bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to demonstrate the bioequivalence between IN-A012 and
      Akynzeo capsules by pharmacokinetic(PK) evaluation
    

Detailed description: 
      [Pharmacokinetics Assessment]

        -  Primary Parameter

           - AUC0-t

        -  Secondary Parameters - Cmax, tmax

      [Safety Assessment]

      - Adverse events, vital signs, physical examination, 12-lead ECGs, and clinical laboratory
      tests
    

Intervention name(s): IN-A012; Akynzeo 300Mg-0.5Mg Capsule
Intervention type(s): Drug; Drug
Intervention description(s): The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.; The subjects will be administrated Akynzeo by Orally with water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Evaluation of a Self-management Oriented Diabetes Education Program for Intensified Insulin Therapy in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      A new diabetes education program for the initiation of intensive insulin therapy in type 2
      diabetic patients (MEDIAS 2 ICT) was developed.

      In the evaluation, this new developed program is compared with an education programs which is
      currently used for diabetes education. It is expected that the new developed program (MEDIAS
      2 ICT) can demonstrate non-inferiority with regard to the main outcome variable glycemic
      control. If non-inferiority can be demonstrated superiority of this programs will be tested.

      The results regarding the intervention arms "MEDIAS ICT" vs. " ACC" (control condition) will
      be separately analyzed and published.
    

Detailed description: 
      The MEDIAS 2 ICT program is based on a self-management/empowerment approach. It is conducted
      as a group program comprising 10 lessons of 90 minutes each. MEDIAS 2 ICT is designed to help
      patients perform multiple-injection insulin therapy and adjust their insulin doses depending
      on carbohydrate consumption, physical exercise, and pre-prandial glucose levels. In addition,
      MEDIAS 2 ICT focuses on controlling metabolic risk factors (elevated lipids and blood
      pressure), coping with the risk of late complications, and reducing the emotional burden of
      diabetes and its treatment.

      The active comparator condition (ACC) consist of a combination of two previously established
      and evaluated education programs - a diabetes education program to initiate mealtime insulin
      and a hypertension education program for the treatment of hypertension. These education
      programs were developed in the 1980s and 1990s and were more didactic-oriented, focusing
      primarily on the acquisition of knowledge, skills, and information about the correct
      treatment of diabetes and hypertension.

      Both treatment arms (MEDIAS 2 ICT and ACC) consisted of 10 lessons, which were conducted as
      group sessions.
    

Intervention name(s): MEDIAS 2 ICT; Current ICT program (ACC-ICT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MEDIAS 2 ICT is a newly developed education program for the initiation of intensive conventional insulin therapy in type 2 diabetic patients (10 lessons of group sessions for 4-8 participants); This program is conducted in 10 lessons in a group setting (4-8 participants)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; education; self-management; insulin therapy
Use of Botulinum Toxin to Treat Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees,
      elbows, scalp and trunk. Evidence suggests the role of neurogenic inflammation in the
      pathogenesis of psoriasis. Botulinum toxin has been shown to have an effect on inhibiting
      neurogenic inflammation.

      Recently, it was reported that patients who suffered from dystonia and had concomitant
      psoriasis, when treated with botulinum toxin for dystonia noted a dramatic improvement of
      their psoriatic lesions.

      This pilot study will determine the safety and efficacy of botulinum toxin in the management
      of psoriasis vulgaris.
    


Intervention name(s): injection of botulinum toxin type A.
Intervention type(s): Biological
Intervention description(s): 35 to 100 units injected around a skin lesion (plaque) one time.
Other intervention name(s): Botox.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriasis; Botulinum toxin
Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Overweight
Study type: Interventional

Summary: 
      The proposed research will determine the feasibility of delivering two behavioral weight loss
      interventions for 1 year in adults with autosomal dominant polycystic kidney disease (ADPKD)
      who are overweight or obese. The study will also compare these two interventions in terms of
      safety, acceptability, and tolerability. Last, this pilot trial will provide initial insight
      into a) biological changes and b) changes in kidney growth with each of the two weight loss
      interventions.
    

Detailed description: 
      Autosomal dominant polycystic kidney disease (ADPKD) is characterized by development and
      continued growth of numerous fluid-filled renal cysts that ultimately result in renal
      failure. Similar to the general population, the prevalence of overweight and obesity have
      been rising in ADPKD patients, effecting about two-thirds of individuals. Surprisingly, the
      role of obesity in ADPKD progression is currently unknown. The investigators have novel
      preliminary data that overweight and obesity are independently associated with substantially
      faster kidney growth in ADPKD patients. Furthermore, in rodent models of ADPKD,
      mild-to-moderate food restriction profoundly slows cyst growth and maintains renal function
      via mechanisms including AMPK-activated kinase pathway activation and suppression of
      mammalian target of rapamycin/S6 kinase signaling and insulin-like growth factor-1 levels.
      Collectively, these data suggest that dietary restriction regimens may slow ADPKD
      progression. Accordingly, the primary aim is to determine the feasibility of delivering a 1
      year behavioral weight loss intervention program in 30 overweight/obese adults with ADPKD,
      based on either daily caloric restriction (DCR) or intermittent fasting (IMF), with a similar
      (~34%) targeted weekly energy deficit. A key secondary goal is to evaluate safety,
      acceptability, and tolerability of IMF in ADPKD versus DCR. Last, the third exploratory aim
      is to a) obtain mechanistic insight into biological pathways that may be altered and b)
      provide initial insight into any changes in total kidney volume by magnetic resonance imaging
      with IMF and/or DCR.
    

Intervention name(s): Weight Loss
Intervention type(s): Behavioral
Intervention description(s): Weight loss behavioral intervention via one of two strategies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Determine clinical and pathological factors associated with perioperative morbidity and
      mortality, and oncological outcomes after multivisceral en bloc resection in patients with
      colorectal cancer.
    

Detailed description: 
      Between January/2009 and February/2014, 105 patients with primary colorectal cancer selected
      for multivisceral resection were selected from a prospective database. Clinical and
      pathological factors, perioperative morbidity and mortality and outcome were verified from
      medical records. Estimated local recurrence, and overall survival were compared using the log
      rank method, and Cox regression analysis was used to determine the independence of the
      studied parameters.
    

Intervention name(s): Multivisceral en bloc resection surgery
Intervention type(s): Procedure
Intervention description(s): Multivisceral en bloc resection for colorectal cancer in advance patients (T4)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain
Condition: Temporomandibular Disorders; Pain; Headaches
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      This purpose of this study is to evaluate the safety and efficacy of treatment with nasal CO2
      in the treatment of pain and other symptoms related to temporomandibular disorder (TMD).
    

Detailed description: 
      This is a randomized, controlled trial evaluating the safety and efficacy of nasal carbon
      dioxide for the treatment of pain and other symptoms related to temporomandibular disorders
      (TMD). Approximately 115 men and women ages 18 to 70 years old who have a history consistent
      with TMD-related pain for at least 3 months and meet all other eligibility criteria will be
      enrolled in this study. There may be up to two (2) visits to the clinic, screening and
      treatment. Screening and treatment may occur on the same day.
    

Intervention name(s): Nasal Carbon Dioxide; Air
Intervention type(s): Drug; Other
Intervention description(s): Nasal Carbon Dioxide; Air (Medical Grade)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Temporomandibular Disorders; TMD; TMJ/TMD; Pain Management; Pain; Headaches
S-1 and Photodynamic Therapy in Cholangiocarcinoma
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary
      stent has been known for palliation of jaundice and improving survival. But most of
      therapeutic effects were expected to delay bile duct obstruction rather than to decrease the
      tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in
      patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the
      combined effect of photodynamic therapy and S-1.
    

Detailed description: 
      In patients with unresectable perihilar cholangiocarcinoma, photodynamic therapy with biliary
      stent has been known for palliation of jaundice and improving survival. But most of
      therapeutic effects were expected to delay bile duct obstruction rather than to decrease the
      tumor. Recently orally available chemotherapeutic agent, S-1 was reported as effective in
      patients with bile duct adenocarcinoma. The investigators' aims of study evaluate the
      combined effect of photodynamic therapy and S-1.
    

Intervention name(s): S-1 Chemotherapy; Photodynamic therapy; Systemic chemotherapy except S-1
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): S-1 chemotherapy before intolerable complication or definite tumor progression Based on the body surface area, <1.25m2: 80mg/day, 1.25~1.5m2: 100mg/day, ≧1.5m2: 120mg/day Given orally twice daily for 14days, followed by 7 days without treatment; PDT with Photofrin® 2mg/kg i.v. 48hrs before laser activation; Variable systemic chemotherapy except S-1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cholangiocarcinoma; Photodynamic therapy; S-1
Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Compared to the Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients
Condition: Kidney Transplantation; Liver Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant
      morbidity and mortality in both otherwise healthy adult population and in the
      immunocompromised patients. The incidence rate of invasive pneumococcal disease is
      considerably higher among organ transplant patients than in healthy individuals. Routine
      immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after
      the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide
      vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine
      has been shown to be more immunogenic and safe in some other subgroups of immunocompromised
      patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal
      conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal
      polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.
    


Intervention name(s): Prevenar13; Pneumovax
Intervention type(s): Biological; Biological
Intervention description(s): Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.; 0.5ml Pneumovax injected intramuscularly at day 1.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal vaccination; immunogenicity; solid organ transplant
Effect of a 12-month Pharmaceutical Care Program on Control of Severe Asthma
Condition: Asthma; Quality of Life
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Only a few well-designed studies have investigated the effect of pharmaceutical care on
      asthma patients and to date there are no published studies investigating this effect
      specifically on severe and refractory asthma.

      The objective of this study is evaluate the effect of pharmaceutical care on asthma control
      and quality of life (QoL) of patients with severe or refractory asthma compared with
      pharmacist dispensation only.
    


Intervention name(s): Pharmaceutical care
Intervention type(s): Other
Intervention description(s): Pharmacist intervention, focused on the optimization of drug therapy, identification and resolution of drug related problems, resulting in best asthma control and quality of life. Pharmacists document their initial and monthly follow up encounters using a specified form. An action plan for self management of these patients was prepared and discussed aiming at early identification and treatment of an exacerbation episode. Meetings will be held weekly with intervention team to discuss action plan and measure of outcomes of all problems identified.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Electrophysiology and Blood Flow in Patients With Schizophrenia and Their Siblings
Condition: Healthy; Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      This study will explore how the brain works during memory testing in an effort to understand
      why some patients with schizophrenia have memory difficulties.

      Patients with schizophrenia and their unaffected family members are eligible for this study.
      Studying family members may help identify the genes related to the memory deficit in
      schizophrenia. Normal volunteers will also be studied.

      Normal volunteers, patients with schizophrenia, and their family members interested in
      participating in this study will be screened with a complete medical examination and
      psychiatric assessment, and performance of simple tasks. Study participants will be shown
      numbers on a screen and asked to recall them after a brief period. This will be done during
      electroencephalographic (EEG) recording, in which electrodes attached to the scalp measure
      the brain s electrical activity. The same test will be repeated while the patient has
      magnetic resonance imaging of the brain. The combined MRI and EEG testing will permit better
      localization of the brain s electrical activity.

      ...
    

Detailed description: 
      It is the aim of this study to investigate the functional activation and coupling between
      brain regions in normals, patients with schizophrenia and unaffected family members. We will
      perform electrophysiological recordings (MEG, EEG) during cognitive activation (Continuous
      Performance Task, Sternberg paradigm, working memory). We will focus on the investigation of
      oscillatory brain activity as this is considered to be crucial for information processing
      related to neuronal integration. The measurements will be closely adapted to equivalent
      fMRI-measurements presented as an independent protocol (00-M-0085). The combination of both
      methods will help to improve activity source localization (MEG/EEG) and correlation of this
      activity between different parts of the brain. In addition, local activity patterns (fMRI)
      can be better characterized in the time domain (tonic versus phasic BOLD-activation). We will
      address whether cognitive activation goes along with an increase or decrease of correlation
      between regional brain areas. In this context, we will investigate whether this correlated
      activation pattern is different in schizophrenics and unaffected siblings when compared with
      normals. The study is integrated with the schizophrenia-sibling study (95-M-0150). Siblings
      of schizophrenic patients are investigated in order to achieve a better understanding of the
      genetic determination of schizophrenia-related pathophysiology.
    

Keywords: Functional Connectivity; Frontotemporal Interaction; Electrophysiology; Functional Magnetic Resonance Imaging; Healthy Subjects; Schizophrenia; MEG; Neuroimaging; EEG; MRI
Does DHEA Enhance the Effects of Exercise in Postmenopausal Women?
Condition: Aging
Study type: Interventional

Summary: 
      Dehydroepiandrostrone (DHEA) and its sulfated ester (DHEAS) are high circulating weak
      androgens which have been associated with conditions that accompany age-related decline such
      as sarcopenia, hyperinsulinemia, osteopenia, and cardiovascular disease. The decline in DHEA
      with age is particularly marked in postmenopausal women. Exercise has always been advocated
      in women; benefit has been demonstrated inmuscle, bone and lipid physiology, as well as
      perception of energy and sense of well-being. This study aims to explore the combined effect
      of both DHEA and exercise in postmenopausal women, age range 55-75 years old. Subjects will
      receive DHEA (50mg/day) or placebo for a 12-week period. At the beginning and conclusion of
      the study patients will undergo testing for muscle strength, body composition, VO2 max,
      insulin sensitivity, muscle biopsy with mitochondria enzyme measurements, and psychological
      analysis. Blood samples pre and post intervention will also be obtained and the level of
      selected anabolic markers, lipids, and androgenic and sex steroid levels will be assessed.
      For the twelve-week period, both placebo and DHEA treated participants will be involved in a
      resistance and aerobic exercise program coordinated through the GCRC and the Dan Abraham
      Healthy Living Center. Several correlations have been established with respect to exogenous
      DHEA administration in postmenopausal women. None have evaluated oral DHEA therapy in the
      setting resistance and aerobic exercise, key therapies advocated in postmenopausal women. As
      a plausible anabolic hormone DHEA is hypothesized to accentuate the effects of exercise as
      has been shown for testosterone. This study, as a randomized double-blind placebo controlled
      trial, will investigate the effects, if any, of a regimented exercise program and DHEA
      supplementation in postmenopausal women, specifically for evidence of enhancement of exercise
      effect by oral supplementation with DHEA in attenuating age-related decline
    


Intervention name(s): DHEA
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Synthetic Human Secretin in Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether multiple doses of secretin are safe and
      effective in the treatment of children with autism.
    


Intervention name(s): RG1068 (Synthetic Human Secretin)
Intervention type(s): Drug
Intervention MeSH terms: Secretin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
NMES During the Day and Prior to Sleep
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      In the present study, the effect of a bolus of intrinsically labeled milk directly after
      one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions:
      during the day and prior to sleep
    

Detailed description: 
      In the present study, the effect of a bolus of intrinsically labeled milk directly after an
      hour of one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two
      conditions: during the day and immediately prior to sleep
    

Intervention name(s): Dietary protein plus NMES during the day; Dietary protein plus NMES prior to sleep
Intervention type(s): Procedure; Procedure
Intervention description(s): Neuromuscular electrical stimulation after a protein bolus, performed during the day; Neuromuscular electrical stimulation after a protein bolus, performed prior to sleep
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Neuromuscular electrical stimulation; Ageing; Protein ingestion