bioihbjkbjnl/mcl2 huggingface dataset:
Attention & Memory Impairments in Menopausal Women
Condition: Symptomatic Menopause; Cognitive Impairments
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether a medication called Vyvanse®
      (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of
      sustained attention, verbal encoding and recall and working memory, in menopausal aged women.
      LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD). The
      cognitive difficulties that menopausal women report experiencing are typical of adults who
      are diagnosed with ADHD. The investigators will assess whether or not LDX is effective in
      alleviating those cognitive disruptions when compared to a placebo.
    

Detailed description: 
      Midlife decline in cognitive function, particularly attention and working memory, is a
      frequent complaint for which menopausal women seek clinical intervention. Many of the
      cognitive complaints detected in menopausal women including, short-term memory, organization
      of tasks, sustaining focus and concentration, and regulating emotions, overlap with symptoms
      frequently reported by adults with ADHD. These impairments are reported by many women who
      have no previous history of ADHD, and appear to be linked to reduced estrogen levels
      occurring in menopause.

      This is a double-blind, placebo-controlled, cross-over study testing whether LDX, a stimulant
      medication, would be effective in alleviating midlife onset impairments of attention and
      working memory among menopausal women. There will be 3 days in which subjects will undergo a
      brief cognitive testing assessment; the first testing period will occur at baseline prior to
      beginning LDX or placebo treatment (PT) in trial A; the second testing period will occur
      following 4 weeks of double blind LDX or PT; and the final testing period will take place
      after another 4 weeks of double blind LDX or PT in Trial B. Each cognitive test period will
      involve 2 separate cognitive testing batteries that will take approximately 120 minutes total
      to complete.
    

Intervention name(s): Lisdexamfetamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In a counterbalanced fashion, participants would receive titrated doses of LDX 20 to 60 mg/d for 4 weeks followed by a 2-week washout and then crossed over to the placebo tablets for another 4 weeks. All women will start with LDX 20 mg/d and then be titrated to 40 mg/d after 1 week and 60 mg/d after 2 weeks (as tolerated).; In a counterbalanced fashion, participants would receive placebo tablets for 4 weeks followed by a 2 week washout, then will receive titrated doses of LDX 20 to 60 mg/d for 4 weeks.
Other intervention name(s): Vyvanse®
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopause; Aging; Memory; Women
Iron Bioavailability From Cubes
Condition: Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Iron deficiency is a highly prevalent nutrient deficiency which is a public health problem,
      especially in developing countries. There are several strategies to correct iron deficiency
      in populations: besides supplementation with tablets, one of the most sustainable and
      effective strategies on medium term has been iron fortification, the addition of iron to
      regularly consumed foods. In fortification, the chemical nature of the compound to be added
      plays an important role: depending on the compound sensory qualities of the fortified foods
      can vary as well as the iron absorption. Iron pyrophosphate (FePP) and ferrous sulfate
      (FeSO4) are two commonly used iron fortification compounds in foods such as rice, breakfast
      cereals, pasta, flour and others. We want to test the effect of addition a food stabilizer on
      the absorption of ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when added to
      bouillon, as was recently suggested by in vitro experiments in the laboratory.
    


Intervention name(s): Bouillon fortified with FePP; Bouillon fortified with FePP + Stabilizer; Bouillon fortified with FeSO4; Bouillon fortified with FeSO4 + Stabilizer
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Iron deficiency; Iron fortification
Evaluation of Possible Effects on the QT/ QTc Interval of Rupatadine in Healthy Volunteers
Condition: Human Experimentation (Human Volunteers)
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial will evaluate the effects of rupatadine, at a dose of 10 mg OD (authorised
      and marketed dose) and the 100mg/day (supratherapeutic dose) on the ECG parameters with a
      special focus on its effect on cardiac repolarisation (QTc interval duration).Furthermore,
      the study is performed to assess the pharmacokinetic-pharmacodynamic relationship between
      plasma concentration of rupatadine and its effects, if any, on cardiac repolarisation mainly
      in the QTc interval).

      The main objective is to assess whether administration of a repeated dose of 10 and 100
      mg/day , has the potential to cause QT prolongation in healthy volunteers.
    

Detailed description: 
      Recently, as FDA as EMEA provides recommendations to sponsors concerning the design, conduct,
      analysis and interpretation of clinical studies to assess the potential for delaying cardiac
      repolarisation. This paper recommends to perform a 'through Qt/QTc' study to expand ECGs
      safety evaluation during later stages of drug development. It was recomended that the study
      was randomized, blind and placebo controlled. Moreover, as a high sensitivy is necessary in
      order to detect differences in the QTc measure, it was essential a positive control included.
      On that basis, the positive control should be well-characterized and consistently produce an
      effect corresponding to the largest change in the QT/QTc interval that is currently viewed as
      clinically not important to detect (a mean change of around 5 ms. Because of this, we decide
      select as positive control: moxifloxacin, used in the most of similar phase I clinical
      trials.

      In these type of studies, as recommended by the guidelines, there should be a caracterization
      to ensure that the dose-response and generally the concentration-response relationship for
      QT/QTc prolongation, including exploration of concentrations that are higher than those
      achieved following the therapeutic doses. So, thererfore, we decided use 100 mg/daY (10 times
      the therapeutic dose) as supratherapeutic dose to be administered.

      We decide propose a new phase I study as recommended guidelines (a single-blind, randomised,
      placebo and active-controlled, parallel design). With this, we've tried complet the
      rupatadine effects over QTc and another electrocardiographic parameters and valued the
      risk-benefit relationship for this new antiH1 and PAF antagonist

      single
    

Intervention name(s): Rupatadine; moxifloxacin; Continous electrocardiographic register; Pharmacokinetic profile
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Thorough study QT/QTc; Cardiac repolarization; QT prolongation
T-helper 2 (Th2) Cytokine Responses in Overweight/Obese Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Observational

Summary: 
      Cytokines are chemicals that are naturally made by your body. Certain cytokine levels are
      changed in the blood of patients who develop allergies and/or asthma. Cytokine levels may
      also be changed in some individuals who are overweight or obese. The purpose of this study is
      to determine if certain cytokine levels differ based on a person's weight and whether or not
      they have allergies or asthma. Information gathered in this study will be compared to
      information gathered from subjects who have participated in another similar study for
      patients who have allergies and/or asthma.
    

Detailed description: 
      The aims of this study are to:

        1. Characterize the relationship between BMI and Th2 skewing in non-atopic adult subjects.

        2. Compare these results to those previously obtained from atopic adult subjects It is
           expected that the results of this study will demonstrate enhanced Th2 skewing in
           overweight and obese atopic subjects as compared to non-atopic subjects. It is further
           anticipated that the results of this study will be used as preliminary data to generate
           an NIH grant application exploring the link between obesity and atopy.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be male or female, aged 18-50 years, and of any race. Subjects must be
        healthy with no history of allergies or asthma. Subjects will be placed in one of three
        groups based on their BMI: normal, overweight, or obese.
      
Keywords: Healthy
DD Assessment With Diaana #2
Condition: Decision Making; Computer-assisted; General Practitioners; Patient Engagement
Study type: Interventional

Summary: 
      Single-center, unblinded, 1:1 parallel pseudo-randomized efficacy trial.

      In the intervention group only, resident physicians will be assisted by the automated medical
      history-taking device "Diaana" during their consultations in outpatient ambulatory unit of
      the Geneva University Hospital.

      In both groups, the differential diagnosis of the resident physician will be compared to the
      gold-standard differential diagnosis of the senior physician.
    

Detailed description: 
      Automated medical history-taking devices (AMHTD) are emerging tools with the potential to
      increase the quality of medical consultations by providing physicians with an exhaustive,
      high-quality, standardized anamnesis and differential diagnosis. In this study, the
      investigators aimed to establish whether an AMHTD of interest, "Diaana", allowed the
      physician to establish a more precise differential diagnosis.

      A single-center, unblinded, 1:1 parallel pseudo-randomized efficacy trial will be performed.
      No follow-up is necessary, because patients are seen once and all data are collected on this
      time. The study will take place in the emergency outpatient unit of Geneva University
      Hospital and include patients suffering from symptoms covered by Diaana.

      Patients in the intervention group will fullfil Dianna. Then, the resident physician will
      read Diaana summary, perform his consultation, and fullfil case report form, including his
      differential diagnosis. Then, the senior physician will see the patient and establish the
      gold-standard differential diagnosis. In the control group, the residents will directely
      establish a differential diagnosis, without the help of Diaana.
    

Intervention name(s): Diaana
Intervention type(s): Other
Intervention description(s): Diaana, the AMHTD used, functions as follows: on the basis of an interactive questionnaire completed by the patient before the consultation, it performs an exhaustive anamnesis focused on the problem and proposes a panel of DDs with a high sensitivity. The artificial reasoning system of "Diaana" mimics how a specialist physician would reason to establish a DD. The information transmitted is in an easy-to-use form for the physician that includes a summary of the anamnesis centered on relevant elements from the questionnaire and a list of possible diagnoses with their emergency level, potential contributing factors, and first-line management proposals.
Other intervention name(s): Automated medical history-taking device (AMHTD)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: differential diagnosis; hospital outpatient clinics; clinical applications software
A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability (the degree to which the
      study medication becomes available in the blood circulation) of JNJ-47910382, given as an
      uncoated tablet and as a suspension, after a single oral dose of 200 mg in healthy adult
      participants under fed conditions.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), randomized (the
      study medication is assigned by chance), 2-way crossover study (method used to switch
      participants from one treatment arm to another in a clinical study) to compare the oral
      bioavailability of JNJ-47910382 formulated as an uncoated tablet and as a suspension, in
      healthy participants. The study consists of 3 phases, including, a screening phase, an
      open-label treatment phase, and a follow up phase. The screening phase will be within 21 days
      before administration of the first dose of study medication. After screening, participants
      will be randomized according to a classical 2 sequence (ie, treatment sequence AB [where the
      participants will first receive treatment A and then treatment B] and sequence BA [where the
      participants will first receive treatment B and then treatment A]), 2-period crossover design
      to receive the study medication in the treatment phase. In each session (Session 1 or Session
      2), participants will receive either Treatment A: 200 mg dose of JNJ-47910382 formulated as a
      suspension, or Treatment B: 200 mg JNJ-47910382 formulated as an uncoated tablet. There will
      be a washout period (period when participant is not receiving any study medication) of at
      least 7 to 14 days between the 2 sessions. The follow up phase will include 2 follow up
      visits after intake of study medication in last treatment session. Safety evaluations for
      adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical
      examination, and specific toxicities will be monitored throughout the study. The duration of
      the study will be at least 11 to 18 days (screening and follow up phase not included).
    

Intervention name(s): JNJ-47910382 (suspension); JNJ-47910382 (tablet)
Intervention type(s): Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=200, form=suspension, route=oral. JNJ-47910382 administered on Day 1.; Type=exact number, unit=mg, number=200, form=tablet, route=oral. JNJ-47910382 administered on Day 1.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Hepatitis C; Relative bioavailability; Bioavailability; Pharmacokinetics; JNJ-47910382
The Effects of RPL554 in Addition to Tiotropium in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease Moderate
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, randomised, double blind, placebo controlled, complete block, three way
      crossover study to investigate treatment with nebulised RPL554 and tiotropium together in
      patients with moderate to severe chronic obstructive pulmonary disease (COPD). The purpose of
      this study is to assess the bronchodilator effect (opening of the airways) of RPL554 when
      used in combination with a long acting anti-muscarinic receptor antagonist (tiotropium)
      whilst dosing the RPL554 to steady state blood levels. It is planned to randomise up to 30
      patients to have 24 evaluable patients at one study centre. In each treatment period,
      patients will receive an open label dose of tiotropium from a dry power inhaler (DPI)
      followed immediately by a double blind dose of either RPL554 6mg, 1.5mg or placebo (depending
      on treatment sequence) from a nebuliser in the morning on Day 1, Day 2 and Day 3. The dose of
      RPL554 or placebo will be repeated in the evening on Day 1 and Day 2; there will not be an
      evening dose on Day 3.
    


Intervention name(s): 1.5 mg RPL554 plus tiotropium; 6 mg RPL554 plus tiotropium; Placebo plus tiotropium
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of Puzzle Method in Psychiatric Nursing Teaching
Condition: Psychiatric Nursing
Study type: Interventional

Summary: 
      Objective: It is thought that the puzzle technique and teaching method will be useful in
      teaching psychiatric nursing in order to facilitate the learning of psychiatric symptoms and
      findings and to increase awareness in mental state examination. For this reason, the research
      was planned to examine the effectiveness of the puzzle technique in learning psychiatric
      symptoms and findings in psychiatric nursing students.

      Design: This study was planned in a randomized controlled experimental design.

      Method

      Place and Time The research is planned to be carried out between November and January 2022 at
      a foundation university.

      Population and Sample of the Research The population of the research will be 108 students
      enrolled in the nursing program of a foundation university and taking the "Psychiatric
      Nursing" course in the fall semester of the 2022-2023 academic year.

      In the study, it is aimed to reach the entire universe, not selecting the sample. The
      students in the universe, who accepted to participate in the study and completed the
      pre-test, will be assigned to the intervention and control groups by randomization with the
      help of a generator on the www.random.org website by being numbered according to their order
      in the student list.

      Hypothesis: Students who use puzzle method in teaching psychiatric nursing have higher
      knowledge levels than students who do not.
    


Intervention name(s): Puzzle Method; Ongoing Education
Intervention type(s): Other; Other
Intervention description(s): While preparing the puzzle to be used in the study, the puzzle preparation program will be used (Crossword Puzzle Maker). Students in the initiative group will be asked to solve a total of 6 puzzles, one puzzle each week. The answers to the prepared puzzles will cover the theoretical course topics of psychiatric nursing. In the puzzles, students will be expected to place their answers in the specified rows and columns. Students will be asked to solve puzzles individually. In addition, the answer to each puzzle will be found on the reverse on the back page. Students will be reminded that there is no time limit for solving the puzzles. Researchers will guide students while students solve puzzles.; Students in the control group will only take the theoretical course of psychiatric nursing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Education; Puzzle; Psychiatric Nursing
Effects of COP Exercise and HIIT on Vascular Health in Young Overweight Females
Condition: Vascular Diseases
MeSH terms: Vascular Diseases; Overweight
Study type: Interventional

Summary: 
      The goal of this study is to determine the effects of high-intensity interval training and
      crossover point exercise training on vascular health in young overweight women.
    

Detailed description: 
      In recent years, improving cardiovascular health through exercise has become a popular
      research question, however, it is not clear which intensity and modes of exercise bring more
      benefits. Crossover point(COP) intensity has great medical potential as a personalized
      exercise intensity that is based on substrate utilization mode, especially in overweight and
      obese people.On the other hand, several studies have demonstrated that HIIT is an effective
      method in improving vascular endothelial dysfunction. During our study, we evaluated the
      vascular health changes in young overweight women who received either COP exercise or HIIT
      exercise for 10 weeks.
    

Intervention name(s): high-intensity interval training (HIIT); crossover point(COP) exercise training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in both the COP and HIIT groups underwent 30 sessions of exercise performed over 10 weeks. The training sessions in the HIIT group involved five high-intensity intervals of 4 minutes each (running or walking on a treadmill) at 85% VO2max interspersed with 3 minutes of low-intensity walking.; Participants in both the COP and HIIT groups underwent 30 sessions of exercise performed over 10 weeks. The COP exercise training sessions involved 45 minutes of continuous exercise at the COP on a treadmill.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Neutrophil Lymphocyte Ratio as a Predictor of Outcome in Critically Traumatic Patients
Condition: Critical Care
Study type: Observational

Summary: 
      Neutrophil lymphocyte ratio NLR is an important index that evaluate the inflammatory status .
      It is a cost effective and readily available , and simply calculated , so that why
      investigators try to use it as a predictor of short term survival in the critically ill
      patients
    

Detailed description: 
      NLR will be used as predictor for short term survival and patients stay in ICU in 2 groups of
      patients . Investigators will use it in a group of Medical Critically ill patients as
      respiratory failure , neuromuscular disorders , renal impairment . the other group is the
      critically ill surgical patients , as patients with multiple trauma , post major surgery
    

Intervention name(s): Neutrophil Lymphocyte Ratio
Intervention type(s): Other
Intervention description(s): Neutrophil:lymphocyte ratio (NLR) is an emerging biomarker that is used to predict mortality and morbidity. The association of this biomarker with systemic illness and its usefulness in risk assessment of critically ill patients has not been fully elucidated.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        80 adult patients who are admitted to critical care unit in Assiut university Hospital
      
Keywords: Critical Care; Neutrophils; Lymphocytes