bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)
Condition: Chronic Obstructive Pulmonary Disorder
MeSH terms: Lung Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD
      exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6
      μg, all administered BID.
    

Detailed description: 
      This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD
      exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period.
      Subjects who successfully complete the Screening Period will be randomized to one of the
      following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all
      administered BID. Following randomization, subjects will enter the Treatment Period and
      undergo additional treatment visits over 52 weeks.
    

Intervention name(s): BFF MDI (PT009) 320/9.6 μg; BFF MDI (PT009) 160/9.6 μg; FF MDI (PT005) 9.6 μg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Blinded Treatment; Blinded Treatment; Blinded Treatment
Other intervention name(s): Budesonide and Formoterol Fumarate Inhalation Aerosol; Budesonide and Formoterol Fumarate Inhalation Aerosol; Formoterol Fumarate Inhalation
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40
      milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone
      acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who
      previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or
      MVT-601-3102).
    

Detailed description: 
      This study is an international phase 3 open-label, single-arm, long-term efficacy and safety
      extension study that will enroll eligible participants who have completed their participation
      in one of the phase 3 randomized, double-blind, placebo-controlled parent studies,
      MVT-601-3101 (SPIRIT 1 - NCT03204318) or MVT-601-3102 (SPIRIT 2 - NCT03204331). All
      participants will receive relugolix 40 mg orally once daily co-administered with low-dose E2
      (1.0 mg) and NETA (0.5 mg) for 80 weeks.

      Approximately 800 women with endometriosis-associated pain will be enrolled, after having
      completed a 24-week treatment period in one of the parent studies. The objectives of the
      study are to evaluate long-term efficacy and safety through up to 104 weeks of treatment
      (including treatment during the parent study) of relugolix co-administered with low-dose
      E2/NETA.

      Baseline procedures for this extension study will be performed on the same day as the Week 24
      Visit of the parent study. This visit, referred to as the "Week 24/Baseline Visit, will be
      defined as the date of completion of the last Week 24 procedure in the parent study.
      Participants will have received their last dose of study drug in the parent study on the day
      prior to the Week 24/Baseline Visit and will receive their first dose of study drug for this
      extension study in the clinic after the participant is determined to be eligible for this
      extension study and has provided informed consent to participate. The administration of the
      first dose of study drug for MVT-601-3103 will define enrollment into this study. Study
      participants will then take the open-label study treatment orally, once daily for 80 weeks.
    

Intervention name(s): Relugolix; Estradiol/norethindrone acetate
Intervention type(s): Drug; Drug
Intervention description(s): Relugolix 40-mg tablet administered orally once daily; Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
Other intervention name(s): TAK-385; MVT-601; E2/NETA; low-dose hormonal add-back
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol; Relugolix
Intervention model: Single Group Assignment
Intervention model description: Open label extension
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometriosis; Dysmenorrhea; Pain; Dyspareunia; Pelvic Pain
Chronic Pain Dynamic Psychophysical Tests and Genetic Screening
Condition: Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      Incidence and risk factors for persistent post surgical pain after Caesarean section are
      investigated. Demographic, psychophysical testing and genetic screening factors are performed
      in the perioperative period. Phone survey is performed to investigate the incidence of
      persistent post surgical pain after Caesarean section.
    

Detailed description: 
      Persistent post surgical pain after Caesarean section may lead to functional limitation and
      pain during activities of daily living. Demographic factors, psychophysical factors
      (mechanical temporal summation, diffuse noxious inhibitory control, state trait anxiety
      inventory) and genetic screening are used to predict the association with persistent post
      surgical pain. Phone survey follow up is performed to investigate the incidence of persistent
      post surgical pain and functional limitations due to pain experienced.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing spinal anaesthesia for Caesarean section
      
Biospecimen description: 
      Blood sampling
    
Keywords: Pain; Caesarean section
Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children
Condition: Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in
      preschool children undergoing tonsillectomy operations in the prevention sevoflurane
      agitation.
    

Detailed description: 
      Agitation during the emergence from general anesthesia is a great post-operative problem that
      often injures the patients themselves and requires the medical staff to restrain and calm
      them. The predisposing factors for emergence agitation include anesthesia, operation, and
      patient. Sevoflurane anesthesia results in higher incidence of emergence agitation than
      halothane, because of the rapid emergence, and its effects on central nervous system inducing
      convulsion and post-operative behavioral changes. The otorhinolaryngologic and ophthalmologic
      surgeries, post-operative pain, young age, pre-operative anxiety, no past surgical history,
      and adjustment disorder of patients are risk factors.

      Dexmedetomidine (DEX), a selective α (2)-adrenoreceptor agonist. Intravenous DEX used after
      induction of anesthesia reduced sevoflurane-associated EA and postoperative pain in pediatric
      ambulatory surgery.

      The investigators designed this study to prove the efficacy of oral dexmedetomidine a
      selective α (2)-adrenoreceptor agonist, on emergence agitation (EA), recovery profiles, and
      parents' satisfaction after sevoflurane anesthesia in tonsillectomy.
    

Intervention name(s): Dexmedetomidine; saline
Intervention type(s): Drug; Drug
Intervention description(s): oral dexmedetomidine; 2ml 0.9% saline administered orally half an hour before induction of anesthesia
Other intervention name(s): precedex; 0.9% saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sevoflurane emergence agitation
Assessment of Duration of Erection With Vardenafil 10 mg
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting,
      as compared to placebo (dummy medication with no pharmacological activity), on the duration
      of erection from the moment when the patient perceived his erection to be hard enough for
      penetration until withdrawal from the partner's vagina leading to successful completion which
      may or may not have included ejaculation. The patient used the stopwatch for the above
      assessments. The efficacy of oral ED treatments is measured by questionnaires and patient
      diaries.
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg Vardenafil taken orally 1 hour prior to sexual intercourse; Matching placebo
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Vardenafil
The Influence of Running to ACL Deficiency
Condition: ACL Injury; Gait
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The aim of this study is to investigate the influence of running to kinematic parameters of
      patients with anterior cruciate ligament.
    


Intervention name(s): Procedure
Intervention type(s): Procedure
Intervention description(s): Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition. The a gait analysis system will collect the data while they walk/run on the treadmill in barefoot at 4/6km/h.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Knee; ACL Injury; Kinematics
Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions
Condition: Social Anxiety Disorder; Social Anxiety; Social Anxiety Disorder of Childhood
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      Adolescence and young adulthood is a critical period for the development of social anxiety,
      which is often linked to other mental health challenges such as depression, mood disorders,
      and substance abuse. Initial evidence suggests that interacting with animals can reduce
      stress and anxiety, but no research has tested whether this benefit extends to adolescents at
      risk for social anxiety disorder. Additionally, researchers and clinicians do not understand
      what mechanism is responsible for anxiety reduction in animal-assisted interventions (AAIs).
      Therefore, the objectives of this study are to explore the specific mechanisms by which
      interacting with a therapy dog reduces anxiety, and to test whether such an interaction
      reduces anxiety in adolescents with varying levels of social anxiety.
    

Detailed description: 
      The specific aims of this project are to (1) test the mechanisms by which AAIs reduce
      anxiety, and (2) determine if the anxiolytic effect of social and physical interaction is
      moderated by level of pre-existing social anxiety. To achieve these aims, 75 adolescents (age
      13-17) will undergo a well-validated laboratory-based social evaluative stressor, the Trier
      Social Stress Task for Children, and be randomly assigned to one of three conditions: 1) no
      interaction with a dog (control condition), 2) social interaction only (no physical
      interaction) with a therapy dog; or 3) social interaction plus physical interaction with a
      therapy dog. Using a multivariate approach, three levels of outcome data will be collected:
      a) self-reported experience (anxiety), b) autonomic physiology (heart rate), and c)
      behavioral performance (error rates on mental math task). In addition, the interactions will
      be videotaped and behavioral coding will be used to explore the specific social behaviors
      between the participant and the dog that may predict anxiety reduction (such as frequency or
      type of social referencing or physical contact).
    

Intervention name(s): animal-assisted intervention; active control
Intervention type(s): Other; Other
Intervention description(s): Interaction with a therapy dog; Interaction with a stuffed dog
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: human-animal interaction; animal-assisted intervention
Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the
      outcome of non-invasive fat reduction using the ZELTIQ System.
    


Intervention name(s): The Zeltiq System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis; Lipolysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lipolysis; Cryolipolysis; Fat Reduction
Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer
Condition: Neoplasm, Gastric
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin
      for patients with unresectable, advanced gastric cancer who had no prior palliative
      chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase
      2, which has been completed and now a total of 60 qualified patients will be enrolled in the
      phase 2 of this study. The treating physician will determined the maximum number of cycles of
      pemetrexed plus cisplatin that a patient may receive in this study.
    


Intervention name(s): pemetrexed; cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Phase 1 - dose escalating: 600 mg/m2 level 1, 700 mg/m2 level 2, 800 mg/m2 level 3, 900 mg/m2 level 4, intravenous (IV), every 21 days, until disease progression
Phase 2 - 700 mg/m2, intravenous (IV), every 21 days, until disease progression; 75 mg/m2, intravenous (IV), every 21 days, until disease progression
Other intervention name(s): LY231514; Alimta
Intervention MeSH terms: Pemetrexed
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to describe a possible effect of metronidazole on PK
      of budesonide in healthy volunteers.
    

Detailed description: 
      The primary objective of this study is to describe a possible effect of metronidazole on PK
      of budesonide in healthy volunteers.

      Secondary objectives:

        1. Effect of budesonide on metronidazole steady-state PK (primarily described as area under
           the concentration-time-curve).

        2. Urinary 6β-hydroxycortisol (being a marker of CYP3A activity) and cortisol excretion
           before and during metronidazole multiple-dose co-administration.

        3. Safety parameters.
    

Intervention name(s): Budesonide 2 single doses, Metronidazole multiple-dose
Intervention type(s): Drug
Intervention description(s): Budesonide 3 mg single oral dose on Day 1 and Day 9. Metronidazole 750 mg b.i.d. from Day 2 until Day 8, Metronidazole 750 mg once daily (in the morning) on Day 9.
Intervention MeSH terms: Metronidazole; Budesonide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteers
Investigating the Causal Role of Prefrontal Control in Decision-making in Patients With Anhedonia
Condition: Major Depressive Disorder; Anhedonia
MeSH terms: Anhedonia; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Investigating whether delta-beta cross-frequency transcranial alternating current stimulation
      can increase goal-directed behavior in participants with major depressive disorder and
      elevated symptoms of anhedonia.
    

Detailed description: 
      The purpose of this clinical trial is to investigate the causal role that delta-beta coupling
      plays in goal-directed behavior in participants with major depressive disorder (MDD) and
      symptoms of anhedonia. The participants will perform a reward-based decision-making task.
      During the task, cross-frequency transcranial alternating current stimulation (tACS) will be
      delivered at delta-beta frequency, a control-frequency, or an active sham.
      Electroencephalography will be collected in intermittent resting-state periods. Structural
      and functional magnetic resonance imaging (MRI) will be collected during the resting-state
      and during performance of the task.
    

Intervention name(s): Cross-frequency transcranial alternating current stimulation via the NeuroConn Direct Current Stimulator Plus
Intervention type(s): Device
Intervention description(s): Stimulation will be delivered via the NeuroConn Direct Current Stimulator Plus, an investigational electrical non-invasive brain stimulation device that is being used for foundational neuroscience and translational research.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized into one of three arms of the study: delta-beta tACS, control tACS in theta-gamma, or active sham. Randomization is stratified by SHAPS level such that there are an equal number of participants that are high anhedonia (SHAPS > 33) and low anhedonia (SHAPS <=33).
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: transcranial Alternating Current Stimulation; Goal-directed behavior; Cross-frequency coupling; Reward-based decision-making
Posture, Hand Functions and Sensory Processing Skills on Nutrition
Condition: Autism Spectrum Disorder; Autism; Autism, Mild; ASD
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational [Patient Registry]

Summary: 
      To examine the effects of posture, hand functions and sensory processing skills on nutrition
      in children with autism spectrum disorder.

      The study aims to include 40 children diagnosed with Autism Spectrum Disorder (ASD), directed
      from the Department of Child and Adolescent Psychiatry at Istanbul University, along with
      their parents/caregivers, and 40 healthy children along with their parents/caregivers.
    

Detailed description: 
      Parents/caregivers of children diagnosed with ASD will be assessed using a demographic
      information form; sensory processing (Dunn Sensory Profile); nutrition (Screening Tool for
      Eating Problems (STEP), Brief Autism Mealtime Behavior Inventory (BAMBI)); quality of life
      (Pediatric Quality of Life Inventory (PedsQL 4.0)); children will undergo assessments for
      balance (Pediatric Berg Balance Scale); head posture (Craniovertebral angle method), hand
      functions (Jebsen Taylor Hand Function Test); grip strength (Jamar Hand Dynamometer); and
      parents' evaluations for depression, anxiety, and stress levels (Beck Depression Inventory,
      Beck Anxiety Inventory, Spielberger State-Trait Anxiety Inventory).

      The assessment duration, including explanations and questionnaires, will take approximately 1
      hour.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        -  Age between 5-10 years,

          -  Diagnosis of Autism Spectrum Disorder (ASD),

          -  Children scoring between 30-36.5 points on the Childhood Autism Rating Scale (CARS),

          -  Absence of any oral structural disorders,

          -  Willingness of the parent to voluntarily participate in the study
      
Keywords: Autism Spectrum Disorder; posture; sensory processing; hand functions; nutrition
Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity
Condition: Autism; Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the proposed study is to develop and pilot test a manual-based,
      interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder
      (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and
      Expanding variety (CHANGE) obesity program.
    

Detailed description: 
      The purpose of the study is to develop and test the feasibility of a structured, innovative
      approach to treat obesity in 16 children (age 3 to 10 years) with autism spectrum disorder
      (ASD). This 16-week program integrates behavioral psychology and nutrition science to meet
      the challenges of obesity in children with autism spectrum disorder (ASD). The PI will apply
      an evidence-based behavioral intervention to increase food variety,15 use applied behavior
      analytic strategies to teach physical activities in a developmentally-appropriate manner,
      employ biometrics to assess progress, utilize dietetic interventions to improve nutritional
      balance, and train caregivers to use behavior management strategies.
    

Intervention name(s): Parent Education Program; Manual-based Behavioral Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders.; The Manual-based Interdisciplinary Behavioral Treatment consists of nutritional and behavioral interventions to improve dietary intake (increase water, decrease sweetened beverages and snack foods, improve balanced diet), increase exercise, and teach behavioral strategies to address barriers to these goals.
Other intervention name(s): PEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ASD