bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Weight Loss on Tinnitus Symptoms
Condition: Subjective Tinnitus; Obesity
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Subjective tinnitus is the perception of irregular sound at different frequencies. Although
      the underlying cause of tinnitus is unclear, increased body weight is known to increase
      tinnitus symptoms. This study aimed to determine the effects of dietary and physical activity
      interventions on tinnitus symptoms. Sixty-three obese subjects with tinnitus aged 20 to 65
      years were divided into diet + physical 8 activity (P.A.), diet, P.A., and control groups.
      Dietary and anthropometric records, Tinnitus Handicap 9Inventory (THI), Beck Depression
      Inventory (BDI), Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS) of all
      individuals were compared at the baseline and at the end of the study.
    

Detailed description: 
      Although the underlying cause of tinnitus is unclear, increased body weight is known to
      increase tinnitus symptoms. The present study aimed to determine the effects of dietary and
      physical activity interventions on tinnitus symptoms.

      Sixty-three obese subjects with tinnitus aged 20 to 65 years were divided into diet +
      physical activity (P.A.) (n = 15), diet (n = 16), P.A. (n = 15), and control (n = 17) groups.
      Dietary records, anthropometric measurements, Tinnitus Handicap Inventory (THI), Beck
      Depression Inventory (BDI), Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS)
      of all individuals were recorded and compared at the baseline and at study completion.
    

Intervention name(s): diet and physical activity intervention
Intervention type(s): Behavioral
Intervention description(s): Dietary intervention: Preparation and follow-up of diet program Physical activity intervention: Step count monitoring
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tinnitus; diet; physical activity
Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The aim of the present study is to compare the effect of iso-energetic energy deficits
      induced by exercise or dietary restriction on energy intake and appetite feelings in
      adolescents with obesity
    

Detailed description: 
      The present study will compare the nutritional response to an energy deficit of 400 kcal
      induced once by realisation of an acute exercise set at moderate intensity and once by a
      dietary restriction imposed at lunch (compared with a control condition). 18 adolescents with
      obesity will be asked to randomly complete three experimental sessions: i) one control
      session (CON); ii) one session with an exercise-induced energy deficit (Def-EX); iii) one
      session with an energy restriction-induced energy deficit (Def-EI).

      Their ad libitum energy intake will be assessed during dinner time. Appetite feelings will be
      assessed at regular intervals and their food reward in response to the lunch will also be
      assessed.
    

Intervention name(s): Con : control condition without exercise / rest condition; Def-EX : Condition with an exercise-induced energy deficit; Def-EI : Condition with an energy-restriction energy deficit
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.; Condition with an exercise-induced energy deficit The adolescents will be asked to complete an acute exercise set at 65% of their capacities (cycling) during the afternoon, inducing an energy expenditure of 400 kcal. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.; Condition with an energy-restriction energy deficit The adolescents will be asked to remain quiet during the whole day (no physical activity). They will receive a calibrated breakfast reduced from 400 kcal compare to their CON and Def-EX conditions. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
Intervention MeSH terms: Butyl phosphorotrithioate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: appetite control; obesity; Adolescents; exercise; Energy Deficit
A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria
Condition: Malaria, Vivax
MeSH terms: Malaria; Malaria, Vivax
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, open-label, multicenter, non-comparative, single arm study of
      pediatric subjects with Plasmodium vivax (P. vivax) malaria, aged 6 months to <16 years of
      age. A total of 60 subjects will be enrolled. Potential subjects who are slide-positive for
      P. vivax will be started by the site on chloroquine (CQ) per local/national guidelines. Sites
      will have up to 48 hours to obtain consent. Once full consent is provided, all subjects will
      be screened and, if eligible, receive Tafenoquine (TQ), given as a single dose on Day 1. All
      study medication should be taken with food. After the treatment period, subjects will attend
      up to 7 follow-up visits through Day 120 (Days 3, 8, 15, 29, 60, 90 and 120). The main cohort
      will consist of subjects aged >=2 years to <16 years with no restriction on gender. Subjects
      will be dosed according to four weight bands. Within the total of 60 enrolled pediatric
      subjects, a second cohort of up to 6 infants aged >=6 months to <2 years (weighing >=5
      kilogram [kg]) will be recruited following completion of a planned first interim analysis. An
      interim analysis will be conducted once sufficient data from 16 subjects is available to
      assess pharmacokinetic (PK) and safety parameters. If needed, a second interim analysis will
      be conducted after a total of 32 subjects have enrolled. The primary objective of this PK
      bridging study is to adequately characterize the systemic TQ exposure in the pediatric
      population in order to identify appropriate doses that achieve a similar exposure to that of
      the TQ adult dose of 300 milligram (mg).
    


Intervention name(s): Tafenoquine; Chloroquine
Intervention type(s): Drug; Drug
Intervention description(s): Tafenoquine tablet is supplied as film-coated tablet (100 mg, 150 mg, 200 mg and 300 mg) and fast-dispersing film coated tablet (50 mg).; Subjects may receive chloroquine according to local/national treatment guidelines.
Intervention MeSH terms: Chloroquine; Tafenoquine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetic; pediatric; Tafenoquine; Plasmodium vivax Malaria; G6PD deficiency
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted globally. The aim of the trial is to investigate the safety and
      efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.
    


Intervention name(s): nonacog beta pegol
Intervention type(s): Drug
Intervention description(s): For intravenous (i.v.) injection. A single dose of 40 U/kg, unless the bleeding episode is severe in which case it should be treated with 80 U/kg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Levodopa on Human Multifocal Electroretinogram
Condition: Retinal Diseases
MeSH terms: Retinal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      It is known that dopamine is a functional neuromodulator at several levels of the visual
      system. Dopamine seems to be involved in the organization of the ganglion cell and the
      bipolar cell receptive fields and modulation of physiological activity of photoreceptors.
      There is evidence for the functional significance of dopaminergic modulation of visual
      sensitivity in humans which confirms the hypothesis that dopamine plays an important role in
      retinal light adaptation as well as in motion and contrast sensitivity function. The
      electrophysiological effects of dopamine, various dopamine antagonist and levodopa in animals
      and humans have been investigated by means of visual evoked potentials and
      electroretinograms. The multifocal ERG technique, developed by Sutter et al. allows a rapid,
      simultaneous recording of focal ERGs from multiple retinal locations. Although this technique
      is relatively new, it has already provided insights into the mechanisms of retinal diseases
      (e.g. involvement of visual system in Parkinson disease), but until now there is no data on
      influence of dopaminergic substances on mERG.
    


Intervention name(s): levodopa
Intervention type(s): Drug
Intervention description(s): 1 tablet of 200 mg levodopa plus 50 mg benserazide
Other intervention name(s): Madopar
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Electroretinography; levodopa
Syncope Prediction Study
Condition: Vasovagal Syncope
MeSH terms: Syncope; Syncope, Vasovagal
Study type: Observational

Summary: 
      The purpose of this study is to perform a prospective evaluation of the vasovagal syncope
      prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one
      center in the United Kingdom.
    

Detailed description: 
      Vasovagal syncope (VVS) is a form of neurally-mediated reflex syncope, which is marked by a
      sudden fall in blood pressure with an associated fall in heart rate often resulting in
      syncope, head-up tilt (HUT) testing is commonly used to bring information about VVS using ECG
      and blood pressure monitoring with medical observation.

      We developed an algorithm, called Tilt Test Analyzer, to predict VVS during HUT based on the
      simultaneous analysis of heart rate (RR interval), systolic blood pressure (SBP) and an
      indicator of autonomic modulation represented by heart rate and blood pressure variability
      (HRV and BPV).

      The primary objective of this study is to evaluate the VVS prediction algorithm in a
      prospective cohort of patients in the tilt laboratory The primary endpoint is the VVS
      prediction algorithm performance by means of measuring the sensitivity and specificity
      values.

      The study is designed to test if the prospective analysis of tilt-test patients can reproduce
      the results previously obtained in the published retrospective analysis on 1155 patients with
      a similar clinically relevant sensitivity and specificity.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Vasovagal syncope patients
Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this investigational study is to determine if a study medication is safe and
      effective in reducing the symptoms associated with endometriosis; if the study medication
      reduces the need for pain medication for endometriosis symptoms; and if the study medication
      improves a participant's ability to carry out daily activities. Qualified participants will
      receive no cost treatment, which may include study-related examinations, diagnostic
      procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified
      participants will also receive study medication at no cost. As a participant, the study
      volunteer may also experience the satisfaction of knowing she is helping the advancement of
      women's health care.
    


Intervention name(s): ERB-041
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Endometriosis
Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      There are different controlled ovarian hyperstimulation protocols utilized in infertility
      patients. In this study, our aim is to specifically compare three protocols in poor
      responding infertility patients.
    


Intervention name(s): FSH 225IU and hMG 225IU; FSH 150IU and hMG 150IU; Letrozole 5mg and hMG 150IU
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: poor responders
Strategies for Responding to Stress
Condition: Stress
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether changes in psychological and physiological
      responses differ based on different strategies for responding to stress.
    

Detailed description: 
      The purpose of this study is to examine whether changes in psychological and physiological
      responses differ based on different strategies for responding to stress. Different strategies
      being examined in this study include exercise and arousal reappraisal.
    

Intervention name(s): Arousal Reappraisal; Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief readings educating about the stress response and usefulness of arousal reappraisal.; Three 5-minute bouts of exercise at increasing intensities (65%, 75%, and 85%) with 5-15 minute breaks in-between for recovery.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II
Condition: Caries; Initial
Study type: Observational

Summary: 
      There is a paradigm shift in conservative dentistry by substituting the surgical model with
      the medical model of treatment. Early detection of initial carious lesions will aid in
      clinical decision making during management ; either no care advised, preventive care advised
      or operative care advised. According to recent systematic reviews meticulous visual
      examination using ICDAS II presented a substantial level of reproducibility and accuracy for
      assessment of carious lesions and was considered the reference for clinical visual assessment
      . However, visual examination is subjective and is highly dependent on the dentist's skills
      and experience, with high specificity and low sensitivity. New devices have been developed to
      detect and quantify incipient demineralization. Besides visual detection systems, laser
      fluorescence assessment can be considered a suitable method. In vitro data suggested that the
      visual examination and fluorescence method have similar accuracy to detect initial carious
      lesions.
    

Detailed description: 
      This study will be conducted to evaluate the diagnostic accuracy of laser fluorescence device
      (DIAGNOdent) compared to to visual examination (ICDAS II) in detection of incipient carious
      lesions for decision making during caries management
    

Intervention name(s): DIAGNOdent; ICDAS II
Intervention type(s): Device; Diagnostic Test
Intervention description(s): Laser fluorescence device; International Caries Detection and Assessment System (ICDAS II)
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with non cavitated incipient carious white spot lesions
The Effects of Dexamethasone Administration on Jaundice Following Liver Resection
Condition: Liver Dysfunction; Hepatectomy; Bilirubinaemia; Jaundice
MeSH terms: Liver Diseases; Jaundice; Hyperbilirubinemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators were aiming to evaluate whether dexamethasone administration accelerates
      the recovery from hepatectomy-related jaundice and decreases the rates of post-hepatectomy
      liver failure and its safety in the subjects who developed elevated serum total bilirubin.
    

Detailed description: 
      Post-operative jaundice is one of the most common complications after hepatectomy for various
      liver tumors. Glucocorticoids, including dexamethasone, prednisolone, and methylprednisolone,
      were widely used to treat jaundice in the patients with severe hepatitis, liver dysfunction
      or liver failure. It was reported that glucocorticoids decrease the rates of liver
      dysfunction or mortality in those patients. However, whether post-operative glucocorticoids
      administration alleviated jaundice or deceased the rates of post-hepatectomy liver failure
      (PLF) yet to be determined. In this study, the investigators were aiming to evaluate whether
      dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and
      decreases the rates of PLF and its safety in the subjects who developed elevated serum TB.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day
Other intervention name(s): Dexamethasone Sodium Phosphate Injection
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dexamethasone; Liver Dysfunction; Hepatectomy; Bilirubinaemia; Jaundice
Single Dose Study of GSK1440115 in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess bronchodilator effect after single dose administration
      of GSK1440115 in a population of mild to moderate asthmatic patients.
    


Intervention name(s): 1440115; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of either 750 mg or 500 mg administered as 250 mg tablets.; Single dose of matching placebo tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
AIM to Improve Asthma: Airflow Improvements During Meal-Prep
Condition: Asthma in Children; Pollution; Exposure
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The investigators propose a pilot trial of kitchen ventilation in the homes of children using
      a youth engaged research strategy.
    

Detailed description: 
      In this trial of children ages 6-12, children and their households will receive an intensive
      home kitchen ventilation intervention after one week of baseline data collection. The
      intervention includes education regarding improving ventilation in their homes during cooking
      and replacement of their range hood if it has inadequate flow or an intolerable noise level.
      During baseline data collection periods the households will be encouraged to continue their
      regular cooking patterns. The investigators will measure home particulate matter <2.5 microns
      (PM2.5) and nitrogen dioxide (NO2) levels for one week at baseline, and a final week after
      all remaining families receive the cooking ventilation intervention, to assess for changes
      within each household. The investigators will also examine changes in airways inflammation
      (as measured by the exhaled fraction of nitric oxide, FeNO), lung function (as measured by
      spirometry), and reported symptoms after the baseline and intervention period. Members of the
      research team have successfully conducted youth participatory action research in the
      low-income, high asthma prevalence community of Richmond, California (CA) as well as
      extensive youth participatory action research on other environmental health concerns in the
      low income city of Salinas, CA; using a similar model, the investigators aim to teach
      research methods to a new group of Richmond youth.
    

Intervention name(s): Cooking Ventilation Intervention
Intervention type(s): Behavioral
Intervention description(s): An educational video presentation for the families regarding the importance of ventilation use during and after cooking, and strategies for improving the ventilation during cooking, has been created by Dr. Holm, with input from Youth Research Assistants (YRAs) The youth involvement will help to ensure that the information is presented in a way that will resonate with the local community and will also provide the youth with exposure to developing health education tools. The educational video will be shown to families at the time of the intervention visit and they will receive printed reminder materials of what they have learned.
Intervention model: Single Group Assignment
Intervention model description: This is a trial with a single group, where they receive the intervention following one week of baseline data collection.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: asthma; pediatric; indoor air pollution; particulate matter; nitrogen dioxide; cooking; ventilation