bioihbjkbjnl/mcl2 huggingface dataset:
Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis
Condition: Tracheal Stenosis
MeSH terms: Tracheal Stenosis; Constriction, Pathologic
Study type: Observational

Summary: 
      This is a retrospective, observational cohort study carried out in two operative Units of the
      University Hospital of Modena (Italy): the Diagnostic and Interventional Bronchoscopy Unit
      (Unit A) and the Otolaryngology Unit (Unit B). The two units have different protocols
      routinely applied to treat tracheal benign stenosis. In Unit A, endoscopic treatment is
      performed through mechanical dilatation via rigid bronchoscopy and further stent placing
      while in Unit B the endoscopic treatment is performed through balloon dilatation via direct
      laryngoscopy. The primary purpose was to compare the efficacy of the two technique on
      tracheal stenosis treatment over time. Patients were defined as "cured" if during the 2 years
      after 12 months since the last intervention they did not present any of the following:
      respiratory symptoms, need for a re-intervention or stenosis instability.
    


Intervention name(s): Stent placement
Intervention type(s): Procedure
Intervention description(s): All interventional procedures have been performed in the operating room with a Dumon rigid bronchoscope under general anesthesia. Neodymium-doped yttrium aluminium garnet laser photoresection was performed at 15-30 watts and pulse duration of 0.5-1.0s whenever indicated. A silicone stent was placed.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We collected clinical, endoscopic and radiological data of patients with benign tracheal
        stenosis admitted in two operative Units of the University Hospital of Modena (Italy): The
        Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit
        B) from November 2012 to November 2017
Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD
Condition: Exudative Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      The purpose of this trial is to detect the influence of omega-3 supplements on vitreous
      levels of vascular endothelial growth factor (VEGF) in exudative age-related macular
      degeneration (AMD) in patients receiving intravitreal anti-VEGF treatment. Patients are
      randomized to receive either Age-Related Eye Disease Study 1(AREDS-1) supplements formula
      with the addition of Lutein or AREDS-2 supplementation that adds Omega-3 metabolites (DHA and
      EPA) to the formula. Our goal is to take a limited volume of vitreous sample from these
      patients previous to their regular anti-VEGF injection and perform a comprehensive cytokines
      and lipidomic profiling. We hypothesize, based on our previous basic science discovery of a
      potent anti-VEGF action of an Omega-3 metabolite (4-HDHA), that lipid metabolite composition
      and metobolite levels will significantly vary according to VEGF levels. Based on the results
      of this pioneering clinical study, our research team will proceed to evaluate the individual
      anti-angiogenic (vessel growth stopping) properties of the predominant Omega-3 metabolites
      found.
    

Detailed description: 
      The purpose of this trial is to detect the influence of omega-3 supplements on vitreous
      levels of vascular endothelial growth factor (VEGF) in exudative age-related macular
      degeneration (AMD) in patients receiving intravitreal anti-VEGF treatment. Patients are
      randomized to receive either Age-Related Eye Disease Study 1(AREDS-1) supplements formula
      with the addition of Lutein or AREDS-2 supplementation that adds Omega-3 metabolites (DHA and
      EPA) to the formula. Our goal is to take a limited volume of vitreous sample from these
      patients previous to their regular anti-VEGF injection and perform a comprehensive cytokines
      and lipidomic profiling. We hypothesize, based on our previous basic science discovery of a
      potent anti-VEGF action of an Omega-3 metabolite (4-HDHA), that lipid metabolite composition
      and metobolite levels will significantly vary according to VEGF levels.
    

Intervention name(s): Anti-VEGF plus AREDS-2; Anti-VEGF plus AREDS-1
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Omega-3 metabolites supplementation; Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wet AMD; Omega-3; VEGF; Lipidomics; DHA; EPA
Nitric Oxide Therapy for Acute Chest Syndrome in Sickle Cell Disease Children
Condition: Acute Chest Syndrome; Sickle Cell Disease
MeSH terms: Acute Chest Syndrome; Anemia, Sickle Cell; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Acute chest syndrome is a severe sickle cell disease complication in children requiring blood
      transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a potent
      vasodilator that could reverse pulmonary vascular occlusion and restore normal oxygenation.
      The randomized trial will test that hypothesis.
    

Detailed description: 
      Acute chest syndrome is a severe sickle cell disease complication in children requiring blood
      transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a potent
      vasodilator that could reverse pulmonary vascular occlusion and restore normal oxygenation.
      The randomized trial will test that hypothesis in a prospective randomized double-blind
      placebo controlled study. 50 children in two years will be included: 25 in each arm.
    

Intervention name(s): Nitric oxide by inhalation INOMAX; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nitric oxide by inhalation INOMAX 800 ppm
40 ppm during 24 hours then 20 ppm during 24 hours then 10 ppm during 24 hours; placebo
Other intervention name(s): INOMAX
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nitric oxide
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment
Condition: Binge-Eating Disorder; Obesity
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will test the effectiveness of cognitive-behavioral therapy as a specialist
      treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test
      of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments
      on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no
      additional behavioral treatment .
    

Detailed description: 
      Binge eating disorder (BED), the most prevalent formal eating disorder, is associated
      strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with
      obesity and BED are needed that can produce sustained clinical outcomes and promote weight
      loss. This study (specialist treatment) RCT will provide new and novel findings from a
      controlled test, amongst non-responders to acute treatments, whether cognitive-behavioral
      therapy augments on-going blinded pharmacotherapy (naltrexone/bupropion or placebo) compared
      with on-going pharmacotherapy alone (without added cognitive-behavioral therapy).
    

Intervention name(s): Cognitive-Behavioral Therapy (CBT); NB Medication (on-going from acute treatment)
Intervention type(s): Behavioral; Drug
Intervention description(s): CBT specialist treatment; Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
Other intervention name(s): Contrave
Intervention MeSH terms: Bupropion hydrochloride, naltrexone hydrochoride drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression
Condition: Depression; Major Depressive Disorder; Unipolar Depression
MeSH terms: Neurobehavioral Manifestations; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Many people with depression are treated with a serotonin-specific reuptake inhibitor
      anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not
      feel completely 'well'. Often, individuals continue to complain of cognitive problems such as
      lack of attention, diminished motivation, and impaired problem-solving. This study looks at
      whether residual and cognitive symptoms of depression in individuals are affected by the
      addition of Wellbutrin (bupropion).
    

Detailed description: 
      As many as 65-75% of treated patients continue to experience residual symptoms of depression.
      Cognitive impairments feature frontal cognitive dysfunction. Many experts believe that
      executive functions are better predictors of functional level than psychiatric diagnoses.

      Frontal cognitive impairment and changes in neuroimaging are seen in individuals depleted of
      tryptophan, a serotonin precursor. These cognitive changes do not improve following
      serotonin-specific reuptake inhibitor treatment and at least one study has found that
      executive dysfunction predicts non-response to fluoxetine. In many patients, remission of
      mood symptoms in depression requires medications to target non-serotonergic neurotransmitter
      systems. Brain areas mediating executive functions receive rich noradrenergic inputs, and
      norepinephrine is known to be intimately involved in many of the executive functions.

      A better understanding of serotonergic and catecholaminergic interactions would enable
      evidence-based treatment of depression which maximizes executive cognitive functions. This
      study examines the hypothesis that individuals treated with Wellbutrin will have higher
      scores on tests of executive functions and lower scores on depression indices.
    

Intervention name(s): Wellbutrin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): bupropion
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; serotonin; norepinephrine; SSRI; Wellbutrin; bupropion; executive function; residual symptoms
Tinnitus rTMS 2013
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Tinnitus is the perception of sound in the absence of corresponding external sound. Tinnitus
      affects approximately 10-15 % of the population. The prevalence increases with age and it is
      estimated that more than 20 % of the older people have tinnitus. Approximately 10-15 % of
      tinnitus patients have clinically relevant, disabling tinnitus causing for example anxiety,
      depression and sleep disturbances. The treatment of chronic tinnitus is difficult and most
      therapies focus on alleviating the condition rather than treating the cause. Pathophysiology
      of tinnitus still remains incompletely understood. Functional brain imaging data in tinnitus
      patients and animal models suggest that tinnitus is associated with increased neuronal
      activity, increased synchronicity, and functional reorganization within the auditory cortex
      either uni- or bilaterally, but there are also functional alterations in brain areas outside
      the auditory system. Transcranial magnetic stimulation (TMS) is a neuromodulation technique
      based on the principle of electromagnetic induction of an electric field in the brain by
      means of magnetic pulses given to the scalp. TMS is a non-invasive, painless, and safe method
      for modulation of cortical activity. TMS pulses given at low frequencies (≤ 1 Hz) have been
      shown to decrease cortical excitability both in experimental settings and humans, which forms
      the basis for using low frequency rTMS to treat chronic tinnitus patients, in whom
      hyperactivity of the auditory cortex has been observed in functional brain imaging studies
    


Intervention name(s): E-fied navigated rTMS; non-navigated rTMS; sham E-field navigated rTMS; Navigated rTMS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 1 hz on the superior temporal gyrus contralateral/left side with E-field navigated rTMS (Nexstim) targeted at the tonotopic representation area of the main frequency content of tinnitus; 1 hz on the superior temporal gyrus contralateral/left side with non-navigated rTMS according to external landmarks (between T3/T4 and P3/P4 EEG-electrode locations); 1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tinnitus; Transcranial magnetic stimulation
Effect of Different Working Conditions on Risk Factors in Dentists Versus Trainers
Condition: Healthy
Study type: Observational

Summary: 
      The aim of the study is to validate the sanitary consequences of dental studies respectively
      the longtime executed profession. In comparison to this cohort we will also check a
      collective of subjects with an optimum of physical activity.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        male and female students of dentistry male and female students of sports male dentists male
        teachers of physical education
      
Keywords: risk factors; metabolic syndrome; dentists; trainers; Healthy subjects; students; seniors
Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients
      postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen
      demand.
    

Detailed description: 
      Due to blood loss and SIRS postoperative hypovolemia is a usual feature after CABG surgery.
      Substantial controversy persists regarding the best choice of fluid to be used for
      resuscitation in this setting regarding renal function and oxygen supply-demand matching. In
      our study we aim to investigate differences in functional renal parameters by dividing
      patients postoperatively in two groups, substituted either with crystalloid fluid,
      Ringer-Acetat, 20 ml/kg or colloid, HES 6% (130/0,4) 10 ml/kg under 20 minutes. Central and
      renal hemodynamics will be measured before (baseline) and after fluid administration by blood
      sampling and thermodilution in both pulmonary artery catheter and renal vein catheter.
      Measurement endpoints will mainly consist of central hemodynamics, renal blood flow, GFR and
      renal oxygen extraction rate which we aim to compare between groups.
    

Intervention name(s): crystalloid; colloid
Intervention type(s): Drug; Drug
Other intervention name(s): Ringer Lactate; NaCl; Voluven; Venofundin; Tetraspan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: elective CABG; renal impairment; GFR; renal blood flow; colloid; crystalloid; thermodilution technique; oxygen supply demand
Caffeine vs. ALA in BMS Treatment. (BMS: Burning Mouth Syndrome. ALA: Alpha-Lipoic Acid.)
Condition: Caffeine; Burning Mouth Syndrome
MeSH terms: Burning Mouth Syndrome; Syndrome; Burns
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the efficacy of caffeine and alpha-lipoic acid in the
      treatment of burning mouth syndrome by symptom assessment with visual analogue scale.
    

Detailed description: 
      The etiology of BMS is multifactorial, involving a complex interplay of neuropathic,
      psychological, neuroendocrine, and immunological factors. Neurologically, BMS has been
      categorized into three subtypes: peripheral small fiber neuropathy, subclinical trigeminal
      neuropathy, and inhibitory dopaminergic deficiency. Neuroimaging and peripheral nerve studies
      have further implicated altered brain activation patterns and increased expression of
      specific receptors like TRPV1 and P2X3 in the pathogenesis of BMS. Hormonal imbalances,
      particularly in estrogen levels, have also been suggested to contribute to contribute to the
      condition.

      Caffeine, a xanthine alkaloid chemically known as 1,3,7-trimethylxanthine, is recognized for
      its diverse biological functions. As a central nervous system stimulant, its primary
      mechanism involves antagonizing adenosine receptors, thereby enhancing the release of
      neurotransmitters such as dopamine and norepinephrine, which are known to play roles in
      analgesic pathways. Caffeine is also noted for its neuroprotective properties and is
      theorized to reduce the risk of neurodegenerative diseases. It affects the central processing
      of pain and is involved in regulating circadian rhythms and sleep-wake cycles. Additionally,
      caffeine has mild anti-inflammatory properties. Its stimulatory effects may also improve mood
      and cognitive function.
    

Intervention name(s): Caffeine; Alpha Lipoic Acid
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): caffeine supplementation; 600-800 mg ALA
Other intervention name(s): ALA
Intervention MeSH terms: Thioctic Acid; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bone Health in Facioscapulohumeral Muscular Dystrophy
Condition: Facioscapulohumeral Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Observational

Summary: 
      This is a cross-sectional single visit study to determine bone health in individuals with
      FSHD.
    

Detailed description: 
      Bone health will be assessed using 1) a DEXA scan to measure bone mineral density and lean
      body mass, and 2) blood tests of biomarkers of bone resorption and formation. These
      procedures will be correlated to measures of muscle strength testing and timed function tests
      to determine fracture risk in FSHD individuals considering age, gender, muscle strength and
      FSHD allele size.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population consists of individuals with Facioscapulohumeral Muscular Dystrophy.
Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters.
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Pulmonary Arterial Hypertension (PAH) is a severe progressive disease with a high mortality.
      Although several drugs are available for the treatment of PAH none offer a cure, therefore
      there is still a high medical need for new treatments.

      Soluble guanylate cyclase (sGC) is one of the chemicals involved in the pathways controlling
      vascular tone, which is impaired in patients with PAH. This causes constriction and
      thickening of the blood vessels wall in the lungs and increase of blood pressure in the
      lungs. This can lead to the very debilitating symptoms of PAH such as tiredness, shortness of
      breath on exertion, collapse and often the inability of the patient to perform their daily
      life activities.

      Inhalation of Nitric Oxide, which activates sGC is used to treat PAH, but its effect wears
      off as soon as inhalation stops. Direct stimulation of sGC using this new compound Riociguat
      may be a new approach for the treatment of PAH.

      The phosphodiesterase 5 (PDE5)-inhibitor Sildenafil is one of licensed treatments for PAH.
      The Patent Plus is a double-blind, placebo-controlled safety study, designed to investigate
      the effect of Riociguat on blood pressure in patients with PAH when given in combination with
      Sildenafil.
    

Detailed description: 
      Main objective: Evaluation of the pharmacodynamic effect of the combination of Sildenafil and
      Riociguat on blood pressure and other safety parameters in patients with symptomatic PAH
      Secondary objectives:To investigate the safety of the riociguat/sildenafil combination and
      changes in 6-minute walk test, World Health Organization (WHO) functional class, N terminal
      pro-brain natriuretic peptide, and variables obtained during right-heart catheterization
      after 12 weeks of treatment; pharmacokinetics of riociguat and sildenafil.

      The study consists of one part. In study Part 1 only subjects (18) on stable sildenafil
      treatment of 20 mg tid have been enrolled. Study Part 2 will not start.
    

Intervention name(s): Riociguat (Adempas, BAY63-2521); Placebo; Sildenafil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BAY63-2521: 1 mg tid - 2,5 mg tid oral for 12 weeks.; Placebo for 12 weeks; Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
Intervention MeSH terms: Sildenafil Citrate; Riociguat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Hypertension; Riociguat; Blood Pressure
Food Reward Processing in the Human Brain
Condition: Healthy
Study type: Observational

Summary: 
      The aim of this study is to investigate the influence of different metabolic states and
      hormonal satiety signalling on responses in neural reward networks.
    

Detailed description: 
      Given the rapid development of obesity world-wide, a better understanding of the interaction
      between the encoding of food reward in mesocorticolimbic reward pathways and homeostatic
      energy regulation is of paramount importance for the development of new treatment strategies.
      Healthy participants will undergo functional magnetic resonance imaging while performing a
      task distinguishing between the anticipation and the receipt of either food or monetary
      reward. Every participant will be scanned twice in a counterbalanced fashion, both during a
      state of hunger (after 24-hours fasting) and satiety. Blood samples will be collected to
      assess hormonal satiety signalling. We hope to provide new insights into the neurobiological
      underpinnings of motivational processing and hedonic evaluation of food reward.
    

Intervention name(s): Satiety State
Intervention type(s): Behavioral
Intervention description(s): Participants were scanned twice: once after a meal and once after fasting for 24 hours
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy normal weight female participants
      
Keywords: fmri; neuronal reward processing; hormonal satiety signalling; fasting