bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study
      in healthy volunteers, enrolled at a single site in the United States to investigate the
      safety, tolerability, and pharmacokinetics of DSTA4637S.
    


Intervention name(s): DSTA4637S; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive DSTA4637S intravenously on Day 1.; Participants will receive placebo matched to DSTA4637S intravenously on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; DSTA4637S
AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete
      remission after 24 weeks of therapy in subjects with active lupus nephritis.
    

Detailed description: 
      Voclosporin is a next generation CNI intended for use in the prevention of organ graft
      rejection and for the treatment of autoimmune diseases. The aim of the current study is to
      investigate whether voclosporin added to the standard of care treatment in active LN is able
      to reduce disease activity, as measured by a reduction in proteinuria. Two doses of
      voclosporin will be studied and compared in a placebo controlled trial on a background of MMF
      and corticosteroids. Patients with active, flaring LN will be eligible to enter the study.
      They are required to have a diagnosis of LN according to established diagnostic criteria
      (American College of Rheumatology) and clinical and biopsy features suggestive of active
      nephritis. Efficacy will be assessed by the ability of the drug combination to reduce the
      level of proteinuria while demonstrating an acceptable safety profile.
    

Intervention name(s): Voclosporin High Dose; Voclosporin Low Dose; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): ISA247; ISA247
Intervention MeSH terms: Cyclosporine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lupus nephritis; calcineurin inhibitors; voclosporin
CBT for Social Anxiety Disorder Delivered by School Counselors
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      This 5-year study addresses the unmet needs of adolescents with social phobia through the
      testing of a 12-week cognitive-behavioral, school-based group intervention delivered by
      trained school counselors compared to a nonspecific school counseling program. A secondary
      goal is to provide further examination of the efficacy of the CBT program delivered by school
      counselors as compared to the same program delivered by psychologists.
    

Detailed description: 
      The investigators have tested SASS, a school-based group CBT intervention for social phobia,
      and found it to be effective when delivered by psychologists (Masia Warner et al., 2005;
      Masia Warner et al., 2007). The proposed dissemination study extends this work through a
      controlled trial of SASS delivered by school counselors. The investigators will randomize 126
      adolescents with social anxiety disorder, ages 14 through 17, to one of 3 treatments: 1) SASS
      delivered by school counselors (SC-SASS), 2) SASS delivered by psychologists (Expert-SASS),
      or 3) a manualized adolescent group counseling program specifically designed for school
      counselors, called Skills for Living (SFL). A comprehensive evaluation will include
      diagnosis, illness severity, scale ratings of social anxiety and depression, clinical global
      improvement, overall functioning, and school-relevant indices of function. Outcomes will be
      assessed at baseline, mid-point (after 6 weeks of intervention), post-treatment, and 6 months
      following intervention completion.
    

Intervention name(s): Skills for Academic and Social Success; Skills for Life
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-week cognitive-behavioral, school-based group intervention; SFL is the Skills for Life Protocol delivered by school counselors.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bioequivalence Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To determine the bioequivalence between the new formulation and the current
      formulation of the investigational drug, MOA-728.
    


Intervention name(s): MOA-728
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Compare the Pharmacokinetics and Safety of CKD-391
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with
      co-administration of D090 and D337 in healthy adult volunteers
    


Intervention name(s): CKD-391 10/10mg; D090, D337
Intervention type(s): Drug; Drug
Intervention description(s): Drug T: CKD-391 10/10mg(Other Name: Test Drug); D090 and D337 co-administration(Other Name: Reference drug)
Other intervention name(s): Test Drug (T); Reference Drug (R)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Experience With Numeta in Preterm Infants
Condition: Premature Infants
Study type: Observational [Patient Registry]

Summary: 
      The aim of this prospective noninterventional study is to evaluate the clinical application
      of Numeta® in preterm infants and critically ill neonates in comparison to individualized
      prescribed parenteral nutrition. With the prescription software Cato-PAN® (by Cato software
      solutions) exact valid prescriptions for ordering parenteral nutrition solutions for
      premature infants are compared. Each PN solution is prescribed individually as well as with
      Numeta. Prescriptions were mirrored with respect to weight, venous approach, total volume and
      amount of enteral feeding, 24h medication and flipped vice versa. The key nutrient for
      calculating Numeta prescriptions was protein. The results of PN prescriptions were compared
      with each other/ESPGHAN recommendations. The investigators hypothesize that nutrimental
      content of Numeta prescriptions is equal to individually prescribed .parenteral nutrition
      solutions
    


Intervention name(s): Numeta; Individual
Intervention type(s): Other; Other
Intervention description(s): parenteral receipt prescribed with Numeta; parenteral receipt prescribed individually
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        preterm infants
      
Keywords: parenteral nutrition; Numeta; prescription software Cato Pan
Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest
Condition: Cardiac Arrest
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest
Study type: Interventional
Phase: Phase 4

Summary: 
      Recent studies have suggested that arginine-vasopressin could be more effective in the
      treatment of cardiac arrests. The last published study did not outline obvious improvements
      in the prognosis of all cardiac arrests but pointed out a possible increased survival rate
      when arginine-vasopressin is associated with epinephrine. The aim of this study is to compare
      the efficacy of two successive injections of epinephrine (1 mg) with two successive
      injections of epinephrine associated with arginine-vasopressin (40 UI) in out-of-hospital
      cardiac arrests occurring in adult patients. The primary endpoint is the survival rate at
      hospital admission. The inclusion period lasts 18 months and 2416 patients are planned to be
      enrolled.
    


Intervention name(s): epinephrine (1 mg/1 mL); arginine-vasopressin (40 UI/2 mL)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vasopressins; Arginine Vasopressin; Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Out-of-hospital cardiac arrest - Vasopressin - Epinephrine
Benefit of IQP-VV-102 in Reducing Postprandial Glucose Level in Overweight Caucasian Subjects
Condition: Prediabetes; Hyperglycemia
MeSH terms: Overweight; Hyperglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      In this trial, the investigational product , the active ingredients which has been proven to
      reduce postprandial glucose in healthy and diabetic patients, will be tested. The primary aim
      of this clinical study is to evaluate the possibility of the investigational product to
      reduce the rise of postprandial glucose AUC level in overweight Caucasian subjects with
      normal to prediabetic biomarkers (IFG/HbA1C), without prompting a disproportionate rise in
      insulin levels.
    


Intervention name(s): Dose 1 of IQP-VV-102; Dose 2 of IQP-VV-102; Placebo
Intervention type(s): Device; Device; Device
Intervention description(s): Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.; Dose 2 (D2) group will take 4 tablets with active ingredients.; Placebo group will take 4 placebo tablets.
The placebo is designed to be identical to IQP-VV-102.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
FGF21 and Fructose Challenge in Humans
Condition: Fasting
Study type: Interventional

Summary: 
      The primary aim of this study is to examine the effect of acute ingestion of fructose on
      serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with
      metabolic syndrome.
    

Detailed description: 
      Participation in this study involves fasting overnight, drinking a sweet beverage, and
      several blood draws through an IV line. Each subject may drink up to 10 different sweet
      beverages, separated by 2 weeks.
    

Intervention name(s): oral carbohydrate challenge
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will fast for 8 hours and then drink a beverage containing fructose.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: FGF21; Fibroblast growth factor; fructose
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's
      Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA
      Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fasting
      conditions.
    

Detailed description: 
      Open label, balanced, randomized, two-treatment, two-period, two-sequence, cross over, single
      dose, oral bioequivalence study of Valganciclovir Hydrochloride Tablets 450 mg under Fasting
      conditions.
    

Intervention name(s): Valganciclovir Hydrochloride
Intervention type(s): Drug
Intervention description(s): Valganciclovir Hydrochloride Tablets 450 mg
Other intervention name(s): Valcyte
Intervention MeSH terms: Valganciclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Duration Between Sessions on Microperimetric Biofeedback Training in Patients With Maculopathies
Condition: Macular Degeneration; Low Vision; Stargardt Disease
MeSH terms: Vision, Low; Macular Degeneration; Stargardt Disease
Study type: Interventional

Summary: 
      Patients who develop macular diseases have several clinical complications,such as central
      vision loss, the central scotoma of the visual field, the decrease of reading speed and
      fixation stability. At present, there is still no satisfactory effect in the prevention and
      treatment of advanced macular disease. A new rehabitation strategy named microperimetric
      biofeedback training has been shown to be effective in improving patients' visual appearance,
      but there is no consensus regarding the optimal methodology and standard of practice.
      Therefore, we designed a prospective clinical study to verify the effectiveness of MBFT and
      to determine an optimal plan.
    

Detailed description: 
      The present study aimed to investigate the effects of training frequency and number of
      training sessions on the visual outcomes of patients with various macular diseases. A total
      of 15 training sessions were conducted on two distinct frequencies, namely once a day and
      once every other day. Baseline measurements included fixation stability, reading speed, and
      best corrected visual acuity (BCVA) were obtained and followed up after the 5, 10, and 15
      training sessions. By comparing the changes in these visual function parameters across
      different stages of training, the study aimed to identify and analyze the underlying patterns
      and rules governing the training process. Ultimately, the results of this study could serve
      as a valuable reference for standardizing the use of MBFT in clinical practice.
    

Intervention name(s): microperimetric biofeedback training
Intervention type(s): Procedure
Intervention description(s): Microperimetry biofeedback training is a noninvasive stragegy to develop a new trained retinal locus or strength the spontaneous preferred retinal locus to get better visual performances.The rationale of MBFT consists in reeducating visual system to a new visual condition, promoting retina-brain transmission, and further enhancing synaptic plasticity and neural capacity by acoustic biofeedback or structured light stimulus biofeedback.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular disease; low vision; Visual rehabilitation
Muscle Activation Characteristics During Spinal Manipulation in Healthy and Low Back Pain Participants
Condition: Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      To characterize muscle activity through electromyography (EMG) of the lumbar spine during
      high velocity, low amplitude (HVLA) spinal manipulation according to parameters of
      practitioner contact (location, applied force) in healthy participants and two categories of
      low back pain participants.
    


Intervention name(s): Spinal Manipulation
Intervention type(s): Procedure
Intervention description(s): HVLA (High Velocity Low Amplitude) spinal manipulation directed at the lumbar spine and sacroiliac (SI) joints
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Keywords: Manipulation; Spinal; electromyography; kinetics; kinematic
Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Occupancy of SEROQUEL
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to relate pharmacokinetics of two different formulations of
      quetiapine to PET measured receptor occupancy in the brains of healthy subjects.
    


Intervention name(s): SEROQUEL XR (quetiapine); SEROQUEL IR (quetiapine); radioligand [11C]raclopride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): repeated dose of oral tablets, 8 times per subject; repeated dose of oral tablets, 4 times per subject; single dose of iv admin, 5 times per subject
Intervention MeSH terms: Quetiapine Fumarate; Raclopride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PET; Phase 1; Depression; SEROQUEL; Positron Emission Tomography; Drug profile comparison
Effects of Intensive Chiropractic Care to Usual Care for Children With Cerebral Palsy.
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      To determine the effects of chiropractic care on spasticity, functional outcomes and quality
      of life in spastic cerebral Palsy children.
    


Intervention name(s): Sham intervention; Chiropractic Care; Physical therapy intervention
Intervention type(s): Other; Other; Other
Intervention description(s): The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust; A registered chiropractor will assess the entire spine, and both sacroiliac joints will be assessed for vertebral subluxation by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine before spinal adjustment intervention include assessing for joint tenderness to palpation manually palpating for a restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints.; The standardized treatment protocol will be provided according to the guidelines, which will include various modalities and treatment approaches, including stretching exercises; massage; strengthening exercises of weak muscles, weight-bearing, balance (static and dynamic) and gait training; electrical stimulation; treadmill use; and endurance training for the improvement of gait, motor function, strength and functional mobility in Cerebral Palsy children, where Conventional Therapy will be provided according to the respective needs of the individual patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Research
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biological Standardization of Lolium Perenne Allergen Extract
Condition: Allergy to Grass Pollen
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the biologic activity of a Lolium perenne
      allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house
      reference preparation (IHRP).
    

Detailed description: 
      Four concentrations of Lolium perenne allergen extract, together with a positive and negative
      control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline
      solution, respectively, will be tested in every patient in duplicate on the volar surface of
      the forearm.
    

Intervention name(s): Lolium allergen extract
Intervention type(s): Biological
Intervention description(s): This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
Four concentrations of Lolium perenne allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Standardization; Immunotherapy; Skin prick test
A Study to Evaluate the Pharmacokinetics of JNJ-38518168 in Patients With Mild and Moderate Hepatic Impairment Compared With Patients With Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetics (what the body does to the
      study medication) of JNJ-38518168 at approximately steady-state (stable medication levels)
      after administration of multiple oral 30 mg doses of JNJ-38518168 to participants with mild
      or moderate hepatic (liver) impairment (abnormal function) compared with participants with
      normal hepatic function.
    

Detailed description: 
      This is an open-label (both [participants and investigator] know what treatment participants
      will receive) and multicenter study. The study consists of 3 phases: a screening phase
      (approximately 3 weeks), a treatment phase (from day -2 [2 days before the administration of
      study medication] to Day 18), and an end-of-study phase (7 to 10 days after the last dose of
      study medication). Approximately 24 participants (participants with mild hepatic impairment,
      moderate hepatic impairment, and normal liver function) will receive JNJ-38518168 for 14
      days. Hepatic impairment will be evaluated according to Child-Pugh score. It consists of 5
      clinical measures (amount of ascites [an abnormal accumulation of fluid in the abdomen],
      total bilirubin [mg/dL], albumin [g/dL], international normalized ratio, and degree of
      encephalopathy [abnormal functioning of the brain]). Each is scored from 0 (less severity) to
      3 (highest severity). Total Child-Pugh score is the sum of all subscores and is graded as:
      mild (5-6 points), moderate (7-9 points), and severe (10-15 points). Safety will be evaluated
      by the assessment of adverse events, clinical laboratory tests, vital signs, body weight,
      physical examination, and 12-lead electrocardiogram which will be monitored at various
      timepoints throughout the study. The total duration of study participation for each
      participant is approximately 6 weeks.
    

Intervention name(s): JNJ-38518168
Intervention type(s): Drug
Intervention description(s): All participants will receive JNJ-38518168 30 mg tablet once daily from Day 1 to Day 14.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; Mild and moderate hepatic impairment; Normal hepatic function; Pharmacokinetics; JNJ-38518168