bioihbjkbjnl/mcl2 huggingface dataset:
Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification
Condition: Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by
      providing endothelial protection, maintaining space, as well as facilitating surgical
      maneuvers, including IOL implantation. Equally important is the ease of use, good
      visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a
      single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2%
      hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these
      in clinical scenarios, there is no randomized trial comparing intraoperative performance and
      postoperative outcomes. The aim of this study was to compare intraoperative performance and
      postoperative outcomes following microcoaxial phacoemulsification when using one of the three
      OVDs
    


Intervention name(s): Microcoaxial Phacoemulsification
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification:
      Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject,
      Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
    

Detailed description: 
      Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant
      drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal
      cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week
      for 2 weeks. They will be evaluated every 2 weeks.
    

Intervention name(s): Yband(YDT-201N); Sham-Yband(YDT-201N)
Intervention type(s): Device; Device
Intervention description(s): transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC); transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; tDCS; MDD; transcranial Direct Current Stimulation
A Study to Evaluate the Food-Effect of H3B-6527
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to determine the effect of food on the relative bioavailability
      of H3B-6527 following administration of a H3B-6527 capsule with and without a meal.
    


Intervention name(s): H3B-6527
Intervention type(s): Drug
Intervention description(s): Oral capsule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: H3B-6527; Healthy Participants; Pharmacokinetics
Prostate Cancer Screening Trial Using Imaging
Condition: Prostate Neoplasm
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Participants will be recruited from the community and attend a screening clinic and undergo
      the following screening tests:

        1. Bi-parametric MRI - reported by a radiologist and CAD-AI system

        2. Multiparametric ultrasound - including shearwave elastography

        3. A standard-of-care PSA test

      A systematic +/- targeted biopsy will be performed if any tests are positive, independent of
      the other tests.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men aged 50-69 years
Pharmaceutical Care Service in Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of pharmaceutical care service in
      the management of poorly controlled type 2 diabetes mellitus.
    


Intervention name(s): Pharmaceutical care
Intervention type(s): Behavioral
Intervention description(s): Outpatient drug history management, drug regimen review, patient counseling and education before and/or after physician evaluation on the day of facility visit
Other intervention name(s): Pharmaceutical service
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Diabetes Mellitus, Type 2; Pharmaceutical Services
Effect of Beta-Alanine on Heart Rate Response
Condition: Exercise; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle
      buffering capacity and delay fatigue. Various fatigue tests have been utilized to examine the
      effectiveness of beta-alanine supplementation. The physical working capacity test has been
      used to show significant increases in physical working capacities following supplementation.
      The physical working capacity tests were originally developed by Moritani et al. 1981 and
      Devries et al. 1982 to measure the point of onset of muscular fatigue. It is hypothesized
      that beta-alanine will increase physical working capacity at heart rate threshold, thereby
      signifying a delay in fatigue.
    

Detailed description: 
      An equal number of men and women will be recruited [Men, n=20 (10 placebo [PL]; 10
      beta-alanine (Active)]; [Women,n=20 (10 PL; 10 Active)]. Men and women will be randomly
      assigned to respective groups to allow for equal numbers in supplement and placebo groups.
    

Intervention name(s): Placebo; Beta-alanine
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Keywords: dietary supplement; carnosine
Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions
Condition: HIV-1
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, the investigators evaluated a therapeutic HIV-1 DNA vaccine administered with
      a novel topical application method to 12 chronically HIV-infected cART treated patients. The
      HIV DNA plasmids used in this study encode for envelope gp160 of HIV-1 subtypes A, B and C,
      rev B, Gag A and B and reverse transcriptase (RT) B. The patients were randomly assigned to
      three groups; group 1 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids
      topically, group 2 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically
      and treated with 500 mg of hydroxyurea daily until visit 10, group 3 (n=4) four patients
      received placebo. The immunization was performed during three cycles of 7 weeks of cART
      followed by four weeks of therapy interruption. After the last cycle of cART the patients
      were maintained on a definitive treatment interruption until CD4+ T cell counts dropped below
      350/ mm3 at two time points. Cellular and humoral immune responses, viral load and CD4+ T a
      cell count was analysed throughout the study.
    


Intervention name(s): HIV DNA Vaccine
Intervention type(s): Biological
Intervention description(s): 0.4 mg of DNA plasmids encoding HIV env A, B, C and Rev B, gag A, B and RT mut formulated in PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART. Every immunization cycle was followed by four weeks of therapy interruption.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients
Condition: Diabetic Retinopathy; Retinal Imaging
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current
      treatment consists of early detection and laser photocoagulation therapy for preventing
      progressive or severe vision loss. Microaneurysms (MA) are the earliest, clinically visible
      changes of DR, which are visualized using specialized imaging technologies. PulseMedica is
      developing a three-dimensional (3D) retinal imaging system with real-time eye tracking
      capabilities. The purpose of this study is to assess the feasibility of PulseMedica's
      prototype device, the OSNAT800 Imaging Only (IO), in providing real-time tracking of eye
      movements in patients with DR. It is hypothesized that the OSNAT 800 IO will be able to
      perform real-time eye tracking while imaging patients with DR.
    


Intervention name(s): OSNAT 800 IO
Intervention type(s): Device
Intervention description(s): Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Hemophilic Knee Arthropathy Virtual Reality
Condition: Hemophilia; Knee Arthropathy
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      This study intended to examine the effect of a physical rehabilitation program incorporating
      Kinect-based virtual reality on gait characteristics, functional ability, and physical
      activity level in adolescents with hemophilic knee arthropathy.
    

Detailed description: 
      The usage of virtual reality in clinical practice as an alternative for conventional
      procedures has recently sparked the interest of health professionals. Virtual reality is a
      type of computer technology that provides simulated sensory feedback to allow children to
      participate in activities and events that are comparable to those they could face in real
      life. It can be used therapeutically to enhance strength, range of motion, coordination,
      mental concentration, problem solving, decision making, balance, and gait.
    

Intervention name(s): virtual reality group; exercise group
Intervention type(s): Other; Other
Intervention description(s): a 30-minute VR-based training session utilizing Kinect Xbox after the session of traditional physical therapy.; Traditional physical therapy, 30-minutes physical therapy exercise program each week with 48-hour intervals at least
Other intervention name(s): Kinect based virtual reality combined with physical exercises; physical exercises alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic (PK) Study of GSK933776 in Healthy Volunteers
Condition: Atrophy, Geographic
MeSH terms: Geographic Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to enable a possible transition to intramuscular (IM) or subcutaneous
      (SQ) administration for subsequent studies with GSK933776 by characterizing the safety,
      tolerability, PK and pharmacodynamic profiles, and immunogenicity of GSK933776 following IM
      and SQ administration in healthy volunteers. Such alternate routes of administration may
      provide more options in the selection of an efficacious dose for subsequent development in
      patients with geographic atrophy. There will be four treatment arms in the study and
      participants will be assigned to 1 of 4 possible treatment arms in a 1:1:1:1 ratio. The
      planned number of evaluable participants for this study is 24 with 6 participants completing
      all critical assessments in each of the four treatment arms. The total duration of
      participation from screening to follow-up for Treatment Arms A, B and D (single dose of
      GSK933776), will be approximately 113 days and total duration for Treatment Arm C (repeat
      dose of GSK933776) will be approximately 134 days.
    


Intervention name(s): GSK933776 for SQ administration; GSK933776 for IM administration; GSK933776 for IV administration
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Antibody solution for subcutaneous injection with unit dose strength of 50mg/mL administered as 200 mg single dose or as repeat dose of 50 mg weekly for 4 weeks; Antibody solution for intramuscular injection with unit dose strength of 50mg/mL administered as 200 mg single dose; Antibody solution for intravenous injection with unit dose strength of 50mg/mL administered as 200 mg single dose through an IV catheter over approximately 1 hour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioavailability; Pharmacokinetics; intravenous; subcutaneous and intramuscular administration; amyloid beta; monoclonal antibody
Project Powerfood: Promoting Food Security, Equity, and Health
Condition: Diabetes; Obesity
Study type: Interventional

Summary: 
      Project Powerfood is a pilot program aimed at addressing food insecurity and food access in
      primary care through the implementation of a food prescription program in collaboration with
      a number of community partners. The objectives of this project are:

        1. Implement screening for food insecurity in adult and pediatric primary care practices at
           Mount Sinai.

        2. Provide fresh fruit and vegetable "prescriptions" to be redeemed for farm shares from
           local partner, the Corbin Hill Food Project. Prescriptions will provide 50% off of a
           fruit and vegetable box. Participants will have the option to purchase 2 boxes per month
           for 6 months.

        3. Pilot prescriptions with 50 adult patients with poorly-controlled diabetes and 50 obese
           children who are food insecure and/or receive SNAP and/or WIC benefits.
           Examine/evaluate:

             1. Feasibility of program in a busy primary care practice

             2. Outcomes before and after the intervention (at baseline, 6 and 12 months),
                including diet, diabetes control, and body mass index (BMI)

             3. Outcomes in a comparison group (that will receive the food prescriptions beginning
                at 6 months)
    


Intervention name(s): Autumn Group; Spring Group
Intervention type(s): Other; Other
Intervention description(s): The intervention is participating in a fruit and vegetable farm share for 6 months.; The intervention is participating in a fruit and vegetable farm share for 6 months.
Other intervention name(s): Fresh fruit and vegetable subsidy; Fresh fruit and vegetable subsidy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are enrolled in the study and randomly assigned to the immediate intervention or the delayed intervention group. Participants in the immediate intervention group will receive the intervention for 6 months with a 6-month and 12-month follow-up starting from day one of enrollment. Participants in the delayed intervention group will receive the intervention beginning 6 months after enrollment with a 6-month and 12-month follow-up starting from day one of enrollment.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Food Insecure
Immunogenicity and Safety of Pandemic Influenza Vaccine in Healthy Adults
Condition: Pandemic Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of this single arm study are to evaluate the immune response and safety
      profiles of two injections of an inactivated whole-virion vaccine containing aluminum
      hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.
    


Intervention name(s): Pandemic Influenza Vaccine (H5N1)
Intervention type(s): Biological
Intervention description(s): Inactivated whole-virion vaccine
Administration route: Intramuscular Injection
Dosing schedule: 2 injections - at Day 1 and Day 22 separately
Dose(s): Each dose (0.5 mL) contains the 15 mcg hemagglutinin (HA) of influenza A (A/Vietnam/1194/2004)
Other intervention name(s): AdimFlu-W (H5N1) Pandemic Influenza Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pandemic influenza; pandemic influenza vaccine; Influenza; Orthomyxoviruses; A/H5N1
A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate Pharmacodynamics
      (the effect of the investigated drug on the body) , Pharmacokinetics (the exposure of the
      trial drug in the body), and Safety of NNC0143-0406 in Subjects with Type 1 Diabetes Mellitus
    


Intervention name(s): NNC0143-0406; Insulin Aspart
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c. under the skin); Administered subcutaneously (s.c. under the skin)
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Biomarker of Acute Exacerbation of COPD
Condition: COPD Exacerbation
Study type: Observational

Summary: 
      Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is the main factor that
      leads to the deterioration of the disease. Currently, the diagnosis of AECOPD mainly relies
      on clinical manifestations, and good predictors or biomarkers are lacking. This study aims to
      explain the gene expression changes related to the disease at the transcriptional level and
      validate it in multiple levels, reveal specific biomarkers and potential pathogenesis, to
      provide a research basis for the diagnosis and treatment of AECOPD.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with stable COPD and AECOPD and healthy controls were recruited from the Second
        Affiliated Hospital of Zhejiang University School of Medicine and Yuhang District of the
        Second Affiliated Hospital of Zhejiang University, Hangzhou, China.
      
Keywords: chronic obstructive pulmonary disease; acute exacerbation; transcriptomic; pathogenesis; biomarkers
A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation
Condition: Head Lice Infestation
MeSH terms: Lice Infestations; Parasitic Diseases; Mite Infestations
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of the study is to evaluate safety and tolerability of a single
      application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to
      evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric
      population.
    


Intervention name(s): Ha44 Gel 0.74% w/w
Intervention type(s): Drug
Intervention description(s): HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.
Other intervention name(s): Abametapir 0.74%; Benzyl Alcohol
Intervention MeSH terms: Benzyl Alcohol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and tolerability of an
      investigational drug for the treatment of manic episodes of bipolar disorder. The
      investigational drug will be given as additional treatment with either lithium or valproate,
      which are already FDA (Food and Drug Administration)-approved treatments for mania.
    


Intervention name(s): Licarbazepine; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bipolar disorder; manic episode; treatment; licarbazepine
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome
Condition: Lennox-Gastaut Syndrome
MeSH terms: Lennox Gastaut Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Evaluate the safety and efficacy of oral topiramate in patients with Lennox-Gastaut
      syndrome.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Following a 28-day baseline
      period, patients are randomly assigned to oral topiramate or placebo. The dose of study
      medication is titrated over the first 3 weeks; the maintenance dose is administered for the
      next 5 weeks.

      Extended topiramate treatment is available to all patients after randomized therapy.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Lennox-Gastaut syndrome; epilepsy; neurologic and psychiatric disorders; rare disease; seizures