bioihbjkbjnl/mcl2 huggingface dataset:
Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance
      endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic
      breast cancer (MBC).
    

Detailed description: 
      There are several options for MBC patients who are responding to chemotherapy, to continue
      treatment with a fix number of cycles or until disease progression which also known as
      maintenance chemotherapy (MCT), to stop chemotherapy and take a watch and wait strategy, or
      to stop chemotherapy and start the maintenance endocrine therapy (MET) for hormone receptor
      (HR) positive patients. Since the role of maintenance therapy in prolonging the overall
      survival (OS) and progression-free survival (PFS) of MBC was controversial in previous
      studies, the investigators performed a systematic review of randomized controlled trials to
      detect the association of survival with maintenance therapy in patients with MBC after
      first-line chemotherapy. And the investigators further performed a multi-center retrospective
      real-world study to evaluate these two maintenance modalities.
    

Intervention name(s): Capecitabine; Liposomal doxorubicin; Gemcitabine; Fulvestrant; Anastrozole; Letrozole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days; 50 mg/m 2 IV day 1, cycled every 28 days; 800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days; 500mg IH Days 0, 14, 28, then every 28 days; 1mg PO qd; 2.5mg PO qd
Other intervention name(s): Maintenance Chemotherapy; Maintenance Chemotherapy; Maintenance Chemotherapy; Maintenance Endocrine Therapy; Maintenance Endocrine Therapy; Maintenance Endocrine Therapy
Intervention MeSH terms: Gemcitabine; Capecitabine; Doxorubicin; Liposomal doxorubicin; Letrozole; Fulvestrant; Anastrozole
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a multi-center real world study to compare maintenance chemotherapy (MCT),
        maintenance endocrine therapy (MET) and observation in patients with HR-positive MBC who
        achieved disease control after first-line chemotherapy. Patients were retrospectively
        enrolled from 3 different medical center.
      
Keywords: Metastatic Breast Cancer; Maintenance Chemotherapy; Maintenance Endocrine Therapy; Overall Survival; Safety
Botanical/Drug Interactions in HIV: Glucuronidation
Condition: HIV Seronegativity
Study type: Interventional
Phase: Phase 1

Summary: 
      A series of clinical studies will be conducted in normal, healthy adult volunteers to
      evaluate the potential for alterations in the pharmacokinetics of anti HIV drugs when
      botanicals/nutriceuticals are given concurrently via the oral route. Both the drugs and
      botanicals are known to rely upon or to modulate, respectively, metabolism via
      glucuronidation.
    

Detailed description: 
      As per Brief Summary
    

Intervention name(s): silymarin
Intervention type(s): Drug
Intervention MeSH terms: Silymarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Milk thistle; silymarin; piperine; glucarate; zidovudine; abacavir; mycophenolate mofetil; HIV; pharmacokinetics; interaction; glucuronidation; Healthy; Complementary Therapies
The Effects of Single-Pulse Transcranial Magnetic Stimulation on the Autonomic Nervous System in Healthy Adults
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to determine the effects of TMS on the ANS. The investigator
      will determine whether single-pulse TMS of the primary motor cortex in the dominant
      hemisphere in healthy, young adults will affect 1) heart rate and heart rate variability, 2)
      blood pressure and 3) baroreflex function. This study is foundational in that it will begin
      to characterize how single-pulse TMS affects the ANS in healthy adults.
    

Detailed description: 
      The overall purpose of this study is to investigate the effects of TMS on the ANS.
      Specifically; the investigator aim to determine if single-pulse TMS of the primary motor
      cortex in the dominant hemisphere in healthy, young adults will significantly affect 1) heart
      rate and heart rate variability, 2) blood pressure and 3) baroreflex function.

      The first purpose of this study is to measure alterations in sympathetic and parasympathetic
      activation in response to TMS. To do this, we will measure HRV immediately after single-pulse
      TMS. The second purpose is to investigate the changes in blood pressure in response to TMS
      and to determine whether the baroreflex, a critical modulator of blood pressure, is inhibited
      by TMS.

      Aim 1: To determine if single-pulse TMS of the primary motor cortex will significantly alter
      heart rate variability. We hypothesize that single-pulse TMS of the primary motor cortex will
      elicit an acute decrease in heart rate and result in improved heart rate variability
      indicated by a significantly decreased LF power and increased HF power.

      Aim 2: To determine if single-pulse TMS of the primary motor cortex will significantly alter
      blood pressure and baroreflex sensitivity (BRS). We hypothesize that single-pulse TMS of the
      primary motor cortex will elicit an acute decrease in blood pressure by inhibiting the
      baroreflex.
    

Intervention name(s): Single-Pulse Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): Single-pulse Transcranial Magnetic Stimulation activates neurons within the cortex of the brain by way of electromagnetic induction. This causes a small, focused electric field to become present in the brain, which activates the neurons.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy adults
      
Keywords: blood pressure; heart rate variability; single-pulse transcranial magnetic stimulation; non-invasive brain stimulation
Davunetide (AL-108) in Predicted Tauopathies - Pilot Study
Condition: Predicted Tauopathies, Including; Progressive Supranuclear Palsy; Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17; Corticobasal Degeneration Syndrome; Progressive Nonfluent Aphasia
MeSH terms: Dementia; Aphasia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Parkinsonian Disorders; Supranuclear Palsy, Progressive; Tauopathies; Corticobasal Degeneration; Aphasia, Broca; Primary Progressive Nonfluent Aphasia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to obtain preliminary safety and tolerability data with
      davunetide (NAP, AL-108) in patients with a tauopathy (frontotemporal lobar degeneration
      [FTLD] with predicted tau pathology, corticobasal degeneration syndrome [CBS] or progressive
      supranuclear palsy [PSP]). The secondary objectives of this study are to obtain preliminary
      data on short term changes (at 12 weeks) in a variety of clinical, functional and biomarker
      measurements from baseline, including cerebrospinal fluid (CSF) tau levels, eye movements,
      and brain MRI measurements.
    


Intervention name(s): davunetide (AL-108, NAP); Placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized 2:1 (drug:placebo). Subjects will receive twice daily treatment with davunetide 15 mg administered intranasally.; Subjects will be randomized 2:1 (drug:placebo). Subjects will receive twice daily treatment with placebo administered intranasally.
Other intervention name(s): AL-108; NAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Frontotemporal Dementia; Corticobasal Degeneration; Progressive Nonfluent Aphasia; Progressive Supranuclear Palsy; FTLD; FTD; PNFA; CBD; PSP; Predicted tauopathies, including:; Progressive Supranuclear Palsy (PSP); (CBS); Progressive Nonfluent Aphasia (PNFA)
The Effects of Spinomed Orthosis and Biofeedback Orthosis in Elderly Individuals With Thoracic Hyperkyphosis
Condition: Elderly People
MeSH terms: Kyphosis
Study type: Observational

Summary: 
      Hyperkyphosis, defined as excessive sagittal curvature of the thoracic spine, is the most
      common spinal deformity in elderly individuals. The prevalence of hyperkyphosis in elderly
      individuals is reported to be between 20% and 40%. Hyperkyphosis affects the mobility,
      walking, and balance of the individual negatively and causes changes in the physical
      performance of elderly individuals. Therefore, it is important to evaluate and treat
      hyperkyphosis in elderly people. One of the approaches to treating people with hyperkyphosis
      is the use of spinal orthoses such as the Spinomed orthosis and Biofeedback orthosis. Regular
      use of spinal orthoses reduces the angle of kyphosis by 11%. In addition, spinal orthoses
      help increase walking speed and distance, improve balance, and prevent falls. Spinomed and
      Biofeedback soft posture orthoses are spinal orthoses used in the treatment of kyphotic
      posture. Studies on Spinomed orthosis have demonstrated that it strengthens postural muscles,
      and therefore also prevents falls. Soft orthoses, which provide feedback, provide a warning
      to the individual through sound or vibration when the spinal alignment of the individual is
      disturbed, and provide the correction of posture with active muscle strength. However, little
      evidence exists regarding the effect of these two orthoses on improving balance and walking
      performance in elderly people with thoracic hyperkyphosis. Therefore, this study was
      developed to enable a comparison of the effect of the Spinomed orthosis and the biofeedback
      orthosis on balance and walking performance in elderly people with thoracic hyperkyphosis.
    

Detailed description: 
      Volunteer healthy elderly individuals between the ages of 60-80 will be recruited into our
      study and the individuals will be randomly divided into two groups Spinomed orthosis and
      postural orthosis which provides biofeedback. In both groups, balance and gait assessments
      with or without orthosis will be done twice.
    

Intervention name(s): assessment
Intervention type(s): Other
Intervention description(s): Assessments of thoracic kyphosis angle, balance performance, and gait performance.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Elderly people with thoracic hyperkyphosis will be invited to this study.
A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy
Condition: Allergic Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants
      who completed the EXCELS study (NCT00252135) and had received long-term treatment with
      Xolair. In addition, participants who did not participate in the EXCELS study but received
      long-term (~5 years) treatment with Xolair were allowed to enter the study.
    

Detailed description: 
      The treatment designation for participants who reached the primary efficacy endpoint (1
      protocol-defined severe asthma exacerbation) was unblinded to allow appropriate clinical
      intervention. Participants who had their treatment designation unblinded remained in the
      study for ongoing evaluation of safety and were allowed to continue on study drug known to be
      Xolair (or to start study drug known to be Xolair if they were in the placebo group).
    

Intervention name(s): Omalizumab; Placebo; Asthma therapies
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.; Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.; Participants could receive 1 or more of the following medications as concomitant asthma therapy: Inhaled corticosteroids; long acting beta-agonists; zafirlukast or other leukotriene receptor antagonist; zileuton or other 5-lipoxygenase enzyme inhibitors; oral, inhaled, and/or nasal anticholinergic therapy; mast-cell stabilizers; theophyllines; chronic oral corticosteroids, defined as a minimum dose of oral prednisone of 2 to 40 mg/day or 5 to 80 mg every other day.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being done to compare two commonly available types of body contouring,
      VASER-Assisted Lipoplasty (VAL) and Suction-Assisted Lipoplasty (SAL), and to decide if one
      procedure is preferred by patients and/or surgeons over the other. Participants will have VAL
      on one side of their body and SAL on the opposite side.
    


Intervention name(s): Suction-assisted Lipoplasty; VASER-assisted lipoplasty
Intervention type(s): Device; Device
Intervention description(s): Standard Suction-assisted lipoplasty will be performed on one side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back; VASER-assisted lipoplasty will be performed on the opposite side of the body to remove excess fat and contour the body in one or more of the following body areas: arm, inner thigh, outer thigh, back
Other intervention name(s): Suction-assisted lipoplasty, Liposuction; VAL, VASER, LipoSelection, 3rd Generation UAL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: lipoplasty; liposuction; VASER; body contouring; body sculpting; Any patient; expressing; interest; in elective surgery
Brain Perfusion in Pantothenate Kinase-associated Neurodegeneration (PKAN)
Condition: Pantothenate Kinase-associated Neurodegeneration (PKAN)
MeSH terms: Pantothenate Kinase-Associated Neurodegeneration; Nerve Degeneration
Study type: Observational

Summary: 
      The purpose of this study is to learn whether blood flow in the brain is normal in people
      with pantothenate kinase-associated neurodegeneration (PKAN). Specifically, preliminary data
      suggest a region of the brain called the globus pallidus (GP), a key region affected by PKAN,
      may have reduced blood flow. Standard MRI and perfusion scanning techniques will be used to
      learn about cerebral blood flow in the globus pallidus and compare it to blood flow in other
      brain regions as well as to healthy controls.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The PKAN group consists of individuals in the United States diagnosed with PKAN.
      
Keywords: PKAN; brain iron; NBIA; neurodegeneration with brain iron accumulation; Hallervorden Spatz Syndrome
Weight in Lower Limbs Improves Gait Ataxia of in Machado-Joseph Disease Patients
Condition: Machado-Joseph Disease
MeSH terms: Machado-Joseph Disease; Gait Ataxia
Study type: Interventional

Summary: 
      Few studies evaluated the efficacy of adding weights on the lower limbs in patients with
      ataxic disorders. There is no current evidence on which would be the most appropriate weight
      for use in this context. To assess progress and benefits of using this load, gait of
      symptomatic carriers of spinocerebellar ataxia type 3/Machado Joseph disease the objective of
      the study is to evaluate the gait with and without different load weights on lower limbs.
      Outcomes were the Scale for the Assessment and Ataxia Rating of (SARA), kinematic gait
      assessment by the accelerometer and gyroscope and the Patient Global Impression (PGI) about
      which weight they prefer for walking.
    


Intervention name(s): Weight in Lower Limbs
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: SCA 3; Ataxic Gait
Impact of Energy Drink Brands on Heart Rhythm
Condition: Electrical Alternation of Heart; Blood Pressure
Study type: Interventional

Summary: 
      To assess the cardiac effects of energy drink brands in healthy volunteers
    

Detailed description: 
      Energy drinks are widely available and globally consumed. There are many brands of energy
      drinks on the market, and there are differences in the ingredients included. Previous studies
      have tried to evaluate the safety of energy drinks and have demonstrated a signal for some
      electrocardiographic (ECG) and hemodynamic effects. However, product related differences need
      further exploration. This study is designed to assess the effects of 2 different energy drink
      products on heart rhythm and blood pressure in healthy subjects.
    

Intervention name(s): Energy Drink Brand 1; Energy Drink Brand 2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes; Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes; Lime juice, water, and cherry flavoring
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: ECG; Blood Pressure; Energy Drinks
Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
Condition: Rhinitis; Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic, Seasonal; Conjunctivitis; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the more efficient dose for the treatment of
      rhinitis/rhinoconjunctivitis against grass pollen allergy
    

Detailed description: 
      Double blind placebo-controlled study. The subjects will receive medication during 4 months.
    

Intervention name(s): MG56 Mannosylated 500 subcutaneous; MG56 Mannosylated 1000 subcutaneous; MG56 Mannosylated 3000 subcutaneous; MG56 Mannosylated 5000 subcutaneous; MG56 Mannosylated 500 sublingual; MG56 Mannosylated 1000 sublingual; MG56 Mannosylated 3000 sublingual; MG56 Mannosylated 5000 sublingual; Subcutaneous placebo; Sublingual placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml subcutaneous; Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous; Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous; Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous; Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml sublingual; Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml sublingual; Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml sublingual; Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml sublingual; Comparison between placebo and active group; Comparison between placebo and active group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: Rhinitis / Rhinoconjunctivitis; Vaccine; Immunotherapy; Grass pollen; Allergy
Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery
Condition: Coronary Artery Bypass; Antiplatelet Agents
Study type: Interventional
Phase: Phase 4

Summary: 
      The study population will include all patients undergoing elective CABG. Consent and
      randomization will occur before surgery. Total 500 patients undergoing elective CABG will be
      randomly assigned into three groups with 1:1:1 ratio(167 patients per group) in this
      open-label study. All the enrolled patients will stop oral antiplatelet drugs according to
      local protocol before the surgery. Within the first 24 hours after surgery, study medication
      should be restarted and continued for 12 months. Arm A will restart oral antiplatelet drugs
      by giving aspirin 100mg qd, Arm B will also restart oral antiplatelet drugs by giving
      ticagrelor 90mg bid plus aspirin 100mg qd and Arm C will also restart oral antiplatelet drugs
      by giving ticagrelor 90mg bid. Treatment will continue for 12 months, at which time patients
      will undergo a multislice computed tomography angiography to assess vein graft patency.

      This study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as
      compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of
      vein graft patency.
    

Detailed description: 
      The study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as
      compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of
      vein graft patency. The primary comparison includes two separate parts. One is to demonstrate
      T+A better than A and the other is T better than A.

      One year rate of vein graft patency in the aspirin group is estimated as 80%. The assumed
      rate of ticagrelor plus aspirin is 90%. With a two-sided alpha level 0.05 and 80% power, 199
      grafts to each group are required. On the other hand, if we assume the rate of ticagrelor
      monotherapy has the 1-year vein graft patency rate of 87%, under the same two-sided 0.05
      alpha 441 grafts in each arm will offer 80% power to show the superiority of ticagrelor along
      for the primary efficacy end point.

      Combined the above two assumptions, if the allocation rate is 1:1:1, this study needs to
      recruit 1,323 grafts in total (441 in each) to achieve the pre-specified power for both the
      two comparisons (T+A vs. A and T vs. A).

      The principle investigator assumes that the average number of the vien grafts in one patient
      is 2.7-3.0. With this assumption, 500 patients are to be recruited, which will provide us a
      total of 1350 - 1500 grafts.

      According to the above, this study will be a confirmatory clinical trial to the primary
      endpoint.
    

Intervention name(s): Aspirin; Ticagrelor
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CABG; Antiplatelet; Ticagrelor