bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
Condition: Central Precocious Puberty
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg
      6-month formulation in 44 patients suffering from central precocious puberty. The total study
      duration per patient will be 12 months (48 weeks).
    


Intervention name(s): Triptorelin
Intervention type(s): Drug
Intervention description(s): Powder and solution for solution for injection
Other intervention name(s): Trelstar
Intervention MeSH terms: Triptorelin Pamoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Percutaneous Ethanol Alcohol Injection for the Large and Unresectable Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma Non-resectable
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the
      large and unresectable hepatocellular carcinoma: single center non-randomized trial.
    

Detailed description: 
      Assessment of the overall (OS); one year; two years and three years' survival rates; the
      disease free survival (DFS) and the tumor response rate in the patients undergoing (PAT or
      PEI) for the large and inoperable hepatocellular carcinoma. This is a prospective non
      randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.
    

Intervention name(s): Percutaneous ethanol alcohol injection
Intervention type(s): Procedure
Intervention description(s): Day-case procedure; weekly sessions; uses absolute alcohol; under close monitoring; maximum dose of 30 ml; no anesthesia needed and a maximum pain score of "8" limits the procedure. Post-procedure analgesia may be required.
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment. Prospective and non-randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Percutaneuos Ethanol alcohol injection
A Comparison of Magnetic Resonance Imaging in Persons With Heart Failure to Health, Aged Matched Controls
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The purpose of this study is to examine the relation between the structural brain changes
      associated with heart failure, neurocognitive performance, and how these changes impact
      self-care behaviors.
    

Detailed description: 
      The purpose of this study is use neuroimaging techniques to better understand the underlying
      structural brain changes and physiological mechanisms that guide the thinking and decision
      making processes required for people with heart failure. The study will compare how the
      underlying brain structures and circulation are similar to or different in persons with heart
      failure to healthy, aged matched controls using special neuroimaging procedures.
    

Intervention name(s): Brain Imaging (Neuroimaging); Cognitive Function Assessment
Intervention type(s): Other; Other
Intervention description(s): Magnetic Resonance Imaging (MR) will be acquired on a research dedicated Siemens 3Tesla TIM TRIO MRI scanner with a 32-channel head coil.The MRI scanning protocol will have scans to measure voxelwise and whole-brain measures of grey matter (GM) volumes through a high resolution T1-weighted (T1W) multi-echo magnetization prepared gradient echo (MEMPRAGE) anatomic scan.
Total time in scanner will be approximately 53 minutes.; Cognitive function will be assessed using several batteries; the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Controlled Oral Word Association Test (COWA), the Color Trails 1 & 2, the WAIS-III Digit Span and Letter Number Sequence test, the Stroop Test, and the California Computerized Assessment Package Reaction Time test (CALCAP).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women with heart failure and men and women without heart failure to serve as
        healthy age-matched controls.
      
Keywords: Cardiomyopathy; Magnetic Resonance Imaging (MRI)
Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
Condition: Premature Infants
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study will determine levels of vitamin D supplementation to achieve goal serum
      25-hydroxy vitamin D [25(OH)D] levels of 30 ng/mL, and to define serum 25(OH)D levels
      required to achieve suppression of parathyroid hormone in preterm newborn infants
      hospitalized in Newborn Intensive Care Nursery (NICU). Infants 23 weeks gestational age or
      greater will be randomized to two different levels of vitamin D supplementation: 400 IU
      vitamin D3/day, or 800 IU vitamin D3/day.
    

Detailed description: 
      The specific aims of this study are to determine levels of vitamin D supplementation to
      achieve goal serum 25(OH)D levels of 30 ng/mL, and to define serum 25(OH)D levels required to
      achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the
      Nebraska Medical Center Newborn Intensive Care Nursery (NICU). In this randomized, controlled
      trial, infants 23 weeks gestational age or greater will be randomized to two different levels
      of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day. As an
      exploratory aim, vitamin D binding protein levels (VDBP) will also be quantified in these
      infants.
    

Intervention name(s): cholecalciferal; cholecalciferol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400 IU/day; 800 IU/day D3
Other intervention name(s): vitamin D3; vitamin D3
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D3; prematurity; parathyroid hormone; 25(OH)D; NICU hospitalization
Sun Protection Factor Assay (SPF Assay 202/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987517
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
(Formulation Code:Z46-104)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Phase I [18F]THK-5351 Positron Emission Tomography Study in Healthy Subjects and Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate biodistribution, pharmacokinetics and safety of [18F]THK-5351
      positron emission computed tomography in Cognitively Healthy Subjects and Patients with
      Alzheimer's Disease.
    

Detailed description: 
      This is a study to evaluate biodistribution, pharmacokinetics and safety of [18F]THK-5351
      positron emission computed tomography. Ten cognitively healthy subjects and 10 patients with
      Alzheimer's Disease will be enrolled. The primary outcome measures are to evaluate
      pharmacokinetics of [18F]THK-5351 Positron Emission Tomography imaging . Tracer
      biodistribution will be evaluated by global and regional standardized uptake value ratio of
      [18F]THK-5351 in the brain. Safety. For safety assessment, a physical examination,
      Electrocardiogram and vital signs will be performed at baseline and at the completion of all
      imaging to assess for interval change.
    

Intervention name(s): [18F]THK-5351
Intervention type(s): Drug
Intervention description(s): Imaging for evaluating the biodistribution, pharmacokinetics and safety of abnormal tau protein in the brain
Other intervention name(s): FluoroTau
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Tau; neurodegeneration; positron emission tomography
Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Observational

Summary: 
      The purpose of this study is to compare physical activity levels between patients with
      bronchiectasis and healthy subjects.

      We hypothesize that patients with bronchiectasis will have lower levels of physical activity,
      since physical activity levels is affected by reduced exercise tolerance, severity of disease
      and other disease related symptoms and conditions.
    

Detailed description: 
      Physical activity limitation in chronic respiratory diseases is caused by many factors
      including respiratory, hemodynamic, and peripheral muscle weakness. Bronchiectasis is
      characterized by irreversible widening of the medium-sized airways, with inflammation,
      chronic bacterial infection and destruction of the bronchial walls. In addition to pulmonary
      function worsening, extra pulmonary features such as reduced peripheral muscle endurance can
      be a significant physical problem which causing a decrease in physical activity levels.

      Despite physical activity is considered to be essential for the management of chronic
      respiratory diseases, there is a lack of scientific study, which compares physical activity
      levels between patients with bronchiectasis and healthy subjects.

      This study will assess physical activity level, exercise capacity, quality of life and
      peripheral muscle strength in patients with bronchiectasis compared to healthy subjects.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will consist of patients with bronchiectasis and healthy subjects.
      
Keywords: Physical activity levels; Bronchiectasis
Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue
      CM3.1-AC100 after repeated subcutaneous (sc) doses.
    


Intervention name(s): CM3.1-AC100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MAD study with repeated subcutaneous (sc) doses; Placebo for compound CM3.1-AC100 s.c.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: MAD study CM3.1-AC100; Healthy men, age 18 - 50
Pharmacokinetics of Mmf and Valganciclovir
Condition: Kidney Transplant Recipient; Heart Transplant Recipient
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine whether a clinically significant PK drug
      interaction ( a 30% difference in the AUC of MPA) exists between mycophenolate mofetil (under
      steady state conditions) and VGCV in renal and cardiac transplant recipients.

      This study will provide clinically relevant information to the transplant community. It will
      more clearly delineate whether a clinically significant PK drug interaction exists between
      mycophenolate mofetil (under steady-state conditions)and VGCV. Given the established
      dose/efficacy relationship of both MMF and VGCV, this study will provide improved dosing
      guidelines and potentially avoid adverse outcomes due to empiric dosage adjustments.
    

Detailed description: 
      Mycophenolate mofetil (immunosuppressant, MMF) and valganciclovir (antiviral, VGCV) are
      commonly administered together in transplant patients. Following oral administration, both
      MMF and VGCV are metabolized to active forms, mycophenolic acid (MPA) and gancoclovir (GCV)
      respectively. Both MPA and GCV are eliminated through kidney and renal excretion, but there
      is no data on how MPA pharmacokinetic parameters are affected by GCV at steady state
      condition. Both MPA and GCV can cause neutropenia and although unsubstantiated, some
      clinicians have observed an increased occurrence of neutropenia when these agents are used in
      combination. In the presence of neutropenia, practitioners are often challenged when making
      decisions regarding whether the dosage of one or both agents should be reduced. It would be
      useful to know whether the neutropenia is due to increased drug concentration or whether it
      is due to direct effects of these agents on the bone marrow.
    

Intervention name(s): Mycophenolate mofetil; Valganciclovir
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mycophenolic Acid; Valganciclovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Valganciclovir; Mycophenolate Mofetil; Pharmacokinetic; Interaction; MPA
Effect of Naringenin and Beta Carotene on Energy Expenditure
Condition: Energy Expenditure; Safety Issues; Glucose Metabolism
Study type: Interventional

Summary: 
      This study is designed to test the effects of the combination of naringenin (from an extract
      of sweet oranges) and beta carotene on energy expenditure and glucose metabolism in a single
      human subject.
    

Detailed description: 
      The subject will be treated for 8 weeks with the combination of naringenin + beta carotene.

      We will conduct the following assessments before the treatment and at the end of eight weeks.

        1. Resting metabolic rate

        2. Oral glucose tolerance test with glucose and insulin

        3. Ambulatory blood pressure

        4. Recording of adverse events

        5. Body weight
    

Intervention name(s): naringenin and beta carotene
Intervention type(s): Dietary Supplement
Intervention description(s): Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day for eight weeks
Intervention MeSH terms: Beta Carotene; Naringenin; Carotenoids
Intervention model: Single Group Assignment
Intervention model description: Case study in a single human subject
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
Condition: Scar Prevention
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare how well EXC 001 works versus placebo in reducing the appearance of
      scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety
      of EXC 001 in healthy adult subjects.
    


Intervention name(s): EXC 001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple intradermal injections of EXC 001 and placebo; Multiple intradermal injections of EXC 001 and placebo
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Scarring; Cicatrix; Fibrosis; Pathologic Process
IGF1 Generation Test
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1
      changes, on the 24 months growth response to 2 different doses of GH in patients with
      conventional GH deficiency.
    


Intervention name(s): Blood sample; Radiography
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)
Condition: Healthy Postmenopausal Females
Study type: Interventional
Phase: Phase 1

Summary: 
      For the contraceptive application a film-coated tablet has been developed which combines
      nomegestrol acetate (NOMAC) with estradiol (E2). This was an open-label, randomized,
      single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at
      two sites, one site per study part. The primary objective of Part 1 was to assess the
      bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process
      ("commercial batch") versus the Phase 3 drug product ("Batch A"). The primary objective of
      Part 2 was to assess bioequivalence of NOMAC and E2 of the drug product manufactured using
      the commercial process ("commercial batch") versus the Phase 3 drug product ("Batch B").
    


Intervention name(s): Commercial NOMAC-E2; Phase 3 NOMAC-E2 "Batch A"; Phase 3 NOMAC-E2 "Batch B"
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination commercial tablet orally in the morning on Day 1 for all periods; 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch A") orally in the morning on Day 1 for all periods; 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch B") orally in the morning on Day 1 for all periods
Other intervention name(s): SCH 900121; SCH900121; SCH 900121
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the effect of extending maintenance dosing intervals
      beyond 12 weeks on the clinical efficacy and safety of ustekinumab in subjects with
      moderate-to-severe plaque psoriasis.
    

Detailed description: 
      In this study, a proportion of subjects will receive study agent at its recommended dose and
      interval (45mg for subjects less than or equal to 100kg, or 90mg for subjects greater than
      100kg; every 12 weeks after 2 starter doses at Weeks 0 and 4). The majority of subjects will
      have the opportunity to receive study agent less frequently during the randomization period
      depending on the subject's response. The study consists of a 4-week screening period; a
      28-week open-label run-in period; a double-blind treatment period from Week 28 to Week 104; a
      12 week post-treatment period; and a 20-week safety follow-up. Participants will be
      randomized for the double blind period into one of two study groups. Group 1 participants
      will receive an injection of the study medication at a 12 week dosing interval. Group 2
      participants will undergo a placebo withdrawal and may receive study agents at an extended
      interval greater than 12 weeks. During the double-blind treatment period, subjects in Groups
      1 and 2 will receive placebo as necessary to maintain the blind.
    

Intervention name(s): Ustekinumab 45 mg; Ustekinumab 90 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Form = Injection, route = subcutaneous; Form = Injection, route = subcutaneous; Form = Injection, route = subcutaneous
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; Ustekinumab; STELARA; Skin disease; Monoclonal
Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of different extended-release
      formulations of AZD1305 when given as single and multiple oral doses to healthy male
      volunteers.
    


Intervention name(s): AZD1305; AZD1305; AZD1305
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single Oral Dose, ER formulation 1; ER formulation 1, bid for 5 days; Single Oral Dose, ER formulation 2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteer; male; pharmacokinetics; AZD1305
Clinical Study of KD6001 in Advanced Solid Tumours
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and clinical activity of
      KD6001 as treatment for participants with advanced solid tumours.
    


Intervention name(s): KD6001 Injection
Intervention type(s): Biological
Intervention description(s): Solution for intravenous injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sensory Integration for Infants With Cortical Visual Impairment
Condition: Sensory Integration Disorder
MeSH terms: Vision Disorders
Study type: Interventional

Summary: 
      Our study examines the effect of sensory integration training on sensory, motor and
      oculomotor skills in infants with cortical vision impairment .
    

Detailed description: 
      Cortical vision impairment (CVI) and Cerebral Palsy (CP) lead to decrement in sensory and
      motor functions of infants. The current study examined the effectiveness of sensory
      integration interventions on sensory, motor, and oculomotor skills in infants with cortical
      vision impairment. Thirty-four infants with CVI and CP aged 12-18 months were enrolled to the
      study. The infants were randomly divided into 2 groups as the control and intervention
      groups. The intervention group took sensory integration intervention 2 days a week for 8
      weeks in addition to conventional physiotherapy two days a week for eight weeks. The control
      group only received the conventional physiotherapy program 2 days a week for 8 weeks. The
      duration of the treatment sessions were 45 minutes for both interventions. Before and after
      the intervention, sensory processing functions were evaluated with the Test of Sensory
      Functions in Infants (TSFI) and motor functions were evaluated with the Alberta Infant Motor
      Scale (AIMS).
    

Intervention name(s): Sensory integration therapy
Intervention type(s): Other
Intervention description(s): The individuals were divided into two as randomized controlled. Both physiotherapy and sensory integration therapy were applied to the intervention group. Each treatment was applied as 2 sessions per week, 2 days a week for 8 weeks. In the control group, only physiotherapy treatment was applied for 8 weeks, 2 days a week, 2 sessions per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Cortical Visual Impairment; Sensory Integration; Motor Function; Early Intervention.