bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Video Information on Anxiety in Adolescents Having rRT-PCR Test During Corona Virus Pandemic
Condition: Coronavirus
MeSH terms: Coronavirus Infections
Study type: Interventional

Summary: 
      The Polymerase Chain Reaction (rRT-PCR) test is still the gold standard in the diagnosis of
      coronavirus disease. Health workers apply this procedure in a closed area, wearing personal
      protective equipment. Adolescents cannot be informed about the invasive procedure and it is
      difficult to communicate with them. Before the procedure, the effect on anxiety will be
      investigated by watching an informative video (containing information such as the materials
      used in the procedure, how long the procedure will take, how the sample will be taken, why
      healthcare workers wear personal protective equipment) prepared according to the
      developmental characteristics of the adolescents.
    

Detailed description: 
      In the coronavirus pandemic, PCR testing is still the gold standard in the diagnosis of the
      disease. PCR with the right method can increase the sensitivity of the test. Adolescents'
      anxiety and anxiety levels may increase during invasive procedures such as PCR testing. In
      addition, in this process, factors such as the uncertainty created by the pandemic,
      disruption of routines, loss of school and peer social ties, and fear of getting sick bring
      along many mental disorders. The fact that the tests and treatments for the disease are new
      and that they are not informed about the procedures to be done cause the anxiety levels of
      the adolescents to increase. Nurses who treat adolescents with care and personal protective
      equipment may not be able to communicate verbally, sensorially, eye-to-eye with adolescents,
      and may have difficulty in conveying their voices and emotions. Likewise, by wearing a mask,
      it prevents nurses from observing their reactions to the hospital environment and procedures.
      Video education is one of the most effective ways for nurses to fulfill their educational
      roles during the epidemic when communication is limited. For this reason, it is very
      important to inform before the PCR sample collection process with a video prepared in
      accordance with the developmental stages of the adolescents. The aim of this study is to
      investigate the effect of the video that adolescents will watch before the procedure on their
      anxiety.
    

Intervention name(s): Adolescents watching an informational video
Intervention type(s): Other
Intervention description(s): In the information video; The materials used during the PCR test, how long the process will take, how the sample will be taken, why healthcare professionals wear personal protective equipment, and what adolescents should do are included.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Coronavirus; Polymerase Chain Reaction; Adolescent; Anxiety; Information video
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus; Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect the investigative drug has on glycemic
      control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism
    

Detailed description: 
      A phase IIB, multi-center, randomized, parallel, placebo- and active-controlled trial in
      adult male subjects with secondary hypogonadism who have been treated with OHAs but are not
      in glycemic control. All subjects currently treated with exogenous testosterone will
      discontinue at screening for at least 21 days and remain off testosterone for the course of
      the study. One hundred twenty to 150 subjects will be randomly assigned to one of three
      treatment groups according to a 1:1:1 ratio. Subjects will receive one of two dose strengths
      of Androxal or placebo in addition to their usual dose of mono- or combination OHAs for three
      months. Following an initial screening period, subjects will return monthly for 3 months and
      1 month later for a follow-up visit.
    

Intervention name(s): Placebo; Androxal
Intervention type(s): Drug; Drug
Intervention description(s): Placebo capsule 1x daily for 3 months; Capsules 12.5 mg or 25 mg 1x daily for 3 months
Other intervention name(s): Enclomiphene citrate
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adult onset hypogonadotropic hypogonadism
Ultrasound Guided Knee Injections in Musculoskeletal Medicine
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study will compare the accuracy and patient reported outcomes between four different
      techniques used to perform a knee injection.
    

Detailed description: 
      This study will compare the accuracy and patient-oriented outcomes between various techniques
      for intra-articular knee injections. Historically, a joint line (intercondylar) technique of
      injection at the medial or lateral joint line, reliant solely upon clinical palpation, has
      been the most popular approach among primary care and orthopedic providers. Newer approaches,
      making use of ultrasound visualization to accomplish access to the intercondylar recess and
      the anterolateral suprapatellar pouch, have gained in popularity. Because of uncertain
      accuracy with the traditional approach, this study is designed to determine if sonographic
      visualization combined with either of these two newer techniques improves accuracy and
      affects patient-oriented outcomes.
    

Intervention name(s): Joint line ultrasound; Joint line landmark; Suprapatellar ultrasound guided; Suprapatellar Landmark
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will be aided by real time visualization utilizing ultrasound guidance.; Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.; Patients will be lying supine on exam table. Ultrasound will be used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa will be made within the suprapatellar pouch.; Patients will be lying supine on exam table. Injecting physician will insert needle lateral to the vastus lateralis toward the suprapatellar pouch, and will inject of Euflexxa once it is believed that the needle tip is in the pouch.
Other intervention name(s): JLUS; JLL; SPUS; SPL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized into one of four intervention arms for the purpose of obtaining patient reported outcomes as it relates to the accuracy of injections into the knee joint with or without ultrasound guidance.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee; osteoarthritis; ultrasound; sonography; injection
A Phase 2 Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Stable Type 2 Diabetes and Hypertension
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the impact of escalating doses of IW-1973 on endothelial function [using EndoPAT
      to measure fingertip small vessel pulse volume], blood pressure (BP), and heart rate.
    


Intervention name(s): Matching Placebo; IW-1973
Intervention type(s): Drug; Drug
Intervention MeSH terms: Praliciguat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of Sleep Apnea Diagnosis Device
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes
Study type: Observational

Summary: 
      Obstructive sleep apnea (OSA) is common and largely underdiagnosed disease. The standard
      method for the diagnosis of OSA is a complete night polysomnography (PSG). Simple methods for
      OSA diagnosis are necessary. The overnight oximetry with the oxygen desaturation index (ODI)
      has been largely investigated as a diagnostic test for OSA but its accuracy remains
      undefined. The aim of our study is to evaluate if an wireless polygraph (Oxistar) is accurate
      to diagnosis OSA in patients referred to a Sleep Lab.
    

Detailed description: 
      Consecutive patients referred to the sleep laboratory with suspected diagnosis of OSA
      underwent in-laboratory polysomnography (PSG) and simultaneously wireless polygraph. The PSG
      oximeter and the wireless polygraph were worn on different fingers of the same hand. All
      sleep studies were reviewed by one blind investigator according the 2017 American Academy of
      Sleep Medicine recommendations. The number of desaturations from wireless polygraph at the 3
      predefined threshold levels (of ODI-2%, ODI-3%, or ODI-4%) was derived automatically using
      proprietary algorithm. Moderate to severe OSA was defined as AHI ≥ 15 events/h. The
      diagnostic accuracy of ODI-2%, 3%, and 4% for the diagnosis of moderate-severe OSA were
      calculated for cut-off values from 1 to 20 desaturation events/h. The sleep actimetry was
      compared with the sleep stages from PSG, most of the statistical metrics applied for
      diagnosis were used to evaluate the applicability of this proposed method. Finally, the
      snoring events computed by the smartphone application were compared with the events heard by
      a specialist and the statistical comparison metrics were evaluated.
    

Intervention name(s): Polysomnography (PSG) and wireless sensor Oxistar
Intervention type(s): Diagnostic Test
Intervention description(s): Monitoring the apnea-hypopnea index (AHI) derived from PSG and the oxygen desaturation index (ODI) obtained by the Oxistar.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients referred to a university-based tertiary sleep referral centre.
      
Keywords: sleep apnea; polygraph; home sleep apnea test (HSAT); apnea hypopnea index (AHI); oxygen desaturation index (ODI); portable monitor; sleep actimetry; snoring
Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer
Condition: Normal Volunteers
Study type: Observational

Summary: 
      The aim of the study is to investigate the negative symptoms and cognitive function after
      administration of antipsychotics in healthy volunteer.
    


Intervention name(s): risperidone; aripiprazole; haloperidol; amisulpride; lactose
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Haloperidol; Risperidone; Aripiprazole; Haloperidol decanoate; Amisulpride
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Recruited volunteers among normal adults aged from 18 to 38 who responded advertisements
        for research subjects. Then selected subjects from the applicants using various screening
        tests - physical and neurological examination including confirming vital signs after
        examining physical health and sleep habits of volunteers
Process-instructed Self Neuro-Modulation (PRISM) for Attention Deficit/ Hyperactivity Disorder - Adults
Condition: Attention Deficit Hyper Activity
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This is a single-arm, open-label feasibility study. Participants will be assigned and will
      undergo a novel neurofeedback intervention, targeting down-regulation of deep limbic
      structures, specifically the amygdalae. Participants will complete 12 neurofeedback sessions
      delivered twice weekly over 6 consecutive weeks. The intervention will be delivered via the
      PRISM platform.
    

Detailed description: 
      The objectives include: 1)Training the NYU team on the electric finger print
      electroencephalography neurofeedback (EFP-EEG-NF) technology and provide them with hands-on
      experience; 2) Assessing participants' ability to learn the feedback paradigm (i.e. control
      the EFP-EEG-NF signal; time to achieve learning; assess learning curves); 3) Exploring
      preliminary results assessing target symptoms (e.g. AISRS and BRIEF-A).
    

Intervention name(s): PRISM
Intervention type(s): Device
Intervention description(s): The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 "active" weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes.
Other intervention name(s): EEG-based neurofeedback (EEG-NF) device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PRISM
Measurement of Gait Using Opal APDM and Gait Mat in Parkinsonism
Condition: Parkinsonism
MeSH terms: Parkinsonian Disorders
Study type: Observational

Summary: 
      The project is a prospective trial comparing Zeno/GAITRite and APDM® in a cohort of persons
      living with parkinsonian disorders. Ambulatory patients with a parkinsonian syndrome and who
      are able to provide informed consent will participate in the assessments.

      Outcome variables include selected gait and balance parameters such as cadence, gait-cycle,
      stride-length, stride-velocity, turning duration, turning steps, postural sway and
      anticipatory postural control. These parameters will be measured by the portable inertial
      sensors developed by APDM® and the Zeno/GaitRite.
    

Detailed description: 
      Testing

      Participants after screening and consenting will:

        1. Have their height measured and fit with the APDM Opals (each device is a two inch square
           attached by velcro), one device is attached to each leg, each arm, and the trunk and
           chest and receive an introduction to walking on the gait mat.

        2. Participants are then asked to walk at a self selected walking speed down the gait mat.
           The participants will complete multiple passes (8-10 passes, total 75-100 feet) across
           the gait mat while wearing the APDM units to concurrently collect all temporal and
           spatial data needed to answer the research question. The Zeno mat is the intended
           primary gait mat for this study. The GaitRite will only be utilized in the case of a
           technical issue with the Zeno in order to insure completion of the data collection.
    

Intervention name(s): GAITRite; ADPM
Intervention type(s): Other; Other
Intervention description(s): mobility test assessing gait parameters; mobility test assessing gait parameters
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults between the ages of 18 and 80 years of age with a primary diagnosis of PD and
        similar parkinsonian syndromes and clinical signs of FoG
      
Keywords: Parkinson's disease; gait
Acute Pain Study Following Bunionectomy
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study was to evaluate analgesic efficacy and safety of
      hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate
      to severe pain following bunionectomy.
    

Detailed description: 
      The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative
      anesthesia was standardized for all participants. Upon completion of surgery, designated
      study personnel ensured continued eligibility per the selection criteria of the protocol.

      After an appropriate period of time following bunionectomy, participants who had a pain
      intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain
      intensity per the categorical pain intensity scale were eligible for randomization, in equal
      numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.
    

Intervention name(s): Hydrocodone/Acetaminophen Extended Release; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo tablet
Other intervention name(s): ABT-712
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed
      conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and
      pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.
    

Detailed description: 
      This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed
      conditions. On Day 1 of Period 1 (Treatment A), a single oral dose of neratinib will be
      administered followed by PK sampling for 72 hours. In Period 2 (Treatment B), multiple oral
      doses of lansoprazole will be administered once daily for 7 consecutive days with a single
      oral dose of neratinib administered on Day 5. PK sampling for neratinib will be taken for 72
      hours following neratinib dosing on Day 5. The washout period will be at least 14 days
      between each neratinib dose.
    

Intervention name(s): Lansoprazole; Neratinib
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers
Study of the ONS "Nutrinidrink With Dietary Fiber" Use Effect on Some Health Indicators in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      The goal of this low-interventional study was to study the effect of additional nutritional
      support with ONS "Nutrinidrink with dietary fiber" on the anthropometric parameters of
      patients and the dynamics of gastrointestinal symptoms in patients with cerebral palsy. Among
      the additional objectives were to study the quality of life, metabolic parameters and the
      dynamics of some functional parameters of patients. Possible adverse events were also studied
      and described.
    


Intervention name(s): Nutrinidrink with Dietary Fiber
Intervention type(s): Dietary Supplement
Intervention description(s): Nutrinidrink with Dietary Fiber is a specialized nutrition for children during illness and recovery period, as well as with increased protein and energy needs: mental and / or physical stress, chronic diseases, growth and / or weight deficiency
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Boys and girls, aged 4-8 years with confirmed diagnosis of cerebral palsy, spastic and
        hyperkinetic forms (Class of cerebral palsy GMFCS 2-3) and Z-score BMI ≤ -1
      
Keywords: Cerebral Palsy; Nutrition; Quality of Life; Bioimpedance; Z-score
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
Condition: Lipoma
MeSH terms: Lipoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether collagenase is effective in reducing the
      surface area of a subcutaneous benign lipoma.
    

Detailed description: 
      This study will evaluate the safety and efficacy of a Food and Drug Administration (FDA)
      approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors). The fat in the lipoma is
      like normal fat except that it is enclosed in a balloon-like structure which is made of
      collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein
      that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby
      decreasing the size of the lipoma or removing it. Each subject must have two lipomas; one
      lipoma to be treated with placebo and one lipoma to be treated with study drug, both to be
      observed similarly throughout the trial.
    

Intervention name(s): AA4500; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously; Placebo
Other intervention name(s): XIAFLEX, Collagenase Clostridium Histolyticum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal Hyperbaric Prilocaine.
Condition: Anesthesia
Study type: Observational

Summary: 
      The prilocaine is a very common local anesthetic that has the disadvantage of being
      metabolized to o-toluidine, a human carcinogen.

      Hyperbaric 2% prilocaine (HP), recently developped, is increasingly used for spinal
      anesthesia in ambulatory surgery. But the formation of carcinogenic metabolites induced by
      the hyperbaric prilocaine is not yet known. The aim of this study is to investigate whether
      the intrathecal administration of 50 mg hyperbaric prilocaine induces also the formation of
      carcinogenic complexes such as urinary o-toluidine and hemoglobin adducts from o-toluidine in
      blood.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient scheduled for an ambulatory surgery
      
Biospecimen description: 
      Whole blood (2 samples) and Urine (4 samples)
    
Keywords: Hemoglobin adducts from o-toluidine in blood; Urinary o-toluidine; Intrathecal anesthesia; Hyperbaric prilocaine; Ambulatory surgery