bioihbjkbjnl/mcl2 huggingface dataset:
Youth Mayo Clinic Anxiety Coach Randomized Controlled Trial
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This research study aims to test the feasibility and effectiveness of using the Mayo Clinic
      Anxiety Coach smartphone app as an addition to traditional therapy for the treatment of
      anxiety disorders in youth, particularly those youth who may have limited access to mental
      health treatment in the traditional clinical setting.
    

Detailed description: 
      60 therapists in underserved areas will treat children with anxiety disorders in one of three
      conditions (treatment as usual, Anxiety Coach with face-to-face therapy, or Anxiety Coach
      with minimal direct contact) to determine the feasibility of using of Anxiety Coach to
      increase the frequency of exposure and improve outcomes with varying degrees of face-to-face
      contact (N = 60 patients).
    

Intervention name(s): Mayo Clinic Anxiety Coach; Treatment as Usual
Intervention type(s): Device; Other
Intervention description(s): Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity and patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence and theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging behavior change through 1) scheduled reminders to engage in therapeutic exercises, 2) point of performance support, 3) individually tailored information, 4) real-time symptom assessment, and 5) readily accessible asynchronous communication.; In the TAU condition therapists provide treatment consistent with their orientation and clinical judgment. Previous research suggests that TAU will include supportive therapy, relaxation, and cognitive restructuring. The format of treatment will be 6 to 12, 50-minute, face-to-face therapy sessions in the therapist's office, with flexibility to leave the office (e.g., for exposure).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Social Anxiety; Social Phobia; Separation Anxiety; Generalized Anxiety; GAD; Phobia; Panic; Agoraphobia; Obsessive Compulsive Disorder; OCD; Child; Adolescent; Smartphone; Teen; Youth
Effect of Intranasal Insulin on Cognitive Processes and Appetite
Condition: Obesity
Study type: Interventional

Summary: 
      This study investigates the effect of intranasal insulin on cognitive processes (behavioural
      and neural) in healthy lean and obese female adults. All subjects will receive a single-dose
      of intranasal insulin and/or placebo (on different days) before participating in several
      cognitive tasks.
    

Detailed description: 
      It is well established that eating behaviour is affected by metabolic signals (e.g. insulin,
      ghrelin, serotonin) and is also modulated via food reward processes. However, in humans,
      eating behaviour is a complex process, which involves habits, long-term goals and social
      interaction. Thus, recently it has been proposed that higher cognitive processes such as
      inhibitory control, attention and memory also modulate eating.

      Insulin seems to be involved in both metabolic processes and cognitive processes. In the last
      decade it has been shown that intranasal administration of insulin decreases food intake,
      especially in women, and enhances thermogenesis and memory. In addition intranasal insulin
      administration has been shown to affect brain areas related to homeostatic control, reward
      and memory.

      In the proposed study the investigators will examine the effect of intranasal insulin
      administration on eating, and on metabolic, reward and cognitive processes and their
      potential interplay. The investigators will also study the effect of body weight on the
      actions of insulin on these processes.
    

Intervention name(s): Intranasal Insulin; Intranasal Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal insulin; Intranasal placebo manufactured to mimic smell of insulin
Other intervention name(s): Insulin; Actrapid; Placebo
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Cognitive processes; Reward processes; fMRI; Insulin
A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users
Condition: Insomnia Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006)
      in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and
      suvorexant) with similar indications (zolpidem and suvorexant) or mechanisms of action
      (suvorexant).
    

Detailed description: 
      This is a single-center, single oral dose, randomized, double-blind, placebo-controlled,
      6-way crossover study in healthy, non-dependent recreational sedative users.
    

Intervention name(s): Zolpidem tablets; Suvorexant tablets, over-encapsulated; Lemborexant tablets; Placebo lemborexant; Placebo zolpidem; Placebo suvorexant
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Zolpidem 3 x 10 mg tablets will be administered orally.; Suvorexant 2 x 20 mg tablets, over-encapsulated, will be administered orally.; Lemborexant 1 x 10 mg, 2 x 10 mg, or 3 x 10 mg tablets will be administered orally.; Placebo 1 x 10 mg, 2 x 10 mg, or 3 x 10 mg lemborexant tablets will be administered orally.; Placebo 3 x 10 mg zolpidem tablets will be administered orally.; Placebo 2 x 20 mg suvorexant tablets, over-encapsulated, will be administered orally.
Other intervention name(s): AMBIEN; zolpidem tartrate; BELSOMRA; E2006
Intervention MeSH terms: Zolpidem; Suvorexant; Lemborexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Recreational sedatives; Healthy participants; Lemborexant; E2006; Zolpidem; Suvorexant
A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the amount of tirzepatide that gets into the blood
      stream and how long it takes the body to get rid of it, when injected under the skin of the
      upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and
      females with different body sizes. The tolerability of tirzepatide will be evaluated and
      information about any side effects experienced will be collected. For each participant, the
      study will last about 20 weeks, including screening.
    


Intervention name(s): Tirzepatide
Intervention type(s): Drug
Intervention description(s): Tirzepatide administered SC
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Lag of Accommodation With DOT Spectacle Lenses
Condition: Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of the study is to measure the difference in the lag of accommodation between
      DOT spectacle lenses and control spectacles.
    


Intervention name(s): DOT Pattern; Control Spectacles
Intervention type(s): Device; Device
Intervention description(s): DOT Pattern Spectacle Lens; Control lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Pilot Clinical Study of PG2 Injection on Hemorrhagic Stroke
Condition: Hemorrhagic Stroke
MeSH terms: Stroke; Hemorrhagic Stroke
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Astragalus membranaceus (AM) is used to treat stroke for a long time, and a number of studies
      have shown that AM can reduce cerebral infarction area and has anti-oxidation activity. PG2,
      a sterile powder of polysaccharides isolated from the root of astragulus (Huang-Chi) for
      intravenous injection, has been approved as a botanical drug by TFDA. Hemorrhagic stroke will
      induce secondary peri-blood clot edema and that may increase intracranial pressure to
      exacerbate clinical symptom. Therefore, the purpose of the present study was to investigate
      the efficacy of PG2 on hemorrhagic stroke.
    

Detailed description: 
      This will be a double-blind, randomized, placebo-controlled study. An estimated 60 (at least
      48 evaluable) first hemorrhagic stroke patients will be randomly divided into the control and
      treatment groups. Each group will be treated as follows: 1) control group will accept placebo
      t.i.w treatment for 14 days from second day of admission, in addition to standard ordinary
      treatment.; 2) treatment group will accept PG2 t.i.w treatment for 14 days from second day of
      admission, in addition to standard ordinary treatment. Inflammatory index including the
      levels of C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), S-100 protein,
      IL-1, IL-6, and TNF-beta levels will be measured and clinical symptoms including Glasgow
      outcome scale (GOS), modified rankin scale (MRS), Functional Independence Measure (FIM) and
      Barthel Index (BI) will be evaluated during this study.
    

Intervention name(s): PG2; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks; 500 ml normal saline, tiw, 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Astragulus polysaccharides; Hemorrhagic stroke
A Mobile-App Training to Reduce Body Image Disorder Symptoms and Associated Features in Female University Students
Condition: Body Image Disorder; Body Dysmorphic Disorders; Eating Disorders
MeSH terms: Feeding and Eating Disorders; Body Dysmorphic Disorders
Study type: Interventional

Summary: 
      Body dissatisfaction represents a prevalent condition in young women, and it is associated
      with low self-esteem, depression, and symptoms of Body Dysmorphic Disorder (BDD) and Eating
      Disorders (EDs). The aim of the trial is to test the effect of a mobile health application
      called "GGBI: Positive Body Image" in reducing body dissatisfaction, body dysmorphic
      disorder/eating disorder symptoms, and associated psychological features in female university
      students considered at high-risk of developing Body Image Disorders (BIDs).

      Hypothesis: Participants using "GGBI: Positive Body Image" immediately following baseline
      assessment (Time 0; T0) (immediate-use App group: iApp) would exhibit greater reduction in
      body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated
      psychological features than participants who did not use "GGBI: Positive Body Image" in this
      phase of the study (delayed-use App group: dApp). Following crossover (Time 1; T1), the
      investigators expect that participants gains in the iApp group would be maintained at
      follow-up (Time 2; T2).
    


Intervention name(s): GGBI: Positive Body Image (Mobile App)
Intervention type(s): Device
Intervention description(s): Brief, game-like, training exercise for challenging body image disorder symptoms and associated psychological features
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Remodulin® to Oral Treprostinil Transition
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This multi-center, open-label study will assess the tolerability and safety of transitioning
      subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV)
      or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR)
      tablets).

      This study will consist of an in-hospital transition phase, dose optimization/evaluation
      phase, and follow up phase.
    


Intervention name(s): UT-15C SR
Intervention type(s): Drug
Intervention description(s): Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
Intervention MeSH terms: Treprostinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; UT-15C SR; PAH
Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study
Condition: Intrathecal Baclofen; Multiple Sclerosis; Respiratory System; Cerebral Palsy
MeSH terms: Multiple Sclerosis; Cerebral Palsy
Study type: Observational

Summary: 
      The methodology is a feasibility study to determine the feasibility of assessing people in
      the community with a neurological condition before proceeding towards a full powered
      community trial evaluating the influence of intrathecal baclofen.
    

Detailed description: 
      The purpose of this proposed research will evaluate a feasible method to assess the
      respiratory status of people with neurological conditions receiving or scheduled to receive
      Intrathecal Baclofen. The use of Intrathecal Baclofen to manage severe spasticity is a
      developing treatment option with a limited research base, particularly when evaluating the
      influence of intrathecal baclofen on the respiratory system. The proposed research is derived
      from clinical practice and involves joint collaboration between clinical team, research
      professionals and patients.

      In order for the study to evaluate the influence of Intrathecal baclofen has on the
      respiratory system, the proposed research will need to develop and evaluate a method of
      assessing people in the community ensuring it's feasible for people with neurological
      conditions. Prior to implementing a full powered community trial to evaluate the influence of
      intrathecal baclofen on people with neurological conditions.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with Neurological conditions receiving or scheduled to receive intrathecal baclofen
        therapy.
PREDnisolone-induced Beta-cell Dysfunction Prevented by EXenatide
Condition: Glucocorticoid-induced Glucometabolic Abnormalities; Glucocorticoid-induced Beta-cell Dysfunction
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      The purpose of this study is to explore whether the GLP-1 receptor agonist exenatide, may
      prevent glucocorticoid-induced glucometabolic abnormalities and beta-cell dysfunction in
      healthy subjects.
    


Intervention name(s): Placebo; Prednisolone; Prednisolone and Exenatide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of placebo with saline infusion; Single dose of 80 mg prednisolone with saline infusion; Prednisolone 80 mg single dose Exenatide infusion 20 mg/min
Intervention MeSH terms: Exenatide; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Feasibility of the Mindfulness Flow Program (MFP) on Archers
Condition: Athletes
Study type: Interventional

Summary: 
      Mindfulness-based interventions have gained popularity among elite athletes, but their
      effectiveness for enhancing archery performance remains inconsistent. This study examined the
      feasibility of a 12-week mindfulness flow program (MFP) specifically designed for archers,
      and assessed the effect of the MFP on shooting performance. The intervention aims to enhance
      shooting performance, mindfulness, and the flow state, while reducing post-intervention
      anxiety.
    

Detailed description: 
      The primary goal of the present study was to test the feasibility of a prototype mindfulness
      flow program (MFP), with 11 sessions conducted via Zoom video meeting and one in-person
      session of sport-specific session. Additionally, the program seeks to examine the
      psychological outcomes associated with the intervention specifically among archery athletes.
      It is anticipated that the experimental group will show reduced anxiety levels and increased
      levels of mindfulness and flow when comparing their baseline and post-intervention
      assessments. This study explores the potential of delivering mindfulness programs
      conveniently to sport populations via the internet, supplemented by one face-to-face
      sport-specific session to enhance mindfulness and improve sports performance among athletes.
    

Intervention name(s): Mindfulness Flow Program
Intervention type(s): Behavioral
Intervention description(s): The mindfulness flow program (MFP) consisted of eleven 60-minute sessions via Zoom, with one session per week. Additionally, a 120-minute in-person sport-specific session were conducted.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin's Lymphoma and Acute Leukemia
Condition: Lymphoma
MeSH terms: Lymphoma; Hyperuricemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To evaluate safety of rasburicase in pediatric patients with NHL and AL

      Secondary Objective:

      To assess efficacy of rasburicase for prevention and treatment of hyperuricemia
    

Detailed description: 
      Study duration per participants is approximatively 14 days including a 5-day treatment
      period.
    

Intervention name(s): RASBURICASE SR29142
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:solution for infusion Route of administration: intravenous
Intervention MeSH terms: Rasburicase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the safety and effectiveness of 2 doses of the
      investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing
      new spinal fractures in women with osteoporosis.
    


Intervention name(s): lasofoxifene; placebo; lasofoxifene
Intervention type(s): Drug; Other; Drug
Intervention description(s): 0.5 mg once per day, orally; placebo; 0.25 mg once per day, orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Substance P as a Biomarker to Evaluate the Reduction of Multiple Immunization Pain
Condition: Immunisation Anxiety Related Reaction; Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Immunization is one of the most significant preventive health measures in reducing morbidity
      and mortality caused by infectious diseases. Studies have shown that Sucrose is recommended
      to reduce pain associated with vaccination in neonates. The main aim of the study was to
      determine the effectiveness of sucrose in reducing infant's pain outcomes during immunization
      among 10-24 month-old infants and toddlers.
    


Intervention name(s): Sucrose
Intervention type(s): Dietary Supplement
Intervention description(s): Participants in the intervention group were given 2 ml dose of 50% sucrose solution and participants in the placebo group were given 2 ml dose of sterile water. Both groups were administered slowly over 30 seconds sublingually via needle-less syringe immediately prior to the immunization injections.
Other intervention name(s): Sweet solution
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sucrose,; Substance P,; Pain,; Immunization.
Effect of Rosuvastatin on Left Ventricular Remodeling
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated; Ventricular Remodeling
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the the effect of the HMG-CoA reductase inhibitor
      Rosuvastatin on left ventricular remodeling in patients with dilated cardiomyopathy.
    

Detailed description: 
      -  Chronic heart failure (HF) is one of the most important public health problems in
           cardiovascular medicine.

        -  Idioatic dilated cardiomyopathy (CMP) represents the final common expression of primary
           myocardial damage produced by a variety of as yet undefined myocardial insults,
           producing areas of interstitial and perivascular fibrosis, particularly of the left
           ventricle. Chronic HF, including CMP, is a progressive disease with high morbidity and
           mortality, suggesting that important pathogenic mechanisms remain active and unmodified
           by the present treatment modalities. The presence of chronic inflammation in patients
           with chronic heart failure has been widely recognized and coupled with persistent immune
           activation may represent such unmodified mechanisms.

      The effect of statin therapy on lipids are well known, but recent studies suggest that the
      beneficial effects of statins also may be related to their anti-inflammatory properties.

      To further elucidate this issue we want to study the potent new statin Rosuvastatin on
      myocardial function and remodeling and their relation to inflammatory markers in patients
      with IDCM. As hyperlipidemia is not involved in the pathogenesis of IDCM, as opposed to HF
      secondary to CAD, such studies will also be an interesting approach in separating the lipid
      lowering from other effects of these medications in HF.
    

Intervention name(s): Rosuvastatin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 10 mg tablets od for 6 months; placebo
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Heart failure; inflammation; cytokines