bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese
      healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy
      volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial
      design
    


Intervention name(s): HSK21542; HSK21542; HSK21542; HSK21542; HSK21542; HSK21542; HSK21542; HSK21542; HSK21542
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.; Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.; Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.; Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.; Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.; Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.; Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.; Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.; Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other intervention name(s): HSK21542 0.2 μg/kg; HSK21542 0.5 μg/kg; HSK21542 1 μg/kg; HSK21542 1 μg/kg; HSK21542 0.75 μg/kg; HSK21542 1.5 μg/kg; HSK21542 2.25 μg/kg; HSK21542 3.375 μg/kg; HSK21542 0.2 μg/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Alkaline Diet for Insulin Sensitivity
Condition: Dysglycemia; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to test the effect of increasing the body pH acutely with an
      alkaline medication (sodium bicarbonate, NaHCO3, sodibic) on glucose metabolism post meal in
      non diabetic subjects with normal renal function.

      The investigators aim to determine whether there is an acute reduction in venous blood pH
      following a typical Western-style (high acid load) breakfast in healthy men and women, and
      whether this effect is attenuated by the concurrent administration of an alkaline medication.
      The effect on glucose metabolism, hunger/satiety and arterial stiffness post meal will be
      assessed.
    

Detailed description: 
      The aim of the study is to test the effect of increasing the body pH acutely with an alkali
      (NaHCO3) prior to a high acid load meal on glucose metabolism in non-diabetic men and women.

      This is a double-blind placebo-controlled randomised study with a crossover design.

      Study Procedures:

      Two (2) meal studies will be performed 1 to 2 weeks apart. Studies will include collecting
      fasting blood to assess circulating glucose, insulin, C-peptide, free fatty acids,
      glucagon-like peptide-1, acid/base markers, including electrolytes (EUC) and venous blood pH.
      Participants will then be either administered sodibic (1680 mg) or matching placebo and a
      standardised Western style/high acid load meal. Investigators and participants will be
      blinded to the intervention. Blood will be drawn every 15 min in the first hour and then
      every 30 min for 3 hours in total. Arterial stiffness and appetite score will be evaluated at
      ½ h intervals.

      Sample size: 30

      sample size calculation: To detect a difference in area under the curve (AUC) of venous blood
      pH with a paired crossover design, 32 individuals will be required with statistical power
      1-β>0.8 (allowing for drop-out).

      statistical considerations: Differences between AUC of outcome measures post sodium
      bicarbonate vs. placebo will be tested using paired t-tests. Two-way repeated measure ANOVA
      tests will be conducted to assess differences in the response to the meal with sodium
      bicarbonate vs. placebo.
    

Intervention name(s): Sodium Bicarbonate Oral Capsule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sodium bicarbonate 1680 mg will be administered prior to the meal; Sodibic-matching placebo (Stenlake Compounding Chemist, NSW, Australia) will be administered prior to the meal on a different day 1 to 2 weeks apart
Other intervention name(s): Sodibic capsules (Aspen Australia, NSW, Australia)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Glucose metabolism; Potential renal acid load; Postprandial glycemia; Body acid-base homeostasis; Sodium bicarbonate
Testing the Effectiveness of an Online Behavioral Intervention in Reducing Loneliness
Condition: Psychological Distress; Loneliness
Study type: Interventional

Summary: 
      This study will use a longitudinal randomized experimental design. Participants will be
      randomly assigned to either a positive affect skills intervention or a psychoeducation
      control group and assessed with questionnaires at baseline and immediately post 8-week
      intervention.
    

Detailed description: 
      Participants will be randomly assigned to either a positive affect skills intervention or a
      psychoeducation control group, with each intervention lasting 8-weeks. Participants in the
      positive affect skills intervention will have full access to the unchanged Happify platform.

      The psychoeducation control group participants will use a version of the Happify platform
      that encourages thinking about well-being through quizzes and polls without providing any
      instructions for promotion (i.e., Wait-list Control). Participants will be asked to complete
      questionnaires before and after the 8-week program, at which point study participation will
      end.
    

Intervention name(s): Happify
Intervention type(s): Behavioral
Intervention description(s): An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Masking: None (Open Label)
Primary purpose: Other
Eating Disinhibition and Vagal Tone and the Postprandial Response to Glycaemic Load
Condition: Hunger
Study type: Interventional

Summary: 
      Reducing the glycaemic load (GL) of the diet may benefit appetite control but its utility is
      complicated by psychological influences on eating. Disinhibited behaviour, a risk factor for
      overconsumption, is characterized by reduced prefrontal cortex activity, which in turn
      directly modulates vagal tone; a phenomenon inversely associated with blood glucose (BG) and
      insulin levels. This double blind randomised controlled trial explores the influence of
      disinhibited eating and vagal tone (heart rate variability) on the postprandial response to
      GL and hunger.
    

Detailed description: 
      There is growing recognition that lowering the glycaemic load of the diet might reduce a
      range of cardiovascular risk factors such as raised plasma triglycerides, HbA1c and C
      reactive protein and aid in body weight regulation. A proposed mechanism includes higher
      satiety and prolonged satiation by virtue of improved postprandial metabolic control,
      although, whether lower GL meals result in greater weight loss or increased satiety is still
      a matter of debate. One matter complicating the issue is that the desire to consume food may
      be driven by psychological factors; food reward centres in the brain may override hormonal
      regulation of food intake. Amongst psychological factors disinhibition has the largest and
      most consistent body of empirical data that associates it with weight gain although the
      mechanisms involved are unknown. This study will investigate whether, irrespective of BMI or
      habitual diet, disinhibited eaters have greater glycaemic excursions following a high
      glycaemic load drink and whether this predicts subsequent satiation.
    

Intervention name(s): Isomaltulose; Glucose; Sweetened water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 75g Isomaltulose (low glycaemic load intervention); 75g Glucose (high glycaemic load intervention); Sweetened water will be used as a control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Blood glucose
Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and
      single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb®
      tablet (fimasartan) in healthy subjects
    


Intervention name(s): Fimasartan; Fimasartan
Intervention type(s): Drug; Drug
Intervention description(s): Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg; Period 1 first administration of fimasartan 30mg Period 2 second administration of fimasartan 60mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: fimasartan; absolute bioavailability
Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open-label study to assess the efficacy and tolerability of the combination
      Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients.
      HER2 status will be confirmed centrally by fluorescence in situ hybridization (FISH).

      Phase I: Initial doses will be:

      Myocet: 50-60 mg/m² day 1 every 3 weeks; Taxotere 60-75 mg/m² day 1 every 3 weeks; and
      Herceptin (4) 2 mg/kg weekly.

      Sample size will depend on the number of patients recruited during dose escalation. Three
      patients must be recruited in each dose level. If one out of three experiences a
      dose-limiting toxicity (DLT), 3 more patients must be recruited in the same dose level.
      Considering that there are 4 dose levels to be tested, the estimated number of patients is 9
      to 24. Patients receiving the recommended dose (RD) will be incorporated into phase II of the
      study.
    

Detailed description: 
      Phase II: The average pathological complete response rate reported in other trials is around
      11%. The investigators expect to achieve an increase of 14% on this rate; that is, they
      expect a pathological response rate of 25%. With a= 0.05 and β=0.2, 18 patients are initially
      needed. If at least 3 pathological complete responses are achieved, recruitment will continue
      to up to 53 patients. At least 10 pathological complete responses are needed to probe the
      hypothesis. Considering a 10% post-randomization drop-out rate, a total of 59 patients must
      be recruited for the trial.
    

Intervention name(s): Myocet; Taxotere; Herceptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Myocet®: 60-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles; Taxotere® 70-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles; Herceptin® (4) 2 mg/kg (vía IV) Semanal for 6 cycles
Other intervention name(s): Lyposomal Doxorubicin; Docetaxel; Trastuzumab
Intervention MeSH terms: Docetaxel; Doxorubicin; Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Her2neu positive breast cancer.; Neoadjuvant treatment.
Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      A double-blind randomised active-controlled trial aims to assess whether Cogmed (adaptive)
      working memory training results in improvements in untrained measures of cognition, speech
      perception and self-reported hearing abilities in older adults (50-74 years) with
      mild-moderate hearing loss who are existing hearing aid users, compared with an active
      placebo Cogmed (non-adaptive) control. It is hypothesised that improvements on trained Cogmed
      tasks, representing increased working memory capacity, will result in improved performance on
      cognitive and speech perception tasks that engage working memory. We also measure
      self-reported hearing ability to assess self-perceived benefit of Cogmed training.
    

Detailed description: 
      One in ten people aged between 55-74 years have a significant hearing impairment in their
      better hearing ear (as defined by audiometric hearing thresholds). Yet, it is becoming
      increasingly clear that the challenges faced by older listeners cannot be explained by the
      audiogram. The ability for people with hearing loss to use cognition to support context
      allows for compensation of degraded auditory input, which in turn offers promise for new
      cognitive-based rehabilitative interventions. Working memory is known to be highly associated
      with language and recent evidence has shown significant generalisation of on-task learning
      from Cogmed working memory training to improvements in sentence-repetition skills of children
      with severe to profound hearing loss and use cochlear implants. This evidence offers support
      for further investigation into the potential benefits of working memory training to improve
      speech perception abilities in other hearing impaired populations. This study aims to assess
      whether Cogmed (adaptive) working memory training improves the listening abilities of adults
      with mild to moderate hearing loss as assessed using untrained measurers of cognition, speech
      perception and self-reported hearing ability, compared with an active control (Cogmed,
      non-adaptive) group. A 6 month follow-up will assess retention of any training-related
      improvements in outcomes for the adaptive training group.
    

Intervention name(s): Cogmed RM - Online adaptive working memory training; Cogmed RM - Online non-adaptive (placebo) working memory training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hearing loss; Hearing aid; Speech intelligibility; Speech perception; Cognitive training; Working memory; Working memory training
Perioral Rejuvenation and Upper Lip Enhancement
Condition: Perioral Rejuvenation; Upper Lip Projection
Study type: Interventional

Summary: 
      To determine if subjects who receive premaxillary injection demonstrate an increase in nasal
      tip projection and an associated increase in upper lip projection, and vermillion height.
    


Intervention name(s): Restylane® Defyne
Intervention type(s): Device
Intervention description(s): hyaluronic acid filler injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Levetiracetam Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a placebo-controlled study designed to learn if levetiracetam is effective for
      tardive dyskinesia.
    


Intervention name(s): levetiracetam; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement
Condition: Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and tolerability of ascending single doses of
      LNA043 given intra-articularly into the human knee joint prior to its removal at total knee
      replacement surgery. In addition, this will help to establish the presence of LNA043 within
      the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow
      exploration of biomarkers of hyaline cartilage repair.
    


Intervention name(s): LNA043; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery; ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Primary Osteoarthritis, Total Knee Replacement, cartilage
Non-Invasive Brain-Computer Interface for Virtual Object Control
Condition: Individuality
Study type: Observational

Summary: 
      A brain-computer interface (BCI) is a system that provides a separate output pathway for
      neurological signals whereby they can be interpreted to determine the user's intended
      cognitive action. Utilizing EEG-based sensorimotor rhythms (SMRs) generated in the motor
      cortex has allowed subjects to control virtual computer cursors in up to three dimensions by
      simply imagining the movement of a specified body part. Nevertheless, the scalp EEG signals
      are smeared by the volume conduction effect and measurement noise. The overall hypothesis of
      this study is that EEG-based virtual object control may help reveal optimal motor imagination
      tasks best used in a BCI.

      The PI's hypotheses include: (1) The use of advanced signal processing techniques will better
      reveal characteristics of EEG signals that represent the underlying motor cognitive function
      of the subject; (2) BCI systems based on SMR generated using motor imaginations will allow
      effective control of a virtual object in real time; (3) EEG imaging techniques will provide
      insight into the areas of cortical activation during a motor imagery task that can be
      utilized to increase the spatial resolution of non-invasive BCI's.
    

Detailed description: 
      The goal of the present study is to explore advanced signal processing techniques that will
      better reveal characteristics of EEG signals that represent the underlying motor cognitive
      function of the subject, and conduct experiments to better control an virtual object on the
      computer screen including a cursor or a helicopter.

      The primary objective of this study is to test the above hypotheses (1) and (2) in a healthy
      subject population.This study will determine the ability of subjects with full cognitive
      function to control a non-invasive brain-computer interface by imagining a particular
      movement. Using non-invasive methods, we will investigate the neural processes that occur
      during the motor imagination tasks associated with controlling a virtual object. Using a
      variety of motor imaginations, we will determine which tasks are best used for BCI control by
      quantitative means of BCI performance and neurological dynamic system analysis.

      Subjects for this study will be healthy, English speaking adult volunteers (18-64 years old)
      with no history of mental illness, neurological deficit, or traumatic brain injury.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Students and workers at the University of Minnesota - Twin Cities campus
The Use of Narrow Band Imaging in Screening Colonoscopy
Condition: Colonoscopy
Study type: Interventional

Summary: 
      Narrow band imaging (NBI) is an imaging technique that allows a better definition of
      capillary pattern and improves the contrast between adenomas and the surrounding mucosa.
      Conflicting data exist on the ability of NBI in to improve detection of colonic neoplasm; the
      impact of NBI is being tested in several screening scenarios. The investigators evaluated
      whether the routine use of NBI, compared to white light (WL), during the withdrawal phase of
      screening colonoscopy improved adenoma detection.
    


Intervention name(s): Narrow Band Imaging
Intervention type(s): Procedure
Intervention description(s): Narrow Band Imaging
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: screening colonoscopy; narrow band imaging
Military Women's Health and Illness Behaviors in Deployed Settings
Condition: Genitourinary Symptoms
MeSH terms: Illness Behavior
Study type: Observational

Summary: 
      The purpose of this study is to gain better understanding of how recently deployed military
      women managed urinary and vaginal symptoms while deployed. Participants in this study will be
      asked to take part in a 45-60 minute interview.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A total of 50 military women.
      
Keywords: Military Women; Women's Health; Genitourinary Symptoms; Illness Behaviors; To determine how women manage genitourinary symptoms while deployed.