bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Game-based Virtual Reality Intervention on Senior Fitness, Fall Prevention and Balance Function Among Older Adults
Condition: Balance
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effectiveness between game-based virtual reality
      intervention and conventional health education in improving older adults' balance knowledge,
      and let them know how to prevent falling. The intervention group will receive virtual reality
      games in person and read the health education flier, while the control group was assigned to
      read the health education flier and follow suit the video of balance exercise.
    

Detailed description: 
      Falls can lead to disability, sickbed and even death of the elderly, and it ranks second
      among the top ten which causes death in Taiwan. In the past, when multifaceted exercise
      interventions were conducted for the elderly, most of them focused on group strength training
      and aerobic exercise, but lacked individualized balance training, resulting in a low degree
      of cooperation.
    

Intervention name(s): Game-based virtual reality (Game); Conventional health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Besides reading the health education flier, they also need to trained with the game-based virtual reality in Biodex Medical Systems, which is a machine, includes 4 games: Catch Game, boating, Ball Maze, and Word Search. And all of the games are balance control games. The games were implemented in person for 30 minutes one time, total is 16 times (once to twice day a week).; The health education flier was made refer to medical institutions, e.g., hospitals or clinics, the video of balance exercise was collected from the internet. Participants were assigned to read the health education flier, and follow suit the video of balance exercise at home of their free will.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dietary Intervention With Shop Model - SHOPUS
Condition: Obesity
Study type: Interventional

Summary: 
      The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet
      (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can
      improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and
      cardiovascular diseases.
    


Intervention name(s): Dietary intervention
Intervention type(s): Behavioral
Intervention description(s): Instruction to diet for 6 month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation
Condition: Heart Transplantation
Study type: Interventional

Summary: 
      The purpose of this study is to improve or save renal function by optimizing the
      immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of
      Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will
      minimize the risk of acute rejection episodes.
    

Detailed description: 
      The decrease of quality of life in patients after heart transplantation in the long-term is
      determined by an increasing incidence of transplant vasculopathy and by
      immunosuppression-related side effects.Long-term administration of calcineurin inhibitors is
      associated with chronic nephrotoxicity.
    

Intervention name(s): Mycophenolatmofetile; Cyclosporin A
Intervention type(s): Drug; Drug
Intervention description(s): Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily; Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
Other intervention name(s): MMF; CellCept; Sandimmun optoral
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cyclosporine; renal insufficiency, chronic; long-term care
A Clinical Study to Assess the Safety of a New Influenza Vaccine
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the safety of a new influenza virus vaccine containing a new virus strain in
      healthy patients prior to the release of the vaccine.
    

Detailed description: 
      This prospective, randomized, double-blind, placebo-controlled release study will enroll
      approximately 300 healthy adults 18-49 years of age. Eligible subjects will be randomly
      assigned in a 4:1 fashion to receive a single dose of monovalent vaccine or placebo by
      intranasal spray. This study will be conducted at multiple sites in the United States.
      Randomization will be stratified by site.

      Each subject will receive one dose of investigational product on Study Day 1. The duration of
      study participation for each subject is the time from receipt of investigational product
      through 180 days after receipt of investigational product.

      To summarize the primary safety phase data (Study Days 1-8), the study will be unblinded to
      the analysis team at MedImmune after all data through at least Study Day 8 are locked.
    

Intervention name(s): Monovalent Frozen FluMist®; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Single dose of monovalent vaccine (240 subjects) by intranasal spray on Study Day 1.; Single dose of placebo (60 subjects) by intranasal spray on Study Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Statin-induced Lipid-rich Plaque Progression by Optical Coherence Tomography (OCT) Combined With Intravascular Ultrasound (IVUS)
Condition: Coronary Artery Disease; Hyperlipidemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Many trials suggested that lipid lowering therapy could significantly reduce cardiovascular
      events. Enhancing stability of vulnerable plaque is probably the main reason by which statins
      reduce adverse coronary events. The size of lipid core and the fibrous cap thickness (FCT)
      are the major determinants of plaque vulnerability. So, it is very important to accurately
      evaluate changes in plaque after stains therapy.

      Previous reports suggested that intensive lipid lowering therapy provide more significantly
      clinical benefit compared with moderate lipid lowering therapy.Such benefit may contribute to
      the changes in following parameters: FCT, lipid arc(quadrants), TCFA, macrophage, plaque
      disruption, and thrombus measured by OCT, and plaque burden and remodeling index by IVUS.

      Current intravascular imaging modalities, such as optical coherence tomography (OCT) and
      intravascular ultrasound (IVUS) can provide in vivo quantitative and qualitative information
      of coronary plaques. However, there were few studies aimed at monitoring the progression of
      coronary plaques in patients receiving statin therapy by OCT combined with IVUS.

      Therefore, the study we designed were to compare the effect of the rosuvastatin 10mg,
      atorvastatin 20mg and atorvastatin 60mg treatment on the changes in FCT and lipid core arc by
      OCT and plaque burden by IVUS of coronary atherosclerotic plaques.
    


Intervention name(s): Atorvastatin; Atorvastatin; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Atorvastatin 20mg/day; Atorvastatin, 60mg/day; Rosuvastatin,10mg/day
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: optical coherence tomography; intravascular ultrasound; Coronary artery disease; Hyperlipidemia
Effects of Memantine on Magnetic Resonance (MR) Spectroscopy in Subjects at Risk for Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Recent data show that marked cell damage precedes the clinical manifestation of Alzheimer's
      disease (AD). Hence, targeting populations at risk with pharmacological interventions is a
      possible strategy to lessen the burden of the disease. Cognitively normal individuals with
      subjective memory complaints (SMC) manifest biological characteristics consistent with early
      AD and are at risk for future cognitive decline. Family history of AD also constitutes a
      risk. In a previous study the investigators showed that memantine slows down the accumulation
      of phosphorylated tau in normal SMC subjects. Using a multivoxel high field MR spectroscopy
      (MRS) technique, the investigators also demonstrated that memantine decreased hippocampal
      glutamate. Both these findings may be consistent with the drug's anti-excitotoxic activity.
      In this new project the investigators propose to treat a sample of 12 presymptomatic
      individuals at risk (SMC and family history of AD) with memantine. This will be a double
      blind, placebo controlled study with a control group (12 non-treated subjects). The
      investigators will determine whether the effects of memantine as assessed by cognitive
      performance and MRS are present after 4 months of treatment and persist 2 months after
      discontinuation. MRS will be used to evaluate the effect of memantine on levels of the
      neurotransmitter glutamate and neuronal viability marker N-acetylaspartate (NAA) in the
      hippocampus. The investigators will test the following hypotheses:

        1. In subjects with SMC, memantine has modifying effects on brain biochemistry as reflected
           in MRS reductions in glutamate (reduced excitotoxicity) and increases in NAA (neuronal
           integrity).

        2. The effects of the drug persist (as a marker of sustained neuroprotection) and can be
           measured 2 months after discontinuation of the treatment.
    


Intervention name(s): memantine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): participants will be asked to take memantine (20mg/day) for 16 weeks; participants will be asked to take 2 tablets per day to match active drug
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: subjective memory complaints; cognitively healthy; family history; AD
Placement of the Double-Lumen Tube Without Fiberoptic Bronchoscope Assistance
Condition: Therapeutic Procedural Complication
Study type: Interventional

Summary: 
      laryngoscope combined with chest CT in double lumen endotracheal tube accurate positioning
    

Detailed description: 
      Comparing the traditional method of double lumen endotracheal tube intubation and
      laryngoscope combined with chest CT guide the precise localization of double lumen
      endotracheal tube
    

Intervention name(s): laryngoscope and chest CT image; traditional method by experience
Intervention type(s): Device; Device
Intervention description(s): First,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube. Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis; Operator inserted the double lumen tube by experience
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Liver Transplant Does it Affect the Brain
Condition: Brain Damage; Postoperative Cognitive Dysfunction; Neuron Specific Enolase; Glial Fibrillary Acidic Protein
MeSH terms: Brain Injuries; Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Neuronal damage caused by neuroinflammation in patients undergoing major surgery is the most
      determinant factor of postoperative cognitive disfunction (POCD). Neuronal damage can be
      detected through the measurement of biochemical markers of brain damage. The aim of this
      study was to evaluate neuronal damage and its association with POCD during liver
      transplantations. After the approval of the ethics committee and patient consents,
      preoperative and postoperative cognitive functions of 33 patients undergoing liver
      transplantation (LTx) were measured using the Mini Mental Test (MMT) whereas simultaneous
      neuronal damage was evaluated through the measurement of S-100 beta (S100β), Neuron specific
      enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels. As a result, there was no
      statistically significant difference between preoperative and postoperative MMTs. However,
      there was a statistically significant decrease in postoperative GFAP and a statistically
      significant increase in NSE compared to preoperative values. The decrease in S100β level was
      statistically insignificant. In conclusion, neuroprotective approaches in the investigator's
      anesthesia protocol protect patients from brain damage during liver transplantation and
      prevent the development of POCD, which was indicated by the insignificant change in MMT
      scores and S100β level and the significant decrease in GFAP. Since the significant increase
      in NSE levels during liver transplantations was deemed to might have been associated with
      causes other than neuronal damage, NSE should not be evaluated as a marker of brain damage in
      these operations.
    


Intervention name(s): Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein
Intervention type(s): Diagnostic Test
Intervention description(s): Patients undergoing liver transplantation (LTx) were measured using the Mini Mental Test (MMT) whereas simultaneous neuronal damage was evaluated through the measurement of S-100 beta (S100β), Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Liver transplantation; Neuronal damage; Brain; Biochemical marker; Postoperative Cognitive Dysfunction
TMS Treatment in Parkinson's Disease With Pain.
Condition: Transcranial Magnetic Stimulation; Parkinson Disease; Pain
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve pain in
      chronic sufferers. It is a well-tolerated procedure that can be performed on an outpatient
      basis. It uses a plastic covered coil that sends a magnetic pulse through the skull into the
      brain and by targeting particular areas in the brain it can be used to help modulate the
      perception of pain.

      The study intends to use this technique to treat such a disabling symptom in patients who
      suffer from Parkinson's Disease (PD). Initially the aim is to study this technique in 48
      patients who are suffering from pain and have PD. These patients would require an EEG before
      and after the stimulation. The stimulation would be performed over ten sessions and the
      patients would be assessed by a clinician using well recognized clinical tools.

      It is anticipated that there will be a meaningful improvement in pain. It is also anticipated
      that TMS is a safe technique to use in patients with PD. The study will be used to help plan
      a future study that compares TMS with sham technique to prove whether TMS could be an option
      in the treatment of such a disabling condition.
    


Intervention name(s): Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Transcranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS-induced analgesia is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks involved in the processing of painful signals and possibly strengthening the endogenous descending pain modulation system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TMS; Parkinson's disease; pain
A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
Condition: Hypercholesterolemia; Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of MK-0616, an oral PCSK9
      inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with
      hypercholesterolemia. The primary hypothesis is that at least one of the four doses of
      MK-0616 tested in this study is superior to placebo on percent change from baseline in LDL-C
      at Week 8.
    


Intervention name(s): MK-0616; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-0616 administered orally; Placebo matching MK-0616 administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Will Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Change Primary Treatment
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a prospective randomised multicenter trial assessing the additional value of
      breast MRI in women under 56 years of age with newly diagnosed breast cancer. Will
      preoperative breast MRI change treatment regimen? Will preoperative breast MRI reduce the
      number of primary surgeries? Will preoperative breast MRI increase the rate of mastectomies?
      Will preoperative breast MRI be cost effective?
    

Detailed description: 
      Completed: the study has concluded normally; participants are no longer being examined or
      treated (i.e., last patient's last visit has occurred)
    

Intervention name(s): MRI
Intervention type(s): Device
Intervention description(s): The intervention is that preoperative MRI breast will be performed in 220 women under 56 years with newly diagnosed breast cancer. Aims are to analyze if the intervention will affect primary management, decrease the number of reoperations and to analyze if the intervention leads to an increasing number of unnecessary mastectomies compared to the non intervention arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy of Tyrosine in Restless Legs Syndrome
Condition: Restless Legs Syndrome (RLS)
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional

Summary: 
      Tyrosine is a non essential amino acid that is the precursor of the neurotransmitter,
      dopamine. Tyrosine is converted into Levodihydrophenylalanine (L-Dopa) and L-Dopa is
      subsequently and avidly converted into dopamine. It is well known that dopamine deficiency
      leads to the manifestations of restless legs syndrome (RLS). Studies have shown dopamine
      agonists and L-dopa to be effective in controlling symptoms. No studies to date have been
      done to determine the role of tyrosine in RLS. This open-label pilot study aims to determine
      the efficacy and tolerability of tyrosine in RLS, as current agents have limitations in
      treating RLS in addition to adding another possible agent to the investigators arsenal of
      treating RLS that maybe more cost efficient. In this pilot study, the dose of tyrosine will
      be escalated from 750 mg once daily by mouth (PO) up to 3000 mg once daily PO, as tolerated,
      in increments of 750 mg every week in patients who meet the inclusion criteria for RLS.
      Patients' symptoms will be monitored on a weekly basis for six weeks.
    


Intervention name(s): L-Tyrosine
Intervention type(s): Dietary Supplement
Intervention description(s): L-Tyrosine 750 mg PO every day for 7 days, then increase to 1500 mg PO every day for 7 days, then increase to 2250 mg PO every day for 7 days, then increase to 3000 mg PO every day for remainder of the study.
Other intervention name(s): NOW Brand L-Tyrosine 750 mg Tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RLS
A Trial of ABT-888 in Combination With Temozolomide Versus Pegylated Liposomal Doxorubicin Alone in Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the objective response rate of ABT-888 when given
      in combination with temozolomide versus pegylated liposomal doxorubicin (PLD) alone in
      subjects with recurrent high grade serous ovarian cancer.
    

Detailed description: 
      Safety assessments and tolerability will be assessed through electrocardiograms (ECG).
      clinical laboratory tests, vital signs, Adverse Event assessments, and physical exams.
      Baseline radiographic tumor assessments, including CT scans of the chest, abdomen and pelvis
      will be obtained. Radiologic assessments and CA-125 measurements will also be performed every
      8 weeks during dosing and following completion of dosing until disease progression. Study
      visits will be conducted weekly for the first 2 cycles and on Day 1 of each subsequent cycle,
      at the Final Visit and 30 day Follow-up Visit. Study visits will include physical
      examination, complete blood count (CBC) and chemistries. A urinalysis tests will be performed
      at Screening and Final Visit. An ECG will be performed at Screening, Cycle 1 Day 1 and at the
      Final Study Visit. A left ventricular ejection fraction (LVEF) will be measured by
      Echocardiogram or Multiple Gated Acquisition (MUGA) scan on all subjects at Screening.
      Subjects randomized to the PLD arm will have an echocardiogram or MUGA performed at the Final
      Study Visit and at the discretion of the Investigator throughout the study. Adverse events
      will be assessed at every visit.
    

Intervention name(s): ABT-888; pegylated liposomal doxorubicin; temozolomide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Arm-A subjects will be given ABT-888 on Days 1 -7 every 28 days orally; Arm B subjects randomized to pegylated liposomal doxorubicin on Day 1, every 28 days intravenously.; Arm A subjects will be given temozolomide on days 1-5 every 28 days orally with ABT-888
Other intervention name(s): ABT-888, veliparib; doxil/caelyx; temozolomide, temodar/temodal
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Temozolomide; Veliparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian Cancer