bioihbjkbjnl/mcl2 huggingface dataset:
Platelet Reactivity in Stent Thrombosis Patients
Condition: Coronary Artery Stent Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Recent studies have demonstrated a marked interindividual variability of clopidogrel's
      capacity to inhibit platelet aggregation with a substantial proportion (11-34%) of the
      patients considered non-responders to clopidogrel treatment. Variable intestinal absorption
      is suggested to contribute to the inconsistencies in response to clopidogrel. However, little
      is known about intestinal absorption in subjects who had suffered from a stent thrombosis.
      The MAPCAT-study has been designed to investigate whether plasma pharmacokinetics
      (represented by Cmax, Tmax and the AUC) after a 600 mg loading dose are significantly
      different between subjects who have suffered a stent thrombosis and subjects who have not
      suffered a stent thrombosis.
    

Detailed description: 
      Objectives:

      The first objective of the MAPCAT-study is to investigate whether plasma pharmacokinetics
      (Cmax, Tmax and AUC) of an additional 600 mg loading dose are impaired in patients with a
      history of stent thrombosis.

      The second objective of the MAPCAT study is to investigate whether genetic polymorphisms in
      receptors, enzymes and ligands involved in the process of thrombosis and haemostasis as well
      in the conversion-process of clopidogrel into its metabolites do have influence on both the
      absolute magnitude of platelet inhibition and Cmax, Tmax and AUC.
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): both arms of the study (patients with a history of stent thrombosis as well as patients who did not suffer from a stent thrombosis) will be given a 600 mg loading dose of clopidogrel
Other intervention name(s): Plavix
Intervention MeSH terms: Clopidogrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: clopidogrel; pharmacokinetics; platelet function tests; platelet reactivity
tDCS Effects on GABA Concentration and Brain Functional Connectivity in Older Adults Of Working Age
Condition: Healthy Older Adults
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a
      decrease of GABA concentration and alterations of functional brain connectivity in older
      people, compared to sham tDCS.
    


Intervention name(s): tDCS; sham-tDCS
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: GABA concentration; tDCS
An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer
Condition: Locally Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of
      sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by
      4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or
      cytologically confirmed axillary lymph nodes metastasis.
    


Intervention name(s): Neoadjuvant Chemotherapy with Docetaxel
Intervention type(s): Drug
Intervention description(s): Doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (day 1), IV (in the vein), every 21 days, a total of 4 cycles -> Docetaxel 100 mg/m2 (day 1) IV, every 21 days, a total of 4 cycles
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Capsaicin nasal spray is used in daily practice against IR without knowledge about the exact
      mechanisms involved in this treatment. Therefore, this study aims to address this issue by
      studying the functional (electrophysiologic) changes after specific stimulations in IR
      patients and healthy controls before and after capsaicin/placebo treatment.
    

Detailed description: 
      As an essential step towards the improvement of the treatment of IR we will investigate the
      neural mechanisms underlying the therapeutic action of capsaicin. In particular, we plan to
      evaluate the effects of capsaicin on the functional properties of the innervation of nasal
      mucosa by monitoring the trigeminal nerve activity using measurements of negative mucosa
      potentials (NMP). NMPs, will be evoked by chemical and thermal stimuli in IR patients and
      healthy controls. Considering the evidence suggesting a role of sensory C-fibers in the
      pathophysiology of IR, we will employ low concentrations of irritants that specifically
      activate receptors expressed in those fibers, i.e., capsaicin for TRPV1 and cinnamaldehyde
      and allyl-isothiocyanate (mustard oil) for TRPA1. The same stimulations will be performed
      immediately after capsaicin treatment, and after 4 weeks, 3 months and 6 months. This will
      allow for an objective assessment of the functionality of the C-fiber innervation before the
      treatment, during the phase of therapeutic response and during the period of recurrence of
      the IR symptoms. The results of the NMP measurements will be contrasted with the therapeutic
      response and with evaluations of nasal congestion, nasal sensitivity and the presence of
      neuro-mediators found in nasal biopsies. Importantly, the independent assessment of the NMP
      responses mediated by either TRPV1 or TRPA1 will allow determining the specific role of these
      nociceptors in the pathophysiology of IR, which, in turn, may help to design more specific
      and effective therapies.
    

Intervention name(s): Capsaicin; diluent
Intervention type(s): Biological; Biological
Intervention description(s): Thirty-three* well-characterized IR patients will be recruited and screened for participation in this study with nasal capsaicin spray (0,1 mmol/l ) using the treatment regimen described by van Rijswijk et al. (1 x 5 applications in one day, with 1 hour between each application); diluent
Intervention MeSH terms: Capsaicin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the novel oral agent VT-1161 is safe and
      effective in treating patients with moderate - severe tinea pedis (also referred to as
      athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal
      growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the
      fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole
      antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this
      results in many of the side effects associated with the azole antifungals. The safety profile
      of the class similarly limits use in chronic treatment of non-life-threatening fungal
      infections. A safer antifungal drug would improve treatment options for infections seen in
      otherwise healthy individuals where significant side-effect risks are unacceptable.
    


Intervention name(s): VT-1161; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses
Condition: Flexible Flatfoot
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the effects of 3D printed insoles versus
      prefabricated insoles in otherwise healthy subjects with flatfoot condition.

      The main question it aims to answer is:

        -  If 3D printed insoles are better in terms of fit, weight, durability, comfort, and
           effectiveness compared to prefabricated insoles.

        -  If 3D printed insoles are better in terms of reducing pain compared to prefabricated
           insoles.

      Participants will be divided in two groups. One group will receive 3D printed insoles and
      other group will wear prefabricated insoles for four weeks. After four weeks, researchers
      will record their feedback about their insoles which will help them to compare the two
      insoles.
    

Detailed description: 
      The purpose of this research is to compare the effects of 3D printed insoles versus
      prefabricated insoles in flatfoot subjects. This study will recruit healthy adult subjects
      with flexible flat feet but otherwise good physical and mental health. They will be divided
      into groups of an equal number of people. Prefabricated insoles will be given to one group,
      while 3D printed insoles will be given to the other. Subjective feedback will be collected at
      week zero, when the subjects will be given the insoles to wear, and again at the end of
      fourth week. Statistical analysis will be used to determine whether or not there is a
      significant difference in the responses of the two groups. The results will help us in
      identifying which insoles are better than the other in terms of parameters described above.
    

Intervention name(s): 3D Printed Foot Orthosis; Prefabricated Foot Orthosis
Intervention type(s): Device; Device
Intervention description(s): 3D printed foot orthoses designed and fabricated at the Taibah University; Generic foot orthoses available commercially
Other intervention name(s): Insoles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Amino Acid Feed Children's Study
Condition: Milk Hypersensitivity
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional

Summary: 
      This study of the tolerance and acceptability of an amino acid based feed will assess
      gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste,
      smell, texture in 20 patients between 1-10 years currently using or requiring an amino acid
      based feed for the dietary management of Cows' Milk Allergy and food-allergy-associated
      conditions, over 4 weeks.
    

Detailed description: 
      Dietary management of Cows' Milk Allergy (CMA) involves avoiding cow's milk protein in the
      diet, whilst ensuring that an adequate nutritional intake is achieved with suitable
      alternative foods or prescribable feeds. A number of studies and clinical insights indicate
      that CMA is persisting longer than infancy, into later childhood and becoming more complex.
      If a child has CMA, eliminating the offending allergens whilst maintaining an intake of food
      that meets their nutritional requirements for growth and development is challenging due to
      the significant nutritional contribution these foods make to a child's diet, particularly
      milk and dairy products. This supports the need for alternatives to cow's milk to be
      available for children >1year of age to help meet their nutritional needs. Aminoacid based
      feeds are already widely used in clinical practice to meet this need. A new nutritionally
      complete amino acid based powdered feed for the dietary management of CMA, or other
      conditions where an amino acid based is recommended, in children aged 1-10yrs old, has been
      developed.

      This study is to support the use of this new amino acid based feed in clinical practice. The
      study will evaluate the tolerance and acceptability of the amino acid based powdered feed in
      20 children aged 1-10yrs of age receiving or requiring an amino acid based feed for the
      dietary management of CMA and food allergy associated conditions, over 4 weeks. The primary
      outcome will be gastrointestinal tolerance, with secondary outcomes of compliance,
      acceptability, nutrient intake and anthropometry.
    

Intervention name(s): Amino Acid Feed
Intervention type(s): Dietary Supplement
Intervention description(s): Each child will receive the amino acid based feed for a period of up to 4 weeks (28 days). The feed prescription will be determined on an individual basis by the Dietitian responsible for the child's nutritional management. The child will take the feed orally or via a pre-existing naso-gastric, gastrostomy or jejunostomy tube.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution OCT
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Observational

Summary: 
      The OCT used in this trial offers the advantage of both a non-contact method and a very high
      axial resolution. Determined parameters with the highest potential of diagnostic
      discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this
      trial is to investigate differences of specific parameters of epithelium thickness maps at
      healthy eyes and eyes with Keratoconus.
    


Intervention name(s): OCT-scanning
Intervention type(s): Device
Intervention description(s): All participants will be scanned with a OCT-device
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Eyes with Keratoconus Healthy eyes
      
Keywords: Keratoconus; Optical Coherence Tomography; Corneal Epithelium Thickness Maps
The Effect of Leg Position on the Sciatic Nerve on Sonogram
Condition: Sciatic Nerve Block
Study type: Observational

Summary: 
      Little is known about which posture of lower extremity makes it easier to access to the
      sciatic nerve. In this study, the investigators aimed to identify the most appropriate
      positioning of the lower extremity during anterior-approach ultrasound-guided sciatic nerve
      block.
    


Intervention name(s): external rotation of leg; hip flexion and knee flexion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): external rotation of leg by 45 degrees; hip flexion by 15/45 degrees and knee flexion by 15/45 degrees
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing knee surgery requiring peripheral nerve block
Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach
Condition: Sinus Floor Elevation
Study type: Interventional

Summary: 
      Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height
      after dental extraction with sinus pneumatization. Several approaches for sinus floor
      elevation have been documented, and hence flapless transcrestal sinus floor elevation is
      minimally invasive technique which is used in moderately defected maxilla.

      Aim of the study: to evaluate both clinical and radiographic outcomes in sinus floor
      elevation following dental implant placement using flapless transcrestal sinus lift approach
      with Titanium platelet rich fibrin (TPRF) as a sole sinus graft material compared to Platelet
      rich fibrin (PRF).
    


Intervention name(s): Flapless transcrestal sinus lift approach with TPRF; Flapless transcrestal sinus lift approach with PRF
Intervention type(s): Other; Other
Intervention description(s): Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the TPRF as a sole grafting material.; Including 8 patients who will be treated by flapless transcrestal sinus floor elevation using the PRF as a sole grafting material.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™
Condition: Intervertebral Disk Degeneration; Intervertebral Disk Displacement
MeSH terms: Intervertebral Disc Degeneration; Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior
      Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.
    


Intervention name(s): Cervios ChronOs; NovoMax™
Intervention type(s): Device; Device
Intervention description(s): The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.; The ACDF surgery will be carried out with NovoMax™ after randomization procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment group: Bioactive Glass-Ceramic Spacer (NovoMax™) Active comparator: a PEEK cage Filled with β-Tricalcium Phosphate
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anterior cervical discectomy and fusion; NovoMax; Bioactive Glass-ceramic Intervertebral Spacer
Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effect of itraconazole on
      pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390
      tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and
      when co-administered with itraconazole. The exploratory objective of the study is to explore
      the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the
      pharmacokinetics of SHR6390.
    


Intervention name(s): SHR6390 tablet; Itraconazole capsule
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose of SHR6390 or co-administered with itraconazole.; 200 mg itraconazole was administered in the morning.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate and compare the effect of the amount of toothpaste used and brushing
      time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel
      fluoride uptake (EFU).
    


Intervention name(s): Sodium fluoride / silica and carbopol, 0.5g; Sodium fluoride / silica and carbopol, 1.5g; Sodium fluoride / silica and carbopol, 1.5g; Fluoride free dentifrice
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol; Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol; Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol; A non fluoride dentifrice was given to participants of each arm at washout period
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy
Condition: Graves' Disease; Graves' Ophthalmopathy
MeSH terms: Graves Disease; Eye Diseases; Graves Ophthalmopathy
Study type: Observational

Summary: 
      Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation
      forms and stages, made with Color Doppler Imaging
    

Detailed description: 
      Prospective study with Grave's patients in active and fibrotic disease, myogenic and
      lipogenic forms, with muscle restriction and without muscle restriction and with or without
      optic compressive neuropathy. Blood flow was studied with Color Doppler Imaging (CDI) in the
      following orbital vessels:

        -  Superior Ophthalmic Vein (main target of the study protocol)

        -  Retinal Central Vein

        -  Retinal Central Artery

        -  Ophthalmic Artery
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Grave's disease within the orbital service of HCFMUSP at the Ophthalmology
        Department
      
Keywords: Graves; Color Doppler Imaging; Graves' Ophthalmopathy; Orbital Venous Flow
Single Ascending Dose Study of RBP-7000
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess the safety and tolerability of injections of RBP-7000
      in subjects with stable schizophrenia
    

Detailed description: 
      This was an open-label, single-center, Phase 1, single ascending dose study, designed to
      evaluate the safety, tolerability, and pharmacokinetic (PK) profile of a single SC injection
      of low, medium and high doses of RBP-7000 in subjects with clinically stable schizophrenia
      who were not taking risperidone. The design was a sequential cohort with treatment initiated
      in 3 cohorts after safety and tolerability at a lower dose were confirmed.

      Eligible subjects received a single oral test dose of 0.25mg risperidone under medical
      supervision. Subjects who continued to be eligible were admitted to a residential unit for
      approximately 14 days, and received a single dose of RBP-7000. Subjects were discharged on
      Day 15 and returned to the clinical site weekly for approximately 10 weeks.
    

Intervention name(s): RBP-7000; risperidone
Intervention type(s): Drug; Drug
Intervention description(s): Sequential dosing of each cohort; All eligible subjects received a test dose of risperidone to ensure tolerability prior to dosing with RBP-7000.
Other intervention name(s): test dose
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Telephone Care Management to Address Sleep Problems in Young Children With Autism
Condition: Autism Spectrum Disorders; Insomnia
MeSH terms: Dyssomnias; Parasomnias; Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators will conduct a randomized controlled trial comparing a telephone based
      intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series
      of phone calls to assist caregivers in learning and modifying behavioral strategies that may
      help young children with autism to sleep better. Objective (activity monitors) and subjective
      (rating scales) data will be collected by an independent research assistant at the end of the
      project. The investigators hypothesize that TCM improves sleep duration and decreases sleep
      problems relative to a usual care control condition (UC).
    

Detailed description: 
      Please see brief summary.
    

Intervention name(s): Telephone Care Management; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia; educational handouts on pediatric insomnia
Other intervention name(s): TCM; UC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment