bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Bipolar Depression With Pentoxifylline
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Growing theoretical and clinical evidence has suggested that pentoxifylline may have an
      effect in improving depressive symptoms. Herein, we aim to evaluate the effect of
      pentoxifylline in patients with bipolar depression over an 8-week trial.
    

Detailed description: 
      Growing evidence has demonstrated that inflammation and alterations in cerebral blood flow
      (CBF) contribute to the pathophysiology of bipolar depression (BD). Pentoxifylline is a
      phosphodiesterase inhibitor that improves CBF and has potent anti-inflammatory and
      antioxidant effects. We therefore hypothesize that pentoxifylline may have antidepressant
      effects in BD. We will conduct an 8-week, open-label, single-armed, feasibility study
      assessing clinical and neurobiological effects of adjunctive pentoxifylline in the acute
      treatment of BD. Feasibility will be determined by evaluating recruitment/retention rates,
      target engagement (e.g., changes in biomarkers with pentoxifylline treatment) and preliminary
      efficacy testing with 6 participants. Evaluating pentoxifylline's effects may further our
      understanding of BD pathophysiology and help identify novel treatment targets.
    

Intervention name(s): Pentoxifylline 400 MG
Intervention type(s): Drug
Intervention description(s): All patients will be provided with pentoxifylline 400 mg to be orally ingested twice daily for 8 weeks.
Other intervention name(s): Trental
Intervention MeSH terms: Pentoxifylline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine (MERS002)
Condition: Middle East Respiratory Syndrome Coronavirus
MeSH terms: Coronavirus Infections; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase Ib study to determine the safety and immunogenicity of the candidate Middle East
      Respiratory Syndrome Coronavirus (MERS-CoV) vaccine ChAdOx1 MERS in healthy adult Middle
      Eastern volunteers
    

Detailed description: 
      This is an open-label, dose escalation phase 1b trial to assess the safety and immunogenicity
      of the candidate ChAdOx1 MERS vaccine in healthy Middle Eastern adult volunteers aged 18-50.
      The first-in-human trial is now being conducted in Oxford in UK healthy adult volunteers. The
      vaccine will be administered intramuscularly.

      Volunteers will be recruited and vaccinated at the King Abdulaziz Medical City, M-NGHA,
      Riyadh. There will be 3 study groups and a total of 24 volunteers will be enrolled. Staggered
      enrolment will apply for the first three volunteers within each group. Volunteers will be
      first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical
      safety reviews. Volunteers will be allocated to a study group by selecting eligible
      volunteers for enrolment in the order in which they were deemed eligible, following
      screening.
    

Intervention name(s): ChAdOx1 MERS
Intervention type(s): Biological
Intervention description(s): a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-labelled, non-randomised, dose escalation, extension for a first-in-human, single centre, phase Ib clinical trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MERS-CoV; ChAdOx1 MERS
Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold
      Effects (responsivity) of Belsomra 10 mg and 20 mg to Placebo in non-elderly Insomniacs
    

Detailed description: 
      The study is an interventional single site study using a double blind, randomized 3-way
      crossover design with Belsomra 10 mg and 20 mg compared to a placebo. The total number of
      enrolled patients proposed is 12. A cross-over design is utilized so participants will be
      exposed to all treatment conditions in a controlled order (Belsomra 10 mg, 20 mg and
      placebo). Both men and women with insomnia will be utilized as the study population to
      improve the generalizability of outcome data. Subjects with other sleep disorders or unstable
      medical/psychiatric disorders will be excluded from the trial. Inclusion criteria will be men
      and women >18 and < 65 years of age.

      Subjects will be randomly assigned to treatment sequences using a Latin square design. After
      a subject has qualified for the study, the next sequentially available randomization number
      will be assigned. The subject will be administered study drug corresponding with this
      assigned number.

      During the night of each respective Polysomnography (PSG) assessments, subjects will be
      awoken at the approximate T-max of the active drug (2.5 hrs), with a matching placebo
      condition at the same time point using an identical responsivity protocol for each condition.
      The rationale for this is that t-max represents the time of greatest potential risk for a
      hypnotic in terms of balance, responsivity, and memory. Responsivity will be assessed using
      the Auditory Awakening Threshold test (AAT) and will be measured at 2.5 hours post dose for
      the Belsomra 10 and 20 mg (BEL), and placebo (PBO) conditions. Responsivity will be assessed
      at the approximate time above immediately after 5 minutes of consolidated (without arousals)
      NREM ( Non- rapid eye movement) stage 2 sleep has occurred.
    

Intervention name(s): Suvorexant 10 mg; Suvorexant 20 mg; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subject will receive suvorexant 10mg; Subject will receive suvorexant 20mg; Subject will receive placebo.
Other intervention name(s): belsomra 10mg; Belsomra 20mg; placebo
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double-blind, randomized 3-way crossover design
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: insomnia; belsomra; suvorexant
Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study)
Condition: Atrial Functional Mitral Regurgitation; Heart Failure
MeSH terms: Mitral Valve Insufficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate second stage safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty
      with CSTV for repair of functional mitral regurgitation.
    

Detailed description: 
      The objective of this prospective, single-center, open label, feasibility test is to assess
      the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device, in
      treating functional mitral regurgitation (FMR) associated with heart failure and Atrial
      Fibrillation mitral regurgitation Response in Mitral Loop Cerclage annuloplasty.
    

Intervention name(s): Mitral Loop Cerclage Annuloplasty
Intervention type(s): Device
Intervention description(s): Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty
Other intervention name(s): (MLC-B-45-75-R and other 11 models)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Percutaneous mitral valve repair; Coronary sinus annuloplasty; Mitral loop cerclage; atrial fibrillation; Mitral Regurgitation
A Study on the Prevalence of Obstructive Sleep Apnea in Patients With Type II Diabetes Mellitus
Condition: Obstructive Sleep Apnea; Diabetes Mellitus
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Diabetes Mellitus
Study type: Observational

Summary: 
      OSA is prevalent among patients with type II DM
    

Detailed description: 
      Obstructive sleep apnea (OSA) has been reported to be common (prevalence ranged from 23-86%)
      in previous studies involving Caucasian diabetic patients. The investigators aim at finding
      out the prevalence of OSA in Chinese diabetic patients and identify the clinical predictors
      associated with OSA.

      Recruited subjects will undergo overnight polysomnography, anthropometric measurements, blood
      tests including glycosylated hemoglobin, renal function, glucose level, blood pressure
      measurement both during the clinic visit and after admission for in-laboratory sleep study.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All Chinese subjects with type 2 diabetes mellitus being followed up at the diabetic clinic
        of a University affiliated hospital
      
Biospecimen description: 
      Plasma and serum samples were collected from subjects for batch assays for further research
      purposes
    
Keywords: obstructive sleep apnea; prevalence; diabetes mellitus; Chinese
uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes
Condition: Perioperative Care
Study type: Observational

Summary: 
      This is an observational, non-interventional study to assess the equivalence of wearable
      monitors with formal CPET testing for the prediction of physiological reserve before major
      surgery.
    

Detailed description: 
      This project will exploit the rapid development of wearable technology to allow perioperative
      risk prediction to become logistically easier, cost effective and used more broadly. It will
      use low cost wearable technology to complement or act as a surrogate to complex CPET testing
      performed for perioperative risk stratification. The data gained from a Garmin Vivosmart HR+
      wearable device, will be used in the community by patients awaiting surgery, and will be
      correlated with key CPET indices including anaerobic threshold and peak VO2. Ultimately, this
      study aims to assess whether wearable technology can provide the data needed for the
      formation of prediction models to risk assess perioperative outcomes in patients undergoing
      high-risk elective surgery. In addition, an International Physical Activity Questionnaire
      (IPAQ) will be completed to compare the activity captured with self-reported activity. This
      will be combined with frailty scores and handgrip strength as is routinely collected during
      CPET. Finally, a saliva based genetic analysis will be conducted on genetic variations known
      to be of significance in critical illness and response to physical stress. This will be
      delivered by a laboratory (Fitness Genes) that has developed a bespoke panel of genetic
      markers ideally suited to this patient cohort.
    

Intervention name(s): Garmin wearable device
Intervention type(s): Device
Intervention description(s): Physiological data capture only
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Recently, low-cost, wearable activity monitors have become very popular. They can record
        lots of information about a person's general health and activity. In this study, we would
        like to see if an activity monitor can help predict a person's risk of developing
        complications after having major surgery.
Art Therapy in Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic
      art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of
      schizophrenia compared to a group of patients receiving treatment as usual.

      *Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission
      compared to TAU.

      *Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing
      function, self-efficacy and neuroleptic dosage compared to TAU.
    


Intervention name(s): psychodynamic art therapy
Intervention type(s): Behavioral
Intervention description(s): 2 sessions à 1.5 hrs /week, intervention duration 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cardiovascular Risk Stratification in Covid-19
Condition: Covid19; Cardiovascular Risk Factor
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This retrospective double-cohort study seeks to:

        1. Describe the cardiovascular manifestations and electrophysiological (EP) substrate in
           COVID-19 infection and their association with clinical outcomes; and

        2. Develop a method of cardiovascular risk stratification in COVID-19
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Records of patients who had Covid19 test performed
      
Keywords: Covid19; cardiovascular risk factor; electrocardiogram; risk stratification
A Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 2

Summary: 
      16448 is being investigated for the treatment of primary premature ejaculation (PE) using a
      novel mode of action. There are no approved therapies for premature ejaculation, and novel
      therapies are needed for this syndrome.

      16448 has been shown to increase ejaculatory latency in the PCA rat model of premature
      ejaculation.

      A novel instrument, the Sexual Assessment Monitor (SAM), will be used to measure ejaculatory
      latency time in this study. This device, which measures ELT under standard conditions, has
      been shown to provide a more reliable measure of ejaculatory latency compared to the use of a
      stopwatch during sexual intercourse
    


Intervention name(s): 16448
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Premature ejaculation (PE) ejaculatory latency time (ELT)
Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study was to establish that an optimal dose of Quillivant XR oral
      suspension would result in a significant reduction in signs and symptoms of ADHD compared to
      placebo treatment in pediatric patients ages 6-12 years with ADHD.
    


Intervention name(s): Quillivant Oral Suspension XR; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Suspension 25mg/5mL; 20-60 mg/day; Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day; Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.
Other intervention name(s): methylphenidate hydrochloride oral suspension
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperactivity Attention Deficit Disorder; ADHD; Pediatric Patients; Quillivant; methylphenidate
Effect of Neural Mobilization in Bells Palsy: A Randomized Controlled Trial
Condition: Bell Palsy
MeSH terms: Bell Palsy; Facial Paralysis
Study type: Interventional

Summary: 
      Bells palsy is a sudden paralysis of half of the facial muscle. The BP is idiopathic and 70%
      responds well with drug therapy. There are many complementary therapies such as , tapping,
      electrical stimulation, and massage that adds to the recovery of condition. However, efficacy
      of neural mobilization in BP is not reported in the scientific literature.
    

Detailed description: 
      Bells Palsy responds well with drug therapy such as prednisolone and antiviral drugs for the
      duration of 10-12 days. However, the administration of these drugs produce adverse side
      effect. Therapist use a number of techniques to maintain the physiological properties of
      facial muscles. However, adding a new technique would add to the arsenal of techniques
      available for the therapist. The research is intended to determine the effect of adding
      Neural mobilization in the recovery of Bells Palsy. A randomized controlled trail is intended
      to include 60 participants divided into two groups. Experimental group will receive Neural
      Mobilization with conservative treatment and control group will receive conservative
      treatment only.
    

Intervention name(s): Neural Mobilisation; Massage therapy; Faradic electrical stimulation; Exercises
Intervention type(s): Other; Other; Diagnostic Test; Other
Intervention description(s): Neural mobilization was applied by gently holding the lower part of the ear between the index finger and thumb. The thumb was placed at the opening of the external auditory meatus and the index finger placed behind the auricle of the ear (Figure 2). The intensity of auricular traction was determined by the patient reporting the level of discomfort. The patient tolerated 3-4 sets of gentle horizontal traction and circular movement 25 times each with 5 seconds rest.; Massage therapy consisting of tapping, effleurage and finger and thumb kneading for 15-16 minutes.; Faradic electrical stimulation with anode electrode at the back of the neck and cathode over the nerve trunk anterior to the earlobe. The cathodic pen electrode was used to locate the facial nerve trunk for stimulation manually. (Biphasic current, pulse time 300 microseconds, frequency 60 Hz, 20 contractions, Rest 10 seconds). The total treatment time was 15 minutes.; Exercises in front of the mirror like raising the eyebrow, clinching the teeth (patient trying to see his clenched teeth in the mirror), smiling and performing other facial expressions for 12-15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will include a minimum of 60 participants visiting the investigator's outpatient department from 2020-2021. The equal allocation procedure will be used based on the admission of the cases.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the performance of the Bio-Self COVID-19 Antigen
      Home Test. The study will evaluate the accuracy (sensitivity and specificity) in a simulated
      home use environment when compared to a high-sensitivity Emergency Use Authorization (EUA)
      SARS-CoV-2 RT-PCR assay.
    

Detailed description: 
      The Bio-Self COVID-19 Antigen Home Test is immunochromatographic and uses double-antibody
      sandwich method to detect SARS-CoV-2 antigen from individuals with or without symptoms or
      other epidemiological reasons to suspect a COVID-19 infection. The test is intended for
      non-prescription home use with self-collected direct anterior nares swab samples from
      individuals ages 14 years and older or adult collected anterior nares swab samples from
      individuals ages 2 to 13.

      The primary objective of this study is to determine the accuracy of the Bio-Self COVID-19
      Antigen Home Test when compared to a high-sensitivity Emergency Use Authorization (EUA)
      SARS-CoV-2 RT-PCR assay.
    

Intervention name(s): Bio-Self COVID-19 Antigen Home Test; Standard of Care COVID-19 Test; RT-PCR Test
Intervention type(s): Device; Device; Diagnostic Test
Intervention description(s): At home COVID-19 antigen test kit; Standard of care; High Sensitivity RT-PCR COVID-19 Test
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This is an open label, prospective study to evaluate the sensitivity and specificity of the Bio-Self COVID-19 Antigen Home Test when a lay person conducts the test on themselves or another study participant. Potential subjects will be those presenting for COVID-19 testing. The study will evaluate the performance of the Bio-Self COVID-19 Antigen Home Test by comparing it to a high sensitivity EUA SARS-CoV-2 RT-PCR assay to calculate both the positive percent agreement [(PPA) sensitivity] and negative percent agreement [(NPA) specificity].
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Covid, Covid 19, Virus
TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients With Cognitive Dysfunction in Schizophrenia
Condition: Cognitive Dysfunction; Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Schizophrenia affects approximately 1% of the population worldwide, and in about 80% of
      cases, it is a lifelong, disabling illness. It is a multi-dimensional disease that is
      associated with symptoms that have been characterized as positive, negative, and cognitive.
      CDS is a core feature of schizophrenia, and most individuals with schizophrenia exhibit
      cognitive impairment. Attention disorders, slow information processing, working memory
      disorders, and lack of flexibility for adaptive strategies are symptoms of cognitive
      impairment that have a devastating impact on the function, employment, and social status of
      patients with schizophrenia.

      Older typical neuroleptic medications (e.g., haloperidol, fluphenazine) do not improve
      cognition. In fact, haloperidol has been shown to induce cognitive impairment in
      schizophrenic patients.

      Novel atypical antipsychotics, such as risperidone, clozapine, and olanzapine, seem to
      produce gains in cognition. This improvement may reflect a diminution of extrapyramidal side
      effects of the typical high potency neuroleptics. Alternatively, it might reflect more
      effective symptom reduction by the novel antipsychotics, or direct cognitive enhancement
      through the effects of the newer agents on a variety of neurotransmitters, their receptors,
      and gene expression. Even when the newer antipsychotic medications improve cognition, they do
      not normalize it.

      Presently, there are no approved therapies for CDS. However, in schizophrenic patients,
      nicotine improves multiple cognitive domains, including working memory and attention.
      Furthermore, based on a strong body of evidence ranging from genetic mapping to clinical
      trials, the alpha7 NNR subtype has emerged as a primary therapeutic target relevant to CDS
      and other core symptoms of schizophrenia
    


Intervention name(s): TC-5619; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TC-5619-238 will be provided as hard gelatin capsules in strengths of 1mg, 5mg, and 25mg.; Placebo will be provided with exactly the same shape, size and appearance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive dysfunction; schizophrenia; Phase 2