bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1 Study for Safety and Tolerability of EBI-005 Topically Administered to Eyes of Healthy Adult Subjects
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First-In-Human (FIH) study to assess the safety and tolerability of ocular
      administration of EBI-005 in healthy volunteers. Additionally, the PK and immunogenicity of
      EBI-005 will be assessed.
    

Detailed description: 
      The planned dose levels are 5 mg/mL EBI-005 (Group 1) and 20 mg/mL EBI-005 (Group 2).

      A total of 8 subjects will be dosed in each group with subjects randomized in a ratio of 6:2,
      EBI-005:placebo. Treatment administration in Group 2 will proceed following a review of
      safety data from Group 1. In both groups, subjects randomized to active treatment will
      receive EBI-005 in the right eye and placebo in the left eye. Subjects randomized to placebo
      will receive placebo in each eye.
    

Intervention name(s): EBI-005-1; EBI-005-1 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EBI-005-1 is an intervention to two different study arms: 5mg/ml Vs Placebo and 20 mg/ml Vs Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Interleukin 1 Receptor Inhibitor; Dry Eye
Cocaine Effects in Humans: Physiology and Behavior - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effects of buprenorphine or methadone maintenance
      on cocaine taking and on the physiological and subjective effects of cocaine, including
      cocaine craving, in opiate-dependent cocaine users.
    


Intervention name(s): Methadone
Intervention type(s): Drug
Intervention description(s): normal maintenance dose
Intervention MeSH terms: Methadone
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: self-administration
Autonomic Modulation and Facial Expression in Autism Spectrum Disorder
Condition: Autistic Disorder; Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      Background: the autism spectrum disorders (ASD) can be related with abnormalities in cortical
      structures and cause behavior imbalances. In addition, as soon as the diagnosis is done, the
      better will be the prognosis. In this context, heart rate variability (HRV) stands out, which
      is a non-invasive tool representing autonomic modulation, with potential prognostic value.
      The literature showed there are no changes in HRV at rest using linear methods of analysis,
      but changes can be identified during tasks. Nonlinear methods of HRV are more sensitive and
      provide additional information to the linear. Objective: to analyze autonomic modulation
      using nonlinear and linear indexes of HRV in children with ASD at rest and during tasks in
      comparison to typical children. In addition, to correlate HRV analysis between them, also
      between behavior and severity of the disease. Methods: this study involves both typical
      children and children with ASD. Autonomic modulation will be performed using nonlinear
      indices (extracted from Poincaré plot, detrended fluctuation of tendency analysis and
      recurrence plot) and linear indices of HRV in the time (RMSSD e SDNN) and frequency domain
      (LF, HF, VLF). The tasks consist in games to identify and recognize faces and facial
      expressions. Behavior and severity of the disease will be evaluated using the Autism Behavior
      Checklist and the Childhood Autism Rating Scale respectively. Statistical Analysis: to
      identify differences between moments and protocols two-way analysis of variance will be used
      along with the Bonferroni post-test or Dunn post-test according to the data distribution.
      Statistical significance will be set at 5%.
    


Intervention name(s): Autonomic evaluation
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children with autistic disorder or typical development.
      
Keywords: Autonomic Nervous System; Sympathetic Nervous System; Heart Rate
Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI
Condition: Acute Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is is to demonstrate superiority of Polyoxidonium, nasal and
      sublingual spray, 6 mg/ml over placebo in children aged from 1 to 12 years with acute
      respiratory viral infections. This is a multicenter prospective, randomized, double-blind,
      placebo-controlled, parallel-group phase 3 study.
    

Detailed description: 
      This is a multicenter prospective, randomized, double-blind, placebo-controlled,
      parallel-group phase 3 study to evaluate efficacy of Polyoxidonium spray 6 mg/ml on acute
      respiratory viral infections symptoms in children population. A study will last for 13 days
      (maximum) for each participant and will include 6 visits: Day 0 (Screening), Day 1, Day 3,
      Day 5, Day 8 ±1, Day 12 ±1. Express tests will be performed at the screening visit to exclude
      subjects with influenza or streptococcal infection. All eligible subjects will be treated
      with Polyoxidonium spray 6 mg/ml or placebo spray for 7 days. Clinical blood and urine tests
      will be performed at days 0 and 8 ±1. Symptom Assessment Scale (SAS) will be filled in at
      days 0, 1, 3, 5 and 8 ±1. Integrative Medicine Outcome Scale (IMOS) will be filled in by
      investigator and a parent/adopter at day 8 ±1. Adverse events information will be collected
      at days 1, 3, 8 ±1 and 12 ±1.
    

Intervention name(s): Polyoxidonium 6 mg/ml; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:
in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).; Placebo nasal and sublingual spray will be administered for 7 days:
in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours).
Other intervention name(s): Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml; Placebo, Nasal and Sublingual Spray
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ARI, acute respiratory infection
New Conservative Technique for Placenta Accreta Spectrum
Condition: Placenta Accreta Spectrum
MeSH terms: Placenta Accreta
Study type: Interventional

Summary: 
      participants diagnosed as placenta accreta spectrum were subjected to cesarean delivery.

      Investigators manually detected a plan of cleavage through which the placenta was separated
      followed by closure of defective placental bed.

      Data were collected about the outcome.
    

Detailed description: 
      Demographic data, detailed history taking, routine blood tests were done. Trans-abdominal and
      trans-vaginal ultrasound to diagnose placenta accreta spectrum ( PAS). Detecting new signs to
      help sure diagnosis of PAS.

      Cesarean section will be performed through extended transverse supra-pubic incision bladder
      dissection from anterior uterine wall using electro-coagulation instruments and double
      ligation of large caliber bridging vessels.

      Uterine incision above the placental bulge by at least 5 mm then complete separation of the
      placenta starting from least resistance plans to high resistant one leaving a clear defect
      which will be closed by running sutures from inside the uterus and controlling placental bed
      hemorrhage then closing the uterine incision with compressing the bed from outwards ( double
      compression sutures ) internal Iliac artery ligation may be done as a complementary measure
      to control the bleeding from abnormal pelvic vasculature, insertion of intraperitoneal drain
      and closure of abdominal wall in layers.
    

Intervention name(s): ultrasound; closure of uterine wall defect
Intervention type(s): Diagnostic Test; Procedure
Intervention description(s): trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode; uterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen.
Other intervention name(s): Double compression suture
Intervention model: Single Group Assignment
Intervention model description: Investigators conducting prospective study for management of placenta accreta spectrum including diagnosis and uterine sparing surgery.
Masking: None (Open Label)
Primary purpose: Treatment
Effect of the Transcranial Direct Current Stimulation on the Dopaminergic Transmission in Healthy Subjects
Condition: Transcranial Direct Current Stimulation; Dopamine
Study type: Interventional
Phase: Phase 3

Summary: 
      Transcranial direct current stimulation (tDCS) is a technique that is emerging as a
      prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal
      tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement
      of cognitive functions and mood. Despite an increased use in clinical settings, tDCS suffers
      from limitations, especially regarding the strength and the duration of therapeutic effects.
      Strategies to optimize the conditions for tDCS application suffer from the lack of knowledge
      about its neurophysiological impact. Moreover, tDCS is increasingly used in private settings
      through commercial apparatus and tutorials to make a "do-it-yourself" device delivering tDCS
      now available on the Internet. This private use worries neuroscientists and health
      authorities. Even if the general impression is that, in controlled conditions, tDCS is safe
      with only mild and transient adverse effects, whether and how tDCS could be used for
      enhancing cognition in healthy subjects are needed to investigate in more detail. The
      investigators believe that a better understanding of some neurobiological effects of tDCS is
      crucial to further tailor tDCS for experimental and therapeutic applications and to define
      recommendations for a private use.

      As the cortex is densely connected with basal ganglia areas, including dopaminergic areas,
      tDCS is probably not only capable to target cortical but also subcortical structures remote
      from the stimulation sites. Some studies suggest that cortical stimulation by other
      approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased
      dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been
      investigated only indirectly in pharmacological studies. Thus, the direct effect of the DLPFC
      stimulation by tDCS on dopaminergic transmission is still unknown.

      The aim of this project is to reveal the online impact of a single-session of tDCS applied
      bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by
      PET, combined with the [11C]raclopride bolus-plus-continuous-infusion method.
    


Intervention name(s): Procedure: active tDCS; Procedure: sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Intensity 2 mA during 20 minutes; sham condition as delivered by the stimulator
Other intervention name(s): tDCS placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: tDCS; Dopamine; PET
Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The study aims to further assess the safety, efficacy and the performance of its delivery
      system of FIREHAWK rapamycin-eluting stent up to five years.
    

Detailed description: 
      This is a prospective open-labeled, multi-center, single-arm observational registry study.
      Approximately 1,100 subjects will be enrolled to evaluate the TLF as the primary endpoint at
      12-month. Also, the study will follow up those subjects up to 5 years as the secondary
      endpoints.
    

Intervention name(s): FIREHAWK biodegradable polymer rapamycin-eluting stent
Intervention type(s): Device
Intervention description(s): DES PCI for CAD
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DES; CAD; FIREHAWK; MicroPort; PCI
Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Humans
Condition: Endocrine System Diseases
MeSH terms: Endocrine System Diseases
Study type: Interventional

Summary: 
      With this study the investigators investigate the effects of amino acids (tryptophan in two
      different concentrations, leucin) and sugar alcohols (xylitol, erythritol) on satiety
      mechanisms.
    


Intervention name(s): 0.52 g L-Tryptophan; 1.56 g L-Tryptophan; 1.56 g L-Leucine; 50 g Xylitol; 75 g Erythritol; 75 g Glucose; 300 mL tap water; 50 mg 13C-sodium acetate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention MeSH terms: Erythritol; Tryptophan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Bread Study: Comparison of the Tolerance of Spelt and Wheat Bread
Condition: Non-celiac Gluten Sensitivity; Wheat Intolerance
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This project aims to verify the hypothesis that spelt products are more tolerable than bread
      wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In
      addition, the influence of different manufacturing processes will be considered.
    

Detailed description: 
      Wheat cereals are known to be capable of triggering wheat allergy and celiac disease. The
      prevalence of both diseases is about 1%. Recently, another clinical entity was described, the
      non-celiac wheat sensitivity (NCWS). The origin and mechanisms of NCWS are unclear at
      present, but the existence of this new disease entity has been proven by double-blind
      placebo-controlled challenge tests. Three different grain components have been proposed as
      triggers of NCWS, gluten, α-amylase trypsin inhibitors or fermentable carbohydrates
      (FODMAPs).

      It is reported that individuals with self-diagnosed NCWS quite often tolerate spelt products
      much better, even though spelt shows a higher gluten content than bread wheat products.
      Therefore, the question arises whether this putative spelt tolerance can be confirmed on an
      objective basis and whether the underlying molecular mechanisms can be elucidated. So far,
      human study addressing such questions are lacking.

      This project aims to verify the hypothesis that spelt products are more tolerable than bread
      wheat products in a target group of individuals with self-diagnosed wheat sensitivity. In
      addition, the influence of different manufacturing processes on wheat sensitivity will be
      revealed.

      For this purpose, the trial involves individuals with self-diagnosed wheat sensitivity and
      spelt tolerance. Six different kinds of bread will be tested, including 4 wheat and spelt
      breads, each of them produced following a traditional or a conventional way. Aim of this part
      is to objective bread wheat and spelt intolerance in a defined population. To find out
      whether FODMAPs or gluten affect the tolerance of bread, two additional breads will be
      tested, a gluten-free bread with added gluten and a gluten-free bread with added FODMAPs.
    

Intervention name(s): bread
Intervention type(s): Other
Intervention description(s): Different types of bread
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Human Nutrition; NCWS; Spelt; Wheat Bread
Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy
Condition: Polyethylene Glycol; Sodium Phosphate
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to compare polyethylene glycol and sodium phosphate for colonic cleansing of
      colonoscopy.
    


Intervention name(s): polyethylene glycol; sodium phosphate
Intervention type(s): Drug; Drug
Intervention description(s): All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For polyethylene glycol group (group P): the day before colonoscopy, 750 mL (1 box) of polyethylene glycol solution should be drunk 2 hours after dinner; the other 1500 ml (2 boxes) of polyethylene glycol solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same juniar clinician, and related indicators were recorded.; All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For sodium phosphate group (group S), 750 mL (1 box) of sodium phosphate solution should be drunk 2 hours after dinner; and the other 750 mL (1 box) of sodium phosphate solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same clinician, and related indicators were recorded.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Persistence-Targeted Smoking Cessation
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators propose to develop a theory-based smoking cessation intervention (called
      Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling
      sessions and use of nicotine lozenge for 12 weeks. The investigators will test the
      feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and
      prolonged abstinence).
    

Detailed description: 
      In this Stage I Behavioral & Integrative Treatment Development (R34) project, we propose to
      develop a theory-based smoking cessation intervention (called Persistence-targeted smoking
      cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine
      lozenge for 12 weeks. We will test the feasibility and preliminary efficacy of the
      intervention (i.e., cigarettes per day and prolonged abstinence). We hope to develop a
      feasible psychosocial treatment for use in a later randomized controlled trial.
    

Intervention name(s): Persistence Targeted Smoking Cessation; Clearing The Air; Nicotine lozenge
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation"); 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air; 12-weeks 4mg nicotine lozenge
Other intervention name(s): PTSC; CTA
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tobacco; smoking cessation; nicotine dependence
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of
      the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison
      to each component administered in healthy male volunteers.
    


Intervention name(s): gemigliptin and metformin HCl extended release; gemigliptin/metformin HCl extended release
Intervention type(s): Drug; Drug
Intervention description(s): Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day; Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A New Alternative to Traditional Hysteroscopy
Condition: Intrauterine Diseases; Myomas; Polyps
Study type: Interventional

Summary: 
      Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine
      diseases. The development of smaller hysteroscopes allowed to change the approach to the
      intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al.
      developed a mini-resectoscope feasible for "see&treat" hysteroscopy. The objective of the
      study is to compare the new 16 Fr mini28 resectoscope by Gubbini with Traditional 22 Fr
      resectoscope and Bettocchi 15 Fr hysteroscope for the treatment of uterine cavitary lesions.
      The investigators enrolled 401 women affected by endometrial polyps and/or G0 myomas,
      randomly allocated to receive the treatment with traditional resectoscope (127 women), with
      mini-resectoscope by Gubbini (142 women) and Bettocchi hysteroscope (132 women). Operating
      time, distension media delivered, dismiss time and discomfort experienced were recorded.
    


Intervention name(s): resectoscopy
Intervention type(s): Procedure
Intervention description(s): hysteroscopy for myomas G0 and/or polyps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endometrial pathology