bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Anodal Transcranial Direct Current Stimulation (tDCS) Over the Right-hemisphere on Picture Naming in Chronic Aphasia
Condition: Aphasia
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      There are two opposing hypotheses, namely the interference and laterality-shift hypotheses,
      regarding the role of the right hemisphere (RH) in language recovery following a left
      hemisphere damage. Transcranial direct current stimulation (tDCS) has received increasing
      attention as a potential complement to behavioural therapy.

      This preliminary study aimed to examine the effect of excitatory (anodal) stimulation of
      right inferior frontal gyrus (IFG) on naming abilities of chronic people with aphasia (PWA)
      to examine the compensatory versus interference role of RH in language recovery, and to
      confirm the application of tDCS does not induce adverse effects on other cognitive and
      language functions.
    


Intervention name(s): tDCS stimulation
Intervention type(s): Device
Intervention description(s): The study examines the effect of excitatory stimulation of right inferior frontal gyrus (IFG) on naming abilities of people with aphasia (PWA) as compared to sham stimulation to examine the compensatory versus interference role of right hemisphere in language recovery after stroke.
Other intervention name(s): language therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS; Aphasia; naming
Modeling Impaired Judgement in Cocaine Abusers - 6
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is for the modeling of impaired judgement in cocaine abusers.
    

Detailed description: 
      The objective of this study is to investigate recognition memory and appreciation of changing
      contingencies in relation to a response judgement.
    

Intervention name(s): Amantadine
Intervention type(s): Behavioral
Intervention MeSH terms: Amantadine
Masking: None (Open Label)
Primary purpose: Prevention
Safety Study of Tezepelumab (AMG 157) in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate the safety, tolerability, and immunogenicity of
      multiple-dose administration of tezepelumab in healthy adults.
    

Detailed description: 
      This study will follow a randomized, multiple-dose, double-blind, placebo-controlled,
      sequential dose-escalation study design. The study will consist of five subcutaneous (SC)
      cohorts and one intravenous (IV) cohort. Each dose cohort is planned to enroll 8
      participants, randomized such that 6 participants will receive tezepelumab and 2 will receive
      placebo (3:1 ratio).
    

Intervention name(s): Placebo; Tezepelumab
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous or intravenous injection.; Administered by subcutaneous or intravenous injection
Other intervention name(s): AMG 157; Tezspire
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The cohorts will enroll sequentially: enrollment to the subsequent cohort (ie, next higher dose) will proceed only after the previous dose is determined to be safe and well tolerated by a blinded review of available safety data conducted on day 43 of the previous cohort. Within each dose cohort, participants will be randomized 3:1 to receive tezepelumab or placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: healthy volunteers
Myofascial Induction Effects on Plantar Pressures and Stabilometry
Condition: Foot Diseases; Myofascial Pain
MeSH terms: Foot Diseases
Study type: Interventional

Summary: 
      The objective is to determine the effectiveness of myofascial Induction effects on plantar
      pressures and stabilometry variables. Forty healthy subjects (28 females and 12 males) will
      be recruited for a simple blind clinical trial. All subjects will be randomly distributed in
      two different groups: control group (sham treatment of myofascial Induction) and experimental
      group (myofascial Induction). Outcome measurements will be foot plantar pressure area
      (footprint) and center of pressure area (stabilometry) by the Balance Evaluation Systems
      test. Two trials will be recorded for each condition.
    


Intervention name(s): Myofascial induction; Sham myofascial induction
Intervention type(s): Other; Other
Intervention description(s): Myofascial induction in plantar fascia; Sham myofascial induction in plantar fascia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Investigating Markers of Energy Metabolism in Pregnant Women With Insulin Resistance
Condition: Gestational Diabetes; Type 2 Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Observational

Summary: 
      The investigators seek to examine the metabolic changes that occur amongst obese and lean
      pregnant women with normal glycemic control as well as pregnant women with diabetes mellitus
      (gestational diabetes and pre-existing type 2 diabetes mellitus) compared to non-pregnant age
      matched controls. Given the adaptive tendency of the maternal body to use alternative energy
      sources such as ketones and free fatty acids rather than glucose and to shunt glucose and
      amino acids to the fetus, the investigators hypothesize that the amino acid and fatty acid
      profile will be reflective of this adaptive change and that maternal insulin resistance will
      result in alterations in this pattern in both the plasma and CSF. Furthermore, the
      investigators also hypothesize that maternal degrees of insulin resistance will also be
      reflected in CSF hormonal changes.
    

Detailed description: 
      We seek to investigate for the first time whether CSF branched chain amino acid, free fatty
      acid, and energy regulatory hormone levels are altered in comparison to plasma levels among
      pregnant and non-pregnant individuals with varying degrees of insulin resistance.
      Furthermore, we seek to understand the effects of pregnancy on central and peripheral energy
      metabolism using metabolomic profiling as well as traditional hormonal measurements in
      maternal blood, urine, cerebrospinal fluid as well as cord blood.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant subjects will be women recruited from the Women's Center, the high-risk
        prenatal care unit at Tompkins, Long Wharf and L&D.

        The target population in this study includes pregnant women with pregnancies complicated by
        gestational diabetes, DM, and uncomplicated controls.

        The Yale New Haven Hospital Lumbar puncture clinic, located in the Yale Physicians
        Building, is a weekly referral clinic in the department of Neurology. The target population
        for this study includes non-pregnant women, age greater than 18 who require large volume
        lumbar puncture for medical purposes such as for symptomatic treatment of pseudotumor
        cerebri.
      
Biospecimen description: 
      whole blood, urine, cerebrospinal fluid, cord blood
    
Keywords: insulin; metabolomics
An Efficacy and Safety Study of Long Acting Injectable Risperidone and Oral Risperidone in Participants With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of long acting injectable
      (LAI) risperidone and oral risperidone treatment on participants with schizophrenia
      (psychiatric disorder with symptoms of emotional instability, detachment from reality, often
      with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder
      (a mixed psychiatric disorder relating to a complex psychotic state that has features of both
      schizophrenia and a mood disorder such as bipolar disorder).
    

Detailed description: 
      This is a randomized (treatment group assigned by chance), open-label (all involved people
      know the identity of the study drug), active-controlled study to evaluate the improvement in
      social functioning among participants with schizophrenia taking LAI risperidone and oral
      risperidone tablet. The study drug will be administered for 52 weeks in flexible dose (range
      as per Investigator's discretion) and a total of 11 assessment visits will be conducted per
      participant, including Screening. The participant may be withdrawn from the trial for any
      medical reason at the sole discretion of the investigator. Before starting the study
      treatment, participants undergo the period of switching from the previous medication to
      risperidone for 4 weeks, and then they will be evaluated for tolerability for 2 weeks (run-in
      period for stabilizing to risperidone). In this 2-week period, participants will take oral
      risperidone. The efficacy will be primarily evaluated through Personal and Social Performance
      Scale. Safety will be evaluated through Abnormal Involuntary Movement Scale, Barnes Akathisia
      Rating Scale, and Simpson-Angus Rating Scale. Participants' safety will be monitored
      throughout the study.
    

Intervention name(s): Risperidone long acting injectables; Risperidone tablets
Intervention type(s): Drug; Drug
Intervention description(s): Risperidone long acting injectables will be administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. A supplementary oral antipsychotic will also be administered for 3-4 weeks after the initial dose of injection.; Risperidone tablets will be administered orally as 0.5-10 mg daily up to Week 52.
Other intervention name(s): Risperdal Consta; Risperdal
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Risperidone; Risperdal
Cognitive Hyper-performance - Effects of Stimulating Substances in Chess-players
Condition: Cognitively Healthy Subjects Influenced by Psychoactive Drugs
Study type: Interventional
Phase: Phase 1

Summary: 
      Effects of caffeine, methylphenidate, modafinil and placebo on cognitive performance of chess
      players in chess games and neuropsychiatric standardized tests. We hypothesize that
      substances will change cognitive performance in chess players leading to changed results in
      chess games and neuropsychiatric tests.
    


Intervention name(s): Drugs use: methylphenidate; Drug use: modafinil; caffeine; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 40 mg tablets; 40 mg tablets; 400 mg; placebo
Intervention MeSH terms: Caffeine; Methylphenidate; Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: chess, cognition
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Aggression
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810
      in the treatment of Impulsive Aggression (IA) in subjects with
      Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with standard ADHD treatment.
      Approximately 426 subjects aged 6 to 12 years with ADHD and comorbid impulsive aggression
      will be recruited in this study. The frequency of impulsive aggression behaviors will be
      assessed as a primary outcome. Additionally, the severity and improvement in impulsive
      aggression and quality of life measures for the subject and caregiver will be assessed using
      validated scales.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group
      study, to assess the efficacy, safety, and tolerability of SPN-810 in the treatment of IA in
      subjects 6 to 12 years old with ADHD, in conjunction with standard ADHD treatment.
    

Intervention name(s): SPN-810 (18 mg); SPN-810 (36 mg); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects were randomized to receive SPN-810 low dose (18 mg) twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.; Subjects were randomized to receive SPN-810 high dose (36 mg) twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.; Subjects were randomized to receive Placebo twice each day (BID) with or without food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if after noon, the evening dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mountain Hiking & Environmental Influences
Condition: Healthy Participants
Study type: Interventional

Summary: 
      In a randomized crossover design, approximately 50 healthy participants will be randomly
      exposed to outdoor mountain hiking (approximately 6 hours each) in two different areas: an
      anthropogenically influenced area and in a widely pristine area.
    


Intervention name(s): Mountain hiking
Intervention type(s): Behavioral
Intervention description(s): Compare arm description
Other intervention name(s): Walking
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: affective responses; stress-related parameters; green exercise
Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders
Condition: Temporomandibular Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the
      same efficacy in relieving pain and improving the quality of life of TMD patients
    

Detailed description: 
      The aim of the present study was to evaluate and compare the efficacy of red (600nm) and
      infrared (800nm) laser therapy in relieving pain and improving the quality of life of TMD
      patients.
    

Intervention name(s): Red laser; Infrared laser
Intervention type(s): Radiation; Radiation
Intervention description(s): On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.; On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: laser,; quality of life,; orofacial pain
The Success of Opening Single CTO Lesions to Improve Myocardial Viability Study (SOS-comedy)
Condition: Hibernation, Myocardial; Complete Occlusion of Coronary Artery
MeSH terms: Myocardial Stunning
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effect of percutaneous coronary intervention
      (PCI) on myocardial viability in coronary artery disease patients with single coronary total
      occlusion (CTO) lesions.
    

Detailed description: 
      Patients with coronary artery disease might benefit from successful percutaneous coronary
      intervention (PCI). However, there is currently no consensus on an optimal treatment modality
      for single lesions resulting in coronary total occlusion (CTO). Since the other coronary
      arteries are often lesion-free, or with stenosis of less than 50%, patients often present
      with no symptoms. Although the expert consensus on CTO lesion suggests reducing the incidence
      of long-term adverse events via successful revascularization, there are few retrospective
      studies on single CTO lesions. To date, it is unclear whether successful PCI based on optimal
      medication treatment (OMT) can increase myocardial viability and the extent of myocardial
      viability related to prognosis of those CTO patients. Therefore, the aim of this
      multi-center, prospective, open labeled, non-randomized controlled study was to determine if
      the improvement to myocardial viability in single CTO patients with successful PCI plus OMT
      was superior to that of patients with only OMT.
    

Intervention name(s): stenting or balloon expansion; aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc
Intervention type(s): Device; Drug
Intervention description(s): all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA); Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.
Other intervention name(s): percutaneous coronary intervention
Intervention MeSH terms: Aspirin; Metoprolol; Clopidogrel; Ticagrelor; Atorvastatin; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PET-CT; Cardiac magnetic resonance (CMR) imaging; Major adverse cardiac events (MACEs); coronary artery disease
The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis
Condition: Halitosis
MeSH terms: Halitosis
Study type: Interventional

Summary: 
      the efficacy of commercially available oregano essential oil mouthwash in the reduction of
      oral halitosis was compared to chlorhexidine and distilled water and the results showed
      significant reduction of organoleptic tongue and floss scores and BANA test scores compared
      to placebo
    

Detailed description: 
      the results showed that oregawash showed a comparable effect to chx in reducing oral
      halitosis
    

Intervention name(s): oregawash; corsodyl; placebo
Intervention type(s): Other; Other; Other
Intervention description(s): mouthwash containing oregano essential oil; 0.2% chlorhexidine mouthwash; distilled water
Other intervention name(s): chlorhexdine; distilled water
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: oral halitosis; oregano essential oil; mouthwash
A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate elements of cognitive function in subjects receiving either
      fesoterodine or alprazolam.
    

Detailed description: 
      Evaluation of cognitive function
    

Intervention name(s): 4mg fesoterodine; 8mg fesoterodine; alprazolam 1mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4mg tablet once daily for 6 days; 4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days; 1mg tablet once on last day of treatment period at clinic; Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic
Intervention MeSH terms: Alprazolam; Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effects of ElDOA and Post-Facilitation Stretching Technique on Pain and Disability in Patients With Text Neck Syndrome
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      In this modern era, Text Neck is a new term used to describe neck pain and associated damage
      caused by continuous flexed posture due to excessive use of smartphones for a long time. The
      term text neck was first introduced by Dr. Dean L. Fishman, who is US based chiropractor.
      Text neck can also be described as overuse syndrome caused by repetitive stress on neck due
      to prolonged flexion. There is coordinated work between cervical spine and surrounding
      structure such as muscles, ligament, nerves and bones. In addition, any nerve compression at
      cervical spine leads to radiating pain in neck, shoulder and arm. Previous literature
      reported use of cell phone is very common in population of 18 to 44 years of age. Seventy
      nine percent (79%) population have smartphone with them all the time. Technology has become
      essential part of modern lifestyle. Sustained flexed posture forces the head to exert weight
      on neck of varying degrees. Weight of neutral head is 10 to 12 pounds and increases 6 times 1
      inch forward movement of head. Children are at higher risk because of their large head size.
      This study will be a Randomized clinical trial with objective to reduce neck pain and
      disability in patients with text neck syndrome. Two groups will be designed, in one group
      ElDOA (n=20) and in other group post facilitation technique (n=20) will be applied. Patients
      will be recruited into two groups by consecutive sampling by non-replacement lottery method
      with equal no. of chits. Patients will be assessed by Numeric pain rating scale (NPRS), Neck
      disability index (NDI), smartphone addiction scale before and after treatment. Both groups
      will receive heating pad as common treatment first after that group A will be treated with
      ELDOA and group B will be treated with Post-facilitation. Session of 6 weeks with 3 days per
      week will be conducted. After that post treatment assessment will be done.
    


Intervention name(s): ELDOA method; Post-facilitation stretching
Intervention type(s): Other; Other
Intervention description(s): group A will receive; Group B will receive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Text Neck Syndrome