bioihbjkbjnl/mcl2 huggingface dataset:
Sahoor Meal Regimen for Patients With Type1 Diabetes
Condition: Type1diabetes; Fasting Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      To examine effects of two approaches to sahoor meal consumption during Ramadan on blood sugar
      control and incidence of early day hypoglycemic episodes requring the discontinuation of
      fasting.
    

Detailed description: 
      Most studies and guidelines regarding insulin dose adjustments have focused on basal insulin
      modification rather than boluses or timing of meals. There hasn't been so far any study that
      examines a specific dose reduction or timing that is best to avoid early day (post Suhoor)
      hypo or hyperglycemia, and the advised dose reductions are based on expert opinion with small
      observational studies that used certain dose changes.

      The timing of sleep and meals are different during Ramadan and therefore have a direct impact
      on blood glucose levels, we demonstrated in a previous prospective cohort of 156 T1DM
      patients contrary to other studies, the post suhoor and early day period had the highest
      incidence time for hypoglycemia in the Saudi population. It is therefore necessary to
      understand how adjustments to the timing of the meals and their doses can achieve better
      glycemic control during fastin Ramadan. Current guidelines recomend that the Suhoor meal is
      delayed as much as possible in order to reduce the fasting duration to be taken with a
      claculated insulin dose. However, the concern is that this would not allow patients to
      correct the hypoglycemic or hyperglycemic events related to miscalculation of Suhoor insulin
      dose if they occur as the fasting time begins and they must break their fast to correct their
      blood glucose levels. Many people with T1DM do not count meal carbohydrates correctly,
      therefore, there is a need for an approach that allows patients to correct their blood
      glucose levels after having a large meal that requires insulin administration without having
      to break their fast, as well as the ability to have a snack or a late Suhoor without the need
      for insulin administration to minimize the fasting period and insure that the blood glucose
      is in range before starting to fast. The approach that we are proposing will allow patients
      to do that by having the Suhoor meal with its bolus at least two hours before fasting begins,
      and having a low carbohydrate snack - late suhoor- just before starting to fast without the
      need for insulin administration (regimen 1). It is going to be compared with having the
      Suhoor with its insulin bolus just before the start of fasting (regimen 2).
    

Intervention name(s): Meal timing in relation to time of starting the fast
Intervention type(s): Other
Intervention description(s): as described
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized cross over design
Masking: None (Open Label)
Primary purpose: Treatment
Secondary Cancer Risk After Radiation Therapy for Rectal Cancer
Condition: Neoplasms, Second Primary
MeSH terms: Neoplasms, Second Primary
Study type: Observational

Summary: 
      Retrospective study comparing dose distribution of 3D conformal radiotherapy (3DCRT) and
      volumetric-modulated arc therapy (VMAT) to estimate secondary cancer risk for patients having
      had radiation therapy for rectal cancer. Twenty-five patients are included in this study.
      Planning CT scans are used for comparison of dose distribution and calculation of second
      cancer risk.
    

Detailed description: 
      A model-based Analysis calculating the organ-specific excess lifetime attributable risk using
      the planning CT data sets of 25 patients to estimate second cancer risk for patients after
      radiotherapy for rectal cancer comparing conventional 3DCRT with VAMT techniques.
    

Intervention name(s): No intervention in this retrospective study
Intervention type(s): Other
Intervention description(s): No Intervention in this retrospective Analysis. All patients included did receive Radiation therapy Independent of this study
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients having had radiation therapy for rectal cancer. Estimation of second cancer risk
        using data from planning CTs comparing dose Distribution using different Radiation therapy
        techniques (3DCRT vs VMAT).
Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Inflammation
Study type: Interventional

Summary: 
      This study will evaluate whether multiple nasal antigen challenges with dust mite allergen
      produces increases in nasal symptoms and local allergic inflammatory cells in the nose and
      the blood.
    


Intervention name(s): Dust mite extract, Fluticasone, Methacholine
Intervention type(s): Drug
Intervention description(s): Dust mite extract, Fluticasone, Methacholine
Intervention MeSH terms: Fluticasone; Methacholine Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Allergic Rhinitis; dust mites; IgE; IL-13; nasal; inflammation
Gait Modification Treatments for Knee Pathology
Condition: Knee Injuries; Knee Osteoarthritis
MeSH terms: Knee Injuries
Study type: Interventional

Summary: 
      The objective of this study is complete a longitudinal cross-over clinical study to
      investigate the effect of treatments for knee pathology, including cutaneous stimulation
      (skin vibration and soft knee brace), on locomotion tasks (i.e. walking, jogging, stair
      ascending and descending), muscle function, and pain/function.
    


Intervention name(s): Cutaneous Stimulation; Knee Sleeve
Intervention type(s): Device; Device
Intervention description(s): A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.; Commercially-available knee sleeve.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Knee pathology
Exercise, Executive Processes and the Aging Brain
Condition: Cognition; Aging
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effect of aerobic exercise on the brain and
      cognition through the measurement of neuroelectric and behavioral indices of executive
      control cognitive function in older adults.
    

Detailed description: 
      The aim of this research is to gain a better understanding of factors that relate to the
      increased health and effective functioning of older adults. Specifically, efficiency of
      psychomotor performance declines with advancing age leading to profound effects on older
      adults' quality of life. For this reason, researchers have focused on the influence that
      individual lifestyle habits have on the aging process. One lifestyle choice that has been
      found to positively contribute to the efficiency of older adults' psychomotor performance is
      cardiovascular exercise. This relationship appears to be especially significant when older
      adults are challenged with more complex or effortful tasks. Previous research has led
      investigators to believe that aging has a specific, rather than generalized, impact on
      cognitive functioning. Also, prolonged participation in cardiovascular exercise has been
      found to maintain the cognitive functioning critical for healthy aging.

      Therefore, the purpose of this research is to examine the role of an organized 6-month
      cardiovascular exercise intervention trial on electrocortical (event-related brain potential)
      and behavioral measures (reaction time) of executive control. In addition, a
      non-cardiovascular exercise control group that participates in a 6-month stretching and
      toning program will be used for comparison. Participants will be measured before and after
      exercise training during engagement in several tasks designed to elicit different executive
      functions (e.g., discrimination, task switching, inhibition). Each task also contains a
      non-executive condition that will be used for comparison to examine the specificity of
      exercise participation of cognitive functioning. A secondary aim of this project is to
      determine the effects of an acute bout of exercise on cognitive functioning. Both groups will
      participate in several bouts of exercise followed by immediate measurement on the tasks
      outlined above to determine whether acute exercise has beneficial effects on executive
      processes. The significance of this research may include the increased understanding of
      factors related to the amelioration of age-related decrements in central nervous system
      functioning and recommendations for the maintenance of cognitive health during the later
      stages of life.
    

Intervention name(s): Minds in Motion
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psychomotor function; neuromuscular system; memory; brain electrical activity; Mental Processes
DHA Supplementation and Pregnancy Outcome
Condition: Pregnancy
Study type: Interventional

Summary: 
      Supplementation with DHA during pregnancy will increase gestational length and improve
      cognitive development.
    

Detailed description: 
      This was a trial of supplementation with DHA during pregnancy to increase gestational length.
      Subjects were provided with 300 mg, 600 mg or placebo (olive oil) in a randomized design from
      week 24-26 of pregnancy until delivery. Gestational age, birth weight and birth length data
      were collected and infants growth at 2 and 4 months and cognitive development at 4 months and
      1 year were measured.
    

Intervention name(s): 600 mg DHA; 300 mg DHA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Pregnant women were given 600 mg DHA in the last trimester of pregnancy; Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding; Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Pregnancy; DHA; Gestational Length; Cognitive Development
New Robotic Assistance System for Spinal Fusion Surgery
Condition: Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis; Spondylosis
MeSH terms: Spinal Stenosis; Intervertebral Disc Degeneration; Spondylolisthesis; Spondylosis
Study type: Interventional

Summary: 
      The main objectives of the study are to evaluate the acceptance into operating flow,
      performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
    

Detailed description: 
      Based on the literature review of similar devices and on the pre-clinical tests performed
      with the AQrate System on bench and cadavers, the study is build around the following
      hypothesis:

        1. The design and principle of operation of the AQrate System permits a correct integration
           in the surgical procedure flow thus enabling the surgeon to benefit from its advantages
           while not generating any additional operational difficulties

        2. The stability and ease of use of the device will permit the surgeon to achieve any
           planned spinal fusion without requiring additional assistance from the medical staff
           compared to a conventional spinal fusion surgery.

        3. A spinal fusion surgery procedure that is performed with the use of the AQrate System is
           similar to conventional spinal fusion surgery. If correctly used, no additional adverse
           event should be observed.

        4. The exposure to x-ray should decrease as the need of intraoperative recheck of pedicle
           screws placed should be reduced

        5. The precision of placement of pedicle screw should not be adversely affected by the use
           of the system compared to conventional spinal surgery.
    

Intervention name(s): AQrate Robotic Assistance System
Intervention type(s): Device
Intervention description(s): Robotic guidance during spinal fusion surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Robotic Spinal Fusion Surgery
A Study to Assess New Ebola Vaccines, cAd3-EBO Z and MVA-BN® Filo
Condition: Ebola; Ebola Zaire
MeSH terms: Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess two new Ebola vaccines: cAd3-EBO Z at 3 different
      doses, and a second vaccine, MVA-BN® Filo, at 3 different doses. The study will enable us to
      assess the safety of the vaccines and the extent of the immune response in healthy
      volunteers. The investigators will do this by giving volunteers a either one or two
      vaccinations, doing blood and saliva tests and collecting information about any symptoms that
      occur after vaccination. This is the first trial to use either of these vaccines in humans.
      We plan to recruit a total of 92 volunteers to be vaccinated.
    

Detailed description: 
      Long- term immunology follow-up: In order to assess the durability of vaccine induced
      immunogenicity, all vaccinated subjects will be invited back to attend a maximum of 3 further
      optional follow up visits at least 12 months after their final vaccination. The 3 visits will
      have a minimum interval of 3 months between them, and the final visit must take place no
      longer than 12 months after the first optional visit.

      Volunteers who attend these visits will be asked about occurrence of any SAEs during the
      intervening period. SAE data for this period will not be collected in those volunteers who
      decline to attend these additional visits.
    

Intervention name(s): cAd3-EBO Z at 1 x 10^10 vp; cAd3-EBO Z at 2.5 x 10^10 vp; cAd3-EBO Z at 5 x 10^10 vp; 4.4x10^8 TCID50s MVA-BN® Filo; 2.2x10^8 TCID50s MVA-BN® Filo; 4.4 x 10^7 TCID50s MVA-BN® Filo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Low dose cAd3-EBO Z; Medium dose cAd3-EBO Z; High dose cAd3-EBO Z; High dose MVA-BN® Filo; Low dose MVA-BN® Filo; Very low dose MVA-BN® Filo
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ebola; Zaire
Study to Assess Safety, Tolerability and Pharmacokinetics of XC7 (Which is Planned Use in the Treatment of COVID-19) in Healthy Volunteers
Condition: Covid19; Healthy Volunteers
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety,
      tolerability and pharmacokinetics (PK) of ascending doses of XC7 after single and multiple
      oral administration in healthy volunteers. It's planned to include sequentially 2 cohorts of
      4 volunteers who will receive a single dose of XC7 (100 mg and 200 mg) or placebo (cohort
      ratio 3:1) and 1 cohort of 8 volunteers who will receive multiple doses of the XC7 (200 mg)
      or placebo during 14 days (cohort ratio 6:2).
    

Detailed description: 
      The study will be conducted in 1 centre. The study will consist of 3 periods: screening (7
      days), treatment (1 or 14 days) and follow-up (7 or 28 days).

      The volunteers of single dosing cohorts will receive the investigated drug (ID) ХС7 or
      placebo once and stay at the study center for at least 24 hours after the ID administration
      to monitor the safety parameters and for sampling for PK analysis. The Follow-up will last 7
      days, during which safety parameters and PK in volunteers will be studied. Based on all
      safety data from the XC7 100 mg cohort, the Data Safety Monitoring Committee (DSMC) will
      consider dose increase and entry of the 200 mg cohort. If the single dose of ХС7 200 mg is
      considered to be safe, the third multiple dosing cohort of 200 mg will be included in the
      study.

      The volunteers from multiple dosing cohort will receive the ID (ХС7 or placebo) once a day
      during 14 days and will stay at the hospital (study center) during the first five days after
      administration of the ID. The Follow-up will last 14 days, during which they will study
      safety parameters and PK in volunteers.
    

Intervention name(s): XC7 100 mg single; XC7 200 mg single; Placebo single; XC7 200 mg multiple; Placebo multiple
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): The volunteers will receive a single dose of the ID (1 capsule once, 100 mg); The volunteers will receive a single dose of the ID (2 capsules once, 100 mg each); The volunteers will receive a single dose of the ID (1 or 2 capsules once); The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily, 100 mg each); The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily)
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The dose cohorts cohorts will be included into the study subsequently based on preliminary safety results evaluation performed by the DSMC. 2 doses of XC7/placebo (100 mg, 200 mg) were used in the study.The duration of exposure to the ID is planned 1 day in single dosing cohorts and 14 days in multiple dosing cohort.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Coronavirus; Phase I
Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of asthma treatment is to achieve and maintain asthma control and to reduce the
      future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most
      effective anti- inflammatory treatment for all severities of persistent asthma. For children
      >=5 years of age and adolescents whose asthma is uncontrolled, low-dose ICS plus adjunctive
      therapy with long-acting beta agonist (LABA) is considered as effective. Thus, this study is
      designed to evaluate the efficacy and safety of FF (ICS component)/VI (LABA component)
      compared to FF alone for the treatment of asthma, in subjects aged 5 to 17 years old
      currently uncontrolled on ICS. The study will be conducted over a total duration of
      approximately 29 weeks: 4 week run-in period, 24-week double-blind treatment period and
      1-week follow-up period. Subjects will be randomized to receive FDC of FF/VI or FF
      administered via ELLIPTA® dry powder inhaler (DPI). The dose of both FF/VI and FF alone will
      be selected based on the age of subjects. Subjects will receive a short acting beta 2 agonist
      (SABA) (albuterol /salbutamol) as a rescue medication throughout the study. A total of 870
      subjects will be randomized in the study. Of this, 652 subjects will be aged 5 to 11 years
      (cohort A), and 218 will be aged 12 to 17 years inclusive (cohort B). ELLIPTA is a registered
      trademark of GlaxoSmithKline (GSK) group of companies.
    


Intervention name(s): FF/VI via ELLIPTA DPI; FF via ELLIPTA DPI
Intervention type(s): Drug; Drug
Intervention description(s): ELLIPTA DPI inhaler will contain two individual blister strips; the first strip will contain FF(50 or 100 mcg) and second strip will contain VI (25 mcg).; ELLIPTA DPI inhaler will contain a single blister strip of FF (50 or 100 mcg).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive FDC of FF/VI inhalation powder compared to FF inhalation powder, once daily in cohort A and cohort B.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fluticasone furoate; Efficacy; Vilanterol; Asthma; Safety; GW642444; GW685698
Physical Activity and Cognitive Behavioural Therapy in Panic Disorder and Agoraphobia
Condition: Panic Disorder; Agoraphobia
MeSH terms: Panic Disorder; Agoraphobia
Study type: Interventional

Summary: 
      Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive
      behavioural therapy in patients with panic disorder and agoraphobia.
    

Detailed description: 
      Patients receive a 12-session manualized cognitive behavioural therapy, implemented over 7
      weeks and followed by two booster sessions. Five sessions consist of in-vivo exposures. Prior
      to these sessions patients undergo a training of physical activity. Half of the patients
      complete training on a treadmill at 70% of their maximal oxygen uptake while the other half
      complete training at 30%.
    

Intervention name(s): Cognitive Behavioural Therapy
Intervention type(s): Behavioral
Intervention description(s): 12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Panic Disorder; Agoraphobia; Physical Activity
An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer
      term, following MT-3995-J05 study.
    


Intervention name(s): MT-3995 Low; MT-3995 Middle; MT-3995 High
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic Nephropathy