bioihbjkbjnl/mcl2 huggingface dataset:
MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer
Condition: Prostate Cancer; Prostate Adenocarcinoma
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The hypotheses of this study are:

        1. Delivery of single fraction Lattice Extreme Ablative Dose (LEAD) radiotherapy (RT) to
           the dominant tumor lesion(s) in the prostate as identified by multiparametric functional
           Magnetic Resonance Imaging is safe and feasible when given prior to standard prostate
           radiotherapy.

        2. Biomarker expression levels differ in the functional MRI identified suspicious tumor
           regions and unsuspicious tumor regions. The investigators hypothesize that a significant
           source of variation in biomarker levels is due to tumor heterogeneity and that it is
           molecular abnormalities in the dominant tumor areas that are angiogenic and determine
           outcome.
    


Intervention name(s): Lattice Extreme Ablative Dose Radiation Therapy; Standard IMRT
Intervention type(s): Radiation; Radiation
Intervention description(s): 12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.; 76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
Other intervention name(s): LEAD RT; IMRT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Resveratrol Supplementation in Patients With Mitochondrial Myopathies and Skeletal Muscle Fatty Acid Oxidation Disorders
Condition: Mitochondrial Myopathies; Fatty Acid Oxidation Defects
MeSH terms: Muscular Diseases; Mitochondrial Myopathies
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the potential beneficial effects of a daily
      supplement of Resveratrol (1000mg/day) on physical ability and on muscle metabolism in
      patients with verified mitochondrial myopathy and patients with a verified fatty acid
      oxidation defect of VLCAD and CPTII deficiencies. Investigators hypothesize an improved
      muscle metabolism, mitochondrial function, fatty acid oxidation and thus improvement of
      physical ability.
    

Detailed description: 
      Study design: double-blind, randomized, placebo-controlled, cross-over study.

      To ensure enough participants, and due to the risk of a heterogeneous cohort, a cross-over
      design is chosen, where participants are their own controls. 10 patients with mitochondrial
      myopathy and 10 patients with fatty acid oxidation defects will be included. Eligible
      patients will be randomized using a 1:1 assignment ratio to receive placebo or RSV first.
      Each treatment will be administered orally twice daily for 8 weeks, followed by a 4 weeks
      wash-out, and afterwards a new 8-week treatment period.

      During the 20-week trial period, subjects will visit the trial site on five occasions, for
      functional assessments (cycle ergometer testing), blood sampling and questionnaires.
    

Intervention name(s): Resveratrol
Intervention type(s): Dietary Supplement
Intervention description(s): Resveratrol supplementation 1000 mg /day or placebo
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double-blind, randomized, placebo-controlled, cross-over study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation
Condition: Dermal Filler
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm
      (hyaluronic acid) dermal filler injection for soft tissue augmentation. The main questions it
      aims to answer are:

        -  The differences of Wrinkle Severity Rating Scale (WSRS) after the injection.

        -  The differences of Global Aesthetic Improvement Scale (GAIS) after the injection.

        -  The subjective satisfaction of treatment.

        -  Safety Indicators of which incidences on the day of the injection or after the
           injection.

      Participants will be self-controlled and randomized for same period

        -  received both trial product and control product at the same time.

        -  re-visited on week 2, 4, 12, 24, 36, and 52 after injection.

      Researchers will compare if the test product is non-inferiority to Q-Med Restylane.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and efficacy of Formaderm (hyaluronic
      acid) dermal filler injection for soft tissue augmentation. A single-centre, non-inferior,
      randomized, double-blind trial with a control group was conducted in this study. Every
      subject received the trial product and control product injections at the same time. It was
      planned to recruit 95 subjects with the 10% dropout rate. This clinical trial is accordance
      with the "Good Clinical Practice (GCP) issued by the Department of Health and ISO14155-1：2003
      Clinical investigation of medical devices for human subjects - Part 1: General Requirements
      and carried out according to the trial proposal approved by the Tri-Service General Hospital
      Human Subjects Review Committee.
    

Intervention name(s): Formaderm Dermal Filler Injection; "Q-MED" RESTYLANE
Intervention type(s): Device; Device
Intervention description(s): Dermal filler injection to facial areas; Dermal filler injection to facial areas
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: hyaluronic acid filler; nasolabial folds
Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
Condition: Stool Composition
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary efficacy objective was to determine and compare stool composition (stool soap and
      non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the
      feeding groups.
    

Detailed description: 
      The purpose of this study is to evaluate the effects of term infant formula containing high
      2-palmitic vegetable oil on stool composition and characteristics and to investigate the
      effect of both high 2-palmitic vegetable oil and oligofructose in infant formula on stool
      softness and bacteria. Because some studies demonstrate the benefit of high concentrations of
      a non-digestible carbohydrate in the formula, we will study 2 concentrations of added
      oligofructose.
    

Intervention name(s): S-26 Gold; S-26 Gold EF1; S-26 Gold EF2; S-26 Gold EF3; Human Milk
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): (13.4 g/L protein) with 100% Fat Blend A; (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend; (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 3.0 g/L oligofructose; (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 5.0 g/L oligofructose; Human Milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Stool composition
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      We are testing to see if Galantamine, a learning enhancing medication, will help methadone
      maintained cocaine abusers with their learning and memory specific to CBT using an innovative
      CBT computer program.
    

Detailed description: 
      We are proposing a randomized double blind clinical trial of galantamine and our innovative
      computer-assisted version of CBT, alone and in combination, to improve treatment outcome and
      cognitive functioning among cocaine users. The proposed study will be the first to evaluate a
      cognitive enhancing medication as a means of enhancing the effects of an extremely promising
      empirically validated behavioral therapy for addiction, and hence bridge cognitive
      neuroscience and behavioral therapies development.

      The aim is to conduct a 12 week randomized placebo controlled trial, using a 2x2 factorial
      model, that will evaluate the efficacy of adding computer assisted training in CBT
      ("CBT4CBT") and galantamine to standard treatment for 160 cocaine abusing or dependent
      methadone-maintained individuals. Participants will be randomized to (1) standard treatment
      (TAU) plus placebo, (2) TAU plus galantamine, (3) TAU plus CBT4CBT plus placebo, or (4) TAU
      plus CBT4CBT plus galantamine.
    

Intervention name(s): Galantamine; Computer Assisted Cognitive Behavioral Therapy (CBT)
Intervention type(s): Drug; Behavioral
Intervention description(s): Daily 8 mg galantamine capsule; CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.
Other intervention name(s): Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine; Methadone; CBT
Intra- and Interobserver Agreement in the Assessment of Human Embryos
Condition: the Focus of This Study is to Measure the Intra- and Interobserver Agreement for the Evaluation of Early Stage Embryos
Study type: Observational

Summary: 
      The purpose of this study is to determine the intra- and interobserver agreement.
    


Intervention name(s): embryo development
Intervention type(s): Other
Intervention description(s): intra- and inter-observator analysis
Sampling method: Probability Sample
Study population: 
        embryos of IVF/ICSI patients
Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to compare the efficacy and safety of 3 dose levels of
      oral ERB-041 administered daily for 12 weeks versus placebo in subjects with active
      rheumatoid arthritis who have had a suboptimal response to therapy with stable doses of
      methotrexate (MTX).
    


Intervention name(s): Methotrexate plus ERB-041 for 12 weeks; Placebo for 12 weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis
Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Pain; Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a) the feasibility of applying a painful exercise
      program in the treatment of subacromial shoulder pain and b) the time needed to collect
      clinical outcomes for a future randomized controlled trial.
    

Detailed description: 
      Exercise therapy is the first choice of treatment in the management of subacromial shoulder
      pain (SSP). Guidelines suggest active rehabilitation program for at least three months and
      existing research highlights the importance of progressive loaded exercise therapy at higher
      dosage. However, it is not clear which is the best type of exercise and if pain should be
      provoked during exercise. Recent research found that painful exercises are beneficial in
      short term on pain and function in patients with different kinds of chronic musculoskeletal
      pain. The aim of the future randomized clinical trial is to investigate if "exercising into
      pain" gives better results in term of clinical outcomes compared to a non-painful exercise
      program. Since the intervention consists in painful exercises, it is essential to test the
      rate of adherence in the intervention group (both during physiotherapist-led session and
      home-based exercises). Moreover, the practicability of clinical questionnaire via online
      survey will be tested and the time needed to collect clinical data will be calculated as
      well. Furthermore, feedback from physiotherapists and participants will be collected and
      analyzed.
    

Intervention name(s): Exercise therapy (exercising into pain)
Intervention type(s): Other
Intervention description(s): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Intervention model: Single Group Assignment
Intervention model description: Prospective single-group study design
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug
Condition: Renal Anemia Associated With Chronic Renal Failure (CRF)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate safety and efficacy of intermittent oral dosing of ASP1517 in
      dialysis chronic kidney disease patients with anemia.
    

Detailed description: 
      To evaluate the safety and the dose-response of ASP1517 on hemoglobin (Hb) correction when
      ASP1517 is applied intermittently in dialysis chronic kidney disease patients with anemia.

      To evaluate the treatment effect on Hb maintenance of ASP1517 administered intermittently in
      dialysis chronic kidney disease patients with anemia.
    

Intervention name(s): roxadustat; darbepoetin alfa
Intervention type(s): Drug; Drug
Intervention description(s): oral; iv
Other intervention name(s): ASP1517
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Renal Failure; ASP1517; Renal anemia
Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity
Condition: Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, multicentre (7 sites), randomized, double-blind, study comparing
      intravesical injection of BOTOX to placebo in 56 subjects with NDO secondary to spinal cord
      injury or multiple sclerosis. Study subjects will be randomized to one of the following two
      treatment groups:

      Group 1 n=28 BOTOX - 300U Group 2 n=28 Placebo BOTOX (saline)

      All study subjects will receive one injection cycle (BOTOX 300U or Placebo) at Visit 2
      (Treatment, Day 0) as per Supplement III. The study duration is approximately 61 weeks and
      consists of a Pre-Treatment Evaluation, a Treatment/Randomization Visit (Visit 2, Day 0),
      Telephone Follow-ups at 1, 3 and 4 weeks post-treatment, and Follow-up Visits at 6, 24 and 36
      weeks (Visits 3 to 5). At Week 36, subjects will be offered open-label BOTOX 300U and will be
      followed for an additional 6 months, returning for evaluations at Weeks 48 and 60.
    

Detailed description: 
      This is a prospective, multicentre (7 sites), randomized, double-blind, study comparing
      intravesical injection of BOTOX to placebo in 56 subjects with NDO secondary to spinal cord
      injury or multiple sclerosis. Study subjects will be randomized to one of the following two
      treatment groups:

      Group 1 n=28 BOTOX - 300U Group 2 n=28 Placebo BOTOX (saline) All study subjects will receive
      one injection cycle (BOTOX 300U or Placebo) at Visit 2 (Treatment, Day 0) as per Supplement
      III. The study duration is approximately 61 weeks and consists of a Pre-Treatment Evaluation,
      a Treatment/Randomization Visit (Visit 2, Day 0), Telephone Follow-ups at 1, 3 and 4 weeks
      post-treatment, and Follow-up Visits at 6, 24 and 36 weeks (Visits 3 to 5). At Week 36,
      subjects will be offered open-label BOTOX 300U and will be followed for an additional 6
      months, returning for evaluations at Weeks 48 and 60.
    

Intervention name(s): Botulinum toxin A
Intervention type(s): Drug
Intervention description(s): Comparison of intra-detrusor injection of 300U of Botulinum toxin A versus placebo for effect on neurogenic detrusor overactivity and urinary incontinence.
Other intervention name(s): Botox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neurogenic; Detrusor; Overactive; Overactivity; Bladder; Spinal; Cord; Injury
A Study of the Efficacy of Erbium:YAG 2940nm in Combination With 1064nm Laser on Facial Rejuvenation
Condition: Facial Rejuvenation
MeSH terms: Facies
Study type: Interventional

Summary: 
      1. Facial aging is a progressive, multifactor-induced and multidimensional process which is
           naturally irreversible. The prominent clinical features of skin aging include loss of
           volume, pigmentation irregularity, low light reflectance, static and dynamic wrinkles,
           etc.

        2. The development of superpulsed CO2 and Erbium: YAG 2940 nm resurfacing lasers was
           considered as the "gold standard" for the treatment of facial aging [8,9]. However, many
           drawbacks including intraoperative pain, post procedural erythema, edema, high risk of
           changes of pigmentation and long downtime have drawn concerns to patients and
           practitioners. Therefore, the facial rejuvenation therapies based on combined modalities
           to target various factors simutaneously have raised more and more interests.

        3. The Fotona 4D laser platform incorporates the long pulsed 1064 nm and 2940 nm lasers,
           which provides versatile modalities to target various skin aging problems
           simultaneously. The 1064 nm laser can penetrate deep into the skin to explode pigment
           particles, destroy blood vessels and heat the dermal collagen by targeting melanin and
           haemoglobin. The 2940 nm Er:YAG laser in Fotona 4D system integrates a non-ablative
           Smooth® mode and cold peel SupErficial™ mode. the half-face treated by a 2940 nm laser
           alone showed a significant improvement on indexes of skin wrinkles, texture, pores and
           elasticity as compared to the baseline.
    


Intervention name(s): Fotona 4D 1064 nm laser; Fotona 4D 2940 nm laser
Intervention type(s): Radiation; Radiation
Intervention description(s): The 1064 nm laser can penetrate deep into the skin to explode pigment particles, destroy blood vessels and heat the dermal collagen by targeting melanin and haemoglobin.(1) Frac3®: 30-35 J/cm2, 1.6 ms pulse width, 4mm spot size, unilaterally accumulated 2000 shots; and (2) PIANO®: 160 J/cm2, 5s pulse width, spot size 9mm, unilaterally accumulated 20000 shots, to increase and maintain facial skin temperature to 39-40oC.; Er:YAG 2940nm have been considered as a good treatment of facial aging, especially in wrinkles.(1) Smooth®: 9-10 J/cm2, 7mm spot size, which is sequentially delivered to upper and lower labial mucosa and buccal mucosa to unilaterally accumulate 5000 shots; (2) SupErficial™: 0.5-1.0 J/cm2, 7mm spot size, a single pass
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Facial rejuvenation, Erbium: YAG Laser, 1064 nm laser, skin aging
Sertindole in Asian Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of sertindole in patients with
      schizophrenia in Asia.
    

Detailed description: 
      This study is the first randomised clinical trial performed in Asia with sertindole, aiming
      at comparing sertindole efficacy and safety to that of another atypical antipsychotic.

      Sertindole is a limbic-selective antipsychotic agent with a unique neuropharmacological
      profile. Sertindole has shown significant improvements relative to placebo against both
      positive and negative symptoms of schizophrenia (measured by PANSS total, PANSS negative and
      positive subscale scores). It is well tolerated and shows placebo-level incidence of
      extrapyramidal symptoms (EPS). Sertindole is associated with a dose-dependent increase in the
      QT interval, but this does not translate into an excess mortality with sertindole relative to
      that of other recently developed antipsychotics in their respective clinical development
      programmes.
    

Intervention name(s): Sertindole; Olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): Sertindole flexible doses per os, 12, 16 or 20mg/day according to response and tolerability, initially up-titrated from 4mg/day to target dose 16mg/day within the first 16 days; Olanzapine flexible doses per os, 10, 15 or 20mg/day according to response and tolerability, initially up-titrated from 10mg/day to target dose 15mg/day within the first 16 days
Intervention MeSH terms: Olanzapine; Sertindole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Relative Bioavailability of STI-1558 and the Effect of Itraconazole and Rifampin on the Pharmacokinetics of STI-1558
Condition: COVID-19 Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study. This study includes 2 parts, in which part 1 is a relative BA
      study, Part 2 is a DDI study. Part 1 and Part 2 could be performed in parallel.
    


Intervention name(s): STI-1558; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): An oral small molecule prodrug that effectively inhibits the SARS-CoV-2 main protease (Mpro).; A strong CYP3A4 inhibitor; A strong CYP3A4 inducer
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other