstetric care providers, the control group consisted of parturients who has spontaneous
      vaginal deliveries (SVD) in the same 24 hour period who were case-matched for gravidity and
      parity. Parturients with twin deliveries and fetal demise were not selected for either group.

      The database will be queried for the following: maternal age, parity, gestational age, type
      of analgesia, changes in epidural infusion rate and/or concentration, and supplemental bolus
      doses of local anesthesia. The data will be stripped of identification by the database
      manager and entered into a secured computer which is password protected and maintained in the
      Department of Anesthesiology. The primary endpoint is to evaluate if decreasing the epidural
      infusion rate was associated with a forceps delivery.
    

Intervention name(s): Case controlled analysis of epidural labor analgesia patterns
Intervention type(s): Other
Intervention description(s): A retrospective study utilizing the Obstetric Anesthesiology Database to identify parturients who received neuraxial labor analgesia initiated with a combined spinal epidural (CSE) technique and maintained with a continuous epidural infusion with patient controlled epidural analgesia boluses
Other intervention name(s): combined spinal epidural analgesia; epidural labor analgesia; bupivacaine; fentanyl
Intervention MeSH terms: Fentanyl; Bupivacaine
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Pregnant Women
      
Keywords: Labor; Epidural Analgesia; delivery; vacuum extraction; obstetrical Forceps
Natural Supplements for Unipolar Depression
Condition: Unipolar Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to determine the clinical response rate for the regimen of
      L-methionine, betaine and folate for unipolar depression.
    

Detailed description: 
      The study is 6 weeks long, with 9 clinical visits. All visits will take place at our location
      in Massachusetts.
    

Intervention name(s): Supplements of L-methionine, betaine and folate
Intervention type(s): Drug
Intervention MeSH terms: Betaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in
      subjects with moderate to severe psoriasis to assess the safety, tolerability,
      immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple
      subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F [Anti-IL-17A/F] Nanobody).
    


Intervention name(s): MSB0010841; MSB0010841; MSB0010841; MSB0010841; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): MSB0010841(Anti- IL-17A/F Nanobody) will be administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.; MSB0010841 will be administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.; MSB0010841 will be administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.; MSB0010841 will be administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.; Placebo matched to MSB0010841 will be administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
Other intervention name(s): Anti-IL-17A/F Nanobody; M1095; Anti-IL-17A/F Nanobody; M1095; Anti-IL-17A/F Nanobody; M1095; Anti-IL-17A/F Nanobody; M1095
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; MSB0010841; Anti-IL17A/F Nanobody; M1095
A Repeat Dose Study in Healthy Volunteers Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK356278
Condition: Huntington Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study drug, GSK356278, is a possible new medicine for the treatment of Huntington's
      disease. Huntington's disease, which is often called HD, is caused by a faulty gene that is
      passed down through families. HD causes damage to nerve cells in the brain which causes them
      to waste away. As the damage progresses patients develop symptoms that affect every aspect of
      life. HD reduces people's ability to walk, talk, think, communicate and causes uncontrolled
      movements. GSK356278 may slow down the progression of damage to nerve cells in people with HD
      and help with their ability to think.

      GSK356278 was well tolerated when it was given as a single dose to healthy people. In this
      study we want to see what effects, both good and bad, GSK356278 has in people when it is
      taken every day. During the study we will look at about 3 different doses of GSK356278 in
      about 36 healthy people. The study will also look at how GSK356278 tablets behave in the body
      after it is swallowed (this is called pharmacokinetics). The study will also look at effects
      of GSK356278 on the body (this is called pharmacodynamics). The study will help to design
      future clinical studies with GSK356278.
    


Intervention name(s): GSK356278; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1: A dose of 2mg per day for 10 days; Cohort 2: A dose of Xmg for 14 days. the dose will be determined from Cohort 1 not to exceed 14 mg; Cohort 3: a single dose of Ymg with a wash out of 7 days followed by 28 days of repeat dosing. The dose (Ymg) will be determined from cohort 1 and 2 not to exceed 14 mg.; Cohort 1, a placebo per day for 10 days Cohort 2, a placebo per day for 14 days Cohort 3, a single placebo with a wash out of 7 days followed by 28 days of repeat dosing of a placebo per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: repeat dose; PDE4; healthy volunteers; GSK356278