bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study to Characterize Individual Metabolic Profile
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to descibe the pharmacokinetics of 10 substrates of enzymes involved in drug
      metabolism and their metabolites, after administration singly and simultaenously at
      predefined doses in 10 health volunteers.
    

Detailed description: 
      The aim of this study is to test the administration of combination of substrates and thereby
      to characterise simultaneously the main enzymes and transporters involved in drug metabolism.
      The doses of substrates administered will first assessed in terms of safety and their
      appropriateness for determination of pharmacokinetic parameters. Ten volunteers will be used,
      this number having been defined in view of the aims of this proof-of-concept pilot
      study,ie,safety and determination of pharmacokinetic parameters. The number was not the
      result of statistical calculation.
    

Intervention name(s): 10 parents drugs adminstration
Intervention type(s): Drug
Intervention description(s): A single and concomittant administration of 10 parent drugs will be performed: Acetaminophene, cafeine, dextrometorphan, digoxin, memantine,midazolam, omeprazole, repaglinide, rosuvastatine, tolbutamide.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; enzymes; metabolism prediction
Maxillary and Mandibular Arch Response to RME: a Multicentric Randomized Controlled Trial
Condition: Posterior Crossbite
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Posterior crossbite is a common clinical condition often associated with transverse maxillary
      deficiency and functional mandibular shift. This frequent malocclusion is not self-correcting
      and can lead to the development of craniofacial asymmetries and mandibular dysfunction.

      The aim of the current study was to evaluate maxillary and mandibular arch widths' response
      to RME when it is anchored to the upper second deciduous molars or to the upper first
      permanent molars and to create a decision-making protocol for RME therapy in mixed-dentition
      patients.
    

Detailed description: 
      The effects of rapid maxillary expansion (RME) on the maxillary complex have been highly
      investigated,4 reporting a maximum maxillary intermolar and intercanine width increase of 6.7
      mm and 5.3 mm,5 respectively, when RME is banded on upper first permanent molars.

      Literature also reported cases of periodontal and endodontic damage on RME anchoring teeth;
      therefore, some authors have suggested banding RME on primary teeth and reporting also
      different mean intermolar (3.6-4.1 mm) and intercanine width increases (5-5.9 mm).

      Few studies have investigated the changes in molar dental tipping and inclinations (on
      average from 3° up to 16.7°) following RME but comprised difficult (ie, barium sulfate
      solution) and more invasive examinations such as computed tomography and cone beam computed
      tomography (CBCT) Few articles concerning the indirect effects on mandibular arch following
      RME reported a low but statistically significant increase of lower intermolar (0.66-0.97 mm)
      and intercanine width (0.9 mm). Since no studies in the literature have analyzed the
      differences in permanent vs primary molars as anchoring teeth for RME, the decision to band
      the permanent deciduous molars did not follow a clinical protocol, but an individual decision
      was made for each patient based on clinician experience.
    

Intervention name(s): Rapid maxillary expansion
Intervention type(s): Procedure
Intervention description(s): When rapid maxillary expander was in-situ, patients waited 7 days before starting the screw activation of one quarter turn a day (0.22 mm) until overcorrection. Expansion was considered adequate when the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp. When was achieved, rapid maxillary expander stayed in place for 10 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Youth-Nominated Support Team Intervention for Suicidal Adolescents
Condition: Suicide, Attempted
MeSH terms: Suicide; Suicide, Attempted
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will attempt to improve treatment adherence and reduce suicide risk among
      adolescents who are at risk for attempting suicide.
    

Detailed description: 
      Despite substantial knowledge about adolescent suicide risk factors, few studies have been
      conducted to identify effective interventions for suicidal adolescents.

      Youth-Nominated Support Team (YST) is an intervention designed to help suicidal adolescents
      after hospitalization. It is a psychoeducational social network intervention that targets
      poor treatment adherence and difficulties with social support. YST is designed to be a
      supplement to traditional or usual treatments.

      Participants are randomly assigned to receive either treatment as usual (TAU) or TAU plus YST
      for 3 months. Adolescents who receive TAU plus YST nominate three or four adults from their
      family, school, and community settings to function as support persons. The support persons
      participate in a psychoeducation session that focuses on the adolescent's psychiatric
      disorder(s), individualized treatment plan, importance of treatment adherence, and suicide
      risk factors. They also maintain regular contact with the adolescent to support treatment
      adherence and progress toward treatment goals. Adolescents have assessments at 6 weeks, 3
      months, 6 months, and 12 months. Internalizing behavior problems, perceived social support,
      treatment adherence, adaptive functioning, severity of depression and anxiety, severity and
      frequency of suicidal thoughts, and suicide attempts are assessed.
    

Intervention name(s): Youth-Nominated Support Team
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Suicide; Adolescence
Rivaroxaban 2.5 mg BID and Aspirin for Intermittent Claudication in PAD Patients
Condition: Peripheral Artery Disease; Intermittent Claudication
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is evaluating if rivaroxaban 2.5 mg BID and aspirin 100 mg OD compared to aspirin
      alone improves on intermittent claudication distance in PAD patients.
    

Detailed description: 
      Background: The COMPASS trial demonstrated that in patients with peripheral arterial disease
      the combination of rivaroxaban and aspirin compared with aspirin reduces the risk of major
      adverse limb events, but it is not known whether this combination can also improve symptoms
      in patients with intermittent claudication. The primary objective of this study is to
      evaluate the effect of the combination on intermittent claudication distance.

      Study design: Eighty-eight patients with intermittent claudication will be randomized to
      receive rivaroxaban 2,5 mg twice daily plus aspirin 100 mg once daily or aspirin 100 mg once
      daily for 24 weeks. The primary outcome is the change in claudication distance from baseline
      to 24 hours as measured by 6 minutes walking test and treadmill test. The main safety outcome
      is the incidence of major bleeding according to ISTH criteria.

      Summary: The COMPASS CLAUDICATION trial will provide high-quality evidence regarding the
      effect of the combination of rivaroxaban and aspirin on claudication distance in patients
      with peripheral arterial disease.
    

Intervention name(s): Rivaroxaban 2.5 Mg Oral Tablet
Intervention type(s): Drug
Intervention description(s): oral anticoagulants plus antiplatelet agent
Other intervention name(s): Aspirin 100 Mg oral Tablet
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arms, active comparator (vascular dose) versus aspirin alone
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Pain, Disability and Cervicokinesthesia After Cervical Manipulation
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Cervical spine manipulation has been found to be effective in patients with mechanical neck
      pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual
      intervention. In addition, some authors have proposed that spinal manipulation can alter
      proprioception of the cervical spine. The aim of this study will be to investigate the
      effects of cervical spine manipulation on pain, disability, widespread pressure pain
      sensitivity, and cervicokinethesia in patients with mechanical neck pain.
    

Detailed description: 
      Cervical spine manipulation has been found to be effective in patients with mechanical neck
      pain. Discrepancies exist on the side of manipulation and the placebo effect of this manual
      intervention. In addition, some authors have proposed that spinal manipulation can alter
      proprioception of the cervical spine. The aim of this study will be to investigate the
      effects of cervical spine manipulation on pain, disability and cervicokinethesia in patients
      with mechanical neck pain. Patients will receive cervical spine manipulation in either right
      or left side of the neck and will be assessed on pain intensity, neck-related disability,
      widespread pressure pain sensitivity, and cervicokinethesia by an assessor blinded to the
      allocation group.
    

Intervention name(s): Right Cervical Manipulation; Left Cervical Manipulation; Sham Cervical Manipulation
Intervention type(s): Other; Other; Other
Intervention description(s): We will use a high-velocity, mid-range, left rotational force to the right articular pillar of C3, on the right articular pillar of C4 with the patient in supine, with left rotation and right side-bending.; We will use a high-velocity, mid-range, left rotational force to the left articular pillar of C3, on the left articular pillar of C4 with the patient in supine, with right rotation and left side-bending.; The sham procedure will simulate C3/C4 manipulation in both sides without any therapeutic thrust
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervical spine; Spinal manipulation
Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure
Condition: Pulpotomy
Study type: Interventional

Summary: 
      Many deep carious teeth are treated unnecessarily by root canal therapy, while with using
      current techniques and advances in compatible dental materials in addition to better
      understanding of biological response of the dental pulp, many can be treated conservatively
      via vital pulp therapy procedures.
    

Detailed description: 
      Vital pulp therapy is recommended for teeth diagnosed with reversible pulpitis or partially
      inflamed pulps in which the remaining healthy tissue can be conserved and protected by a
      biologically active material to generate a hard tissue barrier that seals and protects the
      pulp from future microbial insult.

      The aim of this in vivo study is to clinically and radiographically assess the outcome of
      full pulpotomy using a calcium silicate based material (NeoMTA Plus) in permanent teeth with
      carious exposure.

      Ethics approval was obtained from the institutional ethics and research committee, and the
      patients were informed about details of the treatment and the possible complications. An
      informed consent was obtained. 120 patients meeting the inclusion criteria will be selected
      for this study and they will be subsequently followed up clinically and radiographically
      after 3 months, 6 months, 1 year and yearly afterward for 5 years.
    

Intervention name(s): calcium silicate based material,
Intervention type(s): Other
Intervention description(s): Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation
Other intervention name(s): Neo MTA plus, Avalon Biomed
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Intervention model description: Patients with symptomatic deep caries in a permanent molar tooth will receive pulpotomy treatment and placement of a calcium silicate based material (Neo MTA plus) over the pulp and followed by restoration.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: teeth; pulpitis; deep caries; pulpotomy; Mineral Trioxide Aggregate (MTA)
Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic Acid
Condition: Cathartic Colon
Study type: Interventional
Phase: Phase 4

Summary: 
      The aims of the present study is to compare oral sulfate solution (OSS) with low-dose
      polyethylene glycol plus ascorbic acid (2-L PEG/Asc) for bowel cleansing efficacy.
    

Detailed description: 
      High-quality bowel cleansing is critical to effective colonoscopy. Studies in the past decade
      have demonstrated that many clinical practices continue to have rates of adequate preparation
      as low as 60% to 80%.

      Low-volume preparations for colonoscopy are designed to improve patient tolerability, another
      important aspect of bowel preparation. In addition, low-volume preparations should ideally
      not sacrifice efficacy. There are few data comparing the efficacy of available low-volume
      bowel preparations.

      In this study, we describe a prospective, single-blind, randomized, controlled trial
      comparing oral sulfate solution (OSS) (SUPREP, Braintree Laboratories, Braintree, Mass) with
      low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc).
    

Intervention name(s): Oral sulfate solution (OSS); 2-L PEG/Asc
Intervention type(s): Drug; Drug
Intervention description(s): Oral sulfate solution (OSS); Low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) COOLPREP is a proprietary name of 2-L PEG/Asc.
Other intervention name(s): SUPREP; COOLPREP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Brain Responses to Intragastric Administration of a Bitter Agonist in Homeostatic and Hedonic Brain Regions
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators aim to study the brain mechanisms underlying the effect of subliminal (not
      consciously perceived) intragastric administration of bitter tastants on hunger and food
      intake, which was previously found. The investigators will assess brain activation patterns
      after an acute intragastric administration of Quinine-hydrochloride versus saline on two
      different test days, and will simultaneously assess a putative role of altered gut peptide
      release in these effects. The hypothesis is that intragastric infusion of a bitter agonist
      will decrease the activity in homeostatic and hedonic brain regions and that this effect is
      mediated by gut peptide release.
    


Intervention name(s): Quinine hydrochloride; Control
Intervention type(s): Other; Other
Intervention description(s): Intragastric administration of a bitter tastant agonist (10 μmol/kg quinine-hydrochloride); Intragastric administration of distilled water
Intervention MeSH terms: Quinine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder
Condition: Depressive Disorder; Anxiety Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its
      metabolites in connection with multiple oral dosing in child and adolescent patients with a
      DSM-IV-TR diagnosis of Depressive or Anxiety Disorder
    

Detailed description: 
      The study will be conducted in the US and in Europe and will include paediatric patients
      diagnosed with depressive or anxiety disorders of two age populations; children aged 7-11
      years and adolescents of the age 12-17 years. It is an open study to allow pharmacokinetic
      (PK) sampling of all patients and four dose levels will be tested. Following lower initial
      doses for 2 to 6 days, the patients will be treated once daily at the assigned dose levels
      for 14 days, and it is expected that patients may benefit from treatment during this period.
      As the treatment duration is not sufficient according to treatment guidelines, if judged or
      indicated by the investigator, the patients are offered to continue in an extension treatment
      of up to six months to allow possibility for therapeutic satisfaction.

      Preferably, the cohorts will be dosed in the following order: AC1, AC2, CC1, AC3, CC2, AC4,
      CC3, and CC4. An external data safety monitoring board (DSMB) will be established to evaluate
      safety, tolerability and preliminary PK data from the dosed cohort(s) prior to any dosing of
      subsequent cohort (s). The dose regimen may be adjusted based on the recommendation of the
      DSMB. Adolescents will be exposed to a certain dose of vortioxetine before children receive
      the same dose.
    

Intervention name(s): Vortioxetine; Vortioxetine; Vortioxetine; Vortioxetine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5 mg tablets for 14 days; orally; once daily; 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily; 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily; 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
Other intervention name(s): Brintellix; Brintellix; Brintellix; Brintellix
Intervention MeSH terms: Vortioxetine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; Adolescents; Pharmacokinetic; Pharmacodynamic
The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia
Condition: Stroke Rehabilitation; Hemiplegia
MeSH terms: Stroke; Hemiplegia
Study type: Interventional

Summary: 
      This randomised controlled study will investigate the effectiveness of isokinetic
      strengthening on the upper extremity functionality and strength in post-stroke hemiplegic
      patients.
    


Intervention name(s): isokinetic strengthening; exercise band strengthening
Intervention type(s): Device; Other
Intervention description(s): isokinetic upper extremity (forearm) strengthening for 4 weeks 3d/w; upper extremity (forearm) strengthening with exercise band 4 weeks 3d/w
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Systematic Evaluation of Antiviral Medication in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine whether antiviral medication will help improve
      psychotic symptoms and cognition in individuals early in the course of schizophrenia or
      schizoaffective disorder who are exposed to herpes simplex virus, type 1 (HSV 1), a virus
      that causes commonly occurring and recurrent cold sores.
    

Detailed description: 
      The main objective of the study is to evaluate the efficacy of add-on treatment of
      Valacyclovir (VAV), an antiviral medication, in the treatment of early course
      schizophrenia/schizoaffective disorder patients. Our main hypothesis is that the VAV add-on
      treatment will improve positive, negative and cognitive symptoms in herpes simplex virus
      (HSV) positive schizophrenia or schizoaffective disorder patients. We hypothesize that the
      grey matter reductions in specific brain regions (such as prefrontal regions) will improve in
      patients on VAV + antipsychotic compared to those on placebo + antipsychotic and the
      improvements in positive, negative and cognitive symptoms will be correlated with the grey
      matter changes.
    

Intervention name(s): Valacyclovir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 g PO BID x 2 weeks after 2 weeks it goes up to 1.5 g PO BID x 16 weeks along with antipsychotic; 2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment