bioihbjkbjnl/mcl2 huggingface dataset:
a Clinical Study to Evaluate the Safety, Pharmacokinetic Profile and Efficacy of CU-20401
Condition: Safety
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a Phase Ib/II clinical study. Phase 1b was a single-center, nonrandomized,
      single-arm study to evaluate the safety, PK profile, preliminary efficacy, and immunogenicity
      of different groups (SC) of CU-20401 in the submental fat accumulation population. Phase 2 is
      a multicenter, randomized, placebo parallel-controlled study to evaluate the safety,
      efficacy, and immunogenicity of the preferred group (SC) of CU-20401 in a submental fat
      accumulation population.
    

Detailed description: 
      Eligible subjects will first enter Arm A1, receive treatment for this group on D1, and
      undergo study visits and biological sample collection (PK samples and immunogenicity samples)
      at established timepoints. After the last subject in Arm A1 has completed at least 3 days of
      safety and tolerability observation,After no safety events (≥ Grade 2 study drug-related AEs)
      have occurred as assessed by the investigator, enrollment into the A2 Arm may be initiated.
      Enrollment in subsequent treatment groups and so on. If a subject in this dose group
      experiences an AE ≥ Grade 2 related to the investigational product, the investigator will
      assess the time to continue observation and start the next treatment group according to the
      subject ' s condition.

      Based on the data obtained in Phase 1b, the grouping for Phase 2 will be determined by the
      investigator and the sponsor in consultation. It may be Group X1, Group X2, and Group X3.
      Eligible subjects were randomized 1: 1: 1: 1 to receive treatment in Group X1, X2, X3, or
      placebo on D1 and to undergo study visits and biological sample collection (immunogenicity
      samples) at established timepoints.
    

Intervention name(s): CU-20401
Intervention type(s): Drug
Intervention description(s): Subcutaneous injection in the subcutaneous fat area，0.2ml
Other intervention name(s): injection，CU-20401
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetic profile; efficacy
Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)
Condition: Respiratory Syncytial Viruses
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine if a single intravenous (IV) dose of
      clesrovimab when administered at 1 of 4 dose levels results in a reduction in viral load
      after intranasal inoculation (with RSV A Memphis 37b) compared to IV placebo. It is
      hypothesized that at least 1 of the 4 dose levels of clesrovimab given prior to inoculation
      will reduce the area under the viral load-time curve (VL-AUC) from Day 2 through Day 11
      (inclusive) after viral inoculation (Study Day 31 through Day 40) compared to placebo.
    


Intervention name(s): Clesrovimab; Placebo; RSV-A Memphis 37b
Intervention type(s): Biological; Other; Biological
Intervention description(s): Single dose of clesrovimab administered via IV infusion.; Placebo (0.9% sodium chloride, USP sterile saline) administered via IV infusion.; Approximately 4Log10 plaque-forming units (PFU)/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.
Other intervention name(s): MK-1654
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Microgreen Consumption for Healthy Aging
Condition: Aging; Menopause; Healthy
Study type: Interventional

Summary: 
      Microgreens are an emerging horticultural food crop with potential to improve human health.
      Previous research suggests they have broad consumer acceptance and that the micronutrient and
      bioactive compound levels are higher than that of their mature counterparts. To date, no
      studies have explored the feasibility of microgreen consumption, gastrointestinal tolerance
      of microgreen consumption, or their potential health impacts in humans. Therefore, the
      overall goal of this study is to explore the feasibility and acceptability of daily
      microgreen consumption, gastrointestinal tolerability, and potential health impacts of red
      cabbage and red beet microgreens in healthy middle-aged/older men and postmenopausal women -
      a population inherently at risk for chronic disease, e.g. cardiovascular disease.
    


Intervention name(s): Red cabbage microgreens; Red beet microgreens
Intervention type(s): Other; Other
Intervention description(s): 2 cups per day; 2 cups per day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Dose-ranging Study to Evaluate the Safety & Immunogenicity of a HIV Vaccine 732461 in Healthy HIV Seronegative Volunteers
Condition: AIDS; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK has constructed a new HIV immunogen comprised of conserved parts of the HIV virus (gag,
      pol and nef). The principal objectives of this study are to evaluate the reactogenicity and
      safety of this candidate vaccine with or without a GSK proprietary adjuvant system at three
      different doses and to evaluate the CD4+ T-cell response in terms of proportion of responders
      to the antigens two weeks after the second vaccination.
    

Detailed description: 
      This is a single center, observer-blind, randomized, dose-escalating, staggered study with 6
      groups: 3 groups of 50 subjects receiving the adjuvanted candidate vaccine, at 3 different
      doses and 3 groups of 10 subjects receiving the non-adjuvanted candidate vaccine in water for
      injection, at 3 different doses. The vaccination schedule will be 0-1 month. Blood samples
      will be collected at 8 visits. The duration of the study will be approximately 14 months for
      each subject. Rationale for Protocol Posting Amendment: The third vaccination will be
      cancelled and the visit at Month 7 will be postponed to Month 9. The Protocol Posting has
      also been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Intervention name(s): HIV vaccine 732461
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gag; vaccine; adjuvant; HIV; Pol; Nef
Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of
      TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period
      and then 14 consecutive days). Dose escalation design is utilized in this study, and dose
      escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step
      2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of
      the previous step.
    


Intervention name(s): TA-7284; Placebo of TA-7284
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive single ascending dose of TA-7284 in each step (4 doses planned: 25, 100, 200 and 400 mg), once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days); Patients will receive placebo tablets in each step, once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; TA-7284
Mechanisms of Massage
Condition: Healthy; Pain
Study type: Interventional

Summary: 
      The investigators have previously found moderately painful massage produces comparable
      changes in pain sensitivity as a conditioned pain modulation paradigm in healthy participants
      suggesting shared underlying mechanisms. The researchers aim to extend these findings by
      understanding the influence of expectation on these findings.
    

Detailed description: 
      Massage is a muscle biased intervention individuals seek for pain alleviation; however, the
      mechanisms of massage are not well established. In this study, the investigators aim to
      determine the effect of expectations on massage related hypoalgesia. Individuals meeting
      eligibility criteria and agreeing to participate will attend one session that lasts
      approximately one hour. A myofascial trigger point (taut band of muscle tissue) will be
      assessed on the neck of the participant. Next, a baseline assessment of pressure pain
      threshold will be performed followed by random assignment to one of four study arms.
    

Intervention name(s): Pain Inducing Massage; Pain Free Massage; Positive Expectation Instructional Set; Negative Expectation Instructional Set
Intervention type(s): Other; Other; Other; Other
Intervention description(s): A pain inducing massage (pain intensity = 50/100) will be applied for 60 seconds, 4 times.; A pain free massage (pain intensity = 0/100) will be applied for 60 seconds, 4 times.; Participants will be instructed that the massage is effective for some people with neck pain.; Participants will be instructed that the massage is ineffective for some people with neck pain.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions
Condition: Biological Availability
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, single-center, balanced, randomized, two-treatment, two-sequence, four-period,
      full replicate, crossover, single dose, Phase I, oral comparative bioavailability study in
      healthy, adult participants (male subjects and female subjects of non-childbearing potential)
      under fasting conditions with a screening period of 21 days prior to enrollment. In each
      study period, 21 blood samples were collected from each participant to analyze the
      pharmacokinetic profile of the test as well as the reference drug.
    


Intervention name(s): Dasatinib ASD 100 mg; Dasatinib 140 MG [Sprycel]
Intervention type(s): Drug; Drug
Intervention description(s): XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 100 mg Test Formulation; SPRYCEL® (dasatinib) 140 mg Film-Coated Tablets
Intervention MeSH terms: Dasatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
Condition: Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus
MeSH terms: Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this study are to assess the safety and the SVR12 rate of
      ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with
      decompensated cirrhosis.
    


Intervention name(s): ombitasvir/paritaprevir/ritonavir; dasabuvir; ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet; paritaprevir co-formulated with ritonavir and ombitasvir; tablet; tablet
Other intervention name(s): ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ritonavir also known as norvir; ABT-333
Intervention MeSH terms: Ritonavir; Ribavirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cirrhosis; Hepatitis C; Child-Pugh B; Hepatitis C Genotype 4; Interferon-Free; Hepatitis C Genotype 1; Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus
Effect of Custom Foot Orthoses in Patients With Psoriatic Arthritis
Condition: Psoriatic Arthritis; Foot Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional

Summary: 
      Foot involvement is a major concern in psoriatic arthritis (PsA). The patients could
      experience severe levels of foot pain and disability and reduced mobility and quality of
      life. Previous studies showed that the use of Custom foot orthoses (CFO) was effective to
      improve foot pain and perceived disability in patients with foot disease associated with
      rheumatoid arthritis. However, there are no records in the literature on the effectiveness of
      CFO in PsA patients. Therefore, our objective was o explore the effects of CFO on foot pain,
      foot function, gait spatiotemporal parameters (STP), and ambulatory physical activity (APA)
      in PsA patients with foot involvement.

      In this pre-experimental exploratory study, 22 PsA patients having stable medication in the
      last 3 months preceding the recruitment were recruited. All the patients wore functional CFO
      designed by an experimented podiatrist during a 7-week period. Foot and lower limb pain and
      foot function were measured at baseline (T0) and after the 7-week period using the numerical
      rating scale (NRS) and the foot function index (FFI), respectively. Gait function was
      assessed by recording spatiotemporal parameters (STPs) during a 10-meter walk test using an
      instrumented gait analysis system (Mobility Lab) at T0 and T7. Freeliving walking activities
      (step count, freeliving cadence, time spent in different ambulatory physical activity (APA)
      intensities) at T0 and T7 were recorded over 7 days using accelerometer data collected from
      an instrumented sock worn by the participants during waking hours.
    


Intervention name(s): Custom foot orthoses
Intervention type(s): Device
Intervention description(s): 3D printed custom foot orthoses (CFO) were designed by the same experimented podiatrist based on a detailed clinical and biomechanical examination and a 3D foot scan obtained for each participant. The degrees and types were adjusted at the CFO delivery according to each patient's comfort and tolerance.
The intervention period was 7weeks. The participants were taught to wear the CFO progressively during the first two weeks to allow for the lower limbs' muscles and structures to adjust to the CFO, and to wear the orthoses for the next 5 weeks, 7 days a week as often as they could.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of Chronotropic Index, Exercise Capacity in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      To investigate whether diabetes affects lung function and exercise capacity and impairs
      autonomic nervous system.
    

Detailed description: 
      Type 1 diabetes mellitus is a systemic disease that affects the biochemical, morphological
      and functional properties of various tissues of the body. It is characterized by the loss of
      insulin-producing cells associated with an autoimmune disorder.

      The chronotropic response is an increase in heart rate due to physical activity and metabolic
      demand. Chronotropic disorder is an inadequate cardiac response and is frequently encountered
      in individuals with diabetes. Diabetes-related comorbidities or physiological abnormalities
      may lead to impaired chronotropic response, such as altered blood catecholamine levels during
      exercise, structural myocardial anomalies, and impaired baroreflex sensitivity. While there
      are studies on chronotropic response in individuals with type 2 diabetes, chronotropic
      disorders have not been investigated in adults with type 1 diabetes.

      Diabetes affects the lungs negatively. In individuals with diabetes decreased lung volume,
      and diffusion were observed. Dynamic lung capacity of individuals with type 1 diabetes with
      the pulmonary function test will be investigated.

      There are limited studies evaluating respiratory muscle strength and endurance in individuals
      with type 1 diabetes. These studies have presented conflicting findings. Informations will be
      provided to literature by evaluating respiratory muscle strength and endurance.

      Physical activity is positively correlated with in the cardiovascular risk factor.
      Hyperglycemia stresses or fear of hypoglycemia experienced by individuals with type 1
      diabetes may lead people to a sedentary life.

      Physical activity level of individuals with type 1 diabetes will be evaluated using metabolic
      holter, which is an objective method.

      Patients and healthy individuals will be evaluated and compared. According to the sample size
      analysis, 27 patients and 27 healthy individuals with similar demographic characteristics
      will be included in the study. Evaluations will be completed within two days.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        27 patients with Type 1 Diabetes mellitus and 27 healthy individuals will be included.
      
Keywords: Type 1 Diabetes mellitus; Chronotropic index; Exercise Capacity; Pulmonary Function
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to compare the PK of a single dose of brensocatib in
      participants with hepatic impairment to that in matched healthy control participants with
      normal hepatic function.
    


Intervention name(s): Brensocatib
Intervention type(s): Drug
Intervention description(s): Oral tablet.
Other intervention name(s): INS1007
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brensocatib; INS1007
Light Therapy in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease, a degenerative disorder of the dopaminergic system, combines motor
      symptoms but also non-motor, such as depression, sleep disorders and circadian rhythms and
      impaired cognitive functions. Difficulties in balancing the dopaminergic treatment of these
      patients emphasizes the need to find effective adjuvant therapies. Light therapy (LT)
      represents one such innovative therapeutic approach. Although light has an obvious to visual
      pathways within the brain, today it is known to additionally exert non-visual effects
      throughout the body. Recently our team has shown that non-visual, non-circadian light plays a
      major role in the regulation of sleep, as well as cognitive brain function in general. The
      retina, the primary conduit for the transmission of light information is weakened or thinned
      in Parkinson's patients. The dopamine system is known to enhance the processing of light
      information and intraocular injection of L-dopa in animal models of Parkinson's disease, can
      reverse associated motor symptoms. This allows for the possibility that LT would strengthen
      the dopaminergic tone in the central nervous system. However, to this date its effectiveness
      for alleviating Parkinson's symptoms has only been suggested by two studies, both poorly
      controlled. Thus, through the convergence of basic and clinical data, a study examining the
      effect of LT directly in people Parkinson's disease symptoms, whilst controlling for the
      effects on sleep, circadian system, mood, and cognitive functioning, is of extreme
      importance. With this information our hope is to determine if these polymorphisms allow for a
      predictive model of response to LT treatment.
    


Intervention name(s): active light therapy : Light therapy: DayVia lamp 10000 lux; Placebo light therapy
Intervention type(s): Device; Device
Intervention description(s): 4 weeks of active light therapy with DayVia lamp 10000 lux; 4 weeks with Placebo light therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to evaluate whether administration of a CYP1A2
      inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The
      safety and tolerability of tasimelteon will also be assessed throughout the study.
    


Intervention name(s): Tasimelteon; Fluvoxamine
Intervention type(s): Drug; Drug
Intervention description(s): 5.66 mg dose on Day 1 and Day 8; 50 mg Dose on Days 2-8
Other intervention name(s): VEC-162; BMS-214778
Intervention MeSH terms: Fluvoxamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Drug Interaction
Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients
Condition: Ventilation
Study type: Interventional

Summary: 
      The purpose of this study is to find out if NAVA-technology is better in detecting patients
      own inspiratory efforts during mechanical ventilation than currently used flow-triggering in
      PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for
      patients or not.

      The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration
      more accurately than currently used methods, and thus will lead to more smooth adaptation to
      mechanical ventilation in pediatric patients. The investigators expect this to decrease the
      time of ventilatory support needed.
    

Detailed description: 
      Asynchrony means that the timing of support given by ventilator is different from patients
      own breathing pattern. Asynchrony during ventilatory care may increase the risk for
      complications, make the weaning more difficult and may affect the survival rates.

      In our study we randomly treat pediatric patients needing ventilatory support with neurally
      adjusted ventilatory assist and pressure controlled or PRVC-ventilation. We are willing to
      find out if there are any special benefits for patients with each treatment mode.
    

Intervention name(s): Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden); Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)
Intervention type(s): Device; Device
Intervention description(s): Treatment with neurally adjusted ventilatory assist; Treatment with PC or PRVC ventilation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ventilatory care, children, intensive care, NAVA; Children needing ventilatory care