bioihbjkbjnl/mcl2 huggingface dataset:
Brain Metabolism in Polycystic Ovary Syndrome
Condition: Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance
Study type: Observational

Summary: 
      The purpose of this study is to investigate whether higher insulin resistance in young women
      with Polycystic ovary syndrome (PCOS) is associated with reduced cerebral metabolic rate of
      glucose (CMRglu). Brain volumes using magnetic resonance imaging (MRI) and quantitative
      cerebral glucose uptake using dynamic positron emission tomography (PET) were obtained.
    

Detailed description: 
      MRI and FDG PET scan for each participant were obtained within an average time frame of 3
      weeks. Isulin resistance were assessed with the updated homeostasis model assessment
      (HOMA2-IR).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women with PCOS (n=7) were referred by physician specialist in endocrinology between March,
        2010 and September, 2013. The diagnosis of PCOS was based on clinical examination using the
        Rotterdam criteria.
      
Biospecimen description: 
      Blood plasma
    
Keywords: Insulin Resistance; Brain metabolism; PET; MRI
Reduced Appetite in Crohn's Disease: The Role of the Brain in the Control of Food Intake
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      Crohn's disease (CD) is becoming more common, specifically in the western world. One of the
      main features of this disease is weight loss and malnutrition. Although clinically common,
      these problems are not well understood. Loss of appetite and symptoms such as tummy aches and
      bloating are common causes for weight loss in this group of patients. This problem has a
      strong negative effect on the patients' quality of life and significantly increases the cost
      of treating CD. Enteroendocrine cells are nutrient sensors in the bowel that relay to the
      brain to control food intake. Recent evidence has showed that these cells increase in number
      in active CD and secrete more hormones that negatively affect appetite. The increased levels
      of these hormones should have an overall negative effect on the brain and thus decrease food
      intake, bloating, symptoms of sickness. All these symptoms lead to malnutrition. These are
      hypotheses that require further proof. Current technological advances in magnetic resonance
      imaging (MRI) has enabled the mapping of changes in activity in important areas in the brain
      that control food intake. The involvement of the brain in control of food intake is still not
      fully understood. This work will be the first step in the right direction to start targeting
      the problems of appetite, weight loss and a poor quality of life.
    


Intervention name(s): Dodecanoate acid and saline
Intervention type(s): Other
Intervention description(s): Test drink
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Crohn's Disease; gut brain axis; reduced appetite
PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)
Condition: Seasonal Allergic Rhinitis; Hay Fever; Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the relative efficacy of four dosing regimens of
      bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen
      using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores
      (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history
      of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two
      ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months
      prior to randomization.
    


Intervention name(s): Bilastine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.; Placebo Tablets administered twice per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Seasonal Allergic Rhinitis (SAR); Environmental Exposure Chamber (EEC); Therapeutic Uses; Antihistamine Drug; Ragweed Pollen
A Study to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics of oral multiple-dose of DWCZP tablet 100mg.
    

Detailed description: 
      A randomized, 2-way crossover, open, phase I study to compare the pharmacokinetics profile of
      DWCZP tablet 100mg and Clozaril® tablet 100mg after a multiple-dose oral administration in
      schizophrenia patients.
    

Intervention name(s): DWCZP; Clozaril
Intervention type(s): Drug; Drug
Intervention description(s): Multiple dose; multiple-dose
Other intervention name(s): DWCZP Tablet 100mg; Clozaril Tablet 100mg
Intervention MeSH terms: Clozapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Schizophrenia
Interoceptive Nutritional Processing in Healthy Participants and Patients With Binge-Eating-Disorder
Condition: Food Habits; Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Observational

Summary: 
      Binge-Eating-Disorder (BED) is a common eating disorder characterized by recurring episodes
      of uncontrollable eating. The underlying neural mechanisms are largely unknown. However,
      dysfunctional hormonal satiety signaling as well as dysfunctional neural processing of food
      cues are discussed as possible casual factors in the development and maintenance of this
      disorder. Additional research is needed to specify the exact contribution of these
      observations and how they interact with each other. Accordingly, the current study plans to
      investigate metabolic gut-brain signaling to better understand the underlying causes of
      abnormal eating behavior. To this end, 25 healthy normal weight control participants as well
      as 25 patients with BED will be recruited. The responsivity of the hypothalamus (i.e., the
      core region of homeostatic control) and its interaction with the mesocorticolimbic reward
      system will be assessed by applying a single-blind, randomized, crossover design of
      intravenous infusion of glucose or NaCl. This approach allows the study of gut-brain
      signaling to the hypothalamus and the reward system by controlling for sensory aspects of
      food intake (sight, smell, and taste). The interaction between the hypothalamus and the
      mesocorticolimbic reward system will be investigated using an effective connectivity
      analysis. FMRI with high spatial resolution and with an optimized protocol for the
      investigation of the hypothalamus and the mesocorticolimbic reward system will be employed. A
      better understanding of the underlying psychobiological mechanisms of BED is a fundamental
      requirement for the development of improved prevention and treatment strategies
    


Intervention name(s): fmri
Intervention type(s): Behavioral
Intervention description(s): functional magnetic resonance imaging
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study will enroll 25 patients with BED. Patients will be recruited from the
        investigator's in- and out-patient department or by public advertisement after giving their
        written informed consent. Additionally, a healthy control group of 25 participants will be
        recruited by public advertisement.
      
Keywords: fmri; interoceptive food processing
A Study in Healthy Participants Investigating Biomarkers After Exposure to Heparin When Heparin is Administered in the Fasted State or After a High-fat Meal. Heparin, a Registered Drug, is an Anticoagulant (Blood Thinner) That Prevents the Formation of Blood Clots.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In this study biomarkers in the blood after exposure to heparin in the fasted state or after
      a high-fat meal will be investigated. Heparin will be administered as an intravenous (iv)
      injection (injection directly in a blood vessel). In this study, the effects of
      administration of heparin will be compared with the effects of administration of normal
      saline which will also be administered as an iv injection.
    


Intervention name(s): Heparin
Intervention type(s): Drug
Intervention description(s): intravenous [iv] injection
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.
    

Detailed description: 
      This was a Phase 2, open-label study in male participants with Fabry disease. All
      participants who met initial eligibility criteria underwent a 28-day screening period,
      including a 14-day run-in with migalastat (150 milligrams [mg] migalastat once a day [QD]
      from Days -28 to -15) to assess eligibility for entering the treatment period of the study.
      Participants who entered the treatment period were required to have α-galactosidase A (α-Gal
      A) activity responsive to migalastat.

      Fifteen participants received at least 1 dose of study drug, however, 6 of these participants
      did not demonstrate α-Gal A activity responsive to migalastat and were thus screen failures
      (these participants are hereafter referred to as "dosed screen failures") due to not meeting
      all inclusion criteria for treatment. Therefore, 9 participants were enrolled into the
      treatment period (these participants are hereafter referred to as "eligible-enrolled").

      Eligible-enrolled participants (those who satisfied the criteria for inclusion in the study)
      received escalating doses of migalastat twice a day (BID) for 6 weeks (Days 1 to 42),
      followed by 6 weeks at 1 dose level BID (Days 43 to 84) during the treatment period.
      Participants could then opt to participate in the extension period. The study consisted of 2
      optional extension periods, the first through Week 48 and the second through Week 96. For
      participants who did not continue into the optional treatment extension, the study included a
      2-week follow-up period.
    

Intervention name(s): migalastat HCl
Intervention type(s): Drug
Other intervention name(s): AT1001; Galafold; migalastat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amicus Therapeutics; AT1001; Galafold; Migalastat; Substrate
LEO 22811 - A Phase 1, Double-Blind, Placebo-controlled, Single and Multiple Oral Dose Study in Healthy Subjects
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first-in-man trial is to determine the safety and tolerability of
      ascending single and multiple doses of LEO 22811 in healthy male subjects as well as to
      determine the safety and tolerability of single oral doses of LEO 22811 in healthy female
      subjects. The trial will be performed in two parts. In Part 1, single doses of LEO 22811 will
      be administered to healthy male and female subjects. In Part 2, multiple doses of LEO 22811
      will be administered to healthy male subjects.
    


Intervention name(s): LEO 22811; placebo solution
Intervention type(s): Drug; Drug
Intervention description(s): First-in-man
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
"Steroids and Azathioprine Versus Steroids Alone in IgAN"
Condition: IGA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 4

Summary: 
      In a previous trial the investigators found that the effect of steroids in IgA nephropathy
      diminish over time. The difference in renal survival is striking up till the third year, but
      then remains constant. A six-month course of steroid therapy may be not enough to ensure a
      stable remission. The investigators hypothesized that a more aggressive treatment may obtain
      long-term better results. The investigators conducted a randomised controlled trial to assess
      the utility of low-dose azathioprine added to steroids in adult IgAN patients.
    

Detailed description: 
      In 1999, we published a multicenter, randomized, controlled trial, which compared a 6-month
      steroid course with supportive therapy in 86 patients with IgAN. After 5 years of follow-up,
      the risk of a 50% increase in plasma creatinine from baseline was significantly lower in the
      treated patients; proteinuria also decreased. However, the effect of steroids seemed to
      diminish over time. The difference in renal survival was particularly striking up till the
      third year, but then remained constant. We hypothesised that a six-month course of steroid
      therapy is not enough to ensure a stable remission, and a more aggressive treatment may be
      required to obtain long-term better results. At this regard, some studies of combined
      treatment with corticosteroids and azathioprine found that treatment was effective in
      preserving renal function and in reducing proteinuria. However, these studies did not clarify
      whether azathioprine added further benefit to steroids in the long term. We conducted a
      randomised controlled trial to assess the utility of low-dose azathioprine added to steroids
      in adult IgAN patients.
    

Intervention name(s): steroids plus azathioprine; steroids
Intervention type(s): Drug; Drug
Intervention description(s): methylprednisolone 1 g i.v. for three consecutive days at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day plus azathioprine 1.5 mg/kg/day for six months; methylprednisolone 1 g i.v. for three consecutive days at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day for six months
Other intervention name(s): solumedrol; deltacortene; azatioprina; solumedrol; deltacortene
Intervention MeSH terms: Prednisone; Methylprednisolone Hemisuccinate; Methylprednisolone Acetate; Methylprednisolone; Prednisolone; Prednisolone acetate; Azathioprine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IgA nephropathy; steroids; azathioprine; chronic kidney disease progression; proteinuria
Role of Self-focused Attention in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Using a task measuring the tracking of eye movements, the aim of this study is to demonstrate
      that individuals suffering from depression focus their attention more on their reflection in
      the screen after recalling a failure (and this all the more so as their depressive
      symptomatology is strong) .
    


Intervention name(s): Eye tracker
Intervention type(s): Behavioral
Intervention description(s): Eye movements on a screen are captured with an eye tracker during a repeated measures before/after a directed autobiographical recall.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
Condition: Herpes Simplex
MeSH terms: Herpes Simplex; Neutropenia
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in
      patients with neutropenia.

      PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is
      comparing two doses of acyclovir in preventing herpes simplex virus infection in patients
      with neutropenia.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the difference in nephrotoxicity between low-dose and weight-based
           intravenous acyclovir sodium as herpes simplex virus infection prophylaxis in patients
           with neutropenia.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.

        -  Arm II: Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. Treatment
           continues for approximately 2 weeks unless clinical herpes simplex virus infection is
           confirmed or the patient is no longer neutropenic.
    

Intervention name(s): acyclovir sodium
Intervention type(s): Drug
Intervention description(s): Given IV
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: chemotherapeutic agent toxicity; renal toxicity; infection; neutropenia
A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of
      Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the
      NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP,
      Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a
      free combination of BDP DPI plus FF DPI licensed products after a morning dose administration
      of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic
      patients.
    


Intervention name(s): CHF1535 NEXT DPI; BDP DPI and formoterol DPI
Intervention type(s): Drug; Drug
Intervention description(s): FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER; FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; PK; Adolescents; Adults
OPEN-LABEL, MULTI-CENTER, PHASE 1b/2a CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF IONTOPHORETIC DEXAMETHASONE PHOSPHATE OPHTHALMIC SOLUTION IN PATIENTS HAVING UNDERGONE CATARACT SURGERY WITH IMPLANTATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Condition: Patients Having Undergone Unilateral Cataract Extraction and Implantation of a Monofocal
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate
      ophthalmic solution, EGP-437®, using the EyeGate® II Drug Delivery System (EGDS) in patients
      having undergone cataract surgery with implantation of a posterior chamber intraocular lens
      (IOL)
    

Detailed description: 
      This will be a Phase 1b/2a, open-label, multi-site study, in which a total of up to 20 eyes
      of up to 20 patients will be enrolled. Patients having undergone unilateral cataract surgery
      with implantation of a posterior chamber monofocal intraocular lens (IOL) who are interested
      in participating in the study will be provided an informed consent form prior to screening.
      Screening/Baseline procedures which include best corrected visual acuity (BCVA), slit lamp
      examination, conjunctival injection, and intraocular pressure (IOP) by tonometry will be used
      to determine eligibility just prior to cataract surgery on Day 0. Eligible subjects will
      undergo iontophoresis treatment immediately post-cataract surgery on Day 0 and Day 7, and
      will return to the clinic for examination on Days 1, 14, and 28.
    

Intervention name(s): Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA
Intervention type(s): Drug
Intervention description(s): Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA
Other intervention name(s): EGP-437
Intervention MeSH terms: Dexamethasone; Ophthalmic Solutions; Dexamethasone 21-phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Determination of Protocol of Nocturnal Food Intake of Shift Workers.
Condition: Shift Work Type Circadian Rhythm Sleep Disorder
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional

Summary: 
      This study evaluates the effect of different dietary conducts in the nocturnal period on the
      postprandial metabolism and food perceptions of night workers of the Hospital of Clinics of
      Uberlândia, Federal University of Uberlândia.
    

Detailed description: 
      Due to imbalances in the circadian rhythm, shift workers may present inadequate eating
      habits, which provoke metabolic and nutritional disorders. In this crossover study the
      participants consumed, at different times and separated by 6 days interval, two meals
      pre-established at the time of night work: a control and a higher-protein. On the day of each
      intervention, the participants were evaluated for response of blood and subjective markers
      after meal (glucose, insulin, triglycerides and subjective perceptions related to ingestion
      after each meal). It is expected that the standardization of a glycemic reduction diet will
      improve the metabolic response of the workers, demonstrated in the results of the biochemical
      parameters. If this scenario is confirmed, it is still expected that the data and results
      obtained in this study may serve as subsidies for the elaboration of nutritional
      interventions consistent with the work routine at night.
    

Intervention name(s): Normal protein diet; High-protein diet
Intervention type(s): Other; Other
Intervention description(s): The intervention with the control diet was composed of 65% of carbohydrates, 15% of proteins and 20% of lipids.; The intervention with the higher-protein diet was composed of 45% of carbohydrates, 35% of proteins and 20% of lipids.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Food intake; Sleep; Shift work; Postprandial metabolic response