bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this
      study is to assess the bioequivalence between Test Product and the corresponding Reference
      Product under fed condition in normal, healthy, adult, human subjects.
    

Detailed description: 
      Primary Objective of this pivotal study was to assess the bioequivalence between Test
      Product: Levocetirizine Dihydrochloride 5 mg Tablets of M/s Ipca Laboratories Limited, India
      and the corresponding Reference Product: Xyzal® (levocetirizine dihydrochloride) 5 mg Tablets
      of M/s UCB Inc.,USA, under fed condition in normal, healthy, adult, human subjects in a
      randomized crossover study.

      Secondary Objective was to monitor the safety and tolerability of a single oral dose of
      Levocetirizine Dihydrochloride 5 mg Tablets in normal,healthy, adult, human subjects.

      The study was conducted with 28 healthy adult subjects. In each study period, a single 5 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 11 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Levocetirizine Dihydrochloride tablets 5 mg; Levocetirizine Dihydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg tablet once in a day; 5 mg tablet once in a day
Other intervention name(s): Test product; Xyzal
Intervention MeSH terms: Cetirizine; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploratory Study of NS-065/NCNP-01 in DMD
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the safety, tolerability, efficacy and pharmacokinetics (PK)
      of NS-065/NCNP-01 in subjects diagnosed with Duchenne muscular dystrophy (DMD).
    


Intervention name(s): NS-065/NCNP-01
Intervention type(s): Drug
Intervention description(s): NS-065/NCNP-01 for Infusion is packaged as 25 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
Cohort 1: 1.25mg/kg once weekly for 12 weeks; Cohort 2: 5.0mg/kg once weekly for 12 weeks; Cohort 3: 20.0mg/kg once weekly for 12 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Duchenne muscular dystrophy; NS-065/NCNP-01; exon 53 skipping; morpholino
Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily
      individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the
      investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2
      diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD
      background treatment: Metformin plus/minus alpha-glucosidase inhibitor.
    


Intervention name(s): biphasic insulin aspart 30
Intervention type(s): Drug
Intervention description(s): Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043)
Condition: Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate whether corifollitropin alfa (MK-8962),
      administered alone for 12 weeks and then in combination with human chorionic gonadotropin
      (hCG) for 52 weeks, increases the testicular volume in adolescent males aged 14 to <18. In
      addition, the study will evaluate participants for safety, tolerability and for the
      development of corifollitropin alfa antibodies. No formal hypothesis will be tested for this
      estimation study
    


Intervention name(s): Corifollitropin alfa; hCG
Intervention type(s): Drug; Drug
Intervention description(s): CFA administered 100 μg (if body weight ≤60 kg) or 150 μg (if body weight >60 kg) by SC injection, once every 2 weeks for 64 weeks (Day 1, Week 0 through Week 64).; hCG 500-5000 IU reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64).
Other intervention name(s): MK-8962; Elonva
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Active Control, Double-blind, Double-dummy, Parallel-group, Randomized Study to Assess the Effect of VECAM 40/300, Administered at Bedtime, vs. Esomeprazole 20 mg, Administered 30-60 Min. Before Dinner, on Daytime and Nighttime GERD Symptoms
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to assess the effect and safety of oral administration of VECAM 40/300
      administered at bedtime compared to Esomeprazole 20 mg administered 30-60 minutes before
      dinner, for control of nighttime and daytime HB and other 24 hour GERD symptoms.

      The rational for the study is based on the contention that VECAM exhibits potent inhibition
      of acid secretion and because of its mechanism of action, it can be administered at bedtime
      without food. Such timing of drug dosing will allow effective inhibition of nighttime acid
      secretion. Because of its mechanism of action, VECAM exhibits improved 24-hour inhibition of
      acid secretion and hence, its bedtime administration will not compromise its effect during
      the daytime. This improved control of acid secretion will predictably result in better
      control of nighttime as well as daytime heartburn (HB) symptoms.
    


Intervention name(s): VECAM 40/300; Esomeprazole 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule, orally, once daily at bedtime.; 1 capsule, orally, once daily 30-60 min. before dinner
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux; GERD; Nocturnal GERD; Heartburn; Nighttime Heartburn
A Study to Compare the 12-month Spatz3 Adjustable Balloon With a 6-month Non Adjustable Balloon
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to compare a 12-month adjustable balloon over a 6-month
      non-adjustable balloon with 6-month dietician follow-up. The endpoint is %TBL at 12 months.
    

Detailed description: 
      Subjects will be studied in a randomized open label single center study that will run 52
      weeks. Subjects will be randomized to two treatment groups: Group 1- Spatz3 adjustable
      balloon 12-month implantation; and Group 2 - non adjustable 6-month implantation with
      additional 6 months of dietician follow-up after balloon extraction. Fourth four eligible
      subjects will be randomized to treatment groups 1 and 2 and will undergo endoscopy and
      implantation of either the Spatz3 Adjustable Balloon or the 6-month non adjustable Balloon.
      All subjects will follow a calorie restricted diet designed by the dietician. The initial
      diet will be liquid and will be advanced as per the dietician's recommendations. Changes in
      diet will depend on subject tolerance to the balloon and specific food intolerances and will
      be adjusted frequently by the dietician. The initial balloon volume will be 500 ml of 0.9%
      normal saline with 2 ml of a 1% solution of methylene blue. An adjustment will be performed
      for treatment Group 1 at Week 24 (±6 weeks) with the addition of 200-300 ml of 0.9% normal
      saline, as per section 1.6.2.1.3.3. The balloon adjustment procedure is done with an
      endoscopy procedure under the same sedation as the implantation procedure. The subjects will
      have follow up by the PI/Nurse Practitioner and the Dietician/Nutritionist periodically as
      per section 1.7.3. until extraction at 52 weeks. The 6-month non adjustable balloon treatment
      group will undergo balloon extraction at 6 months followed by monthly dietician vists for an
      additional 6 months. The study will terminate at the end of 12 months.
    

Intervention name(s): Gastric Balloon
Intervention type(s): Device
Intervention description(s): implantation of two types of gastric balloons. Spatz3 Adjustable balloon will be implanted for 12 months and 6-month non adjustable balloon will be implanted for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be studied in a randomized open label single center study that will run 52 weeks. Subjects will be randomized to two treatment groups: Group 1- Spatz3 adjustable balloon 12-month implantation; and Group 2 - 6-month non adjustable balloon implantation with additional 6 months of dietician follow-up after balloon extraction
Masking: Single (Participant)
Primary purpose: Treatment
Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia
Condition: Hyperinsulinemic Hypoglycemia
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effectiveness of exenatide in adults experiencing
      episodes of hyperinsulinemic hypoglycemia following Roux-en-Y bariatric surgery.
    

Detailed description: 
      Roux-en-Y gastric bypass surgery (RYGB) is one of the most common bariatric surgeries in the
      United States and is generally highly effective for weight loss. Unfortunately, among the
      potential complications is hyperinsulinemic hypoglycemia. Though the prevalence of this
      disorder has not been fully characterized, it can be associated with debilitating symptoms
      which severely impact quality of life and can be life-threatening. The underlying
      pathophysiology of hyperinsulinemic hypoglycemia likely involves a mismatch in the amount of
      insulin secreted in response to mealtime carbohydrate absorption. It has been observed that
      the ingestion of a high carbohydrate load often leads to a modest rise in post-prandial
      glucose levels followed by an inappropriately exaggerated insulin release among individuals
      with this condition. Low carbohydrate diet sometimes provides full or partial relief of the
      symptoms.

      Standard medical management for RYGB associated postprandial hyperinsulinemic hypoglycemia
      includes acarbose, which partially reduces carbohydrate absorption from the gut, and
      diazoxide, which directly inhibits insulin release from pancreatic beta cells. However, the
      medical options are not reliably effective, leading some individuals to reverse RYGB, which
      also may not be effective, or even undergo partial pancreatectomy, risking additional
      complications such as diabetes. Much more reliably effective treatments are needed for this
      special population who develop this bariatric surgical complication.

      Potential mechanisms contributing to the mismatched insulin secretion post RYGB include
      decreased systemic and adipose tissue inflammation, and increased insulin receptor expression
      in liver and skeletal muscle, and increases in adiponectin.
    

Intervention name(s): Exenatide; Acarbose; Exenatide Placebo; Acarbose Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Exenatide at a dose of 5 mcg; Acarbose at a dose of 25 mg; Placebo for Exenatide; Placebo for Acarbose
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide; Acarbose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Influence of Qigong Wuqinxi on Health Status of the Community-Dwelling Older Adults
Condition: Sleep Quality; Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Pain and sleep disturbance are common symptoms of community-dwelling older adults observed in
      traditional Chinese medical(TCM) clinics. Acupuncture or other medical treatments have their
      side effects and usage limitations, so it is expected that other non-medical interventions
      can relieve the symptoms. The purpose of this study was to test the effect of Qigong Wuqinxi
      intervention on pain, sleep quality, TCM body constitution and tongue features of the
      community-dwelling older adults.
    

Detailed description: 
      Methods: using cluster randomised clinical trial , two community care sites in Sanmin
      District, Kaohsiung City were selected. Community-dwelling older adults who are over 65 years
      old and have the ability to communicate in Mandarin and Taiwanese were recruited . Those who
      had severe mental illness, moderate to severe dementia (level 2 or above on the Clinical
      Dementia Assessment Scale) and Barthel Index score <60 were excluded. There were 63 valid
      cases divided into experimental group(n=32) and control group(n=31). The experimental group
      practiced Qigong Wuqinxi 50 minutes three times a week for 12 weeks; meanwhile, the control
      group maintained routine daily activities. The two groups of participants were tested before
      and after the intervention period with the following research tools: 1) The Brief Pain
      Inventory, (BPI), 2) Pittsburgh Sleep Quality Index (PSQI), 3) Body Constitution
      Questionnaire (BCQ), 4) automatic tongue diagnosis system (ATDS). The research data were
      analyzed with SPSS 19 software package for descriptive statistics, chi-square test,
      independent t test and paired t test.
    

Intervention name(s): Qigong Wuqinxi
Intervention type(s): Behavioral
Intervention description(s): Wuqinxi is an exercise method developed by the ancient Chinese physician Hua Tuo by combining the ancient guide, breathing, and imitating the shapes of five animals, such as tiger, deer, bear, ape, and bird, combined with the zang-fu and meridian theory of traditional Chinese medicine. There have been studies in the past proven that this exercise can achieve health-promoting effects
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Qigong Wuqinxi; Chronic Pain; Sleep Quality; Traditional Chinese Medical Body Constitution; Tongue Features; Community-Dwelling Older Adults
OKS for the Treatment of Hemispatial Neglect
Condition: Neglect, Hemispatial; Neglect, Sensory; Neglect, Hemisensory
MeSH terms: Perceptual Disorders
Study type: Interventional

Summary: 
      Hemispatial neglect is a disorder where the patient has difficulty attending to objects and
      information in the left side of space, which occurs following strokes to the right side of
      the brain. This project is designed to help us understand how optokinetic stimulation treats
      the symptoms of hemispatial neglect.
    


Intervention name(s): OKS
Intervention type(s): Device
Intervention description(s): Optokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Two Blades of Videolaryngoscope in Simulated Difficult Airway in Children
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      Airway management and tracheal intubation are routinely performed in paediatric anaesthesia
      and yet are associated with preventable adverse events. The D-blade of videolaryngoscope is
      preferred in difficult intubation with a more curved blade then the Macintosh
      videolaryngoscope blade, which may be more useful in difficult intubation. The aim of the
      study is to compare the D-blade of videolaryngoscope with Macintosh videolaryngoscope blade.
    


Intervention name(s): D-blade of videolaryngoscope; simulated difficult airway; Macintosh videolaryngoscope
Intervention type(s): Device; Other; Device
Intervention description(s): intubation will be done using d-blade of videolaryngoscope; extension of head will be limited by using collar.; intubation will be done using macintosh videolaryngoscope
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: D-Blade; Macintosh videolaryngoscope blade; Simulated difficult intubation
Effect of Cenicriviroc on HIV Neurocognitive Impairment
Condition: AIDS Dementia Complex; HIV-1-Associated Cognitive Motor Complex; Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; AIDS Dementia Complex; Dementia; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypothesis is that cenicriviroc will improve cognition in HIV infected individuals
      with cognitive impairment. The investigators will study the effect of cenicriviroc on
      cognition in 24 subjects over a 24 week period.
    

Detailed description: 
      HIV-associated neurocognitive disease (HAND), particularly in its milder form, is estimated
      to occur in greater than 30% of HIV infected individuals in the era of potent antiretroviral
      therapy. As even mild disease leads to functional consequences with decreased ability to live
      independently, HAND is of substantial public health concern. HIV-induced immune
      activation/inflammation of monocytes (MO) may be primarily responsible for the development of
      HAND.

      Cenicriviroc is a combined CCR5 and CCR2 chemokine co-receptor antagonist. The investigators
      hypothesize that dual CCR5 and CCR2 blockade with the use of CVC will lead to measurable
      reductions in MO activation and lead to cognitive improvement by decreasing HIV infection of
      MO and by interrupting the trafficking of such MO into the central nervous system.

      The investigators propose a single arm, 24-week trial of CVC in 24 subjects with HIV-1
      infection suppressed on ART (plasma HIV RNA < 50 copies/ml) for 1 year or more with mild to
      moderate cognitive impairment.
    

Intervention name(s): cenicriviroc
Intervention type(s): Drug
Intervention description(s): cenicriviroc given once daily for 24 weeks; number of pills dependent on recommended modifications based on patient's other antiretroviral medications and certain other medications anticipated to interact with cenicriviroc
Other intervention name(s): TBR-652
Intervention MeSH terms: Cenicriviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AIDS Dementia Complex; HIV-1-Associated Cognitive Motor Complex; Human Immunodeficiency Virus
Proof-of-concept Study on Disinfection and Healing Acceleration Capabilities of 222nm Wave Length Narrow Band Ultraviolet Lighting Device
Condition: Ultraviolet Rays
Study type: Interventional

Summary: 
      The threat of MRSA and multi-drug resistant pathogens have been growing in recent years. A
      new means of countering the infectious threat is required and one such modality is the use of
      UV light for disinfection. The aim of the study is to proof the efficacy of the 222nm UV
      light in disinfection on patients with sacral sores. This is a first in human
      proof-of-concept study
    

Detailed description: 
      Recent outbreaks of Ebola and MERS, and in the trend of growing threat of MRSA and multi-drug
      resistant pathogens, it is clear that a new means of countering the infectious threat is
      needed - even the US, EU, and Korean hospitals with the latest facilities has failed to stop
      the spread of these pathogens inside their wards.

      This novel "Harmless UV Light," operating within the "Safe Zone Wave Length," will be a
      disruptive technology to counter the growing threats of infectious diseases, such as
      multi-drug-resistant bacteria and also viruses such as Ebola, MERS and new type Influenza. It
      will be a disruptive device in that it aims to be applied to fast, effective and labor-free
      disinfection of living environments, such as hospital wards, airports, and other public
      spaces to stop the spread of pathogens. This research is the first human clinical trial using
      this device that will spearhead the development of this technology, providing the key
      starting clinical data which would be the lead to development for a wider range of
      indications and markets. Successful proof of concept will lead to the next stage
      collaboration of larger scale clinical trials, and trials targeting wider range of
      indications and markets, at NUHS.
    

Intervention name(s): SafeZoneUVC
Intervention type(s): Device
Intervention description(s): SafeZoneUVC® uses a Krypton Chloride (Kr-Cl) excimer lamp as its light source. The Kr-Cl excimer lamp emits UVC light having a main wavelength of 222 nm when the Kr-Cl exciplex is deactivated to non-excited state molecule in the lamp. This 222 nm UVC light can inactivate bacteria, while the Kr-Cl excimer lamp also emits UVC light having a wavelength of 230 nm or more. SafeZoneUVC® effectively eliminates UVC light with a wavelength of 230 nm or more by incorporating an appropriate optical filter inside the unit and also utilizing an opaque guide to ensure that light is not dispersed beyond the target area.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants
Condition: Healthy Study Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of
      Staccato alprazolam in healthy Japanese, Chinese, and Caucasian participants.
    


Intervention name(s): Alprazolam; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Study participants will receive Staccato alprazolam at prespecified time-point.; Study participants will receive Staccato placebo at prespecified time-point.
Other intervention name(s): UCB7538; PBO
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Study Participants; Phase 1; Staccato alprazolam; Alprazolam; STAP-001