bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42847922 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, pharmacokinetic (the
      study of the way a drug enters and leaves the blood and tissues over time),
      dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how
      drugs act on the body) and sedative effects of JNJ-42847922 in healthy male and female
      participants.
    

Detailed description: 
      This is a Phase 1, double blind (a medical research study in which neither the researchers
      nor the participants know what treatment the participants is receiving), randomized (study
      drug assigned by chance), placebo controlled, multiple ascending dose study. The study will
      consist of 3 parts: a Screening period (Days -21 to -2), a Double-blind treatment period (Day
      -1 to Day 11), and a Follow-up period (within 7 to 14 days after last dose administration).
      In double blind treatment period, participants will be randomly assigned to 5, 10, 20, and 40
      milligram (mg) or placebo. Number of participants with any clinically relevant changes
      (adverse events [AEs], laboratory results,electrocardiogram [ECG], Vital signs, Physical and
      neurological, sedation & concentration) and columbia suicide severity rating (CSSR) scale
      will be evaluated as primary outcome measure. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): JNJ-42847922 5 mg; JNJ-42847922 10 mg; JNJ-42847922 20 mg; JNJ-42847922 40 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive 5 mg of JNJ-42847922, from Day 1 up to Day 10.; Participants will receive 10 mg of JNJ-42847922, from Day 1 up to Day 10.; Participants will receive 20 mg of JNJ-42847922, from Day 1 up to Day 10.; Participants will receive 40 mg of JNJ-42847922, from Day 1 up to Day 10 .; Participants will receive matching placebo from Day 1 up to Day 10.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: JNJ-42847922; Phase 1; Healthy; Placebo
Effectiveness of YNSA Acupuncture on Brain Networks
Condition: Acupuncture
Study type: Observational

Summary: 
      This study investigates the effects of a new form of acupuncture (Yamamoto's New Skull
      Acupuncture [YNSA]) on resting-state brain networks. Therefore, two resting-state fMRI scans
      are measured (one without and one with acupuncture needles) in healthy adults. It is expected
      that acupuncture is associated with changes in functional connectivity within different brain
      networks.
    

Detailed description: 
      Although acupuncture has been used in China and Japan for over 2000 years, it has only become
      increasingly important in Western medicine in the last few decades. A special form of
      acupuncture is "Yamamoto's New Skull Acupuncture" (YNSA), which was developed by Toshikatsu
      Yamamoto. Here, the needling is limited to the skull.

      Acupuncture is a safe and almost painless procedure that is usually well tolerated. One
      indication might be the therapy of neurological diseases. Schockert and colleagues examined
      the effectiveness of YNSA in a placebo-controlled study. To investigate the effectiveness of
      cranial acupuncture, three fMRI sequences were performed: 1) without acupuncture, 2) sham
      acupuncture (acupressure without needling) and 3) YNSA acupuncture. The subjects (17 stroke
      patients with right hemisphere lesions and 19 healthy controls) were instructed to
      alternately make a fist (3s) and close it again (2s). There were a total of five blocks, each
      with a duration of 120s. Compared to sham acupuncture, cortical activations in motor,
      premotor and supplementary motor areas were observed during YNSA acupuncture.

      In contrast to Schockert and colleagues, the planned study uses resting-state fMRI to
      determine whether YNSA acupuncture is associated with changes of functional connectivity
      within different resting-state networks.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy volunteers of both sexes aged 18-65 years
      
Keywords: Resting-state fMRI
The Effect of Cinacalcet on Gastric Acid Output in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether cinacalcet will increase gastric acid
      secretion in healthy volunteers.
    

Detailed description: 
      The calcium sensing receptor (CaSR) was originally found on parathyroid and renal cells and
      more recently it has been identified on cells that regulate gastric acid secretion (G cells
      and parietal cells). However, its role in regulating acid secretion in humans is completely
      unknown and is of potential importance because an acid environment in the stomach enhances
      intestinal calcium absorption. In this pilot project, we will stimulate the CaSR with a
      CaSR-agonist called cinacalcet. Our hypothesis is that activation of the CaSR will in turn
      increase gastric acid production in healthy volunteers.
    

Intervention name(s): cinacalcet
Intervention type(s): Drug
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Gastric acidity determination; Calcium sensing receptor
Evaluation of the Ear-EEG System for Sleep Monitoring in Healthy Subjects
Condition: Sleep Monitoring
Study type: Interventional

Summary: 
      Subjects sleep multiple nights in their own home, wearing actigraph, PSG (PolySomnoGraphy)
      and ear-EEG sensors. The object of the study is to determine the applicability of ear-EEG for
      sleep monitoring.
    


Intervention name(s): ear-EEG
Intervention type(s): Device
Intervention description(s): soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Relation of Glucose and Acute Pancreatitis
Condition: Acute Pancreatitis
MeSH terms: Pancreatitis
Study type: Observational

Summary: 
      Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a
      systemic inflammatory response syndrome with significant morbidity and mortality in 20% of
      patients. Part of endocrine function of pancreas would be affected in AP. Stress
      hyperglycemia would explode at acute phase. So the investigators decide to follow up and
      observe 200 cases of patients with acute pancreatitis, determining of blood sugar, blood
      amylase, hemoglobin and glycosylated hemoglobin level. At last, using ROC curve method to
      identify the die cutting between blood glucose level and acute pancreatitis, and makes
      analysis of the diagnostic value.
    

Detailed description: 
      Acute pancreatitis (AP) is an acute inflammatory disease of the pancreas which can lead to a
      systemic inflammatory response syndrome with significant morbidity and mortality in 20% of
      patients. Part of endocrine function of pancreas would be affected in AP. Stress
      hyperglycemia would explode at acute phase. There are two reasons. One is because that
      sympathetic hyperactivity makes glucagon elevated. Secondary, microcirculation disorder makes
      pancreas edema, ischemia and necrosis, affecting secretion and excretion of insulin. In
      severe acute pancreatitis, there may be ketoacidosis. Many scoring systems for predicting
      prognosis of severe acute pancreatitis also contains glucose values, such as the Ranson
      scoring system and the Glascow scoring system. On the other hand, Type 2 diabetes has become
      a global pandemic disease. Most of patients of type 2 diabetes are obese, who easily
      complicated gallstone disease and hypertriglyceridemia. All of above could be the risk
      factors for acute pancreatitis. Our initial small sample research also suggests undiagnosed
      diabetes patients whose glucose value elevated is significantly worse than the known diabetic
      patients. Therefore, the investigators believe that glucose directly affects the prognosis of
      AP. So the investigators decide to follow up and observe 1000 cases of patients with acute
      pancreatitis, determining of blood sugar, blood amylase, hemoglobin and glycosylated
      hemoglobin level. At last, using ROC curve method to identify the die cutting between blood
      glucose level and acute pancreatitis, and makes analysis of the diagnostic value.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Keywords: glucose; prognosis; glycated hemoglobin
Exploratory Study on POL6326 in Stem Cell Mobilization
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether POL6326 is safe and clinically active to
      mobilize hematopoietic stem cells followed by transplantation
    


Intervention name(s): POL6326
Intervention type(s): Drug
Intervention description(s): IV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood
Other intervention name(s): not appicable
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematopoietic stem cells; Mobilisation; Autologous transplantation
Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with
      broader requirements to be considered an eligible candidate.
    

Detailed description: 
      The Food and Drug Administration recently approved the Cochlear Nucleus Hybrid L24 Implant
      System (P130016) for individuals aged 18 years and older who present with bilateral residual
      low frequency hearing sensitivity and severe to profound high frequency sensorineural hearing
      loss with limited benefit from appropriately fitted bilateral amplification. Additionally,
      the Nucleus Hybrid S12 Implant has been under evaluation since 2007 (IDE G#070016). The
      Nucleus Hybrid S-RW is a modification of the current Hybrid S12 implant. The Hybrid S-RW is
      designed to support implantation via a round window (RW) approach while maintaining the same
      relative insertion depth as the previous Hybrid S12 when implanted via cochleostomy
    

Intervention name(s): Hybrid SRW cochlear implant
Intervention type(s): Device
Intervention description(s): Subjects will be implanted with the Hybrid SRW
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adults; high frequency SNHL
A Biomarker Stress Test for Detection of Early Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Veterans have much higher risk of osteoarthritis (OA) then the general population. Knee OA is
      common among Veterans and is a leading cause of disability. The earliest stages of OA
      development, where the joint cartilage wears away, is usually painless. By the time Veterans
      experience symptoms, the OA is typically advanced and there is nothing that can be done
      except palliation until the joint is replaced with metal and plastic. If there was a blood
      test to provide early warning of cartilage wear and joint deterioration, Veterans could
      potentially be treated early enough to slow down or even prevent OA. So far, development of
      such a blood test has proved elusive. The investigators propose a new method to amplify the
      signs of cartilage wear in the blood by challenging the affected joint with a walking task.
      Similar to a cardiac stress test, this walking challenge may help to separate joints at risk
      from healthy joints. The investigators will also see if this 'OA stress test' can show if a
      simple and inexpensive load-modifying shoe can improve joint health in Veterans with early
      knee OA.
    


Intervention name(s): Variable-Stiffness Shoe
Intervention type(s): Device
Intervention description(s): A load-modifying variable-stiffness shoe previously shown to reduce joint loading
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Return to Everyday Activities in the Community and Home
Condition: Aging; Activity; Lifestyle
Study type: Interventional

Summary: 
      The purpose of this study is to test feasibility for the delivery and perceptions of a
      lifestyle model for middle-aged and older adults by involving participants in its
      development. The goal of the program is to reduce sedentary behaviour, increase physical
      activity, and increase strength and balance. An optional walking program will be run in
      parallel to emphasize the importance of moving more. Participants will be asked to fill out
      questionnaires on course delivery, content and effect throughout the program and 2-3 recorded
      interviews throughout the study. We will collect measurements of physical performance before
      and after the program.
    

Detailed description: 
      This study aims to describe the delivery of a lifestyle model for older adults. Return to
      Everyday Activities in the Community and Home (REACH) is a health promotion program aimed at
      middle-aged and older adults. The goal of REACH is to reduce sedentary behaviour, increase
      physical activity, and increase strength and balance. The REACH program is comprised of six
      sessions which include evidence-based education, behaviour change theory, and activity
      instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active
      community engagement. In this study we are running the REACH program for women aged 55 and
      older alongside a supplementary optional walking program run by SportMedBC. We will gather
      pre- and post-intervention measures of program perceptions, delivery psychological variables
      and physical performance outcomes. We will also collect participant feedback about course
      delivery, content and effect throughout the program. This study will allow us to describe the
      delivery strategies of REACH and involve the participants in the development of the REACH
      program. The optional walking program will emphasize the importance of increasing daily
      physical activity.
    

Intervention name(s): REACH
Intervention type(s): Behavioral
Intervention description(s): REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Multi-Center Prospective Randomized Trial Comparing Standard Esophagectomy Against Chemo-Radiotherapy for Treatment of Squamous Esophageal Cancer - Early Results From the Chinese University Research Group for Esophageal Cancer (CURE)
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter randomized comparison of primary esophagectomy against definitive
      chemoradiotherapy for the treatment of squamous esophageal cancer.
    

Detailed description: 
      Cancer of the oesophagus is notorious for its grave prognosis with an overall 5-year survival
      rate of 10-20%. Surgical resection with curative intent remains the most effective treatment
      for this disease. To improve the survival, a better treatment approach is in need to manage
      patients with oesophageal cancer. Unfortunately, the use of preoperative adjuvant
      chemotherapy or adjuvant radiotherapy does not confer any survival benefit to patients with
      localized oesophageal cancer as proven in most randomized studies. However, the combination
      of chemotherapy and radiotherapy has greater clinical efficacy in achieving complete
      pathological regression of the tumour as well as the response rate as shown in our
      preliminary results. In fact, treatment of squamous oesophageal cancer by primary
      chemo-irradiation without surgery is now feasible.

      We propose to conduct a multi-center randomized trial to evaluate the efficacy and the
      patients' survival by comparing primary chemo-irradiation without surgery versus standard
      surgical resection as the treatment for squamous oesophageal cancer. Those patients with
      residual cancer after primary chemo-irradiation will have salvage oesophagectomy to control
      the disease. Over a 3-year period, a total of 80 patients will be recruited from 4 different
      hospitals with 100 patients being randomized into each treatment arm. Treatment outcomes will
      be compared on an intention-to-treat analysis basis.
    

Intervention name(s): Esophagectomy; Chemoradiation
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Educational Intervention for Reducing Work Disability in Breast Cancer Survivors
Condition: Breast Cancer; Cancer Survivor
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This randomized clinical trial studies an educational intervention for reducing work
      disability in breast cancer survivors. Web sites providing symptom management education may
      be an effective method to help breast cancer survivors reduce work disability after treatment
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the feasibility and usability of the Work Ability Improvement Through Symptom
      Management and Ergonomic Strategies (WISE) and empirically evaluate its effect on short-term
      work ability among breast cancer survivors (BCS).

      SECONDARY OBJECTIVES:

      I. Explore individual and workplace factors associated with work ability in BCS.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive access to the WISE web-based educational intervention to help BCS
      manage their symptoms, identify ergonomic workplace problems and risks, and implement
      ergonomic modifications. Patients also receive standard of care comprising symptom management
      therapies and a pamphlet on employment rights.

      ARM II: Patients receive standard of care comprising symptom management therapies and a
      pamphlet on employment rights.

      After completion of study treatment, patients are followed up at 3 and 6 months.
    

Intervention name(s): internet-based intervention; management of therapy complications; educational intervention; questionnaire administration; quality-of-life assessment
Intervention type(s): Other; Procedure; Other; Other; Procedure
Intervention description(s): Receive access to the WISE web-based educational intervention; Receive standard of care; Receive access to the WISE web-based educational intervention; Ancillary studies; Ancillary studies
Other intervention name(s): complications of therapy, management of; intervention, educational; quality of life assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety, Tolerability, PK, PD, ADA of Escalating Single Dose of CJ-40002 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are:

        -  To evaluate the safety and tolerability of CJ-40002 after single SC injection in healthy
           male volunteers.

        -  To evaluate the PK of CJ-40002 after single SC injection in healthy male volunteers.

        -  To evaluate the PD of CJ-40002 after single SC injection in healthy male volunteers.

        -  To evaluate the ADA of CJ-40002 after single SC injection in healthy male volunteers.
    


Intervention name(s): CJ-40002
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke
Condition: Intracranial Atherosclerosis; Acute Stroke; Transient Ischemic Attack
MeSH terms: Stroke; Ischemic Attack, Transient; Intracranial Arteriosclerosis; Atherosclerosis
Study type: Observational

Summary: 
      Despite advances in stroke care, women continue to face worse outcomes after stroke than men.
      This disparity in outcomes may be related to biologic sex-differences that manifest in the
      development and progression of atherosclerosis. Decades of cyclic changes in the hormonal
      milieu lead to different metabolic profiles in women. These changes may also explain
      sex-differences in risk factor profiles of atherogenesis and plaque composition. The
      investigators' objective is to conduct a cross-sectional MR imaging study of suspected stroke
      patients to compare the burden and composition of intracranial atherosclerosis and risk
      factors between men and women. Results from this study are expected to show that sex and
      sex-specific risk factors should be considered at the outset of stroke evaluation for
      risk-stratification. In the era of precision medicine, the investigators propose the role of
      sex should be a starting point in the clinical evaluation of stroke.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Suspected stroke patients
      
Keywords: intracranial atherosclerotic disease; acute stroke; transient ischemic attack; vessel wall imaging