bioihbjkbjnl/mcl2 huggingface dataset:
Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty
Condition: Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents
Study type: Interventional

Summary: 
      The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in
      patients undergoing selective nasal sinus surgery and mammaplasty.
    

Detailed description: 
      Acupuncture therapy has been proved helpful in the patients suffering from various pain
      problems. And it is reported to be able to reduce the intraoperative anesthetic requirement.
      However, so far there is few evidence from randomized controlled studies to confirm the
      assistant anesthetic effect of acupuncture. Electroacupuncture (EA) is a modern non-invasive
      technique of traditional acupuncture. Compared to traditional acupuncture, EA is more
      practicable, more easily to be accepted by patients and operated by physicians. Nasal sinus
      surgery and mammaplasty, especially breast augmentation, mostly belong to the scope of day
      surgeries, which demand a rapid, smooth recovery from anesthesia with minimum adverse side
      effects (e.g.: pain, PONV, etc).
    

Intervention name(s): non-electroacupuncture; Electroacupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): The same procedure as electroacupuncture except stimulation; Electrodes are applied to bilateral "Hegu(L14)" acupoints at the time of 1h before operation, and connected to Hwato Electronic Acupuncture Treatment Instrument (Model No. SDZ-V, Suzhou Medical Appliances Co., Ltd., Suzhou, China). The acupoints are stimulated at an intensity of 3~6 mA and a frequency of 2/30 Hz for 30 min. The highest intensity will be chosen at which the patient can tolerate.
Other intervention name(s): Sham; Electroacupuncture preconditioning; Electroacupuncture pretreatment; Transcutaneous electric nerve stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Electroacupuncture; Analgesia; Anesthesia; Nasal septoplasty; Mammaplasty
Investigation of the Effects of Physiotherapy in Patients With Platelet Rich Plasma (PRP) Applied Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study evaluates effects of PRP and physiotherapy on pain, physical function and quality
      of life in patients with knee osteoarthritis.
    

Detailed description: 
      PRP has been reported to have a low to moderate level of evidence in patients with knee
      osteoarthritis (OA) in reducing pain and improving function. Similarly, in individuals with
      knee osteoarthritis, exercise has been reported to be effective in reducing the pain and
      improving physical function of the knee OA patient in the short term, and may be even more
      effective with individual exercise programs. However, there is no study examining the effect
      of PRP and exercise together. PRP and exercise can be more effective together. The aim of our
      study was to investigate the effects of physiotherapy on pain, physical function and quality
      of life in patients with knee OA who underwent PRP injection.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Exercise specific to knee osteoarthritis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis; Platelet rich plasma; Exercise
Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients
Condition: Chronic Abnormal Immune Activation in HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, dose-finding, placebo-controlled study in
      patients with chronic HIV infection and inadequate immune restoration treated with long-term
      highly active antiretroviral therapy (HAART). A total of 150 eligible subjects will be
      selected and randomized at a ratio of 1:1:1 into T8 0.5 mg QD, 1 mg QD, and placebo group,
      with background HAART unchanged, for 48 consecutive weeks.
    


Intervention name(s): T8 tablet 0.5mg; T8 tablet 1mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.; Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.; Blank control.
Other intervention name(s): Leiteng Shu; Leiteng Shu
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic abnormal immune activation; AIDS; T8; Efficacy; Safety
Video Based Mindfulness Based Stress Reduction
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      To evaluate the feasibility of a video based mindfulness intervention for stress reduction
      and to evaluate the cortisol response in persons with PD and their caregivers. The data from
      this project will be used for a future grant application of a stress reduction intervention
      in persons with PD.
    

Detailed description: 
      Participants will be enrolled at the VA Portland and have a baseline assessment. The baseline
      will assess neurological disorders (including Parkinsonism) and current stress. All
      participants will attend 10 weeks of mindfulness based stress reduction (MBSR) through video
      feed on the Portland VA campus. During the week prior to the first class and the week after
      the last class, participants will complete questionnaires regarding stress, collect saliva
      samples, and, for the Parkinson's patient, monitor motor symptoms of PD using diaries and
      inertial sensors. A final visit will assess stress, neurological diseases, and Parkinsonism.
    

Intervention name(s): Mindfulness
Intervention type(s): Behavioral
Intervention description(s): Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
Other intervention name(s): Mindfulness Based Stress REduction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Movement disorders; Metabolic Stress
Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
Condition: Reducing Psychological Side Effects of Ketamine
Study type: Interventional
Phase: Phase 3

Summary: 
      Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches
      peak level 1-4 hours after oral administration.
    

Detailed description: 
      1:1 randomization without stratification use web-based software (Redcap) before surgery.
      Allocation will be concealed from the patient, the nurse, the operating room team. Both
      patient and the operating room team will be blinded to the treatment allocation (double
      blind).

      Standard preoperative care as per anesthesia care team. Patient will receive lamotrigine vs.
      placebo with small sips of water. Lamotrigine reaches peak level 1-4 hours after oral
      administration. Single dose lamotrigine is safe and is not associated with rash.

      Standard intraoperative care as per the anesthesia care team. All patients will receive
      Ketamine 1 mg/kg at induction. Ketamine 5mcg/kg/min will be started at induction and stopped
      at the end of surgery.

      Standard postoperative care as per PACU team. The psychologic side-effects will be measured
      using Brief Psychiatric Rating Scale (BPRS) using an online tool.

      Research fellow will receive standardized training in administering BPRS from Dr. Amit Anand
      using structured material. Dr. Anand has used this training for other current research
      projects.
    

Intervention name(s): Lamotrigine 300 MG; Placebo; Ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300 mg of oral Lamotrigine. One of the key studies in this area was reported at the Society of Neuroscience meeting in 1997 and later published in the Archives of General Psychiatry. This study reported that, in healthy subjects 300 mg oral lamotrigine significantly decreased ketamine-induced perceptual abnormalities as assessed by the Clinician-Administered Dissociative States Scale (P<.001).31 Furthermore lamotrigine increased the immediate mood-elevating effects of ketamine (P<.05).; 300 mg of oral Placebo; 1mg/kg bolus at induction followed by 5 microgram/kg/min infusion till the end of the surgery
Other intervention name(s): Lamictal 300 mg
Intervention MeSH terms: Lamotrigine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomization without stratification
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if a topical otic formulation is safe and effective
      in treating middle ear infections in patients with ear tubes.
    


Intervention name(s): Moxidex otic solution; Moxifloxacin otic solution; Tympanostomy tubes
Intervention type(s): Drug; Drug; Device
Intervention description(s): 4 drops into the infected ear(s) twice daily (morning and evening) for 7 days; 4 drops into the infected ear(s) twice daily (morning and evening) for 7 days; Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Intervention MeSH terms: Moxifloxacin; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ear tubes; ear drainage; ear infection; ear drops
Walk to School and Physical Activity
Condition: Physical Activity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the proposed study is to determine the effect of walking to school for one
      week on total physical activity and patterns of physical activity in third, fourth and fifth
      grade students.
    

Detailed description: 
      Increasing children's physical activity has become an important public health concern. Active
      transportation (walking and bicycling) is one aspect of children's physical activity that has
      received little attention but may provide a means of increasing children's activity levels.
      Traveling to school is a common activity for most children in the United States. Due to this
      regularity, active transportation to school provides a possible way to incorporate an
      increase in children's moderate-to-vigorous physical activity into a routine activity.

      Several "walk to school" programs have been implemented but it is not known if the physical
      activity levels of children walking to school are greater than those that get chauffeured or
      bused. Theoretically, moderate intensity activity should be greater in the walkers compared
      to others. This difference should be in proportion to the duration of the walk to and from
      school; determined by how far the child lives from the school. However, more activity in the
      morning may have an impact on activity levels later in the day. Therefore, differences in
      daily activity patterns in addition to total activity need to be considered.

      Comparison(s): Following a baseline week, the physical activity of students randomized to a
      Walk to School group will be compared to those randomized to a Control group, who will
      continue to be driven to school.
    

Intervention name(s): physical activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: Physical Activity; Walking; Primary Schools; Transportation
Combined Treatment of Resistant Hypertension and Atrial Fibrillation
Condition: Hypertension, Resistant to Conventional Therapy; Atrial Fibrillation
MeSH terms: Hypertension; Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is the comparative evaluation of systolic blood pressure (SBP)
      lowering, atrial fibrillation (AF) recurrence and clinical data in patients with
      paroxysmal/persistent AF and resistant hypertension, undergoing AF ablation alone or combined
      with percutaneous renal denervation.
    


Intervention name(s): Circumferential PV isolation; Circumferential PVI+renal denervation
Intervention type(s): Procedure; Procedure
Intervention description(s): The left atrium (LA) and pulmonary veins (PVs) are explored through a transeptal approach. Real-time 3D LA maps are reconstructed by using a nonfluoroscopic navigation system. The ipsilateral left and right PVs are encircled in one lesion line by circumferential PV isolation. Radiofrequency energy is delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and is reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion is ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of circumferential PV isolation is PV isolation. Additional ablation lines are created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs. After the end of the procedure the implantable loop recorder is implanted in the parasternal area of the chest.; The procedure of AF ablation is the same like in the circumferential PV isolation.
After AF ablation procedure, the angiogram of both renal arteries is performed via femoral access. After that the treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Resistant hypertension; Atrial Fibrillation; Percutaneous renal denervation
Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) - Assay
Condition: Sunscreen Agents
Study type: Interventional

Summary: 
      Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection
      Factor (SPF) on the skin of human subjects.
    


Intervention name(s): BAY 987516; SPF 15 Control
Intervention type(s): Drug; Drug
Intervention description(s): Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.; Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of vaccination with
      autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor
      (GM-CSF) producing cell line.
    


Intervention name(s): Therapeutic Cellular Vaccine, GM-CSF Producing
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Cancer; PSCT; Peripheral Stem Cell Transplant; Chemotherapy; GVAX
A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated
      with either esomeprazole or lansoprazole
    


Intervention name(s): Esomeprazole; Lansoprazole
Intervention type(s): Drug; Drug
Intervention description(s): 40mg once daily; 30mg once daily
Other intervention name(s): Nexium; Prevacid
Intervention MeSH terms: Esomeprazole; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Erosive Esophagitis; Nexium; Heartburn
Isomaltulose VS Sucrose - Postprandial Effect on Incretin Profile and Second Meal Effect
Condition: Diabetes Mellitus, Type 2; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study evaluates the different postprandial effect of isomaltulose and sucrose on the
      incretin profile and as an determinant for the second meal effect.

      In this nutritional intervention study, healthy participants and T2DM patients ingest 2
      standardized meals for breakfast and lunch in combination with either sucrose or palatinose
      on 2 separate days. In addition, blood samples are taken to analyze markers of the
      carbohydrate metabolism, incretins and specific inflammation markers.
    

Detailed description: 
      Isomaltulose is a natural occurring disaccharide with a similar structure to sucrose. It is
      composed of glucose and fructose, but is linked by an α-1,6-glycosidic bond instead of α-1,2.
      Due to its binding, isomaltulose is slowly hydrolysed, which results in a rather weak
      postprandial glycemic-insulinemic response, accompanied by a minimal GIP secretion and a
      stimulated secretion of GLP-1. In addition, several studies have shown that the intake of
      foods with a low glycemic index, such as isomaltulose, tend to improve the metabolic reaction
      to a subsequent meal. As the exact mechanism of this "second meal effect" is still unknown,
      the investigators hypothesize that the modified release and action of GIP and GLP-1 are key
      players in regard to the described effects.Therefore, isomaltulose could be a suitable tool
      for reducing the risk of developing diabetes, obesity and CVD as well as improve blood
      glucose control in people with diabetes.

      In summary, this study evaluates the different postprandial effect of isomaltulose and
      sucrose on the incretin profile and as a determinant for the second meal effect.

      In this nutritional intervention study, healthy participants and T2DM patients ingest 2
      standardized meals for breakfast and lunch in combination with either sucrose or palatinose
      on 2 separated days. In addition, blood samples are taken to analyze markers of the
      carbohydrate metabolism, incretins and specific inflammation markers.
    

Intervention name(s): Intervention A; Intervention B; Intervention C; Intervention D
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Comparison of sucrose vs. palatinose (isomaltulose) on second meal effect (high-GI meal vs. high-protein meal) in subjects with T2DM or metabolic Syndrome without T2DM
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Isomaltulose; Palatinose; second meal effect; incretin; GIP; GLP-1; postprandial inflammation
Primary Osteoarthritis Lumbar Spine: Establishing Its Cause, Pathogenesis and Treatment.
Condition: Lumbar Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Spine
Study type: Observational

Summary: 
      The study was about a root cause of Primary Osteoarthritis Lumbar Spine producing
      disabilities in sitting, climbing and walking etc. In advance stage the person is bereft of
      his/her personal physical activities. The prevalent treatment is temporary and
      dis-satisfactory. A new treatment was designed and a trial was conducted on 154 patients (100
      in the trial group, 50 in the control group) for a duration of six months.
    

Detailed description: 
      The study was focused on establishing the cause, pathogenesis and treatment of painful Lumbar
      Spine disease (Primary Osteoarthritis Lumbar Spine = OA Lumbar Spine) at present the exact
      cause and treatment are not known. It was aimed to find out to latter through a hypothesis by
      designing a treatment and testing it with a clinical trial.

      This established that the deficient full extension of the spinal joints (intervertebral
      joints between the adjacent vertebrae from T12 to S1) producing contracture in their capsules
      in front, was the cause and the correction (Contracture Correction Therapy = CCT) was the
      cure of the disease. The correction was carried out by intermittent and sustained extension
      of the lumbar spin through three designed body postures.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Group includes people across locations in and Gwalior city. Trial was based on "Pragmatic
        Cluster Randomized Controlled Trial", also known as Cluster Randomized Trial (CRT) or Group
        Randomized Trial. In this variety pre-existing groups, called clusters, of individuals are
        randomly allocated to treatment arms. The subjects, who consulted me, were of two types.
        The type I wanted to avoid surgery, had tried other nonsurgical options and did not want
        those anymore. These patients were included in trial group and took my designed treatment
        (Contracture Correction Therapy = CCT). The other type of patients who did not consent for
        the new treatment were included in the control group.
      
Keywords: Osteoarthritis; Lumbar Spine; Intervertebral Joint; Capsule Contracture; Discectomy; Ideopathic