bioihbjkbjnl/mcl2 huggingface dataset:
Dispensing Study for the Phenacite Project
Condition: Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      Dispensing Study for the Phenacite Project.

      The investigational test lens was not the final optical design and the study was not used for
      design validation.
    

Detailed description: 
      Evaluate the objective and patient-reported visual acceptability of the Phenacite contact
      lens.
    

Intervention name(s): Phenacite; comfilcon A
Intervention type(s): Device; Device
Intervention description(s): Subjects will be randomized to wear the Phenacite contact lenses binocularly.; Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care
Condition: HIV Testing
Study type: Interventional

Summary: 
      Because adolescents and young adults face markedly increased HIV risk yet frequently do not
      test, we propose to complete the Mobile Augmented Screening (MAS) tool designed to increase
      HIV testing, and to facilitate linkage to care and ongoing prevention education. This tool
      will help clinicians address undiagnosed youth HIV, and enable young patients to receive much
      needed treatment and avoid unknowingly transmitting infection. Our product is designed to
      help existing program staff reach an increased number of clients; and to improve public
      health by encouraging reluctant young patients to accept important HIV testing and care they
      may otherwise decline.
    

Detailed description: 
      Our randomized trial will evaluate HIV test rates among participants who complete a
      tablet-based intervention, the Mobile Augmented Screening tool (MAS), compared to
      participants in a treatment as usual (TAU) condition.

      Research staff will approach 350 emergency department (ED) patients aged 13 - 24 years.
      Participants will be randomized into the intervention or TAU condition. Participants will be
      randomized in a 1:1 ratio to the intervention or TAU condition, stratified by patient age
      (13-17 and 18-24). Within each of these age strata, permuted blocks randomization with
      varying block sizes will be employed to ensure balance and concealment of allocations prior
      to randomization.

      Participants who are randomized into the intervention condition will watch a 5-minute video
      on a tablet computer, and the tablet will ask intervention participants if they would like an
      HIV test. Possible responses will be "Yes" or "No". Participants who are randomized into TAU
      will be offered HIV tests by research staff. All participants in both conditions who agree to
      HIV testing will be tested by hospital staff in the location where they are receiving
      treatment. All participants who test will receive their results in person from ED staff
      before discharge.

      The primary trial outcome will be percentages of patients, by treatment group, who test for
      HIV.
    

Intervention name(s): Mobile Augmented Screening tool
Intervention type(s): Other
Intervention description(s): Tablet-based intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell
      regeneration.

      The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and
      insulin production.
    


Intervention name(s): Xoma 052; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sterile solution subcutaneously administered every 4 weeks for 12 weeks; Sterile solution subcutaneously administered every 4 weeks for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Type 1
Aromatherapy as Treatment for n/v of Pregnancy
Condition: Pregnancy Emesis
Study type: Interventional

Summary: 
      A double-blinded randomized controlled trial comparing essential oil aromatherapy versus
      placebo for treatment of first trimester nausea and vomiting of pregnancy.
    

Detailed description: 
      This is a double-blinded randomized controlled trial investigating the utility of essential
      oils for aromatherapy, compared to placebo, for treatment of nausea and vomiting in the first
      trimester of pregnancy.
    

Intervention name(s): Aromatherapy; Placebo
Intervention type(s): Other; Other
Intervention description(s): Aromatherapy using essential oils; Aromatherapy using odorless placebo oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Pharmacokinetic Characteristics of DKF-313
Condition: Benign Prostate Hyperplasia; Healthy
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, single-dose, 2-treatment, 2-way, 2-period crossover study
      to evaluate the safety and the pharmacokinetic characteristics of DKF-313 (dutasteride and
      tadalafil) in healthy male volunteers.
    

Detailed description: 
      This study is conducted to evaluate the pharmacokinetics of DKF-313 (dutasteride and
      tadalafil) comparing with the concomitant administration of AVODART and CIALIS in healthy
      male volunteers.
    

Intervention name(s): DKF-313; AVODART; CIALIS
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Combination of dutasteride 0.5 mg and tadalafil 5 mg; Dutasteride 0.5 mg; Tadalafil 5 mg
Other intervention name(s): Dutasteride; Tadalafil
Intervention MeSH terms: Tadalafil; Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Electrophysiological Reactivity Due to Mobile Phone Radiation
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The main objective of this study is to investigate whether radiofrequency electromagnetic
      radiation, induced by a dialing mobile phone placed on the body, causes a change in
      electrophysiology.
    

Detailed description: 
      The aim of this study is to investigate whether placement of a 3G dialing mobile phone causes
      direct changes in EEG activity compared to the placement of a sham phone. Furthermore, it is
      investigated whether placement of the mobile phone on the ear or the heart results in
      different outcomes. The subjects are measured twice: on one of the two days the mobile phone
      is attached to the ear, the other day to the chest. In this single-blind, cross-over design,
      assessments in the sham phone conditions are conducted directly preceding and following the
      mobile phone exposure. During each assessment, EEG activity and radiofrequency radiation are
      recorded jointly. Delta, theta, alpha, slowbeta, fastbeta, and gamma activity are computed.
      The association between radiation exposure and the EEG is tested using multilevel random
      regression analyses with radiation as predictor of main interest.
    

Intervention name(s): a dialing smartphone will be placed on the chest and the ear
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: Single (Participant)
A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicentre, randomised, placebo-controlled, double-blind, three-arm parallel,
      Phase IIa study to evaluate the efficacy, safety and tolerability of MIV-711 in patients with
      knee osteoarthritis (OA).
    


Intervention name(s): MIV-711; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MIV-711 administered orally once daily; Placebo manufactured to mimic MIV-711 capsule.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Heart Rate Variability (HRV) in Patients With Neurogenic Detrusor Overactivity (NDO) Before and After Botulinum Neurotoxin Type A (BoNT/A) Intradetrusor Injections
Condition: Bladder Disorder, Neurogenic
MeSH terms: Urinary Bladder, Neurogenic; Urinary Bladder Diseases
Study type: Observational

Summary: 
      Heart rate variability (HRV) is an important indicator of cardiac autonomic function and
      predictor of cardiac mortality and of all-cause mortality. In this study the investigators
      examined changes of the HRV in patients with neurogenic detrusor overactivity (NDO)
      undergoing botulinum neurotoxin type A intradetrusor injections (BoNT/A).
    

Detailed description: 
      BoNT/A is a common treatment in patients with NDO. Possible known side effects are urinary
      retention or increased post void residual. Systemic side effects seems to be rare. However
      this has not been investigated in detail. Although in very small amounts, BoNT/A can enter
      the systemic circulation during intradetrusor injections and might cause distant effects on
      other neuro-muscular systems, i.e. the heart. Aim of this trial is to asses potential
      systemic adverse effects of BoNT/A on the heart following intradetrusor injections for NDO.
      Potential effects on the cardiac autonomic function can be detected using HRV analysis.
      Patients without relevant preexisting disorders of cardiac function and proven NDO are
      included. During four separate visits, all subjects receive two ECG measurements before
      (Visit 1 and 2) and two ECG measurements following BoNT/A intradetrusor injections (Visit 3
      and 4). We investigate three different groups: 1) patients not receiving BoNT/A intradetrusor
      injections (= control group), 2) patients receiving intradetrusor injections with 100 units
      BoNT/A, and 3) patients receiving intradetrusor injections with 300 units BoNT/A.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Two groups, one control group without treatment, one group with NDO and treated with
        BoNT/A, both measured with ECG
      
Keywords: HRV; NDO; BoNT/A,; adverse effects
Low Dose Cyclophosphamide Treats Genital Warts
Condition: Genital Wart
MeSH terms: Warts; Condylomata Acuminata
Study type: Interventional
Phase: Phase 3

Summary: 
      Condylomata acuminata (CA) caused by human papillomavirus (HPV) is a common sexually
      transmitted disease with half a million new cases diagnosed in the United States per year.
      Recurrence is a major challenge for CA treatment. The investigators have demonstrated that
      FOXP3+ regulatory T (Treg) cells mediate the immunosuppression in large genital warts. And
      low-dose cyclophosphamide (CY), a conventional chemotherapy drug, has been reported to
      selectively deplete Treg cells in cancer patients. Therefore, the investigators hypothesized
      that low-dose CY can be used to treat genital warts. In this study, 104 CA patients have been
      recruited for clinical trial with a 1:2 randomization. Among them, 64 patients received
      low-dose cyclophosphamide and 32 received placebo. In 8 extra patients, high-dose
      cyclophosphamide was given.
    

Detailed description: 
      Patients were first treated with CO2 laser therapy, and then treated with low-dose CY, orally
      50 mg per day for 7 days.The CA recurrence were observed.
    

Intervention name(s): cyclophosphamide
Intervention type(s): Drug
Intervention description(s): 50 mg oral per day for 7 days
Other intervention name(s): CY
Intervention MeSH terms: Cyclophosphamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients
Condition: Chronic Kidney Disease; End Stage Renal Failure on Dialysis; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and
      Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.
    

Detailed description: 
      In this study CKD patients on dialysis previously treated by short-acting epoetins will
      switch to one of darbepoetin alfa products - BCD-066 (experimental arm) or Aranesp (active
      comparator) to maintain previously achieved target level of hemoglobin (100-120 g/l).

      Patients will be treated for 52 weeks. IV iron supplementation will be provided to maintain
      serum ferritin level above 500 µg/l according to KDIGO Anemia Guidelines (2012).
    

Intervention name(s): Darbepoetin alfa
Intervention type(s): Drug
Intervention description(s): Weekly sc administration of darbepoetin alfa
Other intervention name(s): Aranesp; BCD-066
Intervention MeSH terms: Darbepoetin alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: darbepoetin alfa
Combined Exercise Training in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      It is stated that the affected cognitive functions in Multiple Sclerosis are learning,
      memory, attention, speed of information processing, visuospatial skills, and executive
      functions. The speed of information processing, visual learning and memory are the most
      frequently affected components in MS. For this reason, approaches to increase cognitive
      functions by activating neuroprotective mechanisms such as exercise in patients with MS are
      needed.

      The purpose of this study is to examine the effect of combined exercise training on cognitive
      functions in patients with MS.
    

Detailed description: 
      The study was designed as a randomized, controlled, single-blind trial. This study will
      include patients with MS who 0-5.5 according to the Extended Disability Status Scale (EDSS)
      and between 18-65 years. The patient will be randomized into a combined training group and a
      control group. The patients in the control group will not apply an exercise training. The
      combined exercise training group will be given combined exercise training, consisting of
      Pilates and aerobic exercise, three times during 8 weeks. Both groups will be reevaluated 8
      weeks after the initial assessment.

      Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago,
      IL, USA). The pre-training and post-training measurements of groups will be compared with the
      Wilcoxon Test. The significance level was set at p< 0.05.
    

Intervention name(s): combined exercise training
Intervention type(s): Other
Intervention description(s): The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, single-blind trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive function; fatigue; quality of life; Functional exercise capacity
Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when
      used in conjunction with basal insulin, achieves equivalent glycemic control when compared to
      multiple daily injections and to evaluate its preference.
    

Detailed description: 
      The aim of this feasibility study is to compare efficacy, device satisfaction and quality of
      life (QOL) in people with type 1 or 2 diabetes delivering mealtime insulin using a novel
      insulin bolus-patch (Finesse™; Calibra Medical, Inc., Redwood City, CA) versus current
      devices that deliver bolus insulin (pen/syringe). All subjects injected their basal insulin
      using their current pen/syringe.
    

Intervention name(s): Finesse; Pen/Syringe (Usual injection device)
Intervention type(s): Device; Device
Intervention description(s): Finesse Insulin Delivery Patch; Pen/Syringe
Other intervention name(s): Insulin Bolus Patch; Insulin pen; Insulin syringe; Insulin injection device
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autoimmune Diseases; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Immune System Diseases; Insulin; Metabolic Diseases
A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a
      single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by
      prefilled syringe (PFS) or auto injector (AI) in healthy adult participants.
    


Intervention name(s): SHP643
Intervention type(s): Drug
Intervention description(s): Participants will receive injection of SHP643.
Other intervention name(s): DX-2930 (formerly); Lanadelumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
With Love: Using Promotoras for a Hispanic Community Palliative Care Promotora Palliative Care
Condition: Palliative Care
Study type: Interventional

Summary: 
      Despite being strongly recommended, the integration of palliative care in oncology has not
      been widely adopted. Very few people have access to comprehensive palliative care. Access is
      even lower in rural and Hispanic communities. Even in communities with access, uptake is
      often low due to a lack of education on the part of both patients and providers regarding
      palliative care. This study aims to use an innovative approach to provide quality palliative
      care to oncology Hispanic patients by using community health workers also known as
      promotoras.
    

Detailed description: 
      Palliative care has been highly recommended to be an integral part of oncology yet very few
      people have access to comprehensive palliative care. Access is even lower in rural, low
      socio-economic and Hispanic communities. Palliative care has been shown to decrease
      healthcare costs. This study will use an innovative approach to provide quality palliative
      care to gynecology-oncology Hispanic patients by using community health workers also known as
      promotoras. The promotora model has been shown to be successful in several behavioral
      modification programs. The investigators aim to use promotoras to deliver a comprehensive and
      culturally sensitive educational intervention that covers self-care in the presence of
      cancer, advance directives, pain management, and care taker awareness. The goal of the
      intervention will be to decrease number of emergency department visits and hospital
      admissions of patients with advanced cancer, and increase the rate of completion of advanced
      directives, as well as improve overall quality of life (as measured by standardized scales)
      when comparing the intervention group vs. the control (usual care) group. The investigators
      will additionally assess the cost effectiveness of this intervention.
    

Intervention name(s): Intervention (Promotora)
Intervention type(s): Behavioral
Intervention description(s): If the patient is in the intervention group, the promotora will call the patient in order to invite them to a meeting. Meetings will be arranged by the promotora and the patients. A total of 2 group meetings will be required by all participants and 1 family meeting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: cancer
Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This
      triglyceride can then be released into the blood when another meal is consumed or in response
      to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride
      from the gut is not known. The research team in this study is interested in finding out how
      teduglutide (a degradation resistant form of GLP-2) releases stored triglyceride from the gut
      by studying samples from patients undergoing endoscopy and small bowel biopsy.
    

Detailed description: 
      The release of stored enteral lipids will be investigated in 30 patients undergoing upper
      gastrointestinal endoscopy and duodenal biopsy for clinical indications. Patients undergoing
      the procedure will be recruited. Participants will have a high fat liquid meal as breakfast.
      5 hours later, participants will be randomly assigned to receive either a subcutaneous
      injection of placebo (n=15) or a subcutaneous injection of the Health Canada approved
      glucagon-like peptide-2 (GLP-2) analogue (teduglutide, Revestive®, Shire Canada)(n=15
      different subjects). 1 hour later, a duodenal biopsy specimen will be obtained from 2-3
      sample sites,snap frozen in dry ice and stored at -80°C for further analysis.
    

Intervention name(s): Teduglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Teduglutide; Placebo
Intervention MeSH terms: Teduglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to receive either teduglutide or placebo as a single subcutaneous injection, 1 hour prior to duodenal biopsy
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Intestinal lipoprotein; Duodenal biopsy; Gut Peptide; Chylomicrons