bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)
Condition: Acute Hematogenous Osteomyelitis
MeSH terms: Osteomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether daptomycin is effective and safe in the
      treatment of pediatric participants with AHO when compared to vancomycin (or equivalent) or
      nafcillin (or β-lactam equivalent). The primary hypothesis is that daptomycin is non-inferior
      compared with vancomycin (or equivalent) or nafcillin (or β-lactam equivalent) with respect
      to improvement in Pain, Inflammation, and Limb Function on or before study Day 5.
    

Detailed description: 
      Acute hematogenous osteomyelitis is a common problem in the pediatric population, affecting
      approximately 5/10,000 children each year and accounting for approximately 1% of all
      pediatric hospitalizations. In children, osteomyelitis arises from bacteremic seeding of the
      bone metaphysis.

      Daptomycin, is a cyclic lipopeptide antibacterial active against most clinically significant
      gram-positive pathogens including drug-resistant strains such as Methicillin Resistant
      Staphylococcus (S.) aureus (MRSA) and Methicillin Susceptible S. aureus (MSSA). Daptomycin
      has proven clinical efficacy in adults in the treatment of complicated skin and skin
      structure infections (cSSSI) caused by aerobic gram-positive pathogens and the treatment of
      S. aureus bloodstream infections (bacteremia; SAB), including those complicated by
      right-sided infective endocarditis, caused by MSSA and MRSA. Although not indicated for
      osteomyelitis, daptomycin has been successfully used to treat osteoarticular infections in
      adults and children as salvage therapy and at medical centers with increasingly high rates of
      vancomycin resistant organisms.

      In addition, more comparative clinical trials are needed in pediatric AHO to better elucidate
      the optimal treatment regimen and clinical response.
    

Intervention name(s): Daptomycin; Vancomycin (or equivalent); Nafcillin (or equivalent)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV daptomycin Infusion A in 12 to <18 years old (7 mg/kg); in 7 to < 12 year olds (9 mg/kg); in 24 months to <7 year olds (12 mg/kg); in 12 to <24 month olds (12 mg/kg). Infused over 60 minutes ± 10 minutes once daily followed by up to 3 dummy infusions every 6 hours (q6h) infused over 60 (± 10) min to maintain the blind.; IV vancomycin (or equivalent) (Infusions A,B,C,D), 10 to 15 mg/kg, infused over 60 (± 10) minutes q6h (± 1 hour); IV nafcillin (or β-lactam equivalent) (Infusions A,B,C,D) at 100-200 mg/kg/day, in divided doses infused over 60 (± 10) min q6h (± 1 hour)
Intervention MeSH terms: Vancomycin; Daptomycin; Nafcillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Examining a Training Program for for Acute Lymphoblastic Leukemia Childhood Cancer Survivors
Condition: Childhood Cancer
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional

Summary: 
      Acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy, with the peak
      incidences occurring in children two to five years of age. Children with ALL received
      neurotoxic chemotherapy agents for two to three years that causes decreased distal muscle
      strength and poor timing of muscle activation. After completion of medical treatment, ALL
      childhood cancer survivors (ALL CCS) are more likely to have an inactive lifestyle, resulting
      in life-long gross motor proficiency differences compared to their peers. ALL CCS typically
      do not utilize physical therapists' expertise after medical treatment has been completed.
      There are limited physical therapy (PT) intervention studies for ALL CCS.
    

Detailed description: 
      We are performing a feasibility study to examine a movement based intervention that utilizes
      fast movements through jumping rope to improve balance, coordination, movement speed, and
      movement agility. The abilities to generate fast movements are required to perform functional
      activities and for playing sports. Participants will receive five in-person PT sessions and a
      home program for six weeks. The goal of this research is to determine the feasibility,
      acceptability, and promise of a PT program that emphasizes fast movements in ALL CCS.
    

Intervention name(s): JUMP
Intervention type(s): Behavioral
Intervention description(s): Warm-up, stretching, jumping rope, cool-down
Intervention model: Single Group Assignment
Intervention model description: Feasibility study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical therapy; functional mobility
The Effect of Different Force Magnitudes on Maxillary Posterior Segment Intrusion
Condition: Orthodontics
MeSH terms: Open Bite
Study type: Interventional

Summary: 
      A Randomized clinical trial comparing two different force magnitudes in maxillary posterior
      segment intrusion in adult patients with skeletal open bite malocclusion
    

Detailed description: 
      This randomized controlled trial is aiming to study the effect of the different force
      magnitude on maxillary posterior segment intrusion. Two groups are going to be allocated and
      the amount and rate of intrusion will be measured and compared.
    

Intervention name(s): Intrusion by 400 g
Intervention type(s): Device
Intervention description(s): using miniscrews and coil springs to apply the intrusive force on maxillary posterior segment intrusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: skelatal open bite, posterior intrusion
A Prospective Study of Hypothyroidism After Radiotherapy for Breast Cancer
Condition: Breast Neoplasms; Hypothyroidism; Radiation Toxicity
MeSH terms: Breast Neoplasms; Hypothyroidism
Study type: Observational

Summary: 
      This study is to prospectively investigate the incidence of hypothyroidism after
      postoperative radiotherapy and identify risk factors for development of hypothyroidism.
      Patients with breast cancer treated with surgery followed by radiotherapy is enrolled.
      Thyroid function was assessed at baseline and different times after radiotherapy. The
      radiation technique, thyroid dose parameters and hypothyroidism are prospective evaluated,
      and the dose-effect relationship is analyzed.
    

Detailed description: 
      Breast cancer patients treated with radiotherapy after surgery are prospectively enrolled.
      Thyroid function is evaluated mainly by the measurement of thyroid-stimulating hormone (TSH),
      free triiodo-thyronine (FT3) and free thyroxine (FT4). Thyroid function is regularly assessed
      before and after radiotherapy. The radiation technique and thyroid dose parameters are
      assessed. Development of subclinical or biochemical hypothyroidism is noted. The incidence
      and risk factors of hypothyroidism is analyzed. The dose-volume constraints that correlate
      with functional impairment of the thyroid in breast cancer patients treated with radiotherapy
      is discussed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Breast cancer patients treated with radiotherapy after surgery are enrolled.
The Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Observational

Summary: 
      Multiple sclerosis (MS) is a chronic, progressive and unpredictable disease of the central
      nervous system. In MS, various loss of strength, balance and gait disturbances arise in the
      central nervous system due to sensory and/or motor neuron degeneration. These disorders lead
      to limitations in individual activities and participation.

      Fatigue is as reported one of the most common first three symptoms among patients with MS and
      affects up to 80% of the patients. Fatigue is defined as the lack of physical and/or mental
      energy. Sometimes fatigue can reduce the quality of life by leaving other disorders behind.
      The most important effect of fatigue is that individuals reduce their physical activity
      levels. This can lead to the inactivity-related secondary problems being added to the
      findings of the disease. So the physical capacities of individuals may gradually decrease.

      In the literature, there are many studies showing that the level of physical activity of
      individuals with MS is lower than in healthy individuals. When the investigators analyze the
      studies that investigate the relation between fatigue and physical activity levels, it is
      seen that there is the single study about this subject in the literature.

      As a result, additional studies are needed to investigate the level of physical activity and
      the factors affecting it in individuals with MS. Therefore, the investigators planned this
      study to investigate the relationship between fatigue and physical activity levels in
      patients with MS.
    

Detailed description: 
      According to sample size calculation 37 diagnosed Multiple Sclerosis patients and 37 healthy
      individuals will be included.The demographic characteristics of the participants initially
      will be taken and Expanded Disability Status Scale score of those of MS will be recorded.
      Then, fatigue severity and perception, physical activity level, balance, peripheral muscle
      strength, functional mobility, functional exercise capacity will be evaluated. Primary
      outcomes are fatigue and physical activity level; secondary outcomes are balance, peripheral
      muscle strength, functional mobility, functional exercise capacity.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Power analysis was performed using "G * Powerversion3.1 program" in order to determine the
        minimum number of subjects to be taken into operation. Accordingly, the number of
        participants in the study group (n) = 37 (α: 0.05, for power 80%) and in the control group
        (n) = 37).
      
Keywords: Multiple Sclerosis; Fatigue; Physical Activity; Exercise
Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a
      single oral dose of Lu AF11167 with and without administration of multiple oral doses of
      itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status
      as CYP2C19 extensive metabolisers
    


Intervention name(s): Lu AF11167; Itraconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lu AF11167; Interaction
The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work
Condition: Cerebrovascular Circulation; Affect
Study type: Interventional

Summary: 
      Sedentary behaviour of healthy subjects may have a detrimental impact on cerebral blood flow
      as well as cognitive measures related to mood and alertness. In this study we focus on the
      impact of leaving the desk to consume a cup of tea at regular intervals during a sedentary
      working day.
    

Detailed description: 
      Prolonged desk work has detrimental impact on cerebral blood flow as well as cognitive
      measures related to mood and alertness caused. These effects might be prevented by taking
      short breaks with physical activity. Usually, desk workers have short breaks during office
      times for either a visit to the restroom or to enjoy for a moment a (hot) drink. Consumption
      of tea has been associated with benefits related to attention, alertness, mood and
      creativity. This study focuses on the impact of physically leaving the desk to prepare and
      consume a cup of tea at regular intervals during a sedentary working day.
    

Intervention name(s): Tea; Water
Intervention type(s): Other; Other
Intervention description(s): Subjects walk to a nearby area and prepare a cup of 150 ml tea once every hour. The tea is consumed whilst being seated at their desks.; 150 ml water is served to subjects once every hour. The water is consumed whilst being seated at their desks.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, full cross-over study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Reduction Dead Space Volume With Karydakis Modification
Condition: PILONIDAL SINUS
MeSH terms: Pilonidal Sinus
Study type: Interventional

Summary: 
      The purpose of this study is to reduce the volume of dead space by a modification in kardakis
      flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and
      hematoma formation, skin degradation and recurrence rates.
    

Detailed description: 
      The study was a pilot study of 80 patients. Excluding criteria were previous sinüs surgery,
      active infection, patients who did not accept the procedure and patients under age of 18.
      After excision of the sinüs volume was measured using a beaker. A flap extending across the
      cut (Karydakis) was prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be
      towards the interior. Prepared flap was shifted to the medial and sutured to presacral fascia
      with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin was
      excised along the incision in the flap side. Skin was approximated with sutures in the form
      of intermittent, using 2/0 poliprolen. No drain used. All patients were discharged on
      postoperative day 1. Sutures were removed 2 weeks later. All patients for at least 6 months
      were followed for wound drainage, seroma and hematoma formation, separation of skin and and
      recurrence.
    

Intervention name(s): A new surgical technique
Intervention type(s): Procedure
Intervention description(s): Description of a new surgical technique in pilonidal sinüs surgery in order to reduce dead space volume.
A flap extending across the cut (Karydakis) is prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap is shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin is excised along the incision in the flap side. Skin is approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used
Other intervention name(s): Modified Karydakis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: karydakis modification; pilonidal sinus; complication
Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is intended to evaluate the efficacy and safety of MBA-P01 compared to BOTOX in
      treatment of glabellar lines.
    


Intervention name(s): MBA-P01; BOTOX
Intervention type(s): Drug; Drug
Intervention description(s): MBA-P01 will be injected into the Glabellar line.; Botox will be injected into the Glabellar line.
Other intervention name(s): OnabotulinumtoxinA
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)
Condition: Postoperative Pain; Postoperative Sedation
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The
      investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.
    

Detailed description: 
      Pain is a major problem after TKA. Studies indicate that Gabapentin may reduce acute
      postoperative pain. However, the optimal dose is unknown and there is constant controversy on
      analgesic versus side-effects. The investigators therefore investigate the effect of
      Gabapentin as a perioperative analgesic in a dose-related manner and with a sample-size
      allowing evaluation of side-effects.
    

Intervention name(s): Gabapentin; Gabapentin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tables with Gabapentin (1300 mg/ day) for 7 days, starting on the day of surgery; Tables with Gabapentin (900 mg/day) for 7 days, starting on the day of surgery; Placebo tablets for 7 days, starting on the day of surgery
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Genetic Risk Factors for Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to determine whether a specific genetic factor influences the
      severity of asthma symptoms.
    

Detailed description: 
      Asthma is one of the most common chronic diseases in the United States. It is well known that
      asthma susceptibility is inherited; however, it is unknown if asthma severity is heritable.
      Studies suggest that levels of interleukin-16 (IL-16) may influence asthma severity. This
      study will examine the role of differences in the control region of the IL-16 gene in a
      racially diverse group of asthmatics and nonasthmatics and will determine if the IL-16 gene
      control region is related to asthma severity.

      Participants in this study will undergo lung function and blood tests; they will also
      complete a questionnaire about their respiratory health. Asthmatic participants will complete
      a severity-of-asthma questionnaire.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        400 asthmatics and 200 non-asthmatic controls will be recruited. The 200 non-asthmatics
        will be matched for age, gender and ethnicity with the asthmatics in the more severe half
        of the severity distribution. The participants will be from minority populations (at least
        30% African-American and at least 30% Hispanic) and generally of lower socioeconomic
        status.
      
Biospecimen description: 
      40 mL blood
Topical Mitogenic-Activated Protein Kinase (MAPK) Inhibition in Rosacea
Condition: Rosacea, Erythematotelangiectatic
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, vehicle controlled, double blinded study to evaluate the safety and
      potential efficacy of a topical formulation of a MEK inhibitor in patients with
      erythematotelangiectatic rosacea
    

Detailed description: 
      The duration of the study will be 22 days. Subjects will use a cream with a mitogen-activated
      extracellular signal-regulated kinase (MEK) inhibitor on one cheek, and a cream lacking the
      inhibitor (vehicle control) on the other. Patients will receive a randomized set of creams
      for the right and left cheek, one containing the active ingredient. Subjects will be
      evaluated on days 1, 8, 15 and 22. Skin appearance will be scored in each visit. A blood
      sample will be obtained to determine the levels of systemic drug absorption.
    

Intervention name(s): Trametinib
Intervention type(s): Drug
Intervention description(s): Topical cream containing 0.1 mg/g trametinib
Other intervention name(s): MAPK inhibitor
Intervention MeSH terms: Trametinib
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Each patient will receive two creams labeled "right cheek" or "left cheek", one containing the active ingredient and the other serving as vehicle control. The labels of each bottle were randomized and the contents of each remains blinded to both the subject and the investigator.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
AC6 Gene Transfer for CHF
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research study is designed to determine: 1) whether gene transfer using an agent called
      Ad5.hAC6 (adenovirus-5 encoding human adenylyl cyclase type 6) can be given safely to
      patients with congestive heart failure (CHF) and 2) whether this agent may be of benefit in
      heart failure. Gene transfer is a process by which genes are introduced into cells and the
      cells then produce the specific protein that the gene directs, in this case, a protein known
      as adenylyl cyclase type 6 (AC6). The gene is carried into the heart cells by a modified
      virus. The virus that is modified is an adenovirus (Ad5), a virus that sometimes causes a
      brief cold. In extensive animal experiments, it was found that increased amounts of AC6
      protein in heart cells appeared to make the heart pump more vigorously.
    

Detailed description: 
      This research study is designed to determine: 1) whether gene transfer using an agent called
      Ad5.hAC6 (adenovirus-5 encoding human adenylyl cyclase type 6) can be given safely to
      patients with congestive heart failure (CHF) and 2) whether this agent may be of benefit in
      heart failure. Gene transfer is a process by which genes are introduced into cells and the
      cells then produce the specific protein that the gene directs, in this case, a protein known
      as adenylyl cyclase type 6 (AC6). The gene is carried into the heart cells by a modified
      virus. The virus that is modified is an adenovirus (Ad5), a virus that sometimes causes a
      brief cold. In extensive animal experiments, it was found that increased amounts of AC6
      protein in heart cells appear to make the heart pump more vigorously.
    

Intervention name(s): Ad5.hAC6; Sucrose (3%)
Intervention type(s): Drug; Drug
Intervention description(s): Intracoronary delivery of test substance in 3:1 randomization (Ad5.hAC6 : placebo) with dose escalation, starting at 3.2 x 10^9 vp to 10^12 vp in 5 dose groups
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adenylyl Cyclase; AC6; adenovirus; gene therapy; congestive heart failure; intracoronary; nitroprusside