bioihbjkbjnl/mcl2 huggingface dataset:
Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin)
Condition: Visual Field Defect, Peripheral; Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      This study seeks to test whether these over-the-counter nutritional supplements have an
      impact on patients' performance during visual field testing.
    

Detailed description: 
      Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to
      detect progression is visual field testing. Visual field testing is the reference standard to
      measure visual function in glaucoma. It is called called standard automated perimetry (SAP).
      However, this test is very subjective, often unreliable, and variable. One of the main causes
      of unreliable tests is the lack of attentiveness or concentration during the test. Previous
      studies have shown that listening to Mozart or taking vitamin B12 can improve the reliability
      of this test. Recent studies have suggested that over-the-counter medications such as
      nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test.
      This can ultimately reduce costs due to repeated testing and increase doctor's certainty when
      analyzing the results of this test.
    

Intervention name(s): Vitamin B3; Pyruvate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 3 tablets of 1000 mg each will be administered orally.; 2 tablets of 1500 mg each will be administered orally.; Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.
Other intervention name(s): B-3 Nicotinamide; Calcium Pyruvate
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Perimetry; Vitamins; Glaucoma; Supplements; Vitamin B3; Nicotinamide
A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the rate of elimination of bacteria by levofloxacin in
      middle ear fluid of children with a rapid and severe onset of infection and inflammation of
      the middle ear who are at high risk for infections that are difficult to treat.
    

Detailed description: 
      Rapid and severe onset of middle ear infection is a common bacterial infection in children.
      These infections, particularly when they occur early in life and are recurrent, are
      associated with considerable disease and can lead to increasingly serious infections. This is
      a multicenter study to determine the effectiveness of levofloxacin in eliminating bacteria in
      the middle ear fluid of children between 6 months and 5 years of age with a rapid and severe
      onset of infection and inflammation of the middle ear (who are at high risk for infections
      that are difficult to treat). The study consists of a 1-day screening period when patients
      will be tested for eligibility for the study; a 4 to 6-day treatment, blood collection,
      possible collection of fluid from the middle ear, and assessment period; and a post-treatment
      period to assess the status of the middle ear infection. All patients will receive
      levofloxacin 2 times daily (up to a maximum daily dose of 500 mg) mixed with liquid and taken
      by mouth for 10 days. Safety evaluations will include laboratory tests, physical
      examinations, vital sign measurements, and recording of adverse events, including any report
      of joint pain or signs and symptoms of joint disease. Effectiveness will be assessed by the
      rate of elimination of the bacteria identified at the start of the study and by signs and
      symptoms, as well as microscopic evidence that the patient is cured of the middle ear
      infection. The study hypothesis is that levofloxacin will be effective in eliminating
      bacteria in the middle ear fluid of children with a rapid and severe onset of infection and
      inflammation of the middle ear and who are at high risk for infections that are difficult to
      treat. Levofloxacin 10 milligrams/kilogram (mg/kg) 2 times daily (up to a maximum daily dose
      of 500 mg) mixed with liquid and taken by mouth for 10 days
    

Intervention name(s): levofloxacin
Intervention type(s): Drug
Intervention MeSH terms: Levofloxacin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Otitis Media; Ear Diaeases; Levofloxacin; Quinolones
Macrolane for Enhancement of the Shape and Fullness of the Female Breast
Condition: Breast Enhancement
Study type: Interventional

Summary: 
      The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast
      enhancement.
    

Detailed description: 
      This study evaluates the injection technique and treatment outcome by stepwise inclusion and
      treatment of Macrolane for female breast enhancement.
    

Intervention name(s): Macrolane
Intervention type(s): Device
Intervention description(s): Device: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)
Condition: HIV Infections
MeSH terms: AIDS-Related Complex
Study type: Interventional

Summary: 
      The objective is to determine the effect of Isoprinosine (inosine pranobex) in homosexual
      male patients with AIDS related complex (ARC) in delaying the onset of AIDS. Secondly, to
      determine the effect of Isoprinosine in decreasing the severity and/or incidence of lesser
      opportunistic infections and/or other conditions associated with ARC.
    


Intervention name(s): Inosine pranobex
Intervention type(s): Drug
Intervention MeSH terms: Inosine Pranobex
Masking: Double
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; Inosine Pranobex; Homosexuality; Acquired Immunodeficiency Syndrome; AIDS-Related Complex
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in
      adult participants with atopic dermatitis.
    


Intervention name(s): SUN13834; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Low dose, orally 3 times a day (tid) for 28 days of SUN13834; Placebo, orally (tid) for 28 days of SUN13834
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; SUN13834
USPIO-enhanced and Diffusion-weighted MRI for the Detection of Pelvic Lymph Node Metastases
Condition: Prostate Cancer; Bladder Cancer
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis; Urinary Bladder Neoplasms; Lymphatic Metastasis; Body Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      Preoperative detection of lymph node metastases in patients with prostate or bladder cancer
      is crucial for selection of the appropriate treatment strategy (surgery, androgen deprivation
      with/or without radiation therapy or chemotherapy) and thus for patient prognosis. Until now
      CT or MRI have been the modalities of choice for preoperative staging procedures. However,
      current morphological assessment of lymph nodes based on size and shape is unable to detect
      smaller metastases or liable to give false positive results on lymph nodes with reactive
      hyperplasia. We hypothesize that USPIO-enhanced MRI combined with DW-MRI will be able to
      detect pelvic lymph node metastases preoperatively with high sensitivity and specificity.
    


Intervention name(s): Imaging: diffusion-weighted MRI; Sinerem (USPIO) enhanced MRI
Intervention type(s): Other; Other
Intervention description(s): Diffusion-weighted MRI of the entire pelvis to detect lymph node metastases; USPIO (Sinerem) will be administered intravenously immediately after the first MR examination at a dose of 2.6 mg Fe/kg body weight diluted in 100 ml of saline (optimal dose according to: (9, 10)) during a period of about 30 minutes under medical supervision. Postcontrast MR imaging will be performed 24-36 hours after contrast medium injection.
Other intervention name(s): SINEREM
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Prostate cancer; Bladder cancer; Pelvic lymph node metastases; Diffusion-weighted MRI; Sinerem (USPIO)-enhanced MRI; Imaging influence on surgery; Noninvasive detection of pelvic lymph node metastases; Influence of imaging protocol on surgical outcome
Assessment Skin Quality and Efficacy of Dermal Line After Four Bipolar Radiofrequency Microneedling Treatments
Condition: Aging
Study type: Interventional

Summary: 
      This study intends to evaluate the safety and effectiveness of the InMode Morpheus8 System to
      treat facial and neck skin and assess its effect on skin quality and dermal lines. This
      device has been FDA cleared for full body subdermal adipose tissue remodeling.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and efficacy of a bipolar
      fractional radiofrequency treatment via use of the InMode Morpheus8 System to achieve skin
      texture and quality change and to treat facial fine lines and wrinkles of the lower face.
    

Intervention name(s): InMode Morpheus8 System
Intervention type(s): Device
Intervention description(s): The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: skin aging; bipolar radiofrequency; microneedling; dermal lines
Covid-19 Fear and Compliance With Protective Measures of Students
Condition: Covid-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This study was carried out to determine the fear of Covid-19 and the compliance with
      protective measures of students who continue their education face-to-face during the covid-19
      pandemic process.
    

Detailed description: 
      The study was carried out descriptively. The study population of a province pandemic period
      junior ongoing training to face in Turkey. Sample constituted reached 188 students with
      snowball sampling method. The data of the study were collected using the "Questionnaire Form"
      prepared by the researchers and the "Covid-19 Fear Scale". Data collection tools were applied
      to the participants electronically via Google Forms.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        continued face-to-face education students
      
Keywords: Covid-19; School; Student; Fear; Protective Measure
Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Mastodynia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if patient education can affect patient reported
      bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim.
    

Detailed description: 
      In this study, the effect of patient education on reported bone pain in breast cancer
      patients receiving adjuvant or neoadjuvant chemotherapy and pegfilgrastim will be
      investigated.

      Each patient will receive adjuvant or neoadjuvant chemotherapy with pegfilgrastim
      prophylaxis, beginning in the first cycle and continuing throughout the study period. The
      study period for this study is the first 4 cycles of chemotherapy. participants can be
      planning to receive regimens with > 4 cycles, but data will only be collected for the first 4
      cycles. The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion
      of the treating physician. Commercially available pegfilgrastim will be administered
      according to US Prescribing Information and is considered background therapy.
    

Intervention name(s): General Education DVD; Bone Pain Education DVD
Intervention type(s): Other; Other
Intervention description(s): A general chemotherapy side effects education DVD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Breast cancer; Chemotherapy; Pegfilgrastim; Neulasta; Bone Pain; Education
Prevention of Spinal Induced Shivering During CS
Condition: Spinal Induced Shivering
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares the efficacy of two different doses of intravenous (IV) granisetron on
      the prevention of postspinal shivering during cesarean section, in comparison with placebo.
    

Detailed description: 
      The study will includes four groups as follows:

        1. Granisetron1 group: women will receive 1mg IV granisetron

        2. Granisetron 0.7 group: women will receive 0.7 mg IV granisetron and

        3. Control group: women will receive 2 ml of 0.9% sodium chloride. Throughout the study
           period,shivering scores, core temperature, sensory level and motor block will be
           recorded, heart rate will be measured continuously using an electrocardiogram; blood
           pressure will be determined. If heart rate decreases by more than 20% of the baseline
           atropin will be received and if blood pressure decreases 20% of the baseline ephedrine
           will be received.

      Also, Apgar score at one minute and five minutes will be recorded. At the end patient
      satisfaction will be assessed using Verbal Numeric Scoring system Side effects (bradycardia,
      hypotension, hypothermia, nausea and vomiting, pruritus etc ) will be recorded
      perioperatively in the operating room and postanesthetic care unit.
    

Intervention name(s): Granisetron; Granisetron; Sodium chloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV granisetron 1 mg before spinal anethesia; IV granisetron 0.7 mg before spinal anethesia; IV 2 ml 0.9 sodium chloride before spinal anethesia
Other intervention name(s): Kytril ampule 3mg/3ml IV (Roche); Kytril ampule 3mg/3ml IV (Roche); 0.9 Sodium chloride
Intervention MeSH terms: Granisetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Shivering; Granisetron; Spinal; Cesarean section
GLP-1-mediated Gluco-metabolic Effects of Bile Acid Sequestration
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of this study is to investigate the potential GLP-1-mediated contribution to
      the well-established glucose-lowering effect of sevelamer-induced bile acid sequestration .
      Exendin9-39 has been demonstrated to act as a potent and specific GLP-1 receptor antagonist
      with no partial agonistic potential and is considered a useful tool in the assessment of
      GLP-1 physiology. The aim is to evaluate any contribution of sevelamer-induced GLP-1
      secretion to the reduced plasma glucose concentrations observed after treatment with
      sevelamer. A randomised placebo-controlled cross-over study involving two 17-day treatment
      periods with sevelamer and placebo, respectively, in metformin-treated patients with type 2
      diabetes, will be conducted. The impact of bile acid sequestration on GLP-1 secretion and
      effect will be examined during two randomised experimental days after 15 and 17 days of
      treatment with sevelamer (1,600 mg three times a day) and placebo, respectively. During each
      of these two experimental days, a meal test with concomitant exendin9-39 infusion or placebo
      will be performed (for evaluation of any GLP-1-mediated effects). Postprandial plasma glucose
      excursion is the primary endpoint, and secondary endpoints include postprandial plasma/serum
      excursions of insulin, C-peptide, GLP-1, glucagon, glucose-dependent insulinotropic
      polypeptide (GIP), glucagon-like peptide-2 (GLP-2), peptide YY (PYY), oxyntomodulin, ghrelin,
      fibroblast growth factor (FGF)-19, FGF-21, C4 (an intermediate in the de novo synthesis of
      bile acids), cholecystokinin (CCK), bile acids and plasma lipids. Furthermore, gastric
      emptying, gallbladder emptying, liver fat content, appetite and ad libitum food intake will
      be examined.
    


Intervention name(s): Sevelamer; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sevelamer powder dissolved in water 1,600 mg three times a day for 17 days; placebo powder dissolved in water 1,600 mg three times a day for 17 days
Other intervention name(s): Renvela
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: bile acid
Metabolic Effects of Betaine Supplementation
Condition: Obesity; Dysglycemia
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Betaine is important in cellular metabolic pathways. Few epidemiologic studies link betaine
      levels to diabetes and cardiovascular disease. Small human studies suggest benefit for
      non-alcoholic liver disease. In this study we will determine if administration of betaine
      improves metabolic measures, liver fat and/or endothelial function in humans with glucose
      intolerance who are overweight.
    

Detailed description: 
      This study is a single site, prospective, randomized (1:1), double masked, placebo controlled
      trial to assess metabolic effects of betaine compared to placebo on glycemia and insulin
      sensitivity, liver fat and endothelial function.
    

Intervention name(s): Betaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Betaine or placebo administered orally in divided doses over 12 weeks; Placebo administered orally in divided doses over 3 months
Other intervention name(s): trimethyl glycine
Intervention MeSH terms: Betaine; Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Obesity; Glucose Intolerance
Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement
Condition: Orthodontic Tooth Movement; Canine Retraction
Study type: Interventional

Summary: 
      The primary aim of the study is to evaluate the effect of single and repeated piezocisions on
      the rate of orthodontic tooth movement. Secondary aims are to evaluate the effect of both
      protocols on molar anchorage loss, as well as on canine root resorption.
    


Intervention name(s): Single Piezocision; Repeated Piezocision
Intervention type(s): Procedure; Procedure
Intervention description(s): Piezocision will be performed only once before the onset of canine retraction (T0) on one side of the maxillary arch that will be randomly chosen.; Piezocision will be repeated three times, on a monthly basis (T0, T1, and T2), over the 12-week study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Non-intrusive Detection of Temporary Neurologic Impairment by Opioids
Condition: Neurologic Impairment by Opioids
Study type: Observational

Summary: 
      The investigators aim to prove the feasibility of a non-invasive means to identify temporary
      neurological impairment resulting from the use of a commonly prescribed opioid by identifying
      an oculomotor biosignature associated with temporary neurologic impairment in pain-free
      opioid-naïve subjects, and to initiate the development of such a signature. The
      investigators also sought to establish the presence of a dose-dependent biosignature for
      opioid impairment.
    

Detailed description: 
      To determine the detrimental effects of opioid intoxication on normal oculomotor function,
      the investigators will collect data from up to 25 subjects before and during oxycodone
      induced intoxication. A within-subjects design will be used, and subjects will be tested
      under conditions of no dose (placebo), low dose, and high dose. Subjects will be tested
      during 3 sessions (baseline, placebo, oxycodone); separated by 7 days to allow for complete
      washout of any drug that was administered. Subjects will perform tests of visual fixation,
      saccade speed and saccade accuracy, cognitive control over saccades, cognitive control over
      visual scanning, and visual pursuit. Eye movement data will be collected using an SR Research
      EyeLink 1000 Plus eye tracking system.

      Analysis of the data will be performed by comparing each subject state against the baseline
      measurements, where baseline represents an unimpaired subject state. Based on prior work with
      marijuana intoxication, the investigators expect that this data and analysis will
      successfully reveal a constellation of oculomotor dynamics that can be used to classify
      whether an individual is or is not currently impaired by oxycodone. Based on published
      studies, the investigators anticipate these changes will generalize across the opioid class,
      creating a biosignature of opioid impairment.
    

Intervention name(s): Oxycodone
Intervention type(s): Drug
Intervention description(s): Oxycodone in 5mg increments up to a maximum of 10mg
Intervention MeSH terms: Oxycodone
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants recruited from area local to Scottsdale, Arizona