bioihbjkbjnl/mcl2 huggingface dataset:
Using Electroencephalography (EEG) and Transcranial Current Stimulation (tCS) to Study and Modulate Cognition Study
Condition: Inter-individual Variability
Study type: Interventional

Summary: 
      Inter-individual variability in responsiveness to interventions poses great challenges for
      translational neuroscience, and health care in general. The investigations sought to examine
      the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate
      sustained attention in a manner that was informed by individual differences in EEG indices.
    

Detailed description: 
      Inter-individual variability in responsiveness to interventions poses great challenges for
      translational neuroscience, and health care in general. Reliable and cost- effective
      screening procedures that can identify individuals who are more likely to benefit from an
      intervention could have substantial real-world benefits. Here, the investigators sought to
      examine the potential for high-frequency transcranial random noise stimulation (tRNS) to
      modulate sustained attention in a manner that was informed by individual differences in a
      well-studied electrocortical marker, spontaneous theta/beta ratio. The investigators
      hypothesized that individuals with relatively high theta/beta ratios, putatively reflecting
      suboptimal cortical arousal, would be more likely to benefit from the gains in cortical
      excitability afforded by tRNS. Seventy-two young healthy adults were administered 1mA, 2mA
      and sham tRNS in a double-blind, randomised, cross-over manner, while they performed a
      continuous monitoring paradigm. Electroencephalography was acquired before and after each
      stimulation condition.

      This approach may constitute a feasible means of using individual differences in
      neurophysiology to inform predictions about outcomes from targeted cognitive interventions.
    

Intervention name(s): Transcranial Random Noise Stimulation
Intervention type(s): Device
Intervention description(s): The transcranial random noise stimulation was delivered using a StarStim device (Neuroelectrics®, Barcelona, Spain). The electrodes were encased in a pair of saline-soaked sponges (25 cm2 ), and were secured within a Neurolectrics EEG cap over right DLPFC (F4) and right IPL (P4), according to the 10-20 international EEG system. Other details are stated under the 'intervention arm' descriptions.
Other intervention name(s): Starstim; Neuroelectrics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Transcranial electrical stimulation; random noise;; cognitive interventions; electroencephalography;; inter-individual variability; stochastic resonance;
The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic
Condition: HIV Infections; Cytopenias
MeSH terms: AIDS-Related Complex
Study type: Interventional

Summary: 
      To determine the safety and efficacy of erythropoietin administered to patients with AIDS or
      advanced AIDS related complex ARC and anemia.
    


Intervention name(s): Epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Masking: Double
Primary purpose: Treatment
Keywords: Recombinant Proteins; Erythropoietin; Acquired Immunodeficiency Syndrome; Anemia; AIDS-Related Complex; Zidovudine
Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin
Condition: Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the effect of a high-fat meal (breakfast) on
      the concentrations of moxidectin measured in the blood after a single oral administration in
      healthy subjects.
    


Intervention name(s): moxidectin
Intervention type(s): Drug
Intervention MeSH terms: Moxidectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment
Condition: Depression; Anxiety; PTSD; Trauma, Psychological
MeSH terms: Depression; Psychological Trauma
Study type: Interventional

Summary: 
      Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and
      neural development. This trial aims to see whether the 8-week mindfulness based intervention
      can reduce stress related psychological symptoms for young adults with childhood
      maltreatment, and whether it can promote neural plasticity.
    

Detailed description: 
      This study recruits young adults with childhood adversity; enrolled subjects either receive
      an 8-week mindfulness based intervention, or wait for 8 weeks before receiving the
      intervention. MRI and a battery of self report questionnaires will be administered before and
      after the intervention; subjects on the waiting list will undergo the same research
      procedures at the same time as subjects in the intervention group. Primary hypotheses include
      improved hippocampal plasticity, increased mindfulness and reduced stress and related
      psychological symptoms.
    

Intervention name(s): Mindfulness based intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; anxiety; childhood trauma; mindfulness
Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This Study evaluates the pharmacokinetic (PK) profile of different zamicastat doses in
      Pulmonary arterial hypertension (PAH) patients to find the most promising therapeutic dosage
      range for the treatment of PAH disease
    

Detailed description: 
      This is an open-label, multi-centre study in patients with PAH who are currently on stable
      treatment with at least one PAH medication. It is planned to evaluate the PK profile (24 hour
      profile and trough levels) and the safety, tolerability and efficacy of four different
      zamicastat doses. Each patient will start treatment with the lowest dose (50 mg zamicastat
      once daily) and the dose will be up-titrated to the individual highest tolerated dose (HTD)
      i.e. up to 200 mg zamicastat once daily.

      A data safety monitoring board (DSMB) will periodically review the safety data and will issue
      a recommendation if the doses can be used as planned.

      This study will consist of:

        -  A screening period, 5 to 12 days: visit V1

        -  Up to four dose finding periods, 14 days each:

             -  Dose A: visits A1, A2 and A3

             -  Dose B: visits B2 and B3

             -  Dose C: visits C2 and C3

             -  Dose D: visits D2 and D3

        -  Maintenance period, 42 days: visits MPV1, MPV2 and MPV3

        -  Follow-up period, 14 to 28 days: visits FU (down-titration) and FU
    

Intervention name(s): Zamicastat
Intervention type(s): Drug
Intervention description(s): Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)
Other intervention name(s): BIA 5-1058
Intervention MeSH terms: Zamicastat
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAH; BIA 5-1058; Zamicastat; Bial; Bial - Portela & Ca, S.A.; dopamine ß-hydroxylase (DßH) inhibitor; vascular obstruction; pulmonary arteries; right-heart catheterisation (RHC); idiopathic; rare lung disease
Application of Hyperoxygenated Fatty Acids in a Surgical Wound After Laparoscopic Cholecystectomy.
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection; Surgical Wound
Study type: Interventional

Summary: 
      TITLE:

      Application of hyperoxygenated fatty acids (PrevOmega) in a surgical wound of the umbilical
      trocar after laparoscopic cholecystectomy with placement of prostheses in patients with risk
      factors.

      OBJECTIVE: This study aimed to evaluate the effect of topical application of hyperoxygenated
      fatty acids (AGHO), PrevOmega, at the umbilical trocar level after laparoscopic
      cholecystectomy with prosthesis placement, regarding its non-application, on the infection
      rate. of the surgical site (ISQ) and eventration of the trocar orifice (EOT), in patients
      with risk factors for ISQ AND EOT.

      METHODS: A prospective, double-blind, randomized study was performed in patients operated on
      for scheduled cholelithiasis, who also had any of the following risk factors that increase
      the appearance of SSI or OOT: BMI> 30kg / m2, Diabetes Mellitus, age> 65 years and Chronic
      Obstructive Pulmonary Disease. Group A was administered physiological saline (SSF) at the
      umbilical trocar level at the end of the intervention versus the administration of PrevOmega
      to group B. The study was carried out between January 2018 and January 2020 and is registered
      in the European Database of Clinical Trials with the EudraCT Code: 2018-002260-67.
    

Detailed description: 
      This study aimed to evaluate the effect of topical application of hyperoxygenated fatty acids
      (AGHO), PrevOmega, at the umbilical trocar level after laparoscopic cholecystectomy with
      prosthesis placement, regarding its non-application, on the infection rate. of the surgical
      site (ISQ) and eventration of the trocar orifice (EOT), in patients with risk factors for ISQ
      AND EOT.
    

Intervention name(s): PrevOmega; Physiological saline
Intervention type(s): Procedure; Procedure
Intervention description(s): The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of AGHO depending on the randomization performed.; The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of SSF depending on the randomization performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Effect of Hyaluronic-acid on the Healing After Free Gingival Graft
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the effect of topical hyaluronic acid (HA) application on free gingival
      graft (FGG) donor and recipient sites during the early wound healing period with laser
      Doppler flowmetry (LDF) and to investigate the effect of HA application on the dimensional
      change of the graft.Participants were randomly classified into the test group (TG) and
      control group (CG). HA was applied to both donor and recipient sites in 20 patients who
      formed the TG, whereas HA was not applied to the 20 patients who formed the CG.
    

Detailed description: 
      The healing of a transplanted tissue depends on the formation of blood support between the
      donor and recipient sites.

      Hyaluronic acid (HA) is a biomaterial that creates a favorable environment for wound healing
      due to its unique hydroscopic and viscoelastic properties, and it is important for wound
      healing activities.HA induces angiogenesis following degradation and improves the wound
      healing environment.HA supports a mechanism that induces proliferation of capillaries, and
      components produced after HA degradation increase vascularization.Laser Doppler flowmetry
      (LDF) technique is frequently used in the field of plastic surgery for monitoring
      microvascular blood flow to detect insufficient circulation in the skin transplants and flaps
      in the early period and to thereby prevent and predict possible surgical complications.
    

Intervention name(s): Hyaluronic acid group
Intervention type(s): Biological
Intervention description(s): Applicaton of topical Hyaluronic acid
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After FGG was taken from the donor region in the TG, sterile gauze was applied with moderate pressure for 2 minutes, and HA was applied topically after the bleeding stopped. In the TG, HA was applied to the entire recipient bed before suturing the graft taken from the palatial mucosa to the recipient site. In the control group (CG), HA was not applied to the recipient or the donor site.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Prevalence of Distal Radial Artery Occlusion in Cardiovascular Catheterization Via Distal Radial Access
Condition: Catheterization; Complications; Distal Radial Artery
MeSH terms: Arterial Occlusive Diseases
Study type: Observational [Patient Registry]

Summary: 
      Explore the prevalence of distal radial artery occlusion after cardiac catheterization via
      distal radial artery and the risk factors
    

Detailed description: 
      Cardiac catheterization via distal radial artery is prevalent worldwide, which can reduce the
      prevalence of radial artery occlusion. However, the distal radial artery occlusion has not
      been detected. This study is designed to explore the prevalence of distal radial artery
      occlusion in patients undergoing cardiac catheterization via distal radial access at 1 day
      and 3 months after the procedure, which is explored by ultrasound. In addition, the risk
      factors of distal radial artery occlusion are also analyzed.
    

Intervention name(s): cardiac catheterization via distal radial artery
Intervention type(s): Procedure
Intervention description(s): cardiac catheterization via distal radial artery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The subjects consist of patients who present to the cardiac catheterization laboratory for
        an angiogram or percutaneous intervention for the first time.
      
Keywords: distal radial artery occlusion;cardiac catheterization
Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or
      without adenoidectomy may be as high as 75%.

      Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and
      serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic
      antiemetic treatments:

        -  dexamethasone alone (250 mcg/kg)

        -  dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)

        -  dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).
    

Detailed description: 
      Tonsillectomy with or without adenoidectomy may be associated with severe postoperative
      nausea and vomiting (PONV). Causes are principally trigeminal nerve stimulation and presence
      of blood in the stomach. Consequences are disagreement, unsatisfactory, delayed discharge,
      and overnight admission in day-cases. More barely, patients may also have suture and
      esophagus rupture, aspiration of gastric contents, dehydration and electrolyte disturbances.

      Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and
      serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic
      antiemetic treatments:

        -  dexamethasone alone (250 mcg/kg)

        -  dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)

        -  dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).

      The hypothesis is that the combination of dexamethasone and droperidol is as effective as the
      combination of dexamethasone and ondansetron, both of them being more effective than
      dexamethasone alone. Moreover, droperidol is cheaper than ondansetron and may be recommended
      as a first-line treatment.
    

Intervention name(s): Dexamethasone; Dexamethasone and droperidol; Dexamethasone and Ondansetron
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.; Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.; Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Droperidol; Ondansetron; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: PONV; Dexamethasone; Droperidol; Ondansetron; Tonsillectomy
High Agreement Between the Danish Ventral Hernia Database and Hospital Files in Region Zealand
Condition: Data Agreement Between a Database and Hospital Files After a Ventral Hernia Repair
MeSH terms: Hernia; Hernia, Ventral
Study type: Observational

Summary: 
      Is there agreement between data in the Danish Ventral Hernia Database and patient files
    


Intervention name(s): Ventral hernia repair
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Hernia repairs performed in Region Zealand and registered in the Danish Ventral Hernia
        Database during the study period
Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness and safety of reslizumab in the
      treatment of subjects with poorly controlled asthma.
    

Detailed description: 
      Objectives:

      Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with
      active asthma and eosinophilic airway inflammation.

      Secondary:

        -  To study the ability of reslizumab to reduce induced sputum eosinophil (EOS) counts in
           subjects with asthma.

        -  To study the ability of reslizumab to reduce the number of eosinophilic clinical asthma
           exacerbations (CAE) in subjects with asthma. A CAE is defined as a ≥ 20% decrease in
           forced expiratory volume in 1 second (FEV1; absolute value) from the baseline value or a
           requirement for emergency treatment of asthma, hospital admission for asthma or
           treatment with three or more days of oral corticosteroids (OCS) for asthma worsening.

        -  To assess the safety and tolerability of reslizumab in subjects with asthma.
    

Intervention name(s): Reslizumab; Saline
Intervention type(s): Biological; Other
Other intervention name(s): Cinquil™; CEP-38072; CTx55700
Intervention MeSH terms: Reslizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cinquil™; Reslizumab
Pilot Study of an Innovative Physiotherapy in Patients With Infantile Spinal Muscular Atrophy (SMA)
Condition: Infantile Spinal Muscular Atrophy of Type 2 or 3
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Neuromuscular Diseases; Spinal Muscular Atrophies of Childhood; Atrophy
Study type: Interventional

Summary: 
      This clinical trial aims to test a new physio-therapeutic approach tailored to type 2 and 3
      Spinal Muscular Atrophy patients, based on physical training in swimming-pool. This specific
      exercise should promote motor skills of trained patients, as we have observed in different
      mouse models. Patient's motor skills will be assessed using different scales including MFM
      and Hammersmith.

      This clinical trial attempts to develop a new non-invasive motor scale with sophisticated
      instruments.

      This scale will be useful in future clinical trials on SMA, given the lack of sensitivity of
      currently available scales.

      In addition, the study attempts to validate a questionnaire on post-exercise physical
      well-being.
    

Detailed description: 
      This multicenter study is based on a longitudinal assessment of the natural disease
      progression and on the effects of exercise protocol in a swimming pool. This study will
      compare patients to themselves after determining motor skills and the disease natural course
      for 12 months.

      The study will compare different scales (MFM, Hammersmith) to our new innovative scale based
      on non-invasive analysis of motor skills.

      30 patients will be enrolled and tested with MFM, Hammersmith and our non-invasive scale
      every 6 months for a total of 18 to 36 months due to the slow natural progression of the
      disease.

      Among these 30 patients, 10 patients will be selected to perform a 6 months training in a
      swimming pool, from 12 to 18 months or 18 to 24 months or 24 to 30 months after enrollment,
      in defined and reproducible conditions.

      These trained patients will finally be reassessed at 18 and 24 months or 24 and 30 months or
      30 and 36 months to test the therapeutic effect of the training compared to the slope of the
      natural disease progression, and other parameters.

      Only patients who have undergone training in the swimming pool will be reevaluated at 24 or
      30 or 36 months (6 months post-training) to assess long term exercise effects.
    

Intervention name(s): Physical exercise in a swimming pool during 6 months
Intervention type(s): Other
Intervention description(s): 10 patients will undergo a training program of physical exercise in a swimming pool, 3 days per week during 6 months. Each session will last for 20 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neuromuscular disease, Spinal Muscular Atrophy, Infantile,; motor function measure, Hammersmith scale,; rehabilitation program, physical exercise