bioihbjkbjnl/mcl2 huggingface dataset:
Study of BEBT-908 in Subjects With Advanced Hematological Tumors
Condition: Relapsed or Refractory Non-Hodgkin's Lymphoma; Relapsed or Refractory Multiple Myeloma
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the safety and tolerance of BEBT-908 for injection
      in the treatment of recurrent refractory malignant lymphoma, multiple myeloma and chronic
      lymphoblastic leukemia, and to obtain the pharmacokinetic data and preliminary efficacy of
      BEBT-908 for injection, and to explore the relationship between the safety and efficacy of
      BEBT-908 for injection and related biomarkers.
    

Detailed description: 
      This study is divided into two stages: dose increasing stage and expanding into the group.

      Dose escalation phase: The initial dose was 10mg/m2, and the subsequent dose group was
      increased by 100% until the first case of grade 2 non-blood toxicity or grade 3 hematological
      toxicity related to the test drug and no dose-limiting toxicity, then the dose was increased
      by 50%, and a total of 5 dose groups were designed. In this stage, all subjects received a
      single dose first and were observed for 6 days. After the end of the observation period, if
      the subjects were safely tolerant to a single dose，then will receive the same dose of
      treatment for a cycle, administration regimen is 3 times a week, continuous administration
      for 2 weeks, withdrawal for 1 week, a total of 21 days as a cycle.

      Dose expansion phase: according to the results of pharmacokinetics, safety and efficacy of
      BEBT-908 for injection obtained in the dose escalation phase, we plan to select two doses to
      further observe the safety, pharmacokinetic characteristics and preliminary efficacy of
      BEBT-908 for injection in about 20-40 subjects with non-Hodgkin's malignant lymphoma. In this
      stage, all dose groups were administered continuously for 2 weeks and stopped for 1 week for
      a total of 21 days，until the disease progresses or withdraws.

      Participants will need to understand the requirements and risks of the trial, sign an
      informed consent form, accept the dosing regimen required by the trial protocol, and follow
      the investigator's guidance.
    

Intervention name(s): BEBT-908 for injection
Intervention type(s): Drug
Intervention description(s): Dose escalation phase：10 or 15、22.5、33.75、45mg/m2, intravenous drip, firstly single dose, after the observation period, the drug was administered continuously for 1 cycle (21 days), 3 times a week, continuous administration for 2 weeks and withdrawal for 1 week.
Dose expansion phase：15 or 22.5mg/m2，intravenous drip, 3 times a week, continuous administration for 2 weeks and withdrawal for 1 week，21 days as cycle.
Other intervention name(s): CUDC-908
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BEBT-908 for injection; Safety; Tolerability; Pharmacokinetics; Effectiveness
A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is conducted to evaluate the safety and tolerability of the drug product sNN0031,
      containing Platelet Derived Growth Factor (PDGF), when administered directly into one of the
      fluid filled cavities in the brain using an implanted catheter and an implanted SynchroMed®
      II pump. Patients with a diagnosis of Parkinson's disease will be enrolled.
    

Detailed description: 
      Tremor, rigidity, slow movement, poor balance, and difficulty walking are characteristic
      symptoms of Parkinson's disease (PD) that are associated with degeneration of
      dopamine-producing nerve cells in the brain. Administration of growth factors that stimulate
      neuronal stem and progenitor cells is one possible approach to restore the dopaminergic
      activity. The drug product sNN0031 containing the endogenous growth factor PDGF has been
      demonstrated to reduce the typical symptoms in animal models of PD.

      NeuroNova intends to investigate whether intracerebroventricular administration of PDGF in
      the form of the drug product sNN0031 can improve motor function in patients with PD. In this
      first study the safety and tolerability of treatment for 2 weeks followed by 10 weeks
      follow-up will be evaluated.
    

Intervention name(s): sNN0031; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Continuous ICV infusion for two weeks; Continous ICV infusion
Other intervention name(s): PDGF; Artificial CSF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson; Safety; PDGF; Intracerebroventricular; Infusion; Device
An Randomized Open-Label PK Study of LY03004 Compared to Risperdal® Consta® in Stable Patients With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A review of the amount of drug in your blood over time.
    


Intervention name(s): Risperdal® Consta®; LY03004
Intervention type(s): Drug; Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicenter, open label, single-arm study is aim at investigating the the efficacy and
      safety of china made ambrisentan in Chinese subjects with PAH.
    

Detailed description: 
      Pulmonary arterial hypertension is a hemodynamic and pathophysiological state, which can
      cause progressive hyperplasia of pulmonary vascular walls and elevated pulmonary arterial
      pressure for various reasons. Ambrisentan is a selective endothelin-A (ETA) receptor
      antagonist with vasodilatory, antiproliferative and vascular remodeling effects at a dose of
      5 mg or 10 mg once daily, oral. A number of international clinical studies have shown that
      ambrisentan can improve the hemodynamic parameters, WHO functional classification and
      exercise tolerance of PAH patients, and improve the survival rate. The domestic Ambrisentan
      tablet is produced by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. under the trade name of
      "Pu Nuo An". It has been developed and completed according to the consistency evaluation
      standard after the bioequivalence test, and is currently listed in mainland China. In view of
      the low price of the domestic ambrisentan, in order to verify its efficacy and safety in the
      real world, this post-marketing multicenter clinical study was carried out.
    

Intervention name(s): Ambrisentan
Intervention type(s): Drug
Intervention description(s): eligible subjects received 5 mg ambrisentan orally once daily for a 12-week primary evaluation period. Subjects then proceeded to a 12-week dose adjustment period during which dose titration to 10 mg was allowed.
Intervention MeSH terms: Ambrisentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAH; ambrisentan
The Effect of Cochlear Implant on Postural Control
Condition: Cochlear Implant
Study type: Observational

Summary: 
      Some patients are having balance problems after cochlear implant surgery. There are
      contradictory reports about the effect of the implant on postural control. While the cochlear
      implant is working, an electrical current is continuously stimulating the cochlear nerve
      which is in close proximity with vestibular ganglion and nerve. This stimulation may
      contribute to vestibular signals to the central system. The aim of the study is to
      investigate if this stimulation has any effect on postural control.
    

Detailed description: 
      Adult patients who had unilateral cochlear implantation will be included. Postural stability
      measurements will be done by the Biodex Balance System. Three preprogrammed main tests and
      their 9 subtests will be applied. Postural stability, fall index, sensory integration will be
      calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant
      on music on(3), and implant off again(4).
    

Intervention name(s): Postural stability measurements by Biodex Balance System
Intervention type(s): Diagnostic Test
Intervention description(s): Postural stability measurements will be done by Biodex Balance System. Three preprogrammed main tests will be applied. Postural stability, fall index, sensory integration will be calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant on music on(3), and implant off again(4).
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who had cochlear implantation in our hospital will be invited to join the study.
Acute Fatty Acid Intervention Study (AFAST)
Condition: Cardiovascular Disease; The Metabolic Syndrome
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome
Study type: Interventional

Summary: 
      The main objective of this study is to elucidate whether different dietary fatty acids (SFA,
      PUFA, butter fat and margarine fat) in a high fat load will have different effects on PBMC
      gene expression profiles. Secondary objectives are to elucidate the effects of these fat
      loads on individual plasma free fatty acid profiles, triglycerides and cholesterol levels.
    

Detailed description: 
      Nutrition plays a key role in the development of metabolic disorders like cardiovascular
      disease and the metabolic syndrome. Nutrients that can contribute to the risk of developing
      such diseases are fatty acids (FAs). It is known that fatty acids mediate their metabolic
      effects via changes in gene expression, through binding and subsequent activation of the
      transcription factor peroxisome proliferator-activated receptor (PPAR). In addition, it is
      known that unsaturated fatty acids are better ligands for PPAR than saturated fatty acids.
      Peripheral blood mononuclear cells (PBMC) express PPARalpha and are relatively easy to
      isolate from whole blood. We previously showed that the gene expression profiles of these
      cells can reflect free fatty acid increases during fasting. The question still remains
      whether dietary FA can influence gene expression in a similar way and, if so, whether
      different dietary FA result in different gene expression changes and subsequent activation of
      other pathways.
    

Intervention name(s): High fat meal
Intervention type(s): Dietary Supplement
Intervention description(s): A high fat milkshake containing 55g of fat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: postprandial; gene expression profiles; microarray
Single Dose of BI 1744 CL in Patients With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Condition: Healthy; Liver Diseases
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study was to investigate the influence of mild and moderate liver
      impairment on the pharmacokinetics, safety and selected pharmacodynamic parameters of BI 1744
      CL in comparison to a control group with normal hepatic function after single orally inhaled
      administration of BI 1744 CL with the Respimat® Inhaler.
    


Intervention name(s): BI 1744 CL, low dose; BI 1744 CL, high dose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olodaterol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children
      and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit
      hyperactivity disorder.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
      pubertal status.

      There is a 7- to 14-day washout with a placebo prior to treatment for all patients.

      The first group receives oral guanfacine 3 times a day for 8 weeks. The dose is gradually
      increased to minimize sedation; by day 14, most patients are stabilized and the dose is then
      increased as clinically indicated and tolerated.

      The second group receives a placebo 3 times a day for 8 weeks. Patients in either group may
      be treated with guanfacine for an additional 8 weeks.
    

Intervention name(s): guanfacine
Intervention type(s): Drug
Intervention MeSH terms: Guanfacine
Primary purpose: Treatment
Keywords: Tourette syndrome; neurologic and psychiatric disorders; rare disease
Computer-Facilitated 5A's for Smoking Cessation in Primary Care
Condition: Nicotine Addiction; Smoking Cessation
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This study tests the use of handheld computer tablets to promote the integration of 5A's
      (Ask, Advise, Assess, Assist, Arrange) for smoking cessation in academic and community
      primary care clinics. Although most patients receive the "ask" and "advise" steps, only
      slightly more than half are "assessed" for readiness to change, less than half receive
      "assistance" in changing, and only 9% have an "arranged" follow-up. While the large majority
      of primary care providers support the 5A's model, negative attitudes and the lack of time,
      knowledge, and cessation skills are common obstacles. Alternate service delivery systems that
      address these obstacles and evidence-based strategies to promote their implementation are
      needed to improve provider adherence and 5A's fidelity.
    

Detailed description: 
      This project develops and tests a computer-facilitated 5A's (CF-5A's) model that administers
      the 5A's intervention to patients then prompts providers for reinforcing next steps. CF-5A's
      could efficiently and effectively promote smoking cessation while educating providers about
      cessation resources and appropriate follow-up. Based on the Technology Acceptance Model,
      clinically tailored strategies to promote CF-5A's implementation will be developed and tested
      to ensure the appropriate use and uptake of this new service delivery model. Development of
      the model, materials, and strategies will occur in years 1 and 2.

      Baseline data collection occurs in year 2, followed by a randomized trial of CF- 5A's where
      the provider is the unit of randomization. Provider use of the 5A's will primarily be
      assessed with a brief phone call to the patient after the primary care visit has occurred.

      Although focused on 5A's for smoking cessation, this study examines the underlying
      implementation science of computer-aided service delivery models with important implications
      for the integration of other substance use or behavioral health interventions in primary
      care. Implementation factors will be assessed using qualitative interviews and brief pre-post
      surveys.
    

Intervention name(s): Computer Tablet
Intervention type(s): Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: Smoking; 5A's for smoking cessation; tailored health messages; Patient-facing information technology; Mobile health; behavioral health
Relative Bioavailability Study to Investigate a Potential Interaction Between DTG DT and F/TAF TOS.
Condition: Hiv
Study type: Interventional
Phase: Phase 1

Summary: 
      This relative bioavailability (RBA) study will be conducted to investigate whether there is a
      potential pharmacokinetic effect when paediatric DTG and F/TAF are taken together as
      dispersible formulations. This study will be performed in healthy volunteers instead of
      HIV-infected patients.
    

Detailed description: 
      This relative bioavailability (RBA) study will be conducted to investigate whether there is a
      potential pharmacokinetic effect when paediatric DT DTG (30 mg dose) and F/TAF TOS (180/22.5
      mg dose) are taken together. For this purpose, Gilead's F/TAF 60/7.5 mg TOS tablets and ViiV
      Healthcare's DTG 5 mg tablets will be used. Given the very low plasma concentration of TAF
      (very probably mainly under the detection limit) with a single dose of 7.5 mg in adults, 3
      tablets of F/TAF 60/7.5 mg (180/22.5 mg) will be given, which is similar to the adult dose.
      It was considered to keep the ratio between DTG and F/TAF similar to the to be developed
      paediatric fixed dose combination tablet, which would have resulted in a DTG dose of 60mg DTG
      DT. But because DTG shows nonlinear kinetics above a dose of 50 mg FCT (3), it was decided to
      use DTG 30 mg DT tablets, which is bioequivalent to adult dose of 50 mg FCT. For all
      compounds, a dose similar to the adult dose will be given.
    

Intervention name(s): DTG DT (6 x 5 mg); F/TAF TOS (3 x 60/7.5 mg)
Intervention type(s): Drug; Drug
Intervention description(s): DTG 5mg dispersible tablet; 60/7.5 mg TOS emtricitabine/TAF
Other intervention name(s): Tivicay 5 mg (ViiV); F/TAF TOS 60/7.5 mg (Gilead)
Intervention MeSH terms: Dolutegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Predicting Cognitive and Emotional Health From Neurocircuitry Following TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      Abnormalities in structural and functional connectivity between brain regions have been
      suggested as putative biomarkers of mild traumatic brain injury (TBI) and significant
      contributors to neuropsychological functioning and injury outcome. The purpose of this study
      is to use two advanced magnetic resonance imaging (MRI) techniques called diffusion-weighted
      imaging (DWI) and resting state functional MRI to compare structural and functional
      connectivity between individuals with documented mild TBI and healthy controls. To evaluate
      the significance of structural and functional connectivity for behavior, the brain imaging
      data will then be related to measures of cognition and emotion. Over a 4-year period, 150
      adults with documented mild TBI and 30 healthy controls will participate in the study.

      The study will investigate the following questions and hypotheses:

        1. Evaluate the DWI metric fractional anisotropy (FA) as a measure of white matter
           integrity across multiple stages of recovery following mild TBI relative to healthy
           controls. It is hypothesized that mild TBI will be associated with greater white matter
           abnormalities than healthy controls.

        2. It is hypothesized that there will be a relationship between FA, cognition and emotion
           as a function of the injury.

        3. It is hypothesized that functional connectivity will be related to FA.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        One hundred eighty participants aged 20-45, including 150 adults with documented mild TBI
        and 30 healthy controls (HC) will participate in this study. Participants in the TBI group
        will include 30 individuals who will be tested at two weeks post-TBI; 30 individuals who
        will be tested at one month post-TBI; 30 individuals who will be tested at three months
        post-TBI; 30 individuals who will be tested at six months post-TBI; and 30 individuals who
        will be tested at 12 months post-TBI. Participants will be recruited from the local area of
        Boston, MA, via IRB-approved flyers and advertisements placed in newspapers, on the radio
        and within vehicles of the local public transport system (e.g. buses and subway cars).
      
Keywords: Traumatic Brain Injury; Diffusion Weighted Imaging; Resting State Functional Connectivity; Cognition
A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines
Condition: Chronic Migraine, Headaches
MeSH terms: Migraine Disorders; Headache
Study type: Observational

Summary: 
      This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA
      in Chronic Migraine patients who have received a minimum of 7 treatment cycles.
    


Intervention name(s): onabotulinumtoxinA
Intervention type(s): Biological
Intervention description(s): Previous treatment with onabotulinumtoxinA for Chronic Migraine.
Other intervention name(s): Botulinum Toxin Type A; BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants who previously received at least 7 treatment cycles of onabotulinumtoxinA as
        Treatment for Chronic Migraine.