bioihbjkbjnl/mcl2 huggingface dataset:
To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety,
      tolerability, and relative bioavailability of the 2 free base tablet formulations (roller
      compacted [RC] and high shear wet granulation [HSWG]) compared to the reference capsule
      formulation under fasted conditions. This is a 3-period; cross-over study that will guide
      which gepotidacin formulation will be used for future studies. Following review of
      pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed
      with Parts 1b and 2.

      Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the
      selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected
      gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will
      be evaluated under fasted conditions.

      The duration of the study (from Screening to the Follow-up visit) will be approximately 44
      days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The
      approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3
      treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12
      Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.
    


Intervention name(s): Gepotidacin RC Tablet; Gepotidacin HSWG Tablet; Gepotidacin Capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.; The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.; It is a pink gelatin size 00 capsule with no identifying markings containing slightly agglomerated pale yellow to grayish yellow to yellowish gray powder. This is an immediate release capsules containing gepotidacin 500 mg (mesylate salt) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing capsules.
Intervention MeSH terms: Gepotidacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cross-over; Gepotidacin; Pharmacokinetics; Relative Bioavailability; non-compartmental PK analysis; High shear wet granulation
Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
Condition: Diabetes Mellitus, Type 2; Sleep Disturbance
MeSH terms: Dyssomnias; Parasomnias; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study is designed as cross-over double-blind placebo-controlled randomized clinical
      trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter
      into the study and randomly assign to first intervention and first placebo groups.The primary
      outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the
      end of the study.
    

Detailed description: 
      Considering the high prevalence of sleep disturbance in diabetic patients and the
      effectiveness of lavender in treatment of sleep disorders in this study the efficacy of
      Lavender aromatherapy in sleep disorder and metabolic parameters in diabetic patients will be
      investigated. This study is designed as cross-over double-blind placebo-controlled randomized
      clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will
      enter into the study and randomly assign to first intervention and first placebo groups.The
      primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated
      at the end of the study.
    

Intervention name(s): Lavender Oil; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): The intervention group pour 3 drops of Lavender essential oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks; The placebo group pour 3 drops of Almond oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the crossover study and randomly assign to treatment or placebo groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues
Condition: Periapical Diseases
MeSH terms: Periapical Diseases
Study type: Interventional

Summary: 
      Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university
      Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing
      ability of soft tissue diode laser application versus conventional root canal treatment using
      CBCT
    

Detailed description: 
      Sample size is 24 24 Patients were randomly distributed in 2 groups , one group of patients
      received soft tissue laser therapy after root canal treatment and the other group received no
      treatment just conventional RCT. • Patients were equally divided into 2 groups (n=12 in each
      group ) The study in a Single blinded RCT , Numbers for patients will be generated and
      distributed randomly in a table on an Excel sheet, and in front of each number either a
      letter (C) for control or (I) for intervention will be typed After patients were selected in
      the study they will be asked to fill in a consent form , that states that they are part of a
      clinical trial and that they may or may not have a laser session following root canal
      treatment Group A Soft tissue laser application : Endodontically treated teeth were targeted
      by virtue of a dental applicator positioned at a right angle to the mucosa at the level of
      the apices. Application of the laser probe were applied to both the buccal and lingual
      mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60
      seconds (a dose = 70 j/cm2 for analgesia) by the co-investigator The laser unit used in this
      study will be a diode laser (Lite Medics 1.00 Watt serial number 148 Ver.SwvM.
      150VS108VT.100) of wavelength 980nm and Max power 15 WCW Class IV Laser Product ) in
      continuous wave mode Group B : Placebo : conventional root canal treatment : mock laser
      intervention A CBCT was taken preoperative and after 12 month postoperative, both linear and
      volumetric measurements were calculated
    

Intervention name(s): Soft tissue Diode laser application; Placebo
Intervention type(s): Device; Other
Intervention description(s): post-operative soft tissue diode laser application; mock diode laser application
Other intervention name(s): Low laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diode laser; low level laser therapy; CBCT
Healthy Unique Lipids From Almonds
Condition: Nutrition, Healthy
Study type: Interventional

Summary: 
      This project will address the notion that "healthy" lipids such as monounsaturated fatty
      acids in almonds can be used by the bacteria living in our gut to generate "new" molecules
      with potentially interesting health properties. This metabolite pattern is anticipated to
      differ significantly when compared to non-almond foods rich in saturated fats.
    


Intervention name(s): Almonds; Coconut
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will receive 2.2 oz (62 g) of almonds to ingest within 15 minutes.; Participants will receive 1 oz (30 g) of a coconut-chocolate bar and 1.4 oz (40 g) of 100% dried coconut chips to ingest within 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: microbiome; cyclopropane; nutrition; unsaturated; fatty acids
Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients
Condition: Anxiety; Depressive Symptoms; Distress, Emotional; Anxiety and Fear; Anxiety State; Mental Disorders, Severe; Psychiatric Hospitalization
MeSH terms: Anxiety Disorders; Depression; Mental Disorders
Study type: Interventional

Summary: 
      A randomized control trial examining the feasibility, acceptability, and preliminary efficacy
      of providing access to the MindShift CBT mobile app via tablet for acute psychiatric
      inpatients.
    

Detailed description: 
      Psychiatric inpatients expect more psychosocial intervention during their inpatient stay than
      they receive. During the COVID-19 pandemic, existing interventions have been further reduced.
      Mood and anxiety symptoms are common for all inpatients across diagnostic categories. Studies
      have shown that cognitive behavioural therapy (CBT) can be effective for treating these
      symptoms among inpatients. The purpose of this study is to determine whether the Mindshift
      CBT app (an app based on principles of cognitive behavioural therapy) is an acceptable,
      feasible, and useable intervention for inpatients.

      The Mindshift CBT app is a tool designed and maintained by Anxiety Canada. It includes tools
      for daily mood check-ins, healthy thinking, calming intense emotions, and taking actions to
      change behaviours associated with anxiety and low mood. It also includes information about
      the common types of anxiety.

      The proposed trial includes 12 patients per arm. All participants in control and intervention
      groups will have access to assigned tablet devices throughout the study period, though only
      those in the intervention group will have the MindShift CBT app on their device. All
      participants will undergo assessments at baseline and at the end of the intervention period
      (1 week).
    

Intervention name(s): Mindshift CBT; Treatment as Usual
Intervention type(s): Device; Device
Intervention description(s): A tablet with the Mindshift CBT app installed. Mindshift CBT is a free, evidence based app developed by Anxiety Canada, designed to help users reduce symptoms of anxiety and distress.; Treatment as usual. A tablet identical to the intervention group, but without the Mindshift CBT app is available for patients to use during their inpatient stay.
Other intervention name(s): CBT mobile app; Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inpatient psychiatry; psychiatric admission; mobile app; inpatient CBT
Examining Effects of Aerobic Exercise on Pain Sensation
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      By doing this study, researchers hope to learn effects of aerobic exercise on over activated
      nervous system in people with chronic low back pain.
    

Detailed description: 
      Chronic low back pain is a common condition in the world. About 85% of people with low back
      pain do not know the cause of their pain. This leads to ineffective treatments.

      Recently, the idea of an over activated nervous system is thought to be one of the main
      reasons for chronic pain. Over activated nervous system means pain processing areas in the
      spine or brain might be more sensitive. Aerobic exercise, such as walking and cycling, is
      often used to decrease chronic pain. Aerobic exercise is a form of physical exercise that
      strengthen the heart and lungs in order to improve the body's utilization of oxygen.

      The researchers want to examine if aerobic exercise is effective in decreasing over
      activation of the nervous system. Gaining a better understanding of effects of aerobic
      exercise on the nervous system may lead to more effective treatments for low back pain.
    

Intervention name(s): Aerobic exercise program
Intervention type(s): Behavioral
Intervention description(s): Exercise program consists of training for 60 minutes, three times per week for 12 weeks. Participants will use a treadmill, Nu stepper/bike or elliptical to exercise.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Nutrition on Bone Metabolism as Assessed by 41Ca
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The present study aims to develop a technique based on a single dose of a calcium isotope,
      which enables to determine the effect of a nutritional intervention on bone calcium
      metabolism. For this purpose nutritional interventions with calcium, vitamin D and vitamin K
      will be applied in postmenopausal women. Treatment effects will be determined by the urinary
      excretion of the calcium isotope and related to classical bone markers.
    

Detailed description: 
      In the present proposal a method is described that may enable studying the effect of
      nutrition on bone calcium turnover far more accurate, within a shorter time frame and
      therefore less intensive for the volunteers in clinical studies as compared to presently
      existing methods. This method will enable screening for promising food concepts for combating
      osteoporosis within a relatively short time. Recent developments show that use of the nuclide
      41Calcium (41Ca) and measurement by accelerator mass spectrometry (AMS) has great potential
      in measuring effects on bone level within a relatively short period of time. When introducing
      a diet change (intervention) the bone metabolism of calcium may change resulting in a changed
      41Ca-signal in the urine. So far a few medication studies with osteoporotic volunteers have
      been performed and it appears that this ultrahigh sensitive technique may also be applicable
      for nutrition studies in healthy volunteers.
    

Intervention name(s): vitamin K; calcium
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A calcium product will be given either with or without vitamin K. Each intervention will last for 5 weeks, each followed by a 5 week wash-out. The first intervention will start about 4 months after inclusion and the single 41Ca bolus.
Intervention MeSH terms: Vitamin K; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: bone metabolism
Aspirin Dose and Atherosclerosis in Patients With Heart Disease
Condition: Cardiovascular Diseases; Atherosclerosis; Myocardial Infarction
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Atherosclerosis; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to test higher versus lower doses of aspirin on markers of
      atherosclerosis in patients who have had a heart attack.
    

Detailed description: 
      Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in
      patients who have survived a prior event as well as during an acute heart attack.

      Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or
      stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots.

      Our research is designed to explore whether higher doses of aspirin provide additional
      benefits on markers of atherosclerosis.
    

Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): Dosage
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiovascular diseases; Aspirin; Atherosclerosis; Myocardial Infarction
Bacterial Vaginosis Screening at IUD Insertion
Condition: BACTERIAL VAGINOSIS
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Observational

Summary: 
      A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None,
      however, have screened women prior to inserting the IUD. No data exists detailing the status
      of the vaginal microflora and possible cervical infection prior to IUD insertion. Thus, no
      inference can be made about the possible influence of IUD insertion and presence to the
      development of upper genital tract infection . Consequently, with the current literature, it
      would be difficult to make an argument for screening and treatment for BV prior to IUD
      insertion. This study will help us determine whether women with an IUD develop a change in
      the normal bacteria that are present in the vagina, known as bacterial vaginosis (BV). In
      addition, in those women with BV, we are looking to see if they develop more significant
      problems with the IUD, than those who do not have BV. Overall, this will help us determine
      whether all women should be screened for BV prior to IUD insertion.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women between the ages of 18 and 48, who request to have an IUD inserted, both for
        contraceptive and noncontraceptive indications, will be asked to participate in the study.
      
Biospecimen description: 
      WHOLE BLOOD; VAGINAL SWAB
    
Keywords: BACTERIAL VAGINOSIS; IUD INSERTION
Vitamin B12 Pregnancy Supplementation
Condition: Pregnancy Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Pregnancy is associated with increased requirements for iron and increased blood volume of up
      to 40%. Because expansion in plasma volume is higher than the increase in the mass of red
      blood cells, there is a fall in hemoglobin concentration, which leads to physiological
      anemia, characterized with lower hemoglobin (Hb), hematocrit and red blood cells, but without
      changes in mean corpuscular volume (MCV). Anemia in pregnancy is defined with Hb values under
      110 g/L in the first trimester and under 105 g/L in the second and third trimester.

      Iron deficiency is thought to be the most common nutrient deficiency among pregnant women.
      Consequences of anemia include delayed fetal growth, premature delivery, intrauterine fetal
      death, postpartum depression and delayed psychomotor development of a child. It is known that
      in women that are not anemic daily iron supplementation of 27 mg/day is sufficient, which can
      be obtained from adequate nutrition or body supplies. Iron supplementation is pregnancy has
      been recommended by the WHO (World Health Organisation) since 1959, and this recommendation
      was confirmed by numerous professional associations. However, in women with anemia, or women
      subjected to particular dietary regimens with diminished quantity of iron, including
      vegetarian or vegan diet, required supplementation dosage is higher, and estimated in the
      literature to be 120 mg/day.

      The aim of this study was to analyze whether adding vitamin B12 (5 µg /100 days), along with
      folic acid and iron as supplement in pregnant women who are not anemic and who need only iron
      supplementation, will result in improvements of hematological and biochemical markers.
    


Intervention name(s): vitamin b12
Intervention type(s): Dietary Supplement
Intervention description(s): Vitamin B12 has been added to the experimental group of pregnant women, at a dose of 5 μg / 100 days
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized clinical trial
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: vitamin b12; pregnancy; anemia
Metabolic and Appetite Parameters Following Addition of Whey Protein to a Carbohydrate-based Breakfast
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether the addition of whey protein to a
      breakfast high in carbohydrate content will influence acute metabolic and appetite responses,
      as well as responses to a subsequent lunch meal.
    


Intervention name(s): Whey Protein (Arla Foods Ingredients Group); Breakfast meal
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 20 g whey protein isolate added to breakfast meal; Carbohydrate breakfast served as a standard portion (1799 kJ, 93/2/9% energy from carbohydrate/fat/protein)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Postprandial glycemia; metabolic health measures
Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The primary purpose of this study is to determine the effectiveness of the
      Magnetoencephalography (MEG) instrument to record electrical activity from parts of the body
      other than the brain. This study will examine if electrical activity from parts of the body,
      other than the brain, can be imaged by the MEG instrument. Finding will contribute to studies
      of pain, since abnormal electrical activity in skeletal muscle is the basis of pain, which
      can be severe, yet there is no non-invasive way to image this abnormal activity. This is
      particularly relevant to deep muscle pain and back pain.
    


Intervention name(s): Whole-cortex MEG System (with optional EEG)
Intervention type(s): Diagnostic Test
Intervention description(s): "Whole-Cortex MEG System" non- invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The location may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Magnetoencephalography; Whole-cortex MEG System (with optional EEG)