bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure
Condition: Heart Failure; Chagas Disease
MeSH terms: Chagas Disease
Study type: Interventional

Summary: 
      This study will evaluate the applications of ganglionar electrical stimulation in patients
      with Chagas Disease and Ischemic Heart Failure patients.
    

Detailed description: 
      A Crossover Randomized Controlled Study will be developed with 3 groups: Healthy Older,
      Ischemic Heart Failure and Chagas Disease. This individuals will be randomized in two groups:
      TENS and placebo (same stimulus without electrical output) with 48 hrs between the
      interventions.
    

Intervention name(s): TENS; Placebo
Intervention type(s): Device; Device
Intervention description(s): Adhesive electrodes (MultiStick®, USA) were placed on each side, about 3 cm to the right and left of midline vertebral process, at C7 (Channel 1) and T4 (Channel 2).; The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current.
Other intervention name(s): Ganglionar electrical stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Autonomic Nervous System; Neuromodulation; Exercise; Pulmonary oxygen kinetics; Oxygen uptake
Rt-fMRI Neurofeedback and AH in Schizophrenia
Condition: Audio Visual Hallucinations; Neurofeedback; Schizophrenia; Superior Temporal Gyrus
MeSH terms: Hallucinations; Schizophrenia
Study type: Interventional

Summary: 
      Auditory hallucinations in schizophrenia are one of the major symptoms of this disease and a
      major source of psychological discomfort. They are often difficult or impossible to treat
      with existing methods. This study will test the use of real-time fMRI neurofeedback to
      mitigate auditory verbal hallucinations in patients whose hallucinations are resistant to
      medication. Half of the patients will receive real time fMRI neurofeedback from a brain
      region involved in auditory hallucinations and half will receive it from motor cortex.
    

Detailed description: 
      Auditory verbal hallucinations (AH) have long been a hallmark of schizophrenia (SZ) and are
      one of its major diagnostic features. They are difficult to manage with existing treatment
      options. Here, neurofeedback will be used to regulate the superior temporal gyrus (STG)
      activation which will not only lead to activation changes in the STG, but also to changes in
      the default mode network (DMN).

      The investigators will study SZ patients with medication resistant AH in the rt-fMRI
      intervention arm and in the sham-rt-fMRI arm. In both arms, the task and the rt-fMRI session
      structure will be identical. The SZ-intervention group will receive feedback from the STG
      while SZ-sham group will receive feedback from the motor cortex. In addition, 2 functional
      fMRI tasks will examine the effect of rt-fMRI neurofeedback and of sham-rt-fMRI on brain
      response.

      The investigators will randomly assign 48 SZ patients to either SZ-intervention (n=24) or
      SZ-sham-rtfMRI (n=24). The STG targeted neurofeedback is predicted to bring changes in brain
      regions involved in AH (STG and DMN) in SZ-intervention group only. The R61 GO criterion will
      be BOLD signal reduction in the STG, and resting state connectivity reduction between
      MPFC-PCC, post rt-fMRI-feedback in SZ-intervention group.
    

Intervention name(s): rt-fMRI neurofeedback
Intervention type(s): Other
Intervention description(s): use of real time fMRI neurofeedback to achieve targeted brain changes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the R61 phase of the study,changes in a target brain region(s) will be demonstrated after the rt-fMRI based neurofeedback session.
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: rt-fMRI; MRI; schizophrenia; auditory hallucinations; neurofeedback
Multidisciplinary Evaluation of Patients With Hemophilia
Condition: Haemophilia
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      Multidisciplinary assessment of the physical, functional and psychosocial alterations in
      patients with hemophilia around the country. The aims of this study are:

        -  Descriptive study of joint involvement in hemophilia patients with and without a history
           of hemarthrosis.

        -  Descriptive study of the alterations of periarticular muscle strength as a result of
           acute processes or the development of chronic articular sequelae.

        -  Descriptive study of biomechanical changes in lower limb joints and their impact on gait
           in patients with hemophilia.

        -  Descriptive study of the joint space, regarding hemarthrosis and synovitis,
           intraarticular by ultrasonography.

        -  Descriptive study of the relationship between skeletal muscle pathology in patients with
           hemophilia and their perceptions of it and their quality of life.
    

Detailed description: 
      Observational study that will allow us:

      Analyze and evaluate the skeletal muscle of patients with hemophilia involvement.

      Describe the periarticular muscular deficit, depending on the degree of injury, age, presence
      of inhibitors and the development of physical activity.

      Identify the relationship between the functional deficit by clinical assessment performed
      with the use of validated scales measure force production with patients.

      Observe the presence of joint bleeds in children with hemophilia and synovial hypertrophy
      developing therein.

      Detect biomechanical abnormalities of the lower limbs and their impact on gait in patients
      with hemophilia.

      Assess the factors that influence the perception of illness and quality of life of patients
      with hemophilia.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with haemophilia attending hemophilia shelters organized by the Federación
        Española de Hemofilia (Fedhemo) in the Centro de Formación Permanente en Hemofilia La
        Charca (Murcia, Spain).
      
Keywords: Haemophilia; Arthropathy; Range of motion; Strength; Proprioception; Gait; Quality of Life.
Effect of the GSK2245035 on the Allergen-induced Asthmatic Response
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess whether Toll like receptor 7 (TLR7)-mediated pharmacology, with
      intranasal (i.n.) GSK2245035 20 nanogram (ng) administered weekly for a period of 8 weeks,
      will lead to reduced allergic reactivity in the lower airways in subjects with mild allergic
      asthma.

      This will be a randomised, double-blind (sponsor open), placebo-controlled, parallel group,
      8-week treatment study.

      The study will consist of a screening period of up to approximately 4 weeks (involving two
      screening visits), a blinded treatment period of 8 weeks, followed by a follow-up period of
      up to 3 months. The total duration of the study for each subject will therefore be a maximum
      of approximately 6 months.
    


Intervention name(s): GSK2245035 Nasal Spray Solution; Placebo Nasal Spray Solution
Intervention type(s): Drug; Drug
Intervention description(s): GSK2245035 Nasal Spray Solution 0.2 microgram (mcg)/mL delivering 10 ng GSK2245035 per actuation. A solution formulation in saline, preserved with Benzalkonium Chloride and Disodium Edetate.; Nasal Spray Solution as for GSK2245035 without active ingredient.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK2245035; TLR7 agonist; allergic asthma; FEV1
Effects of Nucleus Basalis of Meynert Stimulation on Cognitive Disorders in Dementia With Lewy Bodies
Condition: Dementia With Lewy Bodies
MeSH terms: Dementia; Lewy Body Disease
Study type: Interventional

Summary: 
      Deep brain stimulation has been developed as a substitute for the classical lesioning methods
      previously used in stereotactic and functional neurosurgery. Recent, anecdotal cases reports
      suggested that electrical stimulation of the cholinergic output of the Nucleus Basalis of
      Meynert (NBM) may improve cognitive performances, especially the memory tasks.

      The present study aims to assess the effect of bilateral electrical stimulation of the NBM on
      the mnesic performance [assessed by the sum of the three free recalls of the Free and Cued
      Selective Recall Reminding Test (FCSRT)] in patients diagnosed with probable, moderate,
      Dementia with Lewy Bodies.
    


Intervention name(s): Electrical stimulation of the nucleus basalis of Meynert
Intervention type(s): Procedure
Intervention description(s): Differents parameters will be assessed.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dementia with Lewy bodies; Nucleus basalis of Meynert; Deep brain stimulation
An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times
      per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or
      AIDS related complex (ARC) patients.
    


Intervention name(s): AS-101
Intervention type(s): Drug
Intervention MeSH terms: Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; ammonium trichloro(dioxoethylene-O,O'-)tellurute
Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This dose response study is proposed to explore the extent to which Nexium increases
      endogenous gastrin concentrations and to assess whether Nexium treatment may be useful in the
      setting of islet cell transplantation for type 1 diabetes to expand islet cells in vivo after
      transplant.
    

Detailed description: 
      Islet transplantation has been shown to effectively treat type 1 diabetes by stabilizing
      blood glucose control while reducing/eliminating the need for exogenous insulin injections.
      However, for reasons still not fully understood, islet graft function tends to decline with
      time after transplant. Gastrin has been identified as a growth factor capable of stimulating
      islet cell expansion. Proton pump inhibitors are known to increase endogenous gastrin
      concentrations. This dose response study is proposed to explore the extent to which Nexium
      increases endogenous gastrin concentrations in healthy volunteers and to assess whether
      Nexium treatment may be useful in expanding islet cells in patients with type 1 diabetes.
      Three Nexium dose levels will be tested to determine the optimal dose for increasing plasma
      gastrin levels. The effect of Nexium on plasma concentrations of glucose, insulin, c-peptide,
      glucagon, and somatostatin will also be monitored.
    

Intervention name(s): Esomeprazole Magnesium
Intervention type(s): Drug
Intervention description(s): NEXIUM 40MG ONCE DAILY FOR 7 DAYS WITH A 2 WEEK WASHOUT PERIOD, NEXIUM 40MG TWICE DAILY WITH A 2 WEEK WASHOUT PERIOD, NEXIUM 80MG TWICE DAILY WITH A 2 WEEK WASHOUT PERIOD.
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: NEXIUM; HEALTHY VOLUNTEERS; BLOOD DRAW; to measure gastrin levels in healthy volunteers while taking nexium
Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)
Condition: Acute Respiratory Distress Syndrome (ARDS); Cardiogenic Shock; Cardiac Arrest
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Shock, Cardiogenic
Study type: Observational

Summary: 
      Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of
      neurological complications and cerebral autoregulation (CA) impairment may be a risk factor.
      The first objective is to investigate the association between CA impairments and neurological
      outcome assessed by the onset of an ANE. The secondary objective is to study the underlying
      mechanisms influencing CA.
    

Detailed description: 
      Patients : All children treated by ECMO in the 4 PICUs involved in the study

      Measurements : A correlation coefficient between the variations of regional cerebral oxygen
      saturation (rScO2) as a surrogate of cerebral blood flow and the variations of arterial blood
      pressure (ABP) is calculated as an index of autoregulation (cerebral oxygenation index (COx),
      ICM+ software®). CA is monitored either on left (COxl) or both sides. A COx > 0.3 is
      considered as critical. Neurological outcome is assessed by the onset of an acute neurologic
      event (ANE) during the ECMO run.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 children admitted to the Pediatric Intensive Care Unit (PICU) of Nantes (France),
        Trousseau (Paris, France), Necker (Paris, France) or Genoa (Italy) and supported by ECMO
        for hemodynamic or respiratory indication or during cardiac arrest resuscitation will be
        included in the study.

        As ECMO is an emergency procedure, emergency inclusions may be needed. Other observational
        study may be conducted in parallel in this population.
      
Keywords: ECMO; Cerebral autoregulation
Electrical Pharyngeal Stimulation for Dysphagia Therapy in Tracheostomized Stroke Patients
Condition: Stroke; Dysphagia
MeSH terms: Deglutition Disorders; Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether electrical pharyngeal stimulation in
      addition to standard care can enhance short-term swallow recovery in tracheostomized
      dysphagic stroke patients and thereby facilitate earlier decannulation compared to sham
      treatment plus standard care.
    

Detailed description: 
      Readiness for decannulation is assessed after three days of either real or sham electrical
      pharyngeal stimulation. In case a patient cannot be decannulated at that time point, there is
      an open-label follow-up treatment phase, in which every patient in the sham treatment arm
      gets another three days of real electrical pharyngeal stimulation to not deprive any patient
      of a potentially beneficial treatment.
    

Intervention name(s): Electrical pharyngeal stimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Electrical pharyngeal stimulation via an intraluminal catheter (Phagenesis Ltd.) once daily for 10 minutes on three consecutive days. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.; The intraluminal catheter (Phagenesis Ltd.) for electrical pharyngeal stimulation is placed. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After the optimal stimulation intensity has been determined, no electrical stimulation is delivered.
Other intervention name(s): Phagenesis Limited, UK.; EPS1 device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: electrical pharyngeal stimulation; stroke-related dysphagia; tracheostomy; decannulation
Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The purpose of this study aims to investigate the utility of Pivotal Response Treatment
      (PRT), a behaviorally derived intervention, to improve the quality and frequency of
      communication and social engagement of toddlers with siblings who have an autism spectrum
      disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social
      interaction between 12 and 15 months of age.
    


Intervention name(s): Infant Toddler Years PRT
Intervention type(s): Behavioral
Other intervention name(s): Pivotal Response Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol dry
      powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a DPI
      Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.
    

Detailed description: 
      This study is designed to evaluate the efficacy and safety profiles of A006 and to assist in
      identifying the optimum dose of A006 for future clinical studies. Proventil® HFA MDI, a
      currently marketed Albuterol MDI product, will be used as an Active Control. The study also
      employs a Placebo Control DPI, which has the same configuration as the A006 DPI except that
      it contains no active ingredient.
    

Intervention name(s): A006 DPI; A006 DPI; Placebo DPI; Proventil® MDI; Proventil® MDI
Intervention type(s): Drug; Drug; Other; Drug; Drug
Intervention description(s): Single dose 110 mcg, 1 inhalation; Single dose 220 mcg, 1 inhalation; Placebo, 1 inhalation; Single dose 90 mcg, 1 inhalation; Single dose 90 mcg, 2 inhalations
Other intervention name(s): Albuterol; Albuterol DPI; Albuterol; Albuterol DPI; Placebo; Proventil®; Proventil®
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Mild-to-moderate persistent asthma; Mild asthma; Moderate asthma; Persistent asthma
71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify
      for 17b-HSD5 enzyme (71A>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has
      been suggested in previous studies.

      Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors,
      the investigators hypothesis is that women with PCOS and with the variant allele G have a
      poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive
      pill (OCP) treatment for 6 months.
    


Intervention name(s): oral contraceptive pill
Intervention type(s): Drug
Intervention description(s): ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; oral contraceptive pill; polymorphisms
Primary Aldosteronism and Surgically Curable Forms in Hypertension Patients Using 11C-Metomidate
Condition: Primary Aldosteronism; Primary Aldosteronism Due to Aldosterone Producing Adenoma
MeSH terms: Adenoma; Hypertension; Hyperaldosteronism
Study type: Interventional
Phase: Early Phase 1

Summary: 
      10% of patients with hypertension potentially have the treatable condition - primary
      aldosteronism. Primary aldosteronism (PA) is caused by either bilateral adrenal disease
      (~40%), managed with lifelong medications; or unilateral disease (~60%), cured with
      laparoscopic surgery (adrenalectomy). Unfortunately, many patients with curable hypertension
      remain undiagnosed and consequently develop cardiac disease and strokes. The difficulty with
      identifying curable unilateral disease is due to adrenal vein sampling (AVS): an invasive,
      and technically-difficult procedure, with inconclusive results in 50% of patients. An
      alternative novel imaging, 11C-metomidate Positron emission tomography-computed tomography
      (PET-CT), can detect adrenal tumors, and concurrently confirm their over-activity. It is
      non-invasive, non-operator-dependent, and can identify more patients with curable
      hypertension.

      Investigators hypothesize that 11C-metomidate PET-CT can accurately identify patients with
      surgically-curable unilateral adrenal disease among hypertensive Asians with primary
      aldosteronism.
    

Detailed description: 
      25 patients with confirmed PA who are keen for a surgical cure if unilateral PA is confirmed,
      will undergo conventional tests, CT, AVS, as well as 11C-metomidate PET/CT.

      Results will be reviewed and discussed at a multidisciplinary meeting, and patients with
      unilateral PA will be offered surgery. Patients will be reviewed 6 months post surgery to
      assess for cure of PA.
    

Intervention name(s): 11C-Metomidate PET/CT Scan
Intervention type(s): Combination Product
Intervention description(s): 11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre
Intervention MeSH terms: Metomidate
Intervention model: Single Group Assignment
Intervention model description: 11C-metomidate will be manufactured in Clinical Imaging Research Centre in compliance with good manufacturing practice using a General Electric Medical Systems PET trace 860 cyclotron. Non-contrast CT images will be acquired over the adrenal. After an intravenous injection of 11C-metomidate, PET images will be acquired within the first 45 min. Attenuation and decay-corrected images will be converted to standardized uptake value (SUV) maps through division by (injected activity per patient weight). The maximum SUV values over regions of interest will be determined for 10-min static images starting 35 min after the injection.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 11-C Metomidate PET/CT; Hypertension; Adrenalectomy; Adrenal Vein Sampling; Subtyping
A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1B clinical study evaluating the safety and exploring the effectiveness of
      SP-624 as compared to placebo in the treatment of adults with schizophrenia experiencing
      acute psychosis.
    


Intervention name(s): SP-624; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Capsule; Oral Capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment