bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Bag-Valve-Guedel Adaptor to Common Face Mask for the Ventilation of Bearded Men
Condition: Pre-hospital Ventilation
Study type: Interventional

Summary: 
      Ventilation of a bearded patient with the commonly used face mask has low efficiency because
      of difficulties to achieve a tight seal around the mouth and nose.

      The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor
      (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating the
      need for a face mask.
    

Detailed description: 
      Ventilating a patient using a bag valve and a face mask is not easy to perform, especially
      for a long period of time, and mandates experience and strength by the care giver. The need
      for a tight seal around the mouth and nose is a major challenge especially if the patient has
      a beard. Nevertheless, the face mask is the only approved respiratory support that medics and
      other basic care givers are allowed to use in the out-of-the-hospital setting, and only
      physicians and paramedics are allowed to use more advanced techniques, providing a definite
      airways. Thus, despite its lower effectiveness, the bag valve mask technique is the most
      commonly used in the field

      The purpose of this study is to evaluate the efficacy of a novel bag valve guedel adaptor
      (BVGA) that enables the direct connection of a bag valve device to a guedel - eliminating the
      need for a face mask.

      Study Design: Prospective, randomized, controlled. The volunteers will be asked randomly
      assigned to breathe through the BVGA/Face mask followed by the same protocol with the
      Face-mask/BVGA: 5 minutes room air, 5 minutes 100% oxygen, and 5 minutes room air again. The
      BVGAs/face masks well be connected to a standard operating room ventilation machines, and
      cardiopulmonary parameters will be monitored and documented.
    

Intervention name(s): BVGA; Face Mask
Intervention type(s): Device; Device
Intervention description(s): The BVGA enables the direct connection of a bag valve device to a guedel, eliminating the need for a face mask during ventilation; Classic face mask
Other intervention name(s): Bag Valve Guedel Adaptor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The present pharmacokinetic study is designed to assess the pharmacokinetics of RSG XR as
      monotherapy in patients with mild Alzheimer's disease (AD) as such information will not be
      obtained from the current phase III trials . The study aims to enroll fourteen patients
      (seven of each APOE genotype). Each patient will receive a single oral dose of 4mg of RSG XR
      in the morning under fasted conditions and PK samples will be taken up to 36h.
    


Intervention name(s): Rosiglitazone (Extended Release)
Intervention type(s): Drug
Intervention description(s): open-label, single, oral, 4mg dose
Intervention MeSH terms: Rosiglitazone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PPAR agonist,; Rosiglitazone XR,; BRL-049653.; Alzheimer's disease,
Breast Milk Content Expressed Manually Compared to Electric Pump
Condition: Infant
Study type: Interventional

Summary: 
      Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive
      factors for the health and development of infants.Colostrum, which is produced in low
      quantities for the first 3 to 4 days after birth, is rich in immunologic components and
      developmental factors.

      Breastfeeding difficulties during the first days of life of an infant are common. Moreover,
      not all infants can be directly fed at the breast.

      Therefore, breast milk feeding at this early stage is initiated and promoted by the
      expression of breast milk either manually or by use of a pump. Whether the method of milk
      expression at this stage has a qualitative impact on colostrum is currently unknown.

      The purpose of this randomized controlled study is to compare the effect of manual expression
      with electric pump expression upon the macronutrient composition of breast milk.
    


Intervention name(s): Pump
Intervention type(s): Procedure
Intervention description(s): Breast milk expression using manually or using an electric pump
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Lactation; Breastmilk; Macronutrients
Preventing Knee Injuries in Adolescent Female Football Players
Condition: Knee Injury
MeSH terms: Wounds and Injuries; Knee Injuries
Study type: Interventional

Summary: 
      Football-related knee injuries are common and especially the anterior cruciate ligament (ACL)
      injury constitute a serious problem in football regardless of the playing level. The purpose
      of this study is to conduct a randomized controlled trial evaluating the effect of a training
      program designed to prevent acute knee injury in female adolescent football players.

      The investigators' hypotheses are:

        1. a preventive training program reduces the incidence of ACL injury, and

        2. a high match frequency and match play at senior level increase the risk of ACL injury.
    


Intervention name(s): Knäkontroll, SISU Idrottsböcker©, Sweden, 2005
Intervention type(s): Behavioral
Intervention description(s): The preventive program (Knäkontroll, SISU Idrottsböcker©, Sweden, 2005) consists of six exercises focusing on knee control and core stability and is performed during the warm-up at two training sessions per week throughout the 2009 competitive season.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Incidence of ACL injury; Risk factors for ACL injury; Prevention of ACL injury or any acute knee injury
Breast Cancer Outreach Among Primary Care Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This project aims to evaluate different approaches to increase breast cancer screening among
      primary care patients at Penn Medicine through a centralized screening outreach program. In a
      pragmatic trial, the investigators will evaluate different approaches to increase completion
      of screening among eligible patients, including ordering mammograms in bulk prior to
      outreach, sending personalized text reminders, and endorsing of the communication by the
      primary care provider.
    

Detailed description: 
      While mammograms are recommended by guidelines for early detection of breast cancer,
      mammogram rates are significantly lower now than they were prior to the initial COVID-19
      pandemic surge in early 2020. In this project, the investigators will evaluate different ways
      of reaching out to eligible patients to encourage them to participate in breast cancer
      screening. Through letters, texting, and the electronic health record portal (MyPennMedicine
      (MPM)), the investigators will compare mammogram bulk orders, text messaging, and primary
      care provider endorsement to traditional outreach messaging with the goal of increasing
      breast cancer screening uptake.
    

Intervention name(s): Bulk Order; Texting; Clinician Endorsement; No Bulk Order; Standard Endorsement
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): A mammogram order will be placed using bulk order technology in the EHR in advance of outreach for all patients.; In addition to outreach, patients will receive text messaging with information regarding the importance of screening, how to schedule a mammogram, and locations available for mammography.; Outreach informing patients that they are overdue for a mammogram will be signed by the patient's primary care provider.; The outreach will ask patients to contact their PCP's office in order to have a mammogram order placed on their behalf.; Patient's will receive outreach from the practice informing them that they are overdue for a mammogram.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: Mammography; Preventive Screening; Population Health
Noninvasive Optical Measurement of Critical Care Neonates
Condition: Signs and Symptoms
Study type: Observational

Summary: 
      The purpose of this study is to determine whether reflections of light can be used to provide
      real-time pictures of blood vessel formation around infants' heads. This study device is
      called laser speckle imaging.
    

Detailed description: 
      The researchers can use the laser speckle imaging device to image superficial cerebral blood
      flow in the infant's head. The researchers can quantify blood flow and measured vessel
      diameter, versus actual diameter assessed with conventional digital camera imaging.
    

Intervention name(s): Laser Speckle Imaging
Intervention type(s): Device
Intervention description(s): Laser Speckle Imaging of Critical Care Neonates
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children
A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and
      preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid
      tumors.
    


Intervention name(s): veliparib (ABT-888)
Intervention type(s): Drug
Intervention description(s): Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.
Other intervention name(s): veliparib; ABT-888
Intervention MeSH terms: Veliparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; PARP; Primary peritoneal cancer; Fallopian tube; Ovarian cancer; veliparib; ABT-888; BRCA
First Line mFOLFOXIRI + PANITUMUMAB vs mFOLFOX + PANITUMUMAB IN RAS AND BRAF WT METASTATIC COLORECTAL CANCER PATIENTS
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      -  The association of FOLFOX (5-fluoruracil, folinic acid, and oxaliplatin) and pan is a
           standard option for the first-line treatment of unresectable RAS and BRAF wt mCRC
           patients.

        -  The phase III TRIBE trial recently demonstrated that FOLFOXIRI (5-fluoruracil, folinic
           acid, oxaliplatin and irinotecan) plus bev significantly prolongs PFS and OS and
           increases RECIST response rate, ETS and DoR, as compared to FOLFIRI (5-fluoruracil
           folinic acid, and irinotecan) plus bev. The advantage provided by the intensification of
           the upfront chemotherapy backbone is independent of RAS and BRAF mutational status.

        -  Some phase II trials recently assessed the safety and activity of the combination of
           three-drugs chemotherapy regimens with an anti-EGFR monoclonal antibody. Promising
           activity results in terms of RECIST response rate and R0 resection rate have been
           achieved, with some safety concerns with special regards to gastrointestinal toxicity.

        -  In the phase II randomized MACBETH study the combination of a modified schedule of
           FOLFOXIRI with cetuximab determined remarkable activity results, with an acceptable and
           manageable safety profile.

        -  The optimal duration of the upfront treatment with chemotherapy plus anti-EGFRs is not
           established. The phase II MACRO-2 trial suggested that interrupting FOLFOX after 4
           months while continuing cet alone as maintenance, is a reasonable option.

        -  Activity parameters (RECIST response rate, ETS, DoR) are clinically relevant endpoints,
           associated with longer survival, in particular with anti-EGFR moAb-based treatment.

      On the basis of these considerations, we designed the present phase III randomized trial of
      first-line mFOLFOXIRI plus pan versus mFOLFOX6 plus pan in RAS and BRAF wt unresectable mCRC
      patients.
    


Intervention name(s): Panitumumab; Irinotecan; Oxaliplatin; l-leucovorin; 5-fluorouracil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 6 mg/kg iv over 60 minutes, day 1; 150 mg/sqm iv over 60 minutes day 1; 85 mg/sqm iv over 2 hours day 1; 200 mg/sqm iv over 2 hours; 400 mg/sqm iv bolus, day 1 followed by 2400 mg/sqm 48 h-continuous infusion, starting on day 1;
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Panitumumab; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mFOLFOXIRI + Panitumumab; RAS and BRAF wt
Resistance Training to Improve Fatigue and Physical Function in Postmenopausal Breast Cancer Survivors
Condition: Cancer
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      This study will begin to fill a knowledge gap by determine whether changes in kynurenine
      metabolism occur following Resistance Training (RT) and relate to reductions in inflammation
      and improved behavioral and physical function as this may identify potential targets for
      interventions to promote cancer recovery.
    

Detailed description: 
      Interventions that reduce pro-inflammatory cytokines with resultant stimulation of kynurenine
      metabolism may be increasingly important in Breast Cancer Survivors (BCS) to prevent
      susceptibility to cancer associated fatigue, depression, and declines in muscle mass and
      function.

      There is emerging evidence that supports exercise as a non-pharmacological therapy to prevent
      cancer recurrence, sedentary behaviors, and obesity during cancer survivorship . It seems
      that interventions that include resistance training (RT) are most efficacious at reducing
      fatigue in BCS This study will begin to fill a knowledge gap by determine whether changes in
      kynurenine metabolism occur following RT and relate to reductions in inflammation and
      improved behavioral and physical function as this may identify potential targets for
      interventions to promote cancer recovery.
    

Intervention name(s): Resistance training (RT); Cognitively-based compassion training control (CBCT)
Intervention type(s): Other; Behavioral
Intervention description(s): Resistance training (RT) will include 15 repetitions for two sets and to exhaustion on the third set for seven major muscle groups: the leg and chest press, knee extension, leg curl, row, abdominal crunch, and bicep curl. Resistance is gradually increased to account for strength gains when subjects are able to complete 20 repetitions on the third set.; Cognitively-based compassion training control (CBCT) classes will be performed in a group setting for 1.5-2 hours per week, and consist of didactics, class discussion, and guided meditation practice. Each class will begin with a period of meditation to calm and focus the mind, followed by analytical practices designed to challenge unexamined assumptions regarding feelings, and actions toward others with a focus on generating spontaneous empathy and compassion for themselves and others.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast Cancer Survivors; Resistance Training; Fatigue; Physical Function; Behavioral Function; Kynurenine metabolism
A Study to Assess the Efficacy and Safety of XC221 in Patients With Mild COVID-19
Condition: Sars-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      The innovative drug XC221 100 mg tablet is designed for the treatment of COVID-19 (SARS-CoV-2
      infection). A multicenter, adaptive, randomized, double-blind, placebo-controlled Phase III
      clinical study is aimed to assess the efficacy and safety of XC221 100 mg tablet, in mild
      COVID-19 patients during a 14-days treatment.

      The primary objective of the study is to demonstrate the efficacy of XC221 100 mg tablet (200
      mg daily dose) in achieving clinical improvement of mild COVID-19 symptoms.

      The secondary objective of the study is to evaluate the safety of XC221 100 mg tablet (200 mg
      daily dose) in mild COVID-19 patients.
    

Detailed description: 
      8 Russian centers will participate in this study. The trail will consist of three periods:
      screening (duration not more than 1 day, it may coincide with the randomization visit and
      beginning of drug administration), treatment period (14 full days) and follow-up period (15 ±
      1 days after completion of treatment with XC221 / Placebo). The duration of participation in
      the study for each patient will be no more than 32 days.

      274 eligible patients with confirmed COVID-19 will be randomized into two groups (Group A and
      Group B) in a 1:1 ratio: Group A - XC221 200 mg daily (137 patients); Group В - Placebo (137
      patients).

      During the treatment period (14 full days), 1 tablet of XC221 / Placebo will be administered
      2 times a day in addition to the standard of care (SoC) for COVID-19 according to The
      Temporary guidelines for the prevention, diagnosis and treatment of SARS-CoV-2 infection of
      the Ministry of Health of the Russian Federation (the MoH Temporary Guidelines). The
      follow-up period will last for 15 ± 1 days.
    

Intervention name(s): XC221; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive XC221 100 mg 2 times a day during 14 full days; Participants will receive Placebo 2 times a day during 14 full days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups (Group A and Group B) in a 1:1 ratio: Group A - investigational product; Group В - Placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COVID-19; Coronavirus
Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the efficacy of mindfulness-based
      cognitive-behavior therapy (MBCT) for improvement of symptoms associated with bipolar
      disorder, by comparing MBCT to supportive psychotherapy. Patients who participate in this
      study will be randomly assigned to receive either

        1. state of the art group MBCT, or

        2. supportive group psychotherapy (which is considered part of the standard care available
           to patients at MGH).
    

Detailed description: 
      We will conduct a randomized controlled trial of group MBCT (n=30) vs. SP (n=30) and compare
      the benefits and durability of MBCT vs. SP for decreasing symptoms in DSM-IV bipolar
      individuals over a 12-week period adjunctive to mood stabilizing medications coupled with
      individual-therapy sessions. We will also conduct follow-up assessments at 3, 6, 9, and 12
      months after the active phase of the study. Subjects in the MBCT group will receive group
      therapy sessions of standardized yoga-meditation based exercises enhanced by psychoeducation
      and relapse prevention for bipolar disorder. Subjects in the SP group will receive support
      for coping with the symptoms of bipolar disorder, as well as psychoeducation about bipolar
      disorder. The focus of SP is on reflecting and expressing feelings about current life issues.
      Patients are supported and comforted when coping with difficult situations, depression, mood
      swings, or anger. We will assess mood, cognitive and psychosocial functioning before and
      after treatment for participants in both groups. Finally, we will investigate the functional
      neuroanatomy associated with memory impairment, attention, and mindful breathing in subjects
      with bipolar disorder as a predictor of treatment response using functional Magnetic
      Resonance Imaging (fMRI).
    

Intervention name(s): Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): 12 weekly group therapy sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Mood Disorders; Residual Symptoms; Depression; Mania; Hypomania; Bipolar; Bipolar I; Bipolar II
Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The primary objective of this study is to assess the effectiveness of a school based physical
      activity programme on obesity and related health outcomes in young schoolchildren.
    


Intervention name(s): Physical activity guidance; Health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Physical education class amelioration Additional physical activities for overweight&obese students Family physical activities Parent involvement; Knowledge of obesity prevention and control
Other intervention name(s): Physical activity programme
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obesity; Physical activity; Schoolchildren; Intervention Studies
Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
      multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to
      evaluate the single-dose relative bioavailability of the oral suspension and oral tablet
      formulations.
    


Intervention name(s): AZD1236; Placebo; AZD1236; AZD1236
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 75mg once daily or 75mg twice daily will be administered in multiple dose part.; Placebo tablet matching to the active in multiple dose part.; 75mg single dose will be administered in relative bioavailability part.; 75mg oral suspension single dose will be administered in relative bioavailability part.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Healthy Volunteer; Safety; Tolerability; Pharmacokinetics; AZD1236