bioihbjkbjnl/mcl2 huggingface dataset:
Air Pollution and Implantable Cardioverter Defibrillators
Condition: Arrythmias
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      Community based studies have shown increased cardiovascular mortality associated with acute
      exposures to particulate air pollution. Electrocardiographic changes have also been reported
      in animals exposed to particles in controlled conditions. We have hypothesized that
      cardiovascular patients may experience life-threatening arrhythmias associated with
      particulate air pollution episodes. Implanted cardioverter defibrillator (ICD) devices
      continuously monitor the heart rhythm, and on detecting arrhythmias can initiate
      interventions. These devices provide a passive, continuous monitor of cardiac arrhythmias. We
      are assessing the association between community exposures to air pollution measured by
      ambient monitors and these cardiac arrhythmias detected by implanted cardioverter
      defibrillator devices.
    

Detailed description: 
      Records of cardiac arrhythmias detected in patients with implanted cardioverter
      defibrillators will be linked with measurements of the concentration and constituents of
      ambient particulate air pollution. Time series methods will be used to assess temporal
      associations, adjusting for seasonal, weekly, and diurnal patterns, meteorology, and
      co-pollutants. Characteristics of subjects showing the strongest air pollution associations
      will be assessed, as well as effect modification by medication and co-morbidities.

      ICD patients are followed up clinically every three to six months. The ICD device is
      interrogated and data are retrieved by non-invasive radio frequency retrieval from the
      implanted device. Device performance is checked. Detected arrhythmias and therapeutic
      interventions are listed. For each detected episode, date and time is recorded, along with a
      short electrogram of the heartbeats immediately before and during the event.

      Daily ambient particle mass (PM10 and PM2.5) and particle constituents have been measured in
      Boston since January 1995. The Massachusetts Department of Environmental Protection has
      measured concentrations of gaseous pollutants including carbon monoxide, nitrogen dioxide,
      ozone, and sulfur dioxide. Meteorological factors including temperature, humidity, and
      barometric pressure have been measured at the National Weather Service station at Logan
      airport. Meteorologic factors and gaseous co-pollutants will be considered as independent
      predictors of arrhythmic events, and as confounders of the particulate air pollution
      associations.
    

Observational model: Defined Population
Time perspective: Other
Keywords: arrhythmia; cardiac; air pollution; time series
Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration for Perioperative Analgesia in Spine Surgery.
Condition: Pain, Postoperative; SPINAL Fracture; Spondylolisthesis
MeSH terms: Spondylolisthesis; Pain, Postoperative; Spinal Fractures
Study type: Interventional

Summary: 
      Postoperative pain still represents an important perioperative issue, affecting more than 80%
      of patients undergoing surgery. A suboptimal pain management doesn't just affects quality of
      life, but can compromise rehabilitation plan, increase morbidity and determine the
      development of chronic pain. Last but not least, far from being just an obligation for
      physicians, a good analgesia is a fundamental right of every patient.

      In order to meet these important demands, a great number of guidelines has been provided, all
      of these underlying that the centerpiece of postoperative analgesia lies in the multimodality
      management, thereby combining different medications and different ways of delivering them,
      with the aim of targeting distinct receptor systems and improving efficacy, while limiting
      side effects.

      In 2018, the investigators conducted a case-series analysis on 17 patients undergoing lumbar
      surgery to find out the role of Sublingual Sufentanil Tablet System (SSTS) in a multimodal
      analgesia regimen. Patients expressed a good pain relief, with most benefit during
      physiotherapy sessions and early discharges, in absence of side effects. Since then, SSTS has
      been part of regular clinical practice in our hospital.

      The aim of this randomized trial is to examine the analgesic efficacy and the opioid sparing
      role in spine surgery of a recently developed regional anesthesia technique, the Erector
      Spinae Plane block (ESP block), as opposed to Local Anaesthetic (LA) wound infiltration.

      The latter is a widespread, simple and unexpensive mean of providing postoperative analgesia.
      On the other hand, ESP block is an ultrasound-guided interfascial plain block, in which LA is
      injected below the erector spine muscle, closer to costotransverse foramina and origin of
      dorsal and ventral rami. It does provide an efficient multidermatomal sensory blockade
      (according to craniocaudal LA spread), with the advantage of being simple and safe.
    


Intervention name(s): ESP block; Wound infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): ESP block bilaterally performed at the level of the surgical site prior to surgery.; Wound infiltration performed at the surgical site at the end of surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia, Patient-Controlled; Anesthetics, Local; Pain, Postoperative
Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris; Erythema
Study type: Interventional

Summary: 
      Acne erythema consists of telangiectasia and erythematous papules, without a comedo, which
      occurs as a result of inflammatory acne. Moreover, although acne erythema is common in acne
      patients, no satisfactory medical or surgical treatment is available for this condition. Some
      acne erythema lesions may improve with time, but the persistent acne erythema, which is
      experienced by most patients, is cosmetically unacceptable and leads to frustration and
      psychological distress.
    

Detailed description: 
      Up to the present time, there have been several studies on the clinical efficacy of different
      laser modalities for acne treatment. Pulsed dye laser (PDL), 585 or 595 nm, has been
      demonstrated as one of the effective treatment options Another laser long-pulsed neodymium:
      yttrium-aluminum-garnet (Nd:YAG) laser with 1064 nm has been commonly used for skin
      rejuvenation. Nevertheless, the efficacy of this laser for acne treatment has been shown in
      some studies and case reports. The therapeutic effect on acne lesions is believed to be
      mediated by the selective photothermolysis of vessels, the upregulation of TGF-β, the
      reduction of interleukin-8 (IL-8) and Toll-like receptors-2 (TLR-2), and the thermal
      destruction of sebaceous glands.

      Isotretinoin remains the mainstay of acne treatment. No doubt, the side effects of this
      effective drug holds physicians back from jumping to prescribe it. Recent data suggested that
      lower doses (0.25 mg/kg/day) may lead to fewer side effects. and fewer flares. Clearing the
      use of oral isotretinoin in combination with other procedures has expanded our therapeutic
      options to obtain better control.
    

Intervention name(s): Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser
Intervention type(s): Combination Product
Intervention description(s): Selected patients will be treated with low-dose oral isotretinoin (10mg/day) over a period of sessions and six sessions of 1064 ND- YAG laser (Deka motous AY) using 150 J/cm2, 20-25 milliseconds pulse duration, and 5 mm spot size, at 2 weeks' interval.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preventing Postpartum Depression in African American Home Visiting Clients
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to determine whether a 6 week intervention is effective in
      preventing the worsening of depressive symptoms and development of clinical depression in
      low-income African American pregnant and recently delivered women who are enrolled in home
      visiting programs.
    

Detailed description: 
      This study will conduct a randomized controlled trial (RCT) with women from four Baltimore
      City home visiting programs. We will screen 200 women who are pregnant or have a child < 6
      months for study inclusion; 91 women at elevated risk for developing postpartum depression
      (PPD) will be randomized to an intervention (MB Course) or usual home visiting control group.
      Women in the intervention group will receive the 6-week MB Course delivered in a group
      setting by the Study Clinician with reinforcing messages provided by home visitors during
      1-on-1 home visits, while women in the attention control will receive usual home visiting
      services and information on postpartum depression. Primary outcomes include depressive
      symptoms and depressive episodes.
    

Intervention name(s): Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)
Intervention type(s): Behavioral
Intervention description(s): 6 weekly 2-hour cognitive-behavioral intervention sessions held in group format
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: depression, African American, home visiting, prevention
A Classroom-based Intervention to Promote Physical Literacy in Children: ALPHYL Study Protocol
Condition: Physical Activity
Study type: Interventional

Summary: 
      The goal of this study, named the Active Learning for PHYsical Literacy (ALPHYL) study, was
      to describe a multicomponent class-based physically-active learning randomized control trial
      (RCT) in primary school children. The main purpose was to promote children's physical
      literacy, academic achievement and cognitive function. The ALPHYL study is mainly based on
      physical literacy, active school models and Supportive, Active, Autonomous, Fair and
      Enjoyable principles.
    

Detailed description: 
      The ALPHYL is an 8-10-week RCT that will be conducted in six primary schools (12 classes) in
      Valencia and its metropolitan area. Schools will be randomly assigned to the intervention or
      a waiting-list control group. After a 30 h in-person training course for teachers and weekly
      meetings in the three months of resource preparation, the ALPHYL intervention will be
      conducted in physical education (PE) and non-PE lessons by teachers. The intervention
      consists of at least three physically active learning sessions per day plus model-based PE
      classes. Its feasibility will be evaluated weekly according to the Reach, Effectiveness,
      Adoption, Implementation, and Maintenance framework. To assess its effectiveness, a pre-test,
      post-test and retention (8-10 weeks after the intervention) with primary outcomes (i.e.
      physical activity level, motor competence, perceived motor competence and physical literacy,
      motivation, perceived social support, academic achievement and cognitive function), secondary
      outcomes and covariates will be collected.
    

Intervention name(s): Physical active learning
Intervention type(s): Behavioral
Intervention description(s): The intervention will last for 8-10 weeks. The ALPHYL intervention will be conducted in physical education (PE) and non-PE lessons by teachers. In addition to the PE lessons, at least three physically active activities in subjects other than PE will be conducted every day (5 days per week), with a total duration of approximately 30 minutes of light and moderate-to-vigorous physical activity per day. The weekly dose of physically active learning will thus be 100-150 minutes, so that a volume of 800-1200 minutes is foreseen during the 8-10 weeks. The PE classes will also be conducted in a mix of cooperative learning, non-linear pedagogy and health-based PE.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A classroom-based randomised controlled trial
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Physical Literacy; Academic Achievement; Cognitive Function; Children; School-based Intervention
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric
      monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing
      Crohn's disease.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind, repeated-dose study to evaluate the
      effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo
      in the treatment of patients with fistulizing Crohn's disease. The primary efficacy outcome
      of the study is the number of patients with at least a 50% reduction from baseline in the
      number of open fistulae observed for at least two consecutive evaluation visits.

      Patients will be treated with either anti-TNF chimeric monoclonal antibody (cA2) or matching
      placebo.
    

Intervention name(s): Infliximab 10 mg/kg; Infliximab 5 mg/kg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.; Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.; Matching placebo will be adminstered at Week 0, 2 and 6.
Other intervention name(s): anti-TNF chimeric monoclonal antibody (cA2); anti-TNF chimeric monoclonal antibody (cA2)
Intervention MeSH terms: Infliximab; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: fistulae; Crohn's Disease
Clinical Trial for PB-119 in Subjects With Type 2 Diabetes Mellitus
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, opened, positive drug-controlled (Exenatide, Byetta), sequential
      parallel group, multiple dose study to evaluate the safety, tolerability, pharmacokinetics
      and pharmacodynamics of twelve once-weekly subcutaneous doses of PB-119 to subjects with type
      2 diabetes mellitus (T2DM).
    

Detailed description: 
      There are two study phases according to different doses of investigational drug Phase 1：1
      investigational group and 1 control group, i.e.; investigational drug PB-119 injection 25µg
      group and control drug exenatide group.

      Phase 1： Plan to have 1 or 2 investigational group according to the study result from phase
      1, i.e., investigational drug PB-119 injection 50 µg group and control drug exenatide group.

      Subject Number：18 subjects will be randomized to each group, with equal number of females and
      males. 12 subjects will be in PB-119 group, 6 subjects will be in exenatide group.
    

Intervention name(s): Exenatide injection(Byetta); PB-119 injection
Intervention type(s): Biological; Biological
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: safety; pharmacokinetics; pharmacodynamics
Paclitaxel Plus Carboplatin With or Without Endostar in Patients With Advanced Non-small Cell Lung Cancer
Condition: Advanced Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between
      July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai
      Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital.
      All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy,
      patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus
      TC or TC alone for 3 cycles, 21 days as one cycle.
    


Intervention name(s): Endostar(Recombinant Human Endostatin Injection); paclitaxel-carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle; paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w
Intervention MeSH terms: Paclitaxel; Carboplatin; Endostar protein; Endostatins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-small Cell Lung Cancer; Endostar; Paclitaxel; Carboplatin
Effect of Seminal Plasma Insemination on Pregnancy Rates After IVF-ET
Condition: Effect on Implantation and Pregnancy Rates
Study type: Interventional

Summary: 
      Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases
      uterine receptivity.
    


Intervention name(s): seminal plasma insemination
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: seminal plasma/uterine receptivity
Text-message Program to Reduce Risky Sexual Behavior in Young Adult Female Emergency Department (ED) Patients
Condition: Education, Sex
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 2

Summary: 
      The US preventative services task force (USPSTF) recommends behavioral counseling in the
      primary care setting for prevention of sexually transmitted diseases, however, screening and
      counseling rarely occur. Text messaging (TM) is increasingly being used as a tool to affect
      behavior change in patients, but its effect on patients that report at-risk sexual behavior
      in the emergency department (ED) is unknown. The investigators seek to assess the feasibility
      of ED-based screening of young adult females for at-risk sexual behavior and enrolling them
      in a 3 month trial using TM to deliver information and skill building to improve health
      behavior.
    


Intervention name(s): Lifestyle counseling
Intervention type(s): Behavioral
Intervention description(s): Weekly SMS assessments of risky sexual encounters with feedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Creative Writing for Type 2 Diabetes Management
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study is related to the development of a new model of Group Care for patients with
      Diabetes - the CrewD Program, incorporating close reading and creative writing in group
      education. A randomized trial was designed to evaluate this intervention.
    

Detailed description: 
      A structured educational model for type 2 diabetic patients using Group Care is currently
      being used in several institutions for help managing diabetes in these patients. In this
      study, this model was adjusted by introducing literary texts and using narrative skills. A
      randomized trial was designed to determine whether group dynamic strategies using narrative
      and reading produce the same positive outcomes as a conventional group approach. A total of
      49 patients with type 2 Diabetes were randomized to two different Group Care dynamics, one
      "control group", with a classical structured educational approach and another, "intervention
      group", with close reading and creative writing. Evaluation included anthropometrical
      measures, A1c and questionnaires for psychological evaluation.
    

Intervention name(s): CrewD Program; Classical structured education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The CrewD Program - Creative reading and writing in Diabetes Program - is a Diabetes self-management education and support program to help people with Diabetes coping with the disease.; The Classical educational approach consists in an educational method based on the presentation of relevant theoretical information to help people with Diabetes coping with the disease.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type II Diabetes; Educational methods; Disease self-management
An Assessment of the Glyconutrient Ambrotose™ on Immunity, Gut Health, and Safety in Men and Women
Condition: Healthy
Study type: Interventional

Summary: 
      This study evaluates the impact of two Ambrotose products on immunity, gut health, and
      associated measures in healthy men and women. Subjects are randomly assigned in double-blind
      manner to one of five conditions: 1) 2 grams Advanced Ambrotose, 2) 4 grams Advanced
      Ambrotose, 3) 2 grams Ambrotose LIFE, 4) 4 grams Ambrotose LIFE, or 5) placebo. Subjects
      ingested their assigned condition daily for eight weeks.
    

Detailed description: 
      The product Ambrotose, which contains a blend of glyconutrients, has been used by human
      subjects for several years. It has been shown to enhance immunity, improve cognitive
      performance, and enhance antioxidant capacity. To date, the treatment with Ambrotose has been
      very well tolerated, with adverse events limited to "mild" or "self-limiting" or absent
      altogether.

      This study evaluates the impact of two Ambrotose products on immunity, gut health, and
      associated measures in healthy men and women. Subjects are randomly assigned in double-blind
      manner to one of five conditions: 1) 2 grams Advanced Ambrotose, 2) 4 grams Ambrotose
      Advanced, 3) 2 grams Ambrotose LIFE, 4) 4 grams Ambrotose LIFE, or 5) placebo. Subjects
      ingested their assigned condition daily for eight weeks.
    

Intervention name(s): Ambrotose LIFE; Advanced Ambrotose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Ambrotose LIFE contains aloe vera extract inner leaf gel, arabinogalactin, ghatti gum, glucosamine hydrogen chloride, gum tragacanth, vitamin A, beta carotene, wakame algae extract, rice starch, RiFiber (rice bran), and Modified Citrus Pectin with Sodium Alginate.; Advanced Ambrotose contains aloe vera extract inner leaf gel, arabinogalactan, ghatti gum, glucosamine hydrogen chloride, gum tragacanth, vitamin A, beta carotene, wakame algae extract, and rice starch; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind, Randomized, Control
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Ambrotose; Immunity; Gut Health