bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The study will look to evaluate the tolerance of a light therapy-based acne mask device in
      participants who report having sensitive skin. All participants will receive a cleanser, a
      light therapy mask, and an extra activator for the light therapy mask.
    

Detailed description: 
      Acne and sensitive skin can be closely connected due to the reported involvement of an
      impaired skin barrier in both conditions, which can be further aggravated by potentially
      irritating topical treatments.

      A patient's sensitive skin may be caused by the skincare products that they are using, the
      amount that they are applying (over-usage), or the concomitant effect of the different
      products being used, as well as by underlying medical conditions. While sensitive skin can be
      self-perceived and sometimes clinically apparent, as there is no agreed upon medical
      definition of 'sensitive skin', it is a 'diagnosis' primarily made by the patient's
      perception. The high incidence of this problem and potential for further irritation due to
      current topical treatments has left many patients in need of a sensitive skin solution for
      their acne.

      Current at-home topical treatments for mild to moderate acne include Over-the-Counter (OTC)
      options, primarily with either benzoyl peroxide, or salicylic acid, as well as prescription
      options including retinoid-based products, however the cutaneous irritation potential of
      topical acne active ingredients has been reported in the literature, which is not desirable
      in particular for patients with sensitive skin.

      Research has shown the benefits of red and blue light therapy in the treatment of mild to
      moderate acne, with blue light reported to target acne-causing bacteria and red light
      demonstrating anti-inflammatory activity. Previous studies with these types of modalities
      have shown high tolerance and efficacy. This study will look to evaluate the tolerance of a
      light therapy-based medical device in patients with self-reported sensitive skin.
    

Intervention name(s): Acne Mask
Intervention type(s): Device
Intervention description(s): The light therapy acne mask contains a combination of red and blue light-emitting diodes. The device is applied once daily, in the evening for a duration of 10 minutes.
Other intervention name(s): Light Therapy Acne Mask
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne
Pulsed Dye Laser Treatment of Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser
      for the treatment of onychomycosis, or nail fungus.

      Hypothesis: Complete nail clearance will occur in approximately half of patients after 3
      laser treatments.
    

Detailed description: 
      10 patients will participate nationally. The investigators hope to enroll all 10 patients at
      Jefferson. Involvement in the study will last about 8-12 weeks for the subject. The entire
      study will take about 12 months to complete.
    

Intervention name(s): Pulsed Dye Laser for the treatment of nail fungus
Intervention type(s): Device
Intervention description(s): The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: onychomycosis; nail; fungus
Analysis of Tissues From Patients in Trial of Myo-Inositol to Prevent Lung Cancer
Condition: AKT
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine tissue specimens from patients participating in a trial of high-dose
      myo-inositol to prevent lung cancer. The trial, conducted at the British Columbia Cancer
      Agency-Vancouver Cancer Center (BCCA-VCC), includes people who have pre-cancerous changes in
      the air passages of their lungs.

      The BCCA-VCC trial was designed to determine side effects of taking large amounts of the food
      supplement myo-inositol for longer than a month and if the supplement can help smokers stop
      smoking.

      The current study will look at the levels of a substance called Akt in tissue samples
      obtained from air passages of subjects in the BCCA-VCC trial. Akt is activated by tobacco
      components and can be found in lung tumor specimens and pre-cancerous lesions. Myo-inositol
      may affect Akt levels and help prevent progression of pre-cancerous lesions to cancer.

      People participating in the BCCA-VCC phase 1 myo-inositol trial are eligible for this study.
      Tissue samples obtained from air passages of these patients during their participation in
      that study will be sent to the National Cancer Institute for analysis of Akt levels.
    

Detailed description: 
      Human transbronchial biopsy specimens collected under protocol study numbers CDR0000302633;
      BCCA-U98-0411; BCCA-C02-0298 will be immunohistochemically stained for activated Akt using
      phospho-specific antibodies. These samples are part of a phase I chemoprevention trial of
      myo-inositol being conducted in Vancouver, BC by the British Columbia Cancer Agency in
      collaboration with the National Cancer Institute (NCI). The transbronchial specimens will be
      sent to the NCI for analysis of activated AKT. The study aims to determine whether
      myo-inositol, a putative inhibitor of the upstream kinase phosphatidylinositol 3-kinase, can
      alter activated Akt levels in smokers with bronchial dysplasia.
    

Intervention name(s): Akt levels
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: Akt; Immunohistochemistry; Myoinositol; Bronchial Specimens; Phosphorylation
A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843
Condition: Alopecia
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 1

Summary: 
      A Clinical Traial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of CKD-843
    

Detailed description: 
      A Randomized, Open-label, and Parallel Study to Assess Pharmacokinetic/Pharmacodynamic
      Profiles and Safety of CKD-843 in Male Volunteers
    

Intervention name(s): CKD-843 A; CKD-843 B; CKD-843-R
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single Dose; Single Dose; QD, PO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence and Adhesion Comparison of Buprenorphine Patches
Condition: Pain
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare a 2nd generation Buprenorphine Transdermal System (BTDS) patch with a marketed 1st
      generation BTDS patch to confirm that the two are bioequivalent (deliver the same amount of
      drug) and that they equally both stick to the skin over 7 days of continuous wear.
    

Detailed description: 
      The objective is to compare a 2nd generation BTDS patch 20 µg/h to the 1st generation patch
      to confirm bioequivalence. Determination will be via measurement of drug concentrations in
      the blood at serial collection time points pre-dose until 288 hours post-patch application.
      Approximately 100 healthy male and female volunteers will receive both BTDS patches across
      two study periods with a 14-day wash-out between applications.

      Each patch will be worn for 7 consecutive days and the study will also review the adhesion of
      each patch to the skin of the subjects. The overall safety and tolerability of both patches
      will be assessed.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention description(s): 7 day patch
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer; crossover; open-label; randomised; bioequivalence; pharmacokinetic study
The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery
Condition: Esophageal Neoplasms; Stomach Neoplasms; Weight Loss; Malnutrition; Pancreatic Neoplasms; Duodenal Neoplasms
MeSH terms: Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Duodenal Neoplasms; Malnutrition; Weight Loss
Study type: Interventional

Summary: 
      Improvements to treatment strategies for patients with cancers of the upper gastrointestinal
      tract have produced a large population of people who remain free from cancer recurrence in
      the long term following treatment.

      Surgery is the cornerstone of treatment for patients with these cancers, but while surgical
      removal of the tumour may offer the best chance of cure, these are major operations
      associated with specific long term complications. Weight loss and poor nutrition are common
      problems among patients who attain long-term cancer remission and cure after surgery. The
      mechanisms underlying these problems are not well understood and therefore treatment options
      are limited.

      Our research has demonstrated increased levels of chemical messengers (gut hormones) released
      from the gastrointestinal tract after meals in patients who have previously undergone this
      type of surgery. These chemical messengers play a role in controlling appetite and interest
      in food, and increased levels after surgery may reduce interest in eating. Understanding the
      role of gut hormones in the control of appetite may allow us to use certain medications to
      block gut hormones and hence increase appetite, allowing patients to eat more and regain
      weight, preventing nutritional problems after surgery.

      In this study, the investigators aim to determine whether exaggerated gut hormone secretion
      causes reduced appetite and interest in food after surgery. The information gained from this
      study may help us to develop treatments for patients with weight loss and nutritional
      problems after surgery.
    


Intervention name(s): Octreotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen; Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Other intervention name(s): Sandostatin
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Esophagectomy; Gastrectomy; Octreotide; Somatostatin; Appetite; Hunger; Glucagon-Like Peptide 1; Peptide YY; Reinforcement; Reward; Psychological Phenomena and Processes; Gastrointestinal Agents; Nutritional Status; Pancreaticoduodenectomy; Whipple Procedure
The Pathophysiology of Functional Neurological Disorders
Condition: Functional Neurological Disorders
MeSH terms: Nervous System Diseases; Conversion Disorder; Hysteria
Study type: Observational

Summary: 
      Functional disorders, also called psychogenic or psychosomatic are very common, disabling and
      their costs to society are immense.

      Functional movement disorders are abnormal, involuntary movements, that are illogical in
      terms of classic neurology. Intriguingly, they typically manifest when patients pay attention
      to them and disappear with distraction.

      The investigators aim to further the understanding of the pathophysiological mechanisms
      underlying functional neurological disorders in order to improve treatment. In particular
      they aim to understand the effect of attention on movement in general, on functional
      neurological mechanisms and on the sense of agency (of subjective control) over a movement.

      Patients with a functional neurological disorder, patients with an organic neurological
      disorder and healthy participants will perform simple tasks, such as reaching to a target,
      while additional tasks will manipulate their attention. The effects of these attentional
      manipulations will be analysed on several levels: movement performance, analysed by the
      kinematics and electromyography (EMG),and psychophysical measures, such as the sense of
      agency.

      If the hypothesis turns out to be true, then changing the attentional focus could be used as
      a treatment in functional neurological disorders.
    


Intervention name(s): Behavioural study
Intervention type(s): Other
Intervention description(s): reaching studies and other behavioural studies.
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        see below under inclusion criteria
T-705a Multicenter Study in Adults Subjects With Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is safety and pharmacokinetics (PK) of favipiravir study in adults 18-80 years of age
      diagnosed with uncomplicated influenza.
    


Intervention name(s): Placebo; Favipiravir; Favipiravir; Favipiravir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo BID x 1 day, and Placebo BID x 4 days; Placebo TID x 1 day, and Placebo TID x 4 days; 1200 mg TID on Day 1, then 600 mg TID on Days 2-5; 2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5; 1800 mg BID on Day 1, then 800mg BID for Days 2 5
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Anesthesia Depth Increases the Degree of Postoperative Dementia, Delirium, and Cognitive Dysfunction
Condition: Anesthesia; Delirium; Dementia; Bispectral Index Monitor
MeSH terms: Dementia; Delirium; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Anesthetics and anesthesia are suspicious to induce dementia or aggravate preexistent
      cognitive deficits with or without evoking postoperative delirium. In animal trials various
      anesthetics induce increased levels of misfolded amyloid beta and protein tau, the molecular
      substance of pathophysiologic brain tissues of demented patients. The amount of those markers
      seems to correlate well with the degree of dementia [1]. In contradiction, a single study
      indicates that the incidence of postoperative cognitive deficit (POCD) decreases if hypnotic
      depth is deep [2]. Unfortunately the study did not sum up the amount of anesthetic drug load,
      since this would have clarified if the amount of anesthetics used is associated to POCD and
      dementia. Another possibility is that stress and noxious stimulation induced by light
      anesthesia results in POCD, whereas deep anesthesia protects from it or inhibits implicit
      memory.

      The investigators' prospective randomized trial is underway to verify the impact of
      anesthetics and narcotic depth upon grade of dementia and incidence of early postoperative
      cognitive dysfunction on postoperative day 1 as well as the incidence of delirium within a 90
      day period.

      The investigators' hypothesis is that the incidence of POCD and delirium and the degree of
      early cognitive dysfunction is less when anesthetic and vasoactive drug load is less in the
      BIS- guided anesthesia group with the superficial but sufficient anesthesia level.
    


Intervention name(s): Anesthesia depth monitor; Sham control; propofol and sevoflurane
Intervention type(s): Device; Device; Drug
Intervention description(s): Standard care as usual. Bis m Standard care as usual. Bispectral index monitor is not visible for anesthesia provider.
Other intervention name(s): Aim at an anesthesia level of BIS 50-60 titrating propofol and sevoflurane in the experimental
Intervention MeSH terms: Anesthetics; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN
Condition: Pain, Acute; Anxiety and Fear
MeSH terms: Acute Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      This thesis study was conducted in an unblinded, randomized controlled experimental manner in
      order to analyze the effect of attention-drawing methods that can be used during
      intramuscular injection in children on pain and anxiety.
    

Detailed description: 
      Data were collected in the Pediatric Emergency Injection Unit of Mersin City Training and
      Research Hospital between October and December 2021. Children aged 6-12 years were included
      in the study. In the study, the sample was divided into four groups. The study consisted of
      180 children, 45 children in each group. Using the randomization program, it was determined
      which sample group the children would be included in.

      In the study, video game playing, kaleidoscope and virtual reality glasses were used as a
      distraction method for the experimental group. Intramuscular injection (IM) was applied to
      the control group without any application. The research implementation period lasted an
      average of one minute. Required ethical permissions were obtained prior to the research.
      Wong-Baker Faces Pain Scale (WBFPRS) was used to measure pain level and Child Fear Scale
      (CFS) was used to measure anxiety level in the study. Explanatory information about the
      application to be made to the children and their parents was given by the researcher, and the
      consent form was signed by informing them voluntarily. The research data were collected by
      the researcher by interviewing the children face to face. In line with the data obtained in
      the study, it was concluded that the descriptive characteristics of the children in the
      experimental and control groups were similar (p>0.05). It was concluded that playing video
      games, kaleidoscope, and virtual reality glasses, among the distraction methods applied in
      the study, reduced pain and anxiety. It is expected that techniques that reduce pain and
      anxiety when intramuscular injections are given to children in nursing practices will be used
      in practice and that these practices will be included in the training of nurses.
    

Intervention name(s): video game playing, kaleidoscope and virtual reality glasses
Intervention type(s): Device
Intervention description(s): This thesis study was conducted with randomized controlled methods for control in order to analyze the effect of drawing attention to different directions during intramuscular use in countries to what extent the methods of drawing attention to pain and anxiety.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pain; Anxiety; Distraction; Children; Intramuscular injection
Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles
Condition: Wrinkle
Study type: Interventional

Summary: 
      Objective 1: To evaluate the effect and histologic (cellular) changes associated with varying
      energy and density settings of the Fraxel Repair Laser to determine an optimal dose response.

      Objective 2: To evaluate the clinical response associated with variable energy and density
      settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome
      and safety will be based clinic visits and evaluation of pre- and post- procedural photos.
      The subject's assessment of satisfaction will be characterized using a non-parametric
      assessment scale at each follow-up period.
    

Detailed description: 
      To evaluate the clinical response associated with variable energy and density settings of
      fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety
      will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's
      assessment of satisfaction will be characterized using a non-parametric assessment scale at
      each follow-up period.

      This is a multi-site, non-randomized, non-controlled investigator initiated study designed to
      follow a total of 30 qualified and consenting subjects treated with one Fraxel Repair
      treatment in the course of clinical practice.
    

Intervention name(s): Fraxel Laser Treatment
Intervention type(s): Procedure
Intervention description(s): The device to be used in this study is a FDA approved device [510(k) approval] used for aesthetic dermatological procedures. The Fraxel Repair laser system utilizes a sealed off, all metal carbon dioxide gas tube that is radio frequency (RF) excited and air cooled, emitting light at a wavelength of 10.6 μm with programmable pulse duration and frequency. The Fraxel Repair laser has a continuous motion (rolling) optical tracking system. The Fraxel system consists of a treatment component and an internal control component. The treatment component consists of the laser delivery handpiece. A computer with a touch screen keyboard to enter subjects' information also provides controls for the fractionated delivery of the 10.6 μm beam.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: upper lip wrinkles