bioihbjkbjnl/mcl2 huggingface dataset:
Core Exercises Effects on Muscle Imbalances
Condition: Muscle Atrophy or Weakness; Muscle Contraction; Core Stability
MeSH terms: Muscular Atrophy
Study type: Interventional

Summary: 
      This study aims in investigating the effects of a core muscles' strengthening program on core
      muscles' atrophy and contraction ability. Twenty healthy adults recruited and randomly
      assigned to either a 5-week training group developed to activate and strengthen local trunk
      muscles or a control group. The training program includes isometric bridging exercises from
      various positions and dynamic exercises for lumbopelvic stability. Core muscles' thickness
      will be assessed at rest and contracting conditions, prior and after the intervention, using
      ultrasonography.
    

Detailed description: 
      A total of 136 male and female adults, members of local gyms, were initially invited for
      participation in the study after giving their written consent. After a second contact with
      the participants, forms regarding the inclusion and exclusion criteria were sent for
      completion.

      Of the 136 that initially answered positively for participation, 62 did not meet the
      inclusion criteria, based on their reports and the clinical examination by a health
      professional. Of the remaining 74 participants, 32 were excluded because of previous low back
      pain incidents and other recent musculoskeletal injuries that led to rehabilitation, while 22
      decided to not participate for personal reasons.

      The remaining 20 participants were randomly allocated to either training group or
      intervention group, by a neutral, blinded investigator who had no involvement and was unaware
      of the study purposes. The intervention group will be trained and supervised by a certified
      fitness instructor in a gym class, who will be responsible for the correct execution of the
      exercises. The duration of the intervention will be 5 weeks, 3 times a week.
    

Intervention name(s): Core stability
Intervention type(s): Other
Intervention description(s): The exercise protocol consists of the following sets and repetitions, with a total duration of 5 weeks and a frequency of 3 sessions per week.
Dynamic exercises: 2 sets of 10 to 15 repetitions (each side) Isometric exercises: 2 sets of 5 to 15 seconds (each side) Week 1- As mentioned above Week 2- Add 1 set Week 3 - Add 5 seconds and 5 repetitions Week 4 - Add 1 set Week 5- Add 5 seconds and 5 repetitions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Influence of Body-mass Index on the Outcome of Spinal Anesthesia for Total Knee Replacement Arthroplasty
Condition: Spinal Anesthesia; Success or Failure of Spinal Anesthesia
Study type: Observational

Summary: 
      In these prospective observational study, the investigators are trying to evaluate (1) the
      influence of body-mass index on spinal anesthetic outcome and (2) the determinants on spinal
      anesthetic outcome by logistic regression analysis.
    

Detailed description: 
      Although the spread of spinal anesthetic drug is unpredictable, patients factors (age,
      gender, height,weight, body-mass index), spinal anatomy, anesthetic drug dose, and
      lumbosacral cerebrospinal fluid volume are known to be the determinants of sensory block
      level. Among these determinants, the influence of body-mass index (BMI) on spinal anesthesia
      is controversial, and there is no specific guideline showing the relative priority of these
      determinants.

      Therefore, in these prospective observational study, the investigators are trying to evaluate
      (1) the influence of body-mass index on spinal anesthetic outcome and (2) the relative
      influence of these determinants on spinal anesthetic outcome by logistic regression analysis.
    

Intervention name(s): Spinal anesthesia (heavy bupivacaine)
Intervention type(s): Drug
Intervention description(s): Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg
Other intervention name(s): Spinal anesthesia; heavy bupivacaine
Intervention MeSH terms: Bupivacaine; Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are undergoing spinal anesthesia in Samsung Medical Center during study period
      
Keywords: Spinal anesthesia; determinant; duration
Safety, Tolerability and Pharmacokinetics of Single Rising and Multiple Oral Doses of Telmisartan / Hydrochlorothiazide (HCTZ) in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Group 1:

      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and
      T80/H12.5)

      Group 2:

      To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7
      days)
    


Intervention name(s): Low dose of telmisartan; High dose of telmisartan; HCTZ
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Total Knee Arthroplasty: Functional and Clinical Outcomes
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to assess the differences in functional and patient reported
      outcomes between total knee replacement (TKA) implants. In addition, this work will examine
      the correlation between functional assessments and patient reported outcomes following
      surgery. All subjects will complete assessments preoperatively, 4-6 weeks following TKA and
      then one year following TKA. Subjects will complete a series of patient reported outcomes as
      well as a series of functional outcomes at each of the time points of interest. The analysis
      will include a repeated measures design to determine differences between groups across time
      as well as correlations between the functional and patient reported outcomes. This work will
      hopefully determine the importance of using objective functional outcomes following TKA as
      well as determining the need for patient assessments out to one year following surgery.
    

Detailed description: 
      The number differences in subjects analyzed from baseline to 6 weeks to 52 weeks are due to
      the fact that we did not use the 6 week time point in the final analysis based on the
      clinical decision that 6 weeks was too early in recovery to provide accurate information for
      clinical decision making. Therefore the patients used in the final analysis were those
      subjects who were able to and completed the assessment at pre-op and 1 year post-op which is
      how we get to the 20 subjects per group.
    

Intervention name(s): Zimmer; Stryker
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Total Knee Replacement; Lower Quarter Y-Balance Test; Functional Outcomes; Patient Reported Outcomes
Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
Condition: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV)
      ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and
      dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in
      treatment-naive HCV genotype (GT) 1a-infected adults.
    


Intervention name(s): Ombitasvir/ABT-450/Ritonavir; Dasabuvir; Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ombitasvir/ABT-450/ritonavir combination tablets; Dasabuvir tablets; Ribavirin tablets
Other intervention name(s): ABT-267/ABT-450/ritonavir; ABT-333
Intervention MeSH terms: Ritonavir; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment naive; HCV; Interferon free; Hepatitis C Genotype 1a; Chronic Hepatitis C; Hepatitis C
Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS
Condition: Brain Neoplasms
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      In this research study the investigators want to learn more about the quality of life before,
      during and after cancer treatment in patients with central nervous system brain tumors. Often
      CNS tumors and cancer treatment can cause many physical and emotional problems and side
      effects. Some of these problems and treatment side effects can cause a change in a patient's
      qualify of life and overall well-being. Quality of life questionnaires are used to measure
      well-being and ability to carry out daily activities by asking patients to answer several
      questions about their physical, emotional, and social well-being.

      In this research study we want to find out if patient's answers to these questions change
      over the course of your treatment. We also want to see if doctors and nurses can use these
      answers to the questions to help patients feel better and increase their activity during
      cancer treatment.
    

Detailed description: 
      Pediatric CNS tumors are the second most common form of pediatric cancer and the leading
      cause of death related to pediatric malignancies. Over decades of work and through the
      efforts of collaborative groups, cure rates have increased significantly. However, various
      types of CNS malignancy outcomes have remained stagnant. Moreover, side effects from
      treatments of even the most curable CNS tumors may have dramatic short and long-term sequela
      ranging from cognitive, endocrine malfunction, functional mobility, neurological, and
      ophthalmologic compromises. As science and protocol directed therapies continue to find cures
      for these patients, work also must continue in efforts to explore patient reported outcomes
      (PROs) and health related quality of life (HRQOL) throughout the trajectory of a patient's
      disease process. Increased efforts in patient reported outcomes will lead to improvements in
      symptom management, functional status, and overall quality of life (QOL).
    

Intervention name(s): PROMIS-QOL
Intervention type(s): Other
Intervention description(s): PROMIS questionnaires completed every 3 months for up to 2 years.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients ages 5-35 with a diagnosis of a Central Nervous System (CNS) tumor (newly
        diagnosed, relapsed, refractory, or progressed) and scheduled to receive a new therapy
        including surgery, chemotherapy and/or radiation therapy.
      
Keywords: Newly diagnosed brain tumor; Progressive brain tumor; PROMIS; Quality of life
Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine
Condition: Group B Streptococcus Infection
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label booster vaccine follow-up study. Participants who had received a
      primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive
      a booster dose (or first dose in the case of placebo or vaccine naïve participants) 1 to 5
      years after the completion of the primary course of vaccination. All participants will
      receive a single dose of GBS-NN/NN2 containing 50μg of each fusion protein.
    

Detailed description: 
      This is an open label vaccine booster follow-up study. Participants who had received a
      primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive
      a booster dose (or first dose in the case of placebo or vaccine naïve participants) 1 to 5
      years after the completion of the primary course of vaccination. All participants will
      receive a single dose of GBS-NN/NN2 containing 50μg of each fusion protein.

      A minimum of 30 and a maximum of 40 female participants will be recruited, comprised of
      between 20 and 30 participants who had received previous vaccination with GBS-NN/NN2 in the
      MVX0002 study and up to 10 participants who had received placebo in the MVX0002 study. If an
      insufficient number of participants (less than 5) who previously received placebo return to
      this study, vaccine naïve participants will be recruited.

      The study will include 7 visits: Visit 1 (Screening), Visit 2 (Day 1 dosing), Visit 3 (Day
      8), Visit 4 (Day 29), Visit 5 (Day 57), Visit 6 (Day 85) and Visit 7 (Day 183 Follow-up).
    

Intervention name(s): GBS-NN/NN2
Intervention type(s): Biological
Intervention description(s): GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2
Intervention model: Single Group Assignment
Intervention model description: Open label booster vaccine study
Masking: None (Open Label)
Primary purpose: Prevention
Clinical Outcomes With Omni Apex Ultracongruent Knee System
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      A prospective, matched case comparison of total knee arthroplasty with the OMNI Apex
      Ultracongruent vs. Triathlon® CS tibial insert vs. the Triathlon® PS tibial insert.
    


Intervention name(s): OMNI Apex Ultracongruent Knee Device
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients undergoing total knee replacement
      
Keywords: Osteoarthritis; Total Knee Replacement; Total Knee Arthroplasty; TKA; Knee
Safety, Blood Levels and Effects of AUT00206
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The study medicine is a potential future treatment for schizophrenia, an illness that affects
      the way that people think, feel or behave. It is not clear what causes schizophrenia, but
      it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will
      activate specific sites in the brain to help correct that imbalance. Current treatments for
      schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that
      the study medicine will work better, and have fewer side effects than existing medicines.

      In this 2 part study (Parts A and B), the primary aim is to assess how safe the study
      medicine is in healthy men, aged 18-45 years, and how much of it gets into the blood. Its
      effects on the brain will also be tested.

      In Part A, up to 24 participants will receive up to 5 single doses of the study medicine
      (AUT00206 or placebo) by mouth, either after fasting or after a high fat breakfast. The study
      medicine has never been given to humans before, so the initial doses will be small and the
      dose level will be increased as the study progresses. Participants may take up to 14 weeks to
      finish the study. They'll make up to 22 outpatient visits, and stay on the ward up to 5
      times, for 3 nights in a row each time.

      In Part B, 24 participants will receive daily doses of the study medicine (AUT00206 or
      placebo) for up to 28 days. Participants will take up to 10 weeks to finish the study.
      They'll make 6 outpatient visits, and stay on the ward for up to 30 nights, depending on how
      long we expect it to take until blood levels of the study medicine level off.

      A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will
      take place at 1 centre in London.
    


Intervention name(s): AUT00206
Intervention type(s): Drug
Primary purpose: Treatment
Effects of Sedation on Transpulmonary Pressure and Lung Homogenous
Condition: ARDS
Study type: Interventional

Summary: 
      The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory
      failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS
      patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near
      diaphram during mechanical ventilation, however, strong respiratory drive could generate more
      transpulmonary pressure in ARDS patients, which increase the stress and strain in injured
      lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of
      ARDS patients.The purpose of this study is to investigate the effects of sedation on
      transpulmonary pressure of ARDS patients.
    

Detailed description: 
      Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast
      University
    

Intervention name(s): Deep sedated; Light sedated
Intervention type(s): Drug; Drug
Intervention description(s): Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5); Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)
Other intervention name(s): Deep sedation; Light sedation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Self control
Masking: None (Open Label)
Primary purpose: Screening
Keywords: ARDS,; Transpulmonary pressure,; Sedation
Shared Medical Appointments for Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Randomized controlled trial to determine if a 6 months of shared medical appointments will
      results in clinically and statistically significant weight loss.
    

Detailed description: 
      Obese patients will be randomized to either the control or intervention group. The
      intervention group will participate in 90-minute group visits occurring weekly for 4 weeks,
      then biweekly for a total of 26 weeks/15 visits. Each visit will focus on intensive lifestyle
      changes: calorie restriction to produce a 500-750 calorie deficit, increased physical
      activity, and behavioral therapies including regular self-monitoring of food intake, physical
      activity, and weight. Additional behavioral therapies that will be offered include techniques
      for reducing stress, maximizing sleep, and controlling environments. Further, these patients
      will each have the opportunity to meet one-on-one with a member of the research team at the
      end of each visit in order to discuss individual goals and progress.
    

Intervention name(s): Shared medical appointments for weight loss
Intervention type(s): Behavioral
Intervention description(s): Shared medical appointments providing education and lifestyle change recommendations to promote weight loss in obese patients
Other intervention name(s): SMALL Study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Injeti Self-Esteem Model and University Students
Condition: Self Esteem
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effectiveness of the Injeti Self-Esteem Model
      (ISEM) with a psychoeducational therapy intervention for improving self-esteem among
      university students. To explore the effectiveness of the ISEM (see Appendix A), investigators
      are utilizing a mixed method study design to acquire both quantitative and qualitative data
      to view effectiveness through measurable outcomes and personal experience. The intervention
      will involve a 1-hour session, which will include administration of the ISEM.
    

Detailed description: 
      To explore the effectiveness of the ISEM investigators are utilizing a mixed-method study
      design to acquire both quantitative and qualitative data to view effectiveness through
      measurable outcomes and personal experience. Quantitative data will be gathered through
      standardized assessments, questionnaires, and demographic information. Qualitative
      information will be gathered through two interviews.

      Pre-intervention data collection will include a Demographic Questionnaire, Rosenberg
      Self-Esteem Scale (RSES), and the Adverse Childhood Experience Questionnaire (ACE). The
      intervention itself will involve a 50-minute session consisting of the administration of the
      ISEM. All researchers will be trained to administer the ISEM by the Principal Investigator.
      After the intervention, data collection will involve two semi-structured interviews (SSI 1
      and 2) that each require a completion of the RSES.

      Inclusion/Exclusion Criteria.

      Participants will include up to 150 students from varying universities throughout the Inland
      Empire ranging from 18-35 years of age. Participants must currently be enrolled as full-time
      or part-time students in an undergraduate or graduate program. English fluency in all areas
      (reading, writing, speaking, comprehension) will be required from all participants.

      Investigators will recruit from each of the eight schools at Loma Linda University who have
      provided a signed Letter of Agreement (see Appendix B) using digital flyers via email
      communication. We will also recruit via snowballing.

      The instruments we will use to collect data will include a Demographic Questionnaire, the
      Rosenberg Self-Esteem scale, the Adverse Childhood Experiences Questionnaire for Adults, and
      semi-structured interviews.
    

Intervention name(s): Education on the Injeti Model of Self-Esteem
Intervention type(s): Other
Intervention description(s): 1 hour educational session
Intervention model: Single Group Assignment
Intervention model description: University students will be recruited to participate in 1 educational session on the Injeti Self Esteem Model.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Self Esteem; Relationships; University students