bioihbjkbjnl/mcl2 huggingface dataset:
Oral Sedation During Cervical Dilator Placement
Condition: Oral Sedation and Cervical Dilator Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will
      be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on
      pain scores during cervical dilator placement prior to dilation and evacuation (D&E).
    

Detailed description: 
      Potential participants will be first introduced to the study via routine intake call.
      Participants will be identified at the participant's office visits to the Johns Hopkins'
      Women's Center for Family Planning. If a patient desires D&E for a second trimester
      pregnancy, the patient will first receive standard counseling. Only after providing written
      informed consent for the procedure will the patients be screened for eligibility in the
      study. If the patient is eligible the participant will be asked by a member of the research
      team if the patient is interested in participating. If the patient is, the study will be
      explained to the participant and written consent will be obtained after participant is given
      the opportunity to have all questions answered.

      The study is randomized, double-blind, placebo-controlled trial involving 2 arms.
      Participants will first complete a survey to collect demographic data.

      Participants in both arms will receive the institution's current standard analgesia for
      cervical dilator placement. In addition to this standard regimen, participants will be
      randomized to receive either: (1) a dose of two oral placebo pills, or (2) 1mg of oral
      lorazepam with 5 mg of oral oxycodone prior to cervical dilator placement.
    

Intervention name(s): Oxycodone and Lorazepam (Active Comparator); Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): Oxycodone and Lorazepam; Placebo oral pills
Other intervention name(s): Oral Oxycodone; Oral Lorazepam; Ativan; OxyIR; Roxicodone
Intervention MeSH terms: Oxycodone; Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oral Sedation; Lorazepam; Oxycodone
Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
Condition: Vascular Aging
Study type: Interventional

Summary: 
      The proposed study will assess the ability of a naturally occurring sugar to improve the
      function of arteries with age. Overall, the proposed research project has the long-term
      potential to influence clinical practice guidelines by establishing a novel, easy to deliver,
      cost-effective therapy for treating age-associated arterial dysfunction and reducing the risk
      of cardiovascular disease with age.
    


Intervention name(s): Placebo; High-dose trehalose
Intervention type(s): Drug; Drug
Intervention description(s): 100g maltose 1/day; 100g 1/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arterial function; cardiovascular; aging; endothelial function; arterial stiffness; vascular function; Trehalose
Japanese Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic (PK) & Pharmacodynamic (PD) Study of AZD7687
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in Japanese healthy volunteers to determine the safety and tolerability of
      the compound AZD7687. It will also assess how the body handles the drug and how it responds
      to the drug following single dose followed by multiple dosing over 7 days.
    


Intervention name(s): AZD7687
Intervention type(s): Drug
Intervention description(s): Oral suspension
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Type 2 diabetes; obesity; Japanese healthy volunteer; AZD7687
Addition of Neostigmine to Levobupivacaine
Condition: Spermatic Cord Block
Study type: Interventional

Summary: 
      Using the spermatic cord block has been of great advantage, as it has been cost saving,
      efficient technique whether used inon its own or combination with a sedative or .
      Furthermore, it provides minimal cardiac risks, early case ambulation, satisfactory
      postoperative pain control, as well as a reduced hospital stay and cost. one of the major
      drawbacks of spermatic cord block is being a single injection technique, leading to a short
      postoperative analgesia duration. So, to overcome this flaw some adjuvants were proven to
      prolong the analgesia duration as neostigmine.
    


Intervention name(s): Control Test; Neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml 0.9 normal saline in each side; spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml neostigmine 500 μg in each side .
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Spermatic Cord Block; Neostigmine; Levobupivacaine
Preoxygenation Optimisation in Obese Patients
Condition: Severe Obesity Design as BMI > 35kg/m2
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a
      critical event. The aim of this study is to determine whether Nasal High Flow Therapy by
      nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal
      intubation after crash induction in obese patients
    

Detailed description: 
      This study will be designed as followed : Patients will be randomized in 2 groups :

        -  Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 (fraction of
           inspired oxygen) = 1) before orotracheal intubation after crash induction. The device
           will be maintained in place throughout the intubation procedure in order to achieve
           apnoeic oxygenation.

        -  Or Preoxygenation during 4 minutes with Bi-level Positive Airway Pressure (BIPAP) with
           Expiratory Positive Airway Pressure (EPAP) + 5 cm H2O and Inspiratory Airway Positive
           Airway Pressure (IPAP) + 15, meaning a 10cm H2O pressure support. The facial mask with
           be removed after before crash induction enabling laryngoscopic vision.
    

Intervention name(s): High flow oxygen therapy by nasal cannula. Optiflow®; Facial mask oxygenation in BIPAP ventilation
Intervention type(s): Device; Device
Intervention description(s): Patients randomized in interventional group will received a four minutes preoxygenation period with High Flow nasal cannula (60 l/mn FiO2 = 1) before orotracheal intubation. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.; Patients randomized in BIPAP group will receive a four minutes preoxygenation with EPAP 5, IPAP 15 FiO2 = 1 for a pressure support of 10 cm H2O. The facial mask with be removed after before crash induction enabling laryngoscopic vision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Diet and Exercise in Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Canadian Real Life Evaluation of the Effect of Diet and Exercise in Prostate Cancer Patients
      Managed with Lupron.
    

Detailed description: 
      This is a study utilizing a prospective cohort design. Patients with Prostrate cancer (PCa)
      who are prescribed Lupron will be entered into the study cohort and will be followed for a
      maximum of 18 months with recommended assessments at 3, 6, 12 and 18 months after Day 1.
      Treatment of the patients and follow up will be according to the physicians' judgment,
      regional regulations and the product monograph.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be enrolled from the offices of University or community
        urologists/radio-oncologists across Canada treating patients with PCa
      
Keywords: Prostate cancer
Investigation of the Effect of Conventional Treatment on Postural Stability and Balance in Individuals With Shoulder Pain
Condition: Shoulder Pain; Balance; Distorted
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Shoulder pain is one of the most common musculoskeletal complaints that people need treatment
      for. Typical signs and symptoms include pain during reaching, muscle weakness, and
      interrupted sleep. The shoulder is one of the most common areas of pain, ranking third among
      musculoskeletal pains in the general population. There is a lack of information regarding the
      impact of shoulder-related problems on the general population, and therefore there is a
      growing interest in identifying adverse factors associated with shoulder problems. In our
      study, the postural stability and balance status of individuals with shoulder pain complaints
      will be evaluated and the effects of conventional treatment of shoulder pain on postural
      instability and balance parameters will be investigated.
    

Detailed description: 
      The muscle that is important in lateral flexion of the trunk is the latissimus dorsi. There
      is a hypothesis that this muscle acts as a force transmitter from the gluteus maximus muscle
      to the upper extremity via myofascial connections. In the study of Kaur et al., it was
      reported that the myofascial connection between the hip muscles and the lateral flexors of
      the trunk increases the serratus anterior muscle activation. Therefore, deterioration in the
      performance of trunk muscles may affect the activation of the serratus anterior, resulting in
      decreased scapular upward rotation and posterior tilt, which may contribute to the
      development of pain and shoulder injury. Decreased core endurance can result in poor
      transmission of force generated in the lower body to the upper body and may contribute to
      upper limb incorrect positioning. 40 individuals with shoulder pain symptoms were planned to
      participate in the study. The individuals included in the study were divided into two groups
      the treatment group and the control group. A 24-session physiotherapy program will be applied
      to the patients in the treatment group. Pain, active joint range of motion, balance, and
      postural stability will be evaluated first week and eighth weeks.
    

Intervention name(s): Shoulder Rehabilitation
Intervention type(s): Other
Intervention description(s): hot pack, conventional TENS (COMPEX Rehab 400), 1 MHz frequency, 1.5 W/cm² intensity ultrasound (Chattanooga Intelect Ultrasound), active assistive and active range of motion exercises, stretching exercises for the shoulder muscles at the pain limit and posture exercises will be applied.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: shoulder pain; balance; postural stability
A Pilot Study of Amygdala Retraining Program in Patients With Chronic Fatigue Syndrome, Chronic Fatigue and Fibromyalgia
Condition: Chronic Fatigue Syndrome; Chronic Fatigue; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional

Summary: 
      The purpose of this pilot study is to gather preliminary data on the efficacy and feasibility
      of the Amygdala Retraining Program (ARP), a mind-body practice versus a control (C) on
      fatigue, quality of life and sleep in patients with Chronic Fatigue Syndrome (CFS), Chronic
      Fatigue (CF) and Fibromyalgia (FM).

      CFS, CF and FM are incapacitating disorders characterized by profound fatigue, muscle pain,
      impaired memory, insomnia, and post-exertional malaise (Fukuda 1994). Current literature
      points to a centrally sensitized state in CFS, CF and FM (Meeus 2007). The ARP attempts to
      retrain this neuronal network through mind-body practices such as cognitive restructuring via
      neurolinguistic programming, yoga based breathing and simple mindfulness based meditation. A
      case series of 33 patients with CFS and ARP reported improvement in 92% of patients with
      two-thirds of patients reaching 80-100% of pre-illness levels of health (Gupta 2009). However
      ARP has never been formally studied in CFS.

      We propose to gather preliminary data on the efficacy and feasibility of ARP versus C on
      fatigue, quality of life and sleep in 30 patients with CFS, CF and FM. All participants will
      undergo standard clinical treatment which consist of a 2 day self-management program in the
      Chronic Fatigue Clinic. Following this, participants will be randomized into the ARP or C
      group. The ARP group will receive an additional 2.5 hour training surrounding core concepts
      of the ARP program. They will then be given the ARP DVD program and booklet, to reinforce and
      continue the practice. They will then receive scheduled bi-monthly phone calls for 3 months
      from a study investigator for support. The C group will receive only standard care. However
      they will receive a complementary copy of the ARP program at the end of the study (6 month
      time point) as a gift for participation in the study.

      Preliminary data on efficacy will be assessed at baseline, 1, 3 and 6 months using the
      following validated questionnaires: Multidimensional Fatigue Inventory (MDFI), Short form-36
      (SF36) Fibromyalgia Impact Questionnaire (FIQ), Epworth Sleep Scale (ESS) and Measure Your
      Medical Outcome Profile (MYMOP-2). Feasibility will be assessed by evaluation of a daily
      practice log where patients record the total time spent daily in the practice of ARP and any
      specific difficulties they encountered in the practice of the program.
    


Intervention name(s): Amygdala Retraining Program
Intervention type(s): Behavioral
Intervention description(s): Mind-body intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Remote Ischemic Preconditioning Induces Myocardial RISK Signaling Pathway in Patients Undergoing Valvular Heart Surgery
Condition: Patients With Elective Aortic Valve Replacement
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to investigate whether RIPC protects the heart against ischemia
      reperfusion injury on the concentrically hypertrophied myocardium
    


Intervention name(s): Remote ischemic preconditioning at left upper arm; Control group
Intervention type(s): Procedure; Procedure
Intervention description(s): Placement of automated cuff-inflator on the left upper arm after induction of anesthesia RIPCgroup-3 cycles of 5 min ischemia (300 mmHg inflation) & 5 min reperfusion (deflation); keeping the cuff deflated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Remote ischemic preconditioning; cardiac surgery; left ventricular hypertrophy; reperfusion injury salvage kinase
Hepatitis B Research Network Pediatric Cohort Study (HBRN)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Observational

Summary: 
      The purpose of this study is to describe participants 6 months to <18 years of age with
      hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and
      Canada and identify predictors of disease activation and progression.
    

Detailed description: 
      •Primary Aim:

      o To describe participants 6 months to <18 years of age with hepatitis B virus (HBV)
      infection in a prospective cohort in the United States (US) and Canada and identify
      predictors of disease activation and progression

      Secondary Aims:

        -  To describe clinical, virological, and immunological characteristics of participants
           with HBV in the US and Canada.

        -  To evaluate changes in HBV infection status and hepatitis B surface antigen (HBsAg)
           levels and factors associated with those changes.

        -  To verify whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL is an
           accurate predictor of people who are, or who will become, inactive carriers, defined as
           people who are HBsAg positive, hepatitis B "e" antigen (HBeAg) negative, have normal
           alanine aminotransferase (ALT) and HBV DNA under 1,000 IU/mL on at least two occasions
           over a period of at least 6 months with HBV DNA under 1,000 IU/mL.

        -  To assess the health related quality of life (HRQOL) of treatment naïve hepatitis B
           surface antigen (HBsAg) positive children and adolescents

        -  To develop a bank of biospecimens (e.g., serum, plasma, DNA, liver tissue) obtained from
           participants with HBV infection.

        -  To identify pediatric participants from 2 years to <18 years of age with chronic HBV
           infection for potential participation in treatment study to be conducted by the
           Hepatitis B Research Network (HBRN).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients from Children's Hospitals and university medical centers in the United
        States and Canada
      
Biospecimen description: 
      Liver biopsy tissue, blood (serum, plasma, and DNA)
    
Keywords: Hepatitis B; HBV; Pediatric
Dose Response of Whey and Soy Protein Ingestion With and Without Resistance Exercise in Elderly Men
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      When we age, we lose muscle. It is not exactly clear why this happens, but we do know that
      this muscle loss can increase health risks and lead to health problems. Lifting weights (i.e.
      performing resistance exercise) and proper nutrition, in particular eating enough high
      quality protein, can help slow the loss of muscle mass or potentially even reverse it.
      Protein and resistance exercise are thought to do this by stimulating your muscle to make
      more proteins and/or potentially by slowing down the rate at which your body breaks proteins
      down. Whey protein is a high quality protein isolated from milk and is known to stimulate new
      protein synthesis for all proteins in your body. However, to date, the effect that whey
      protein has on muscle protein synthesis, particularly in the elderly has yet to be
      determined. Thus the purposes of this study are: 1) to determine if whey is an effective
      source of protein that will stimulate muscle protein synthesis in the elderly, similar to
      what we have previously seen in young persons; 2) to determine the smallest amount of whey
      protein to consume to maximally stimulate your muscle to make new proteins; 3) to see if
      performing resistance exercise will augment the increase in new muscle protein synthesis with
      whey consumption; and 4) to try and found out if whey is more effective than soy protein in
      stimulating new muscle protein synthesis and suppressing muscle protein breakdown in the
      elderly, similar to what we have previously seen in young persons
    


Intervention name(s): Whey or soy protein
Intervention type(s): Dietary Supplement
Intervention description(s): Whey and casein are isolated milk proteins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: sarcopenia; muscle; protein; muscle protein synthesis; muscle protein breakdown; whey; soy; casein; dose response; resistance exercise; unilateral; knee extension; whole body protein
Moderate Aerobic Activity Through Yoga
Condition: Physical Activity
Study type: Interventional

Summary: 
      The 2018 Physical Activity Guidelines for Americans (PAGA) recommend 150 minutes of moderate
      intensity activity for adult (18 years and older) Americans to promote health. PAGA also
      recommends that older adults (65+) engage in multicomponent and balance exercises weekly as a
      way to reduce falls and injuries from falls. This recommendation includes yoga, however, the
      current research and recommendations on using yoga to meet moderate intensity activity
      guidelines is limited. This study will utilize heart rate monitoring to determine if certain
      styles of yoga can be used to meet the PAGA.
    

Detailed description: 
      The 2018 Physical Activity Guidelines for Americans recommend 150 minutes of moderate
      intensity physical activity each week to promote health. The most recent scientific advisory
      committee had insufficient evidence to provide recommendations on how the physical practice
      of yoga fits into the physical activity guidelines. Currently, there have been few studies
      done on yoga and its relative intensity. Previous randomized, cross-over trial to determine
      the effects of room temperature (hot yoga versus thermo-neutral environment) on subjective
      and objective markers of exercise intensity. They concluded that using objective markers
      (%VO2max) both thermo-neutral and hot yoga would be considered light intensity activity.
      Previous investigation of power yoga, heart rate, skin temperature, and body mass to
      determine that power yoga could be considered a moderate-vigorous intensity activity.

      Currently, there is a gap in the research on understanding the intensity of exercise offered
      within a typical yoga studio including "flow", hatha/classical, and hot yoga. Most yoga
      classes are about 60 minutes in length, and yoga classes of that length have not been
      investigated. There is also minimal research done on whether wearable activity trackers and
      accelerometers are able to accurately assess heart rate, and therefore activity intensity
      level in a yoga setting.
    

Intervention name(s): Behavioral and environmental
Intervention type(s): Other
Intervention description(s): These are all active comparator yoga sequences
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each group of participants will complete four different yoga classes - hatha thermo-neutral, flow thermo-neutral, hatha hot, and flow hot - in different orders, keeping the time of the class, the other participants in the class, the instructor, and the sequence of the moves the same.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: yoga; heart rate; exercise