bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of efficacy and safety on the use of rotigotine in patients suffering from
      Parkinson's Disease during and after surgery requiring general anaesthesia.
    


Intervention name(s): Rotigotine
Intervention type(s): Drug
Intervention description(s): 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h patch;
Single patches and a combination of 2 of these patches for a dosage of up to 16 mg/24 h;
One (1) regimen on day of surgery, but exceptionally extended for up to 2 (two) weeks if the patient requires unexpected ventilation after surgery.
Intervention MeSH terms: Rotigotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rotigotine; NEUPRO®; Parkinson's Disease (PD); perioperative use; anaesthesia,
The Effect of Wearing Masks on End-tidal Carbon Dioxide and Pulse Oximetry
Condition: Carbon Dioxide
Study type: Interventional

Summary: 
      An Interventional Study is planned with the primary purpose of screening for changes in
      end-tidal carbon dioxide (ETCO2), inspired carbon dioxide (ICO2), and other vital signs that
      may develop after donning a disposable surgical mask.

      Measurements will be taken and recorded during a 5-minute control period without a mask,
      recording non-invasive ETCO2 and ICO2 levels by way of a nasal cannula (NC), oxygen
      saturation (SpO2), breaths per minute (RR), and heart rate (HR) via anesthesia equipment.
      This will be followed by a 15-minute intervention of wearing a disposable surgical mask and
      repeating measurements of ETCO2, ICO2, SpO2, RR, and HR, recorded each minute.

      Data will be collected from adults and children as young as 2 years of age. Age groups will
      include children aged 2-14 and adults aged 18 to 80, as described in the details of the
      research protocol. Parents and their children are invited to participate together.
    


Intervention name(s): wearing a disposable surgical mask
Intervention type(s): Device
Intervention description(s): Physiologic vital signs will be monitored every minute for 5 minutes without a mask, followed by every minute for 15 minutes with a surgical mask.
Intervention model: Sequential Assignment
Intervention model description: Participants will be observed and monitored for 5 minutes without any intervention. After 5 minutes of observation and monitoring, participants will don a disposable surgical mask. Participants will then be observed and monitored for 15 minutes while under the intervention of "mask-wearing". Only one type of mask will be used for all participants.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: surgical masks; end tidal CO2; pulse oximetry
Transcorneal Electrostimulation for Therapy of Retinitis Pigmentosa
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional

Summary: 
      The purpose of this study is to determine the long-term effects of transcorneal
      electrostimulation (TcES) in patients with retinitis pigmentosa (RP). In a prior study
      (NCT00804102) the results of short-term stimulation showed a positive effect on the visual
      field and other parameters. In this study, the patients will be stimulated with either 0%,
      150% or 200% of the individually determined phosphene threshold.
    

Detailed description: 
      The study was performed at the Centre for Ophthalmology, University of Tübingen, Germany. The
      protocol was approved by the local ethics committee. All procedures followed were in
      accordance with the ethical standards of the responsible committee on human experimentation
      (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.
      Informed consent was obtained from all patients for being included in the study. The study
      was conducted according to the standards of GCP, the European Union Directive for Medical
      Devices, and the German Medical Product Law.

      Patients were seen at 14 visits over a period of 78 weeks: one baseline visit (screening),
      followed by 12 visits (in week 1-4 weekly, then in weeks 10, 16, 22, 28, 34, 40, 46 and 52;
      dates varied a maximum of ± 1 week) including application of TcES for 52 weeks and one
      follow-up visit (in week 78, dates varied a maximum of ± 1 week).

      After inclusion patients were randomly assigned to TcES with 0 mA (sham), 150% or 200% of
      their individual electrical phosphene threshold (EPT) current at 20 Hz.

      Patients and technicians who performed kinetic perimetry, as well as full-field
      electrophysiology (ERG), multifocal ERG (mfERG) and dark adaptation, were blinded to the
      treatment group for the entire study period. The physicians who performed all other
      examinations and TcES were not blinded to study treatment because they were responsible for
      setting the stimulation parameters.
    

Intervention name(s): Transcorneal electrostimulation
Intervention type(s): Device
Other intervention name(s): OkuStim; TES; TcES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Transcorneal electrostimulation; TcES; TES
Design Validation of Senofilcon A With New UV-blocking Additive
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a 2-visit, multi-site, partially subject-masked, 2-arm parallel, controlled,
      randomized and dispensing trial. Subjects will be randomized to one of two study lenses for
      the entire duration of the study. The study lenses will be worn for a period of 2 weeks each
      in a bilateral fashion.
    


Intervention name(s): senofilcon A TEST Lens; senofilcon A CONTROL Lens
Intervention type(s): Device; Device
Intervention description(s): JJVC Investigational Contact Lens; Acuvue Oasys
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
B2-Adrenergic Receptor Polymorphisms
Condition: Status Asthmaticus
MeSH terms: Status Asthmaticus
Study type: Observational

Summary: 
      Beta(2)-adrenergic receptor (BAR) agonists are the most important group of drugs used in the
      treatment of asthma. In children unresponsive to inhaled BAR agonist therapy, higher dose
      systemic BAR agonist therapy is frequently the next step in treatment. Despite the widespread
      use of intravenous BAR agonist therapy for pediatric status asthmaticus, there is controversy
      regarding the efficacy of this therapy. A number of studies have established that genetic
      variations of the BAR have important effects in modulating responses to BAR agonist therapy
      for asthma. In particular, changes in amino acid position 16 of the BAR gene are thought to
      be the most functionally important. Patients encoded for two glycine amino acids, rather than
      arginine, at this position appear to have more severe asthma and to respond differently to
      acute BAR agonist therapy.

      Our hypothesis is that genotypic differences may contribute to poor response to acute BAR
      agonist treatment. We propose to conduct a prospective observational study to determine the
      influence of a patient's BAR genotype on the response to acute BAR agonist therapy.

      Our specific hypothesis is that children with genetic polymorphisms of the gene encoding the
      BAR will have a decreased response to acute high-dose continuous BAR therapy (both inhaled
      and intravenous) compared to other children.

      Our primary outcome is ICU length of stay. Secondary outcomes are

        1. to assess the rate of improvement in clinical asthma score based on genotype, and

        2. to attempt to correlate asthma phenotype with genotype by comparing demographic data and
           hospital course.
    

Detailed description: 
      This study has both a prospective and a retrospective arm. In the retrospective arm, patients
      with a history of admission to the ICU with a severe asthma exacerbation are contacted by
      phone and mail and DNA samples are obtained via saliva. In the prospective arm, patients
      admitted to the ICU are contacted prospectively and DNA is obtained either via saliva or
      blood.
    

Intervention name(s): Blood draw
Intervention type(s): Procedure
Intervention description(s): blood drawn
Other intervention name(s): genotyping of ß2-AR at position 16 and 27.
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Children admitted to the ICU with severe asthma exacerbations
      
Keywords: pediatric
Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
Condition: Postoperative Pain
MeSH terms: Hypospadias
Study type: Interventional
Phase: Phase 2

Summary: 
      The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block
      provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone

      It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years
      old, following eletive hypospadias surgery, under general anesthesia and caudal epidural
      block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus
      clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg.
      The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure
      will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs,
      activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at
      24 h will be avaiable.
    

Detailed description: 
      It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years
      old, following eletive hypospadias surgery, under general anesthesia and caudal epidural
      block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus
      clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg.
      The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure
      will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs,
      activity, cry , consolability ) . Requiriments for supplementary postoperative analgesia at
      24 h will be avaiable. Postoperative hemodynamics parameters will be recordes at 24 h.
    

Intervention name(s): Clonidine 1 mcg/Kg; Clonidine 2 mcg/ Kg; Clonidine 3 mcg/ Kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery; Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery; Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Other intervention name(s): Atensine; Atensine; Atensine
Intervention MeSH terms: Clonidine; Diazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Analgesia; Bupivacaine; Clonidine
A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-angle; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, multi-center, randomized, adaptive, investigator/patient-masked,
      placebo-controlled, parallel multiple-ascending dose study (Part A) with an extension
      including up to two selected doses from Part A and latanoprost 0.005% as active comparator
      (Part B).
    


Intervention name(s): 0.01% RO7058584; 0.1% RO7058584; 1% RO7058584; Matching Placebo; Latanoprost 0.005%
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Once daily morning administration for 7 days; Once daily morning administration for 7 days; Once daily morning administration for 7 days; Once daily morning administration for 7 days; Once daily morning or evening dosing
Intervention MeSH terms: Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vaporization as a Smokeless Cannabis Delivery System
Condition: Healthy Volunteers
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the use of a vaporization system as a smokeless delivery system for
      inhaled marijuana.
    

Detailed description: 
      Our primary objective is to evaluate the use of a vaporization system ( the Volcano) as a
      smokeless delivery system for inhaled marijuana. We will compare plasma levels of
      delta-9-tetrahydrocannabinol (THC), cannabinol, cannabidiol, and metabolites, including
      11-OH-THC, in healthy volunteers after smoking ~400 mg each of approximately 1.8, 3.5, and 7%
      THC marijuana cigarettes (using the Foltin puff procedure) to those obtained when the same
      individuals inhale the vaporization product of the rest of the marijuana from the identical
      cigarette processed through the Volcano device. In addition to plasma levels, we will also
      compare the THC concentrations over an 8-hour time period, the subjective high experienced by
      the patients, and clinical evidence of cannabis effect by evaluating conjunctival hyperemia
      and heart rate. We will also compare the tolerability of the two methods of ingestion, and we
      will monitor expired carbon monoxide to evaluate whether the vaporizer reduces exposure to
      respiratory toxins.
    

Intervention name(s): Cannabis
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cannabis; Marijuana; Vaporization; Volcano; THC
The Impact of the COVID-19 Pandemic on the Career Choice of Medicine
Condition: Career Choice of Medicine
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The aim of this study is to determine what impact the COVID-19 pandemic may have had on the
      choices of high school students to pursue medicine as a career.
    

Detailed description: 
      The COVID-19 pandemic poses an unprecedented global health crisis that has affected
      healthcare systems around the world. Those working in the health sector are at the forefront
      of this pandemic and naturally have been deeply impacted by it. Health care workers are at
      risk of serious physical exhaustion owing to long shifts, a major increase in workload and
      working under high-stress conditions. Shortage of Personal Protective Equipment (PPE) in many
      hospitals carries a serious health risk for not only healthcare workers but their families
      and patients as well. In addition to the physical toll that the pandemic has taken on doctors
      and other healthcare professionals, it has also affected their mental health deeply with an
      increase in anxiety and depression. Witnessing firsthand what this virus can do, yet stepping
      in daily into a high-risk area and exposing oneself to possible risk of infection, takes its
      toll on one's psychological well-being. However, the pandemic has allowed health care
      professionals to show higher levels of perseverance and professionalism in the face of the
      pandemic.

      In view of how the COVID-19 pandemic has affected healthcare workers and the perception of
      the medical field around the world, the aim of this cross-sectional study is to determine
      what impact this may have had on the choices of high school students to pursue medicine as a
      career.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention was done.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pakistani high school students
      
Keywords: Medical education; Pre-Medical
Safety Study of a Human Metapneumovirus Challenge Virus in Healthy Adults
Condition: Human Metapneumovirus
Study type: Interventional
Phase: Phase 1

Summary: 
      Human metapneumovirus (HMPV) is a virus that can cause respiratory illness. In older adults,
      those with asthma, infants, and children, illness can be severe, but in healthy adults the
      virus frequently causes no symptoms. The National Institute of Allergy and Infectious
      Diseases (NIAID) is working to develop a vaccine for HMPV that could be given to infants.
      Before potential vaccines can be tested, information about how HMPV affects healthy adults is
      needed. This study will examine the effects of exposure to HMPV in healthy adults.
    

Detailed description: 
      Human metapneumovirus (HMPV), a virus that causes respiratory illness, was first discovered
      in 2001, although humans have been infected with it for at least 50 years. HMPV may cause
      upper respiratory illness or no symptoms at all in healthy adults, but older adults, adults
      with asthma, and children may be at risk of more serious illness. HMPV is a leading cause of
      viral lower respiratory infection (LRI) in children, so finding a vaccine for this virus
      could substantially reduce the instances of childhood respiratory illnesses.

      The National Institute of Allergy and Infectious Diseases (NIAID) is developing a vaccine for
      HMPV for use in infants, but before starting clinical trials with potential HMPV vaccines,
      researchers need to study how wild HMPV affects healthy adults. This study will expose
      healthy adults to a dose of the HMPV virus to assess its ability to infect, cause disease,
      and create an immune system response.

      Participation in this study will last approximately 6 months. Participants will be admitted
      to an inpatient unit, where they will stay for 10 full days. On their second day in the unit,
      participants will receive a single dose of the virus, delivered via nose drops. Twice each
      day while participants are inpatients, they will undergo physical exams and have their vital
      signs recorded. Nasal washes and blood samples will be collected before participants receive
      the virus, and then daily nasal washes will be collected until they are discharged from the
      inpatient unit. Participants will be discharged from the unit on the 9th day after receiving
      virus if their nasal wash from Day 8 was free of virus. Follow-up visits will occur 28, 120,
      and 180 days after participants receive the virus. During follow-up visits nasal washes and
      blood samples will be collected.
    

Intervention name(s): HMPV challenge virus
Intervention type(s): Biological
Intervention description(s): Single dose of 10^6 plaque forming units (PFU) of recombinant HMPV small hydrophobic genes (rHMPV-SHs)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine
Japanese Phase 1 Multiple Ascending Dose Study
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical study is to assess the safety and tolerability of multiple oral
      doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes
      Mellitus.
    

Detailed description: 
      MAD study - Multiple Ascending Dose study
    

Intervention name(s): BMS-823778; BMS-823778; BMS-823778; BMS-823778; Placebo matching with BMS-823778
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsules, Oral, 2 mg, Once daily, 14 days; Capsules, Oral, 12 mg, Once daily, 14 days; Capsules, Oral, 25 mg, Once daily, 14 days; Capsules, Oral, 15 mg, Once daily, 14 days; Capsules, Oral, 0 mg, Once daily, 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
Condition: Incomplete Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the effects of a novel therapeutic approach with
      transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and
      spasticity in chronic spinal cord injury (SCI).
    

Detailed description: 
      The purpose of the study is to investigate the effects of a novel therapeutic approach to
      promote functional recovery and spasticity in chronic SCI. The tsDCS effect on
      neuro-physiological measures such as H reflex and somatosensory evoked potential (SSEP) wiil
      be evaluated in subjects with SCI. This incremental, design will allow the establishment of
      strong electrophysiological data prior to rapid clinical translation of the findings about
      this promising, early-stage technique.

      The central hypothesis is twofold: 1) active tsDCS will lead to a change in Hmax/M max ratio
      than sham tsDCS, in a polarity dependent manner; and 2) active tsDCS will lead to a change in
      SSEP amplitude and latency, in a polarity dependent manner.
    

Intervention name(s): Anodal tsDCS; Cathodal tsDCS; Sham tsDCS
Intervention type(s): Device; Device; Device
Intervention description(s): During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.; During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.; During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover design with 9 arms: Anodal tsDCS, Cathodal tsDCS, Sham tsDCS
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Incomplete SCI