bioihbjkbjnl/mcl2 huggingface dataset:
Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project
Condition: 30% Oxygen Concentration During Colorectal Surgery; 80% Oxygen Concentration During Colorectal Surgery
Study type: Interventional

Summary: 
      Our primary objective is to develop a clinical pathway for care of patients having colorectal
      surgery at the Clinic. In particular, the investigators would like to determine what
      intraoperative concentration of oxygen is optimal in our patients.
    

Detailed description: 
      The investigators therefore propose to test the primary hypothesis that supplemental oxygen
      (80% versus 30%) reduces the risk of a composite of surgical sites infection and potentially
      oxygen-related wound complications. Secondarily, the investigators will assess the
      incremental cost benefit of 80% versus 30% oxygen. As a safety measure, enough oxygen will
      always be given to maintain oxygen saturation (as determined by pulse oximetry) ≥95%.
    

Intervention name(s): 30% oxygen; 80% oxygen
Intervention type(s): Drug; Drug
Intervention description(s): Inspired oxygen will be maintained at 30%.; Inspired oxygen will be maintained at 30%.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The designated operating-room suite alternated between using either 30% oxygen as tolerated or 80% oxygen for periods of 2 weeks. For example, the first period used 30% oxygen, the second 80% oxygen, and so on. The oxygen concentration during the initial period was randomly designated by the study statistician. But, thereafter, oxygen delivery was not randomized on a per-patient or even per-period basis.
Masking: Single (Participant)
Primary purpose: Supportive Care
The Effectiveness of a Recovery Program for People With Mental Illness: A Multicenter Study
Condition: Mental Illness
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Recovery-oriented approach has been the main trend in mental health field. However, few
      recovery-oriented programs are available in Taiwan, and many Taiwanese people with mental
      illness don't understand the concepts of recovery. A program which provides recovery
      knowledge and assists in setting recovery goals is beneficial for Taiwanese people with
      mental illness. Hence, this study aimed to investigate the effectiveness of a recovery
      program for people with mental illness.
    

Detailed description: 
      This is a randomized control trial. Participants will be recruited from the psychiatric
      rehabilitation organizations in Taiwan. They will be randomly assigned to the intervention
      group or control group. The recovery program has 2 phases and consists of 20 classes, 1.5
      hour per class and one class per week. We will introduce concepts of recovery and personal
      strengths in phase 1. Then, we will help participants to set goals and implement their plans
      in phase 2. Participants will fill out five questionnaires during the recruitment meeting,
      including Stages of Recovery Scale, Medical Outcomes Study Social Support Survey, The Hope
      Scale, Rosenberg Self-Esteem Scale and Brief Symptom Rating Scale-50. They will fill out the
      same questionnaires plus the course satisfaction survey in the end of phase 1 and 2. Six
      months later, participants will receive a follow-up interview and fill out the questionnaires
      again. The control group will receive a spiritual book and complete the questionnaires at the
      same time as the intervention group.
    

Intervention name(s): Recovery program
Intervention type(s): Behavioral
Intervention description(s): The researchers designed a recovery group suited to Taiwanese with mental illness, according to content of the Pathways to Recovery (PTR): A Strengths Recovery Self-Help Workbook (Ridgway et al., 2002) and recovery-related literature (Davidson et al., 2005; Ridgway, 2001)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to determine the Pharmacokinetic (PK) and safety
      profiles of fampridine-PR 10 mg in Chinese and Japanese adult healthy volunteers. The
      secondary objective of this study is to compare the PK and safety profiles of fampridine-PR
      10 mg among the Chinese, Japanese, and Caucasian adult healthy volunteers.
    

Detailed description: 
      The Caucasian group is included to allow comparison of pharmacokinetic and safety data from
      different race groups to be performed with data obtained from the same study under the same
      controlled conditions.
    

Intervention name(s): BIIB041 (Fampridine-PR)
Intervention type(s): Drug
Intervention description(s): A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants
Other intervention name(s): AMPYRA®; Dalfampridine; FAMPYRA®
Intervention MeSH terms: 4-Aminopyridine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human Volunteers
Granulocyte-Macrophage Stimulating Factor in the Treatment of Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Peripheral arterial disease is a common condition in older adults involving poor arterial
      circulation in the legs leading to leg pain and debility. The body's own circulating blood
      vessel stem cells may help to improve circulation. This study will test whether treatment
      with the drug granulocyte macrophage colony stimulating factor (GM-CSF) will improve symptoms
      and signs of peripheral arterial disease over placebo after four weeks of therapy. As well
      this study will examine whether improvements in blood vessel function can be observed.
      Finally, we will measure blood vessel function and stem cell levels in order to determine
      whether they can help to predict whether patients wither peripheral arterial disease will
      suffer further cardiovascular complications.
    

Detailed description: 
      Peripheral artery disease (PAD) affects more than 8 million Americans. Although exercise,
      smoking cessation, anti-platelet therapy, cilostazol, statins and revascularization are used
      to treat PAD, men and women with PAD have significantly greater functional impairment and
      fasterfunctional decline than those without PAD. Stem and progenitor cell (PC) therapy that
      promotes neoangiogenesis is an emerging treatment modality in PAD. Progenitor cells,
      particularly those of endothelial origin, are involved in vascular repair and regeneration.
      They originate primarily but not exclusively from the bone marrow, differentiate into
      endothelial and other vascular cells, and contribute to neovascularization during tissue
      repair by direct and paracrine mechanisms. Endogenous, pharmacologically-stimulated, and
      exogenous PCs contribute to re-endothelialization and neovascularization. Granulocyte colony
      stimulating factor (G-CSF) and granulocyte-macrophage colony stimulating factor (GM-CSF)
      stimulate mobilization of hematopoietic and other PCs from the bone marrow.In the murine hind
      limb ischemia model, GM-CSF administered by injection or by plasmid transfer augments
      circulating levels of PCs, increases capillary density, and promotes arteriogenesis.GM-CSF
      also augments neo-endothelialization of denuded arteries, promotes proliferation,
      differentiation and survival of hematopoietic cells, monocytes and macrophages.
    

Intervention name(s): Granulocyte-Macrophage Stimulating Factor (GM-CSF); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 micrograms of GM-CSF; Saline injection
Other intervention name(s): GM-CSF, Leukine
Intervention MeSH terms: Molgramostim; Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: claudication
Evaluation of ALT-2074 in Subjects With Type-2 Diabetes, Haptoglobin Type 2-2 Genotype and Coronary Artery Disease
Condition: Diabetes; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      ALT-2074 (BXT-51072) belongs to a class of drugs called "glutathione peroxidase mimics."
      ALT-2074 works by imitating a substance produced in various tissues in the body, which
      prevents damage of the heart and blood vessels. Diabetic patients with a haptoglobin 2-2
      genotype have poor cardiovascular clinical outcomes.

      The purpose of this study is to assess the safety, the pharmacokinetic profile and
      characterize the effect on biomarkers of inflammation and oxidative stress of repeat doses of
      ALT 2074. Subjects must be diabetic, with evidence of coronary artery disease and a
      haptoglobin 2-2 genotype
    

Detailed description: 
      Subjects will be male and female, 18 to 75 years old, with Type 2 diabetes mellitus, a
      documented or suspected history of coronary artery disease, and a Haptoglobin type 2-2 (Hp
      2-2) genotype. Subjects on prescribed anti-diabetic and coronary artery disease medications
      may continue to take their medications throughout the study.

      Subjects who qualify will receive active drug (ALT-2074 20 mg, 40 mg or 80 mg) or placebo
      every 8 hours for 28 days. There will be three sequential cohorts of increasing doses of
      active drug. There will be 2 follow-up visits (Days 35 and 42). Blood and urine tests for
      safety (chemistry and hematology), pharmacokinetics and relevant biomarkers to measure
      inflammation and oxidative stress will be performed throughout the study. Electrocardiograms
      and 24-hour Holter monitoring will also be performed at various time points during the study.
    

Intervention name(s): ALT-2074
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Antiretroviral Treatment Simplification Study With Efavirenz + Abacavir + 3TC Once Daily
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the proportion of patients with virological failure after 48 weeks of treatment
      with the combination of efavirenz 600 mg + lamivudine (3TC) 300 mg + abacavir 600 mg once
      daily as an antiretroviral simplification regimen.
    

Detailed description: 
      Treatment simplification is a therapeutic strategy that allows patients with controlled viral
      replication to switch to an easier-to-take antiretroviral system to promote long-term
      adherence and thus maintain controlled viral load for longer, delaying the evolution of the
      HIV infection.

      The combination of ABC+3TC+EFV is a potent and easy-to-take regimen (2 tablets once a day)
      that could be suitable for the simplification of antiretroviral treatment in patients with
      controlled viral load with a regimen that includes 2 NRTI taken twice daily.
    

Intervention name(s): efavirenz; Abacavir+lamivudine
Intervention type(s): Drug; Drug
Intervention description(s): Efavirenz; Abacavir+lamivudine
Other intervention name(s): sustiva; Kivexa
Intervention MeSH terms: Lamivudine; Efavirenz; Abacavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiviral efficacy; Tolerability; Immunologic response; Virologic response; HIV
Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment
Condition: Type IV Pressure Ulcers; Chronic Wounds; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Pressure Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to determine the safety and feasibility of an autologous mononuclear
      stem cells infusion in pressure ulcers of paraplegic patients; and moreover, to evaluate the
      efficacy of the treatment.
    

Detailed description: 
      Taking into account the encouraging results obtained in the treatment of non-healing chronic
      wounds using bone marrow cells Given that treatment strategies for pressure ulcers can be
      both costly and complex, in this study we examine the possibility of improving pressure ulcer
      healing using stem cell therapy.
    

Intervention name(s): Infusion of autologous bone marrow stem cells after wound debridement.
Intervention type(s): Procedure
Intervention description(s): Cleaning of the wound with heparinized saline, cell infusion and closing with suture.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pressure ulcers; Chronic wounds; Spinal cord injury patients; Bone marrow; Mononuclear; Debridement
A Pilot Study of Ipilumimab and Radiation in Poor Prognosis Melanoma
Condition: High Risk Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study assessing the safety of the combination of ipilimumab administered
      concurrently with radiotherapy for patients with locally advanced or unresectable melanoma
      and patients at high risk for recurrence after resection.
    


Intervention name(s): Ipilumimab; Radiation
Intervention type(s): Drug; Radiation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma
Transcranial Static Magnetic Field Stimulation of Frontal Cortex
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to see if a new brain stimulation technique, static magnetic
      field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp,
      can influence normal rhythms of brain activity.
    

Detailed description: 
      The investigator's primary objective is to determine the feasibility of modifying frontal
      brain activity using static magnetic fields. The investigator's will be examining the effects
      of static magnetic field of the spectral power of EEG data with healthy human participants.

      This is a within-subjects design, where each participant will receive sham and active
      stimulation on the left and right frontal cortex. EEG data will be collected during each
      stimulation.
    

Intervention name(s): Active tSMS; Sham tSMS
Intervention type(s): Other; Other
Intervention description(s): A cylindrical neodymium magnet is placed above the scalp.; A cylindrical piece of nonferrous metal (brass). This is not attracted to magnets, and is identical in weight and appearance to active magnets.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants will receive three stimulations: left frontal, right frontal, and sham tSMS.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: tSMS; Transcranial Static Magnetic Field Stimulation; healthy control
Metabolic Phenotypes in Childhood Obesity
Condition: Obesity, Pediatric
MeSH terms: Obesity; Pediatric Obesity
Study type: Observational

Summary: 
      This study provides a sound basis towards a better understanding of the biochemical
      mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great
      importance towards the development of more personalized prevention and treatment in future.
    

Detailed description: 
      The aim of this study was to identify the plasma metabolic profile associated with childhood
      obesity and its phenotypes..

      This cross-sectional study was set-up to examine the metabolic profile in fasting plasma
      samples from 65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8
      to 18 years. The obtained plasma 1H-NMR spectra were rationally divided into 110 integration
      regions, representing the metabolic phenotype. These integration regions reflect the relative
      metabolite concentrations and were used as statistical variables to construct a
      classification model in discriminating between OB and NW children and adolescents. In
      addition, two metabolic phenotypes were defined within the OB group, i.e. the metabolically
      "healthy" obese (MHO) and metabolically unhealthy obese (MUO) phenotype which are both
      classified as obese but with respectively, none (MHO) or at least two components (MUO) of the
      metabolic syndrome.
    

Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8 to 18 years
      
Biospecimen description: 
      Blood plasma for proton-NMR spectroscopy
    
Keywords: Metabolic syndrome; Metabolomics; NMR spectroscopy
Study to Learn More About the Stomach and Intestine Complaints of Children Aged From 3 to 14 Years
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Observational

Summary: 
      In this observational study, researchers want to gain more information on children suffering
      from abnormal stomach and intestine function (based on the Rome criteria) and treated
      Iberogast. The Rome criteria have been developed by experts to support doctors to diagnose
      stomach and intestine disorders. This study will focus on children aged from 3 to 14 years in
      age treated by their doctor with the herbal drug Iberogast for their stomach and intestine
      complaints for one week. Researcher want to learn more about the efficacy of Iberogast by
      observing the changes of symptoms related to the stomach and intestine disorders. In addition
      information on the safety of the drug and how well the drug is tolerated by the patients will
      be collected.
    


Intervention name(s): Iberogast®
Intervention type(s): Drug
Intervention description(s): The medication was applied 3 times 20 drops per day before or at meals with some liquid, ideally to one week insofar.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male and female children aged between 3 and up to 14 years with Functional Gastrointestinal
        Complaints
Effects of High Intensity Interval Training on Cognitive Flexibility Among Female Teenagers
Condition: Cognitive Flexibility Among Female Teenagers
Study type: Interventional

Summary: 
      The study suggests that the high intensity exercise training program is beneficial for the
      female teenagers to enhance their cognitive abilities along with the physical strengthening.
      It also helps the teenagers to increase their mental health for better health and memory.
    

Detailed description: 
      The objective of the present study was to determine the effects of high-intensity interval
      training on cognitive flexibility among female teenagers. The current study suggests that the
      high intensity physical training improves the cognitive ability of the participants. Evidence
      indicates that regular physical activity and high intensity interval training improves the
      physical strengthening and corresponding improvements in cardiopulmonary physical fitness
      that results in the increase in cerebral perfusion and vasoreactivity across the human
      lifespan. The betterment in the cerebral perfusion leads to better cognitive ability and
      mental health.

      The physical activity program comprises 8 weeks consisting of Low-intensity interval training
      in the first week to high-intensity interval training in the 8th week. Participants of the
      two groups i.e., experimental and control groups were assessed at baseline fourth and eighth
      week by Digital Span and Mini mental state examination.

      The current study from the statistical analysis suggests that better results are obtained by
      high intensity physical activity among the female teenagers overtime both in terms of
      cognitive ability and physical strength.
    

Intervention name(s): High Intensity Interval Training
Intervention type(s): Other
Intervention description(s): The HIIT sessions ranging from 4-12 minutes in duration for 8 weeks in which three sessions will be conducted each week (weeks 1-3: 4 minutes; weeks 4-6: 8 minutes; weeks 7-8: 12 minutes respectively), with a work to rest ratio of 30sec: 10sec, as mention in table 1. Experimental group/HIT group engaged in their HIIT sessions (inclusive of a short warm-up activity including dynamic exercises i.e., walking/running, 8-10 minutes of HIIT and cool down which include static exercises i.e., shoulder and hip muscle stretches). Session duration and intensity are increased with weekly progression in intervention groups. The high resistance training sessions was be delivered by the researcher to HIT group
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cognitive Flexibility; High Intensity Interval Training; High Intensity Exercises; Digital Span Test; Mini Mental State Examination
v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
Condition: Heart Failure With Reduced Ejection Fraction; Dilated Cardiomyopathy
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this Phase 1b/2a study is to evaluate the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of MYK-491 in patients with stable heart failure.
    


Intervention name(s): MYK-491; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single Ascending Dose and Multiple Ascending Dose of MYK-491; Single Ascending Dose and Multiple Ascending Dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a a two part study. The first part is a randomized, crossover, double-blind, placebo-controlled, two cohort, sequential ascending single dose study. All patients will receive placebo and active doses of MYK-491.
The second part is a randomized, parallel, double-blind, placebo-controlled, sequential ascending multiple dose study. All patients will receive placebo and/or active doses of MYK-491.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment