bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, PK and Efficacy of Single Doses of NV-5138 in Healthy Volunteers and Subjects With Treatment-Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, two-part, placebo-controlled study of single ascending doses of NV-5138 in
      healthy volunteers, and a single dose of NV-5138 in subjects with Treatment-Resistant
      Depression (TRD)
    

Detailed description: 
      This is a randomized, two-part, double-blind, placebo-controlled study of single ascending
      dosage levels of NV-5138 in healthy volunteers and a single dose of NV-5138 in subjects with
      TRD. The study includes an up to 28-day screening period, an in-house period during which
      NV-5138 or placebo will be administered, and a 3- to 7-day follow-up period after discharge.

      In Part A of the study (single-ascending-dose [SAD] portion in healthy volunteers), up to
      approximately 48 healthy volunteers will be randomly assigned to double-blind treatment.
      Eight (8) subjects will be randomized in each of six dosage-level cohorts (150, 300, 600,
      1000, 1600, or 2400 mg NV-5138, or placebo, administered as an oral solution). Within each
      cohort, six subjects will be randomized to receive NV-5138 and two subjects will be
      randomized to receive placebo. Each subject will receive only one dose of either NV-5138 or
      placebo on Day 1. Within each cohort, initially one subject will receive NV-5138 and one
      subject will receive placebo. Provided no clinically significant safety issues are noted in
      the 24 hours after dosing the initial two subjects in the cohort, the six subjects remaining
      in the cohort may be dosed.

      In Part B of the study (single-dose portion in subjects with TRD), up to approximately 40
      subjects will be randomly assigned to double-blind treatment in one cohort. The dosage level
      for this cohort will be determined based on the safety, tolerability, and pharmacokinetic
      data from Part A of the study. However, in no case will the dose in Part B of the study
      exceed the highest dose administered in Part A of the study. Within this cohort, after
      potential eligibility has been confirmed by a site-independent review process, twenty (20)
      subjects will be randomized to receive NV-5138 and twenty (20) subjects will be randomized to
      receive placebo.
    

Intervention name(s): NV-5138; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): single ascending dose; Placebo liquid solution to mimic NV-5138
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, single dose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects
Condition: Smallpox
MeSH terms: Vaccinia; Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and
      safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox
      vaccine in vaccinia-naïve healthy subjects
    


Intervention name(s): LF formulation of IMVAMUNE®; FD formulation of IMVAMUNE®
Intervention type(s): Biological; Biological
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Application of Rectus Sheath Block based-on Incision in Upper Abdominal Surgery
Condition: Opioid Consumption
Study type: Interventional

Summary: 
      General anesthesia combined subcostal transversus abdominis plane (TAP)or rectus sheath block
      (RSB)can significantly reduce the use of opiates in minimally invasive surgery.However,
      similar reduction was not observed in open abdominal surgery during perioperative
      period.Therefore, the investigators should try to improve the blocking methods to reduce the
      side effects of a large number of opiates. Based on the range and its analgesic effect of
      various nerve block is obviously related to the injection site of local anesthetics, this
      randomized controlled study hypothesized that modified RSB under the guidance of surgical
      incision may be more effective in inhibiting the harmful stimulation of surgery.
    

Detailed description: 
      For abdominal cancer surgery with midline incision, subcostal transversus abdominis plane or
      rectus sheath block combined with general anesthesia was more effective in reducing pain
      scores and opioid consumption compared with general anesthesia alone. However, there was no
      statistically significant difference in supplementary fentanyl during operation. Besides
      adequate pain relief around incisions, blunting visceral traction response has also an
      important role in hemodynamic stability.With the evidences for a potential mechanism for the
      antinociceptive effects of propofol on visceral nociception and dexmedetomidine combined with
      oxycodone can provide good visceral analgesia, the investigators supposed that visceral
      nociception was well suppressed by adequate antinociceptive drugs. The propofol combination
      with dexmedetomidine may had significant effect on the reduction of the sympathoadrenergic
      tone with decrease of blood pressure and heart rate.
    

Intervention name(s): Subcostal TAP; Modified RSB; General anesthesia
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): Subcostal transversus abdominis plane block; Rectus Sheath Block under the guidance of surgical incision; Traditional general anesthesia management
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.
Condition: Benign Prostatic Hyperplasia (BPH); Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and
      tolerability when administered separately or co-administered to healthy male volunteers.
    

Detailed description: 
      A total of 36 subjects will be enrolled in one sequence group. The investigational products
      will be administered according to the treatment groups (T, M, T+M) assigned to one sequence
      group in Period 1, Period 2, and Period 3.
    

Intervention name(s): BR9006-1; BR9006-2
Intervention type(s): Drug; Drug
Intervention description(s): Administration to the T/T+M group: 0.2 mg of BR9006-1 will be administered one capsule once a day, five-day repeated-dose; Administration to the M group: 50 mg of BR9006-2 will be administered one tablet once a day, eleven-day repeated-dose
Administration to the T+M group: 50 mg of BR9006-2 will be administered one tablet once a day, five-day repeated-dose
Other intervention name(s): Tamsulosin HCL; Mirabegron
Intervention MeSH terms: Tamsulosin; Mirabegron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068.
      Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and
      smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be
      evaluated.
    


Intervention name(s): SEL-068; Saline
Intervention type(s): Biological; Biological
Intervention description(s): Sub-cutaneous injection, multiple dose; Sub-cutaneous injection, multiple dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nicotine vaccine; smoking vaccine; smoking cessation; SEL-068
Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of a stress management group
      intervention for people with HIV. The study will evaluate several outcomes, including
      perceived stress, quality of life, psychosocial factors, and physiological measures of
      stress.
    

Detailed description: 
      It is well documented that living with HIV/AIDS can cause a great amount of stress, and
      evidence suggests that stress may hasten HIV disease progression by increasing viral
      replication and suppressing the immune response. Stress management intervention studies using
      more complex combinations of cognitive and relaxation therapies have shown improvements in
      both psychological and physiological measures in HIV infected persons. However, no studies
      have focused on only one intervention or have addressed the spiritual component using a
      comparable control group to determine which of these interventions is most effective.

      Participants will be randomly assigned to receive either a spiritually-based cognitive
      intervention to an educational control group. The intervention will be given over a 10-week
      period, with 5 weekly classes, 4 weekly automated phone calls, and one final class meeting.
      Assessments will be conducted at pre-intervention, fifth class midpoint, tenth week
      post-intervention, and 3-month follow-up. Time commitment can vary from 6 months to 9 months,
      depending on when participants are screened.
    

Intervention name(s): Mantram Repetition
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Educational/Counseling/Training
Keywords: HIV; Randomized Trial; Stress; Spirituality; Quality of Life; Complementary Therapies
Evaluation of Drug-drug Interaction Between LCZ696 and Sildenafil in Subjects With Mild to Moderate Hypertension
Condition: Mild to Moderate Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was conducted to investigate the potential for a pharmacokinetic drug-drug
      interaction in support of the co-administration of LCZ696 and sildenafil.
    

Detailed description: 
      This study was conducted to investigate the potential for a pharmacokinetic drug-drug
      interaction in patients with mild-to-moderate hypertension in support of the
      co-administration of LCZ696 and sildenafil.
    

Intervention name(s): LCZ696; Sildenafil
Intervention type(s): Drug; Drug
Intervention description(s): LCZ696 400mg QD was administered alone for 4 days and in combination with sildenafil for 1 day; Sildenafil 50 mg single dose was administered alone for 1 days and in combination with LCZ696 400mg QD for 1 day
Intervention MeSH terms: Sildenafil Citrate; Sacubitril and valsartan sodium hydrate drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: LCZ696, sildenafil, pharmacokinetics, mild to moderate hypertension
The Effect of Single Doses of the Motilin Receptor Agonist GSK962040 in Type I Diabetic Patients With Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the pharmacodynamic effects (gastric emptying),
      safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic
      patients with gastroparesis.
    


Intervention name(s): GSK962040 25 mg; Placebo; GSK962040 50 mg; GSK962040 1250 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25 mg; placebo comparator; 50 mg; 125 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: single dose; gut motility; Type I Diabetes Mellitus patients; tolerability; phase II; 13C octanoic acid breath test; pharmacodynamics; gastric emtpying; pharmacokinetics
RDEA3170 Monotherapy in Subjects With Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the serum uric acid lowering effects and safety of 3 dose levels of
      RDEA3170 compared to placebo in subjects with gout.
    

Detailed description: 
      This monotherapy study is the initial Phase 2 study for RDEA3170 and is designed to compare
      the safety and efficacy of multiple dose levels of RDEA3170 with placebo when given for up to
      24 weeks to subjects with gout. The placebo control for RDEA3170 is included in this study to
      minimize bias in study assessments and monitoring. Further, to accomplish the goal of
      understanding the safety profile of RDEA3170, it is important to compare RDEA3170 monotherapy
      with placebo for at least 24 weeks.
    

Intervention name(s): Placebo; RDEA3170 5 mg; RDEA3170 10 mg; RDEA3170 12.5 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Verinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
Condition: Social Phobia
MeSH terms: Anxiety Disorders; Phobic Disorders; Phobia, Social
Study type: Interventional

Summary: 
      A study investigating six different versions of a computerized attention bias modification
      internet program in the treatment of social phobia / social anxiety disorder.
    

Detailed description: 
      Previous studies have shown that individuals with social phobia have attention biases, often
      focusing on aversive stimuli or avoiding aversive stimuli. Computerized training programs
      have been developed to implicitly direct the users attention towards a neutral,
      non-threatening stimuli. In this study, such a program will be compared with a program that
      implicitly directs the users' attention towards threatening cues. Pre/post-measurements will
      be compared in a sample of individuals that meet diagnostic criteria of Social Anxiety
      Disorder. Participants will be randomized to one of three groups, receiving one of the two
      variants of the attention bias modification program or a control training program.
    

Intervention name(s): Attention bias modification
Intervention type(s): Behavioral
Intervention description(s): All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: social phobia; anxiety
Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test two different formulations. The results will be used to select
      formulation for phase 3.
    


Intervention name(s): Pharmacokinetics
Intervention type(s): Drug
Intervention description(s): Single dose of 750 mg PF-00868554 as a solution and tablets.
Other intervention name(s): pharmacokintics
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety Study of a Shorter (Hypofractionated) Radiotherapy for the Prostate Bed With or Without the Pelvic Lymph Nodes
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial investigates safety and feasibility of a hypofractionated radiotherapy (i.e. with
      higher daily doses and shorter total treatment time compared to standard fractionation) of
      the prostate bed with or without the pelvic lymph nodes.
    

Detailed description: 
      While evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate
      cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed
      and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to
      investigate safety and feasibility of hypofractionated treatment of the prostate bed alone or
      with the pelvic lymph nodes.

      A total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be
      enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40
      patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18
      fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes
      additionally. Helical Tomotherapy and daily image guidance wil be used.
    

Intervention name(s): hypofractionated helical IMRT; hypofractionated helical IMRT
Intervention type(s): Radiation; Radiation
Intervention description(s): hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy; helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostatectomy
Role of Residual Urine and Asymptomatic Prostatitis in the Development of Urinary Tract Infections in Spinal Cord Injury
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Spinal Cord Injuries; Prostatitis
Study type: Observational

Summary: 
      The purpose of this prospective study is to investigate the association between the amount of
      residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent
      (>2 /year) symptomatic urinary tract infections in patients suffering from chronic (> 1 year)
      spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing
      intermittent catheterization.

      The following hypotheses will be tested:

        1. The amount of residual urine after intermittent catheterization is significantly greater
           in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to
           those without.

        2. The incidence of asymptomatic bacterial prostate infections is significantly higher in
           SCI patients suffering from frequent (>2 /year) urinary tract infections compared to
           those without.
    

Detailed description: 
      To investigate the association between the amount of residual urine and asymptomatic
      bacterial prostate infection with the occurrence of recurrent (>2 /year) symptomatic urinary
      tract infections in patients suffering from chronic (> 1 year) spinal cord injury (SCI) and
      neurogenic lower urinary tract dysfunction performing intermittent catheterization, patients
      perform self-catheterization twice (before and after urodynamic testing. After each
      catheterization, residual urine is assessed by ultrasound. Prior to urodynamic testing,
      prostate massage is performed, bacterial cultures of the fluid and the urine are initiated
      and the results of these cultures will be analysed .
    

Intervention name(s): sonographic assessment of residual urine, urine culture
Intervention type(s): Other
Intervention description(s): residual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage
Other intervention name(s): ultrasound; intermittent catheterization
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male patients with chronic (> 1 year) spinal cord injury who perform intermittent
        catheterization due to neurogenic bladder dysfunction
      
Keywords: Urinary Tract Infection; Bacteriuria; Pyuria; Prostatitis; Intermittent Catheterization; Spinal Cord Injuries; Residual Urine
A Study of Inactivated Swine-Origin A/H1N1 Influenza Vaccines in Healthy European Subjects Aged 3 to 17 Years
Condition: Influenza; Swine-origin A/H1N1 Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to generate data on immunogenicity and safety of the monovalent
      H1N1 vaccine in support of the development and registration.

      Primary objectives:

        -  To describe the immune response to vaccines 21 days after each vaccination in all
           participants.

        -  To describe the antibody persistence eight months after the first vaccine administration
           using HAI method, in a subset of participants who received two injections.

        -  To describe the immune response against the A/H1N1 strain using HAI method 21 days after
           a vaccination with the 2010-2011 NH seasonal TIV administered approximately 13 months
           after the first vaccination in the subset of participants who received two injections.

        -  To describe the safety profile of each vaccine in all participants.
    

Detailed description: 
      All participants will receive two injections of their randomized vaccine on Day 0 and Day 21,
      respectively.

      A subset of children and adolescents participants eligible for the antibody persistence
      evaluation were sampled 8 months after the first vaccination, they will also be proposed to
      receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13
      months after the first vaccination. Immunogenicity response will be evaluated before
      vaccination and 21 days after vaccination with TIV, respectively.
    

Intervention name(s): Swine A/H1N1 influenza vaccine (split virion, inactivated); Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant); Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset); 0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).; 0.5 mL, Intramuscular on Day 0 and day 21
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Pandemic Flu; Swine-origin A/H1N1 Influenza; Inactivated split-virion vaccine; Adjuvant