bioihbjkbjnl/mcl2 huggingface dataset:
Renal Denervation in Heart Failure With Preserved Ejection Fraction
Condition: Cardiac Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a
      treatment that lowers the activity of the sympathetic nervous system) is useful in the
      management of patients with heart failure with preserved ejection fraction (HF-PEF).
    

Detailed description: 
      Increasing evidence suggests an important role of activation of the sympathetic nervous
      system (SNS) in heart failure with preserved left ventricular ejection fraction. The current
      study aims to evaluate efficacy of renal sympathetic denervation for the modulation of the
      SNS in patients with HF-PEF.
    

Intervention name(s): Renal sympathetic denervation
Intervention type(s): Device
Intervention description(s): A fit for purpose radiofrequency catheter is guided to the renal artery using fluoroscopy. This is connected to an external RF generator. RF energy is applied through the catheter to the renal artery wall with the goal of disrupting the sympathetic nerves which run in the adventitia
Other intervention name(s): Medtronic Symplicity Catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiac Failure; Autonomic Denervation
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine if aspirin from PL2200, an investigational product, gets into the
      blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether
      PL2200 is able to prevent blood clots as effectively as these other products, when
      administered to patients with diabetes.
    


Intervention name(s): PL2200 Aspirin Capsules; Immediate-Release Aspirin Tablets; Enteric-coated aspirin caplets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 325 mg aspirin; once per day for 3 days; 325 mg aspirin; once per day for 3 days; 325 mg aspirin; once per day for 3 days
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
Condition: Cancer; Cataract; Low Bone Mineral Density; Osteopenia; Osteoporosis; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Osteoporosis; Bone Diseases, Metabolic; Cataract
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or
      worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab
      for bone loss due to androgen deprivation therapy.
    


Intervention name(s): Denosumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg; Prefilled syringe for subcutaneous (SC) injection
Other intervention name(s): Prolia®
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Lens Opacification; Bone Loss; Androgen Deprivation Therapy; Non-metastatic prostate cancer
Training of Eccentric Lower Extremity Function After SCI
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This project will characterize lower extremity eccentric muscle function among individuals
      who have undergone locomotor training after spinal cord injury and will evaluate the effect
      of downhill training at moderate speeds - targeted to rehabilitation eccentric function of
      the knee or hip.
    

Detailed description: 
      Lower extremity eccentric motor control is is critically important for locomotor function but
      is impaired after spinal cord injury (SCI). Even after treadmill training, preliminary
      evidence indicates that eccentric deficits persist among individuals with SCI. This proposal
      aims to characterize eccentric motor control of the muscles about the knee or hip during
      locomotion and evaluate the efficacy of downhill gait training at moderate speeds as an
      intervention to improve eccentric function of the knee joint or hip joint during walking.
    

Intervention name(s): Trained SCI Knee or Trained SCI Hip
Intervention type(s): Behavioral
Intervention description(s): Individuals with SCI will perform downhill walking training 3 times a week for 12 wks with a 4 wk follow-up period. This intervention will be delivered by trained therapists. In order to focus on rehabilitation of knee control or hip control, members of this group will be trained at slow to moderate gait speeds.
Other intervention name(s): DH Knee; DH Hip
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Developmental Monitoring and Language Promotion
Condition: Child Development
Study type: Interventional

Summary: 
      The goal of this study is to pilot test an intervention developed to enhance parent knowledge
      regarding child development and encourage parents to engage in activities that promote
      language acquisition.
    

Detailed description: 
      Our specific aim for this proposal is to pilot test an intervention developed to enhance
      parent knowledge regarding child development and the home cognitive environment comprised of
      distribution of (1) publicly available developmental monitoring materials, (2) age and
      language appropriate children's books, and (3) text message reminders. Participants in this
      intervention will receive: (1) educational materials about child development and
      developmental monitoring checklists; (2) age and language appropriate picture books; and (3)
      two text messages per week for a 6-month period. Differences in pre- and post-intervention
      knowledge regarding child development and the home cognitive environment will be assessed.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will receive the following intervention bundle (1) educational materials about child development and developmental monitoring checklists; (2) age and language appropriate picture books; and (3) two tailored text messages per week for a 6-month period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Child Development; Cognitive Home Environment; Literacy promotion; Text Messages
Quadratus Lumborum Block III Versus Peritubal Local Infiltration
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Investigators compare post operative analgesic efficacy of peritubal local infiltration
      versus Quadratus Lumborum Block III . In patients undergoing Percutaneous Nephrolithotomy
      operation
    


Intervention name(s): Quadratus block versus peritubal local infiltration
Intervention type(s): Procedure
Intervention description(s): Quadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Feasibility of Transvenous Phrenic Nerve Stimulation for Diaphragm Protection in Acute Respiratory Failure
Condition: Acute Hypoxemic Respiratory Failure; Diaphragm Injury; Lung Injury
MeSH terms: Respiratory Insufficiency; Lung Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      This is a single-center proof-of-concept clinical trial designed to establish the feasibility
      of transvenous phrenic-nerve stimulation (PNS) to maintain diaphragm activation over the
      first 24 hours and for up to seven days of mechanical ventilation in patients who are likely
      to require more than 48 hours of invasive mechanical ventilation.
    

Detailed description: 
      The diaphragm is the main muscle of breathing and for most of us therefore is continuously
      being used (and hence exercised) when in health. When people are unwell with severe breathing
      difficulties to the degree that their lungs are needing a lot of support from a breathing
      machine (ventilator) in the intensive care unit (ICU), or are recovering from major
      lung/chest surgery on a ventilator in ICU, the diaphragm can quickly start to weaken from its
      inactivity. This means that even when starting to recover from the underlying medical
      problem, or from the surgery itself, the diaphragm may be unable perform well enough to take
      over the work of breathing once again. This can lead to not only longer times on the
      ventilator (time to gradually rebuild diaphragm strength by rehabilitation and physiotherapy)
      but also therefore longer times in ICU and in hospital with the risk of complications that
      can be associated with this.

      Stimulating the diaphragm by use of a pacemaker (electrical stimulation) is an established
      treatment for a number of patients with certain types of long-term breathing problems. These
      pacemakers are permanent and are inserted by invasive surgical methods. More recently
      however, there have also been a number of studies looking to see if it is possible to safely,
      temporarily and less invasively stimulate the diaphragm of patients who only have temporary
      diaphragm inactivity. This has been done either during surgery or during their intensive care
      stay. A number of methods of temporarily stimulating the diaphragm have been looked at, but
      the simplest has been to integrate the function of stimulating the nerves (that ultimately
      control the diaphragm) with a catheter that is frequently placed into a vein in the neck to
      enable delivery of medications during surgery and in ICU.
    

Intervention name(s): Lungpacer AeroPace Protect System
Intervention type(s): Device
Intervention description(s): AeroPace Catheter will be placed percutaneously into the left internal jugular vein or left subclavian vein and stimulating electrodes mapped for therapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of 14-days of HMB-free Acid on Changes in Muscle During 4-days of Survival Training
Condition: Survival Training
Study type: Interventional

Summary: 
      Sustained high-intensity activity, such as survival training with little nourishment
      available, can result in a loss of muscle performance. This study will examine the effects of
      a nutritional supplement to maintain muscle and muscle performance during this period.
    

Detailed description: 
      Sustained high intensity activity that is often accompanied by sleep and nutrient deprivation
      is a common characteristic of survival training. Survival training is a requirement in the
      preparation of pilots, where they learn evasion and survival skills that they may need to
      avoid capture in a situation in which they have bailed from their plane. The physiological
      stresses associated with the nature of these operations often results in significant
      decrements in lean body mass, muscle size and muscle endurance and power. During a sudden
      evacuation from the aircraft the pilot only takes a small survival bag. There is a limit to
      what can possibly be put in this bag. However, the ability to provide a dietary supplement
      specifically targeting muscle may provide an important resource for maintaining muscle mass
      and performance. Thus, the purpose of this study is to determine the efficacy of 14 days of
      HMB-FA ingestion on maintaining muscle architecture and muscle performance during 4-days of
      survival training. In addition, anabolic and catabolic markers of stress, inflammation and
      muscle damage will be assessed.
    

Intervention name(s): Placebo; HMB-FA
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): beta-hydroxy-beta-methylbutyric acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the
      middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot
      component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter
      to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg,
      and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by
      imaging of the affected artery and functional testing.
    

Detailed description: 
      This is a Phase 1/2a, open-label, multi-center, sequential dose escalation, safety study of
      Plasmin (Human) in acute ischemic stroke caused by middle cerebral artery occlusion
      documented by arteriography. Plasmin (Human) will be administered through a catheter into the
      thrombus within 9 hours of stroke onset. Approximately sixty-one (61) patients will be
      enrolled and will receive Plasmin (Human). The objectives of this study are to determine the
      safety of escalating doses of Plasmin (Human) and to determine the proportion of patients
      with treatment success, defined as partial or full recanalization.
    

Intervention name(s): Plasmin (Human); Plasmin (Human); Plasmin (Human)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus; Plasmin (Human), 40 mg, delivered through a catheter into a thrombus; Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
Other intervention name(s): TAL-05-00018; BAY-57-9602; TAL-05-00018; BAY-57-9602; TAL-05-00018; BAY-57-9602
Intervention MeSH terms: Fibrinolysin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; plasmin; thrombus; ischemic; middle cerebral artery; thrombolysis; intra-arterial; fibrin
Pharmacokinetic Study of Single Doses of Clopidogrel, 75 mg and 300 mg, in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the study are to:

        -  Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel
           and its active metabolite after a replicated single administration of 75 mg of
           clopidogrel in healthy male and female subjects

        -  Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after
           single administration of 75 or 300 mg of clopidogrel
    

Detailed description: 
      The total study duration per subject is 4 - 6 weeks broken down as follows:

        -  Screening: 2 to 21 days before the first dosing

        -  Period 1, 2 and 3: 4 days including 1 treatment day each

        -  Washout between periods: at least 7 days between 2 administrations

        -  End of study: 7 to 10 days after the last dosing
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form : tablet
Route of administration: oral
Other intervention name(s): SR25990
Intervention MeSH terms: Clopidogrel
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cognitive-Motivational Behavior Therapy for Pathological Gamblers
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional

Summary: 
      In the proposed two-arm randomized controlled trial, 200 patients meeting DSM-IV criteria for
      PG will be randomized to 12 sessions of Cognitive-Motivational Behavior Therapy (CMBT) or to
      Cognitive Behavior Therapy (CBT).
    

Detailed description: 
      CMBT has been developed by our team over the last five years, and has shown very promising
      results in a small, NIMH-funded randomized pilot trial (R21 MH 064568). We will assess
      patients biweekly during the active treatment phase and follow them for 12 months after the
      end of treatment to obtain data on long-term treatment outcome. We hypothesize that CMBT will
      show higher efficacy and retention than CBT in the treatment phase, and that gains will be
      maintained at a higher rate during follow-up.

      A second major purpose of the proposed study is to elucidate the presumed mechanisms of
      change by examining potential mediators (readiness to change, irrational beliefs about
      gambling, coping skills, therapeutic alliance) and moderators (psychiatric comorbidity with
      Axis I and II disorders, family history of PG, impulsivity, and baseline motivation to
      change) of treatment response. A better understanding of how the proposed interventions work
      will help advance the science and treatment of PG and will be helpful in the future
      refinement and adaptation of CMBT. Identifying patient subgroups for which the intervention
      is particularly effective is essential for rational treatment selection. Thus, the immediate
      goal of the project is to compare CBMT versus CBT for the treatment of PG. A long-term goal
      of the proposed research is to establish effective treatment procedures that reduce the
      considerable individual and social costs of PG.
    

Intervention name(s): CBT; CMBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The CBT treatment developed by Ladouceur (Consultant) will serve as control condition (outline of published treatment manual by Ladouceur & Lachance, 2006. This treatment served as a model for the cognitive-behavioral component in CMBT and has received empirical support in two studies from Ladouceur's lab (Sylvain et al., 1997; Ladouceur et al., 2004). It places strong emphasis on cognitive correction of erroneous beliefs about gambling and also focuses on coping skills training and relapse prevention. CBT also lasts 12 weekly sessions.; We used the NIMH-funded R21 mechanism to develop and test the CMBT intervention (Wulfert et al., 2003, 2005; 2006). Treatment will be implemented in 12 weekly sessions (3 motivational enhancement sessions, 8 sessions of cognitive-behavioral treatment, 1 session of relapse prevention)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and toxicity of apatinib in patients
      with platinum resistant or refractory ovarian cancer when combined with etoposide.
    

Detailed description: 
      Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. In
      most cases, the disease is diagnosed at an advanced stage and approximately 75% of patients
      will eventually experience disease recurrence. However, the overall response rates of
      second-line chemotherapy for recurrent ovarian cancer are only 20-27%. Therefore, it is
      important to seek alternative agent that can improve the outcome. Apatinib is a novel
      vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor and it has been
      approved for the treatment of advanced gastric cancer. The preclinical studies suggest
      apatinib may be effective in other cancers such as ovarian cancer. Therefore, the purpose of
      this study is to test the efficacy and safety of the study drug apatinib when combined with a
      standard treatment, etoposide, for patients with platinum resistant or refractory ovarian
      cancer.
    

Intervention name(s): Apatinib; Etoposide
Intervention type(s): Drug; Drug
Intervention description(s): Apatinib 500mg daily, po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.; Etoposide 50mg daily, po, day 1 to day 14, repeat every 21 days for 6 cycles
Other intervention name(s): Apatinib mesylate tablets; Aitan; VP-16
Intervention MeSH terms: Etoposide; Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian cancer; Apatinib; Etoposide; Chemotherapy
Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia
Condition: Spinal Cord Injuries; Tetraplegia
MeSH terms: Spinal Cord Injuries; Quadriplegia
Study type: Interventional

Summary: 
      Vibration therapy is a possible alternative to drug-based treatments for spasticity following
      SCI. Research indicates that it may provide temporary relief from spasticity, but many
      interventions under investigation are not portable and therefore access is limited. The aim
      of this study is to investigate the feasibility of using a portable vibrating device to
      decrease UE spasticity.
    


Intervention name(s): Vibrating ball
Intervention type(s): Other
Intervention description(s): Parameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment