bioihbjkbjnl/mcl2 huggingface dataset:
Is Involucrin Has a Role in Verruca Vulgaris? A Clinical and Immunohistochemical Study
Condition: Verruca Vulgaris; Involucrin
MeSH terms: Warts
Study type: Interventional

Summary: 
      Vitamin D3 plays important role in keratinocyte differentiation and had been used recently in
      verruca vulgaris. Aim of the work: To assess the expression of involucrin in verrucae
      vulgaris before and after injection of vitamin D3. Subjects and Methods: This study included
      60 patients with verrucae vulgaris subjected to intralesional injection of vitamin D3 at
      three weeks interval for a maximum of five sessions. Immunohistochemical assessment of
      involucrin was done before and after injection and compared to skin biopsies from 30 healthy
      individuals
    


Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): Cholecalciferol injection
Intervention MeSH terms: Cholecalciferol; Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Probiotic That Reduces Atopic Skin
Condition: Atopic Skin; Children
Study type: Interventional

Summary: 
      To assess the efficacy and safety of the use of probiotics as food supplements in reducing
      the SCORAD index in children with atopic skin compared with placebo. This is a randomized,
      placebo-controlled, double-blind clinical trial with 2 parallel groups, which will include 32
      patients who attend some of the research centers. Patients will be randomized into one of the
      2 study groups (allocation ratio 1: 1): Experimental group (Lactobacillus rhamnosus LRa05)
      and placebo group (placebo). The reduction of the SCORAD index, the number of sprouts in 12
      weeks, the days of use of topical corticosteroids and one valuations of the skin condition
      (hydration).
    


Intervention name(s): probiotic LRa05
Intervention type(s): Dietary Supplement
Intervention description(s): treatment about 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: atopic skin;; eczema;; child population;; probiotic
Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the bioavailability (the extent to which a medication
      becomes available to the body) of subcutaneously (under the skin using a needle) administered
      sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using
      a pre-filled syringe fitted with the UltraSafe Passive™ Delivery system (PFS-U) with the
      SmartJect™ Autoinjector (PFS-AI) in healthy male participants.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), open-label (all people
      know the identity of the intervention), parallel-group (each group of participants will be
      treated at the same time), multicenter; single-dose study. Approximately 138 participants
      will be randomly allocated in a 3:3:3:7:7 ratio to 1 of the 5 treatment groups as follows:
      Group 1 (a single intravenous infusion of 100 mg sirukumab), Group 2 (a single subcutaneous
      [SC] injection of 50 mg sirukumab with PFS-U), Group 3 (a single SC injection of 50 mg
      sirukumab with PFS-AI, Group 4 (a single SC injection of 100 mg sirukumab with PFS-U), and
      Group 5 (a single SC injection of 100 mg sirukumab with PFS-AI). Randomization will be
      stratified by body weight (50.0 kg to <70.0 kg, 70.0 kg to <85.0 kg, 85.0 kg to 100.0 kg).
      Participants will be hospitalized in the study unit for administration of study drug and will
      be discharged after completion of all scheduled assessments on Day 5. Participants will be
      required to return to the study unit for outpatient visits on Days 6 and 7, followed by
      weekly/biweekly outpatient visits, and then a safety follow-up for a total of 13 weeks after
      study drug administration. Safety evaluations will include assessment of adverse events,
      physical examination, vital signs, injection site and infusion reactions, electrocardiogram,
      and clinical laboratory tests. The maximum study duration for each participant will be 120
      days.
    

Intervention name(s): Sirukumab (IV infusion); Sirukumab (SC injection with PFS-U); Sirukumab (SC injection with PFS-AI); Sirukumab (SC injection with PFS-U); Sirukumab (SC injection with PFS-AI)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive a single IV infusion of 100 mg sirukumab.; Participants will receive a single SC injection of 50 mg sirukumab with PFS-U.; Participants will receive a single SC injection of 50 mg sirukumab with PFS-AI.; Participants will receive a single SC injection of 100 mg sirukumab with PFS-U.; Participants will receive a single SC injection of 100 mg sirukumab with PFS-AI.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Healthy; Bioavailability; Pharmacokinetics; Sirukumab; Subcutaneous; Male
The Effect of Case-Based Learning Method on Perceived Competence and Critical Thinking Levels
Condition: Educational Problems
Study type: Interventional

Summary: 
      Second-year nursing students are randomly assigned to experimental and control groups. The
      case-based teaching method was applied to the experimental group and the classical teaching
      method was applied to the control group. After the initiative, both groups observed
      differences in perceived competence and critical thinking levels. In addition, the focus
      groups were interviewed with the experimental group and the opinions and suggestions about
      the initiative were evaluated qualitatively and the total mix method was used.
    

Detailed description: 
      Nursing secondary school students were randomized into two groups. Case-based training was
      given to the experimental group, and classical training was given to the control group.
      Critical thinking scale and self-efficacy scale both before and after the training were
      applied to both groups. Posttest scores were calculated and compared for both groups. The
      focus group consultation with 10 people from the experimental group was carried out and the
      opinions and suggestions about the initiative were taken and evaluated. Permission was
      obtained in writing from all institutions before and after the participants, and the study
      was conducted by creating ethical conditions.Four separate training cases were given to the
      experimental group. the control group continued the classical training and no intervention
      was made.
    

Intervention name(s): Case- based Learning
Intervention type(s): Behavioral
Intervention description(s): critical thinking, self efficacy, focus group interview
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: case- based learning; critical thinking; self-efficacy; nursing education; nursing
Relative Bioavailability of Olodaterol and Fluconazole
Condition: Healthy; Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor
      fluconazole on the bioavailability of olodaterol
    


Intervention name(s): BI 1744; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): 10 mcg solution for oral inhalation; 400 mg capsule
Intervention MeSH terms: Fluconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease
Condition: COPD
Study type: Observational

Summary: 
      An open, single group, single center Study to confirm CTC-Actiwise™ as a means to record and
      monitor the progression of a patient's COPD.

      Chronic Obstructive Pulmonary Disease (COPD) affects growing patient groups. Current
      knowledge about the disease limits the investigators ability to cure or interfere with the
      progression of the disease. COPD is often characterized by exacerbating infections requiring
      emergency care.

      The project aims to examine whether disease progression of COPD can be better controlled by
      continuously monitoring the patient's physical activity, along with the assessment of
      pulmonary symptoms and lung function. A key question is: can investigators find indicators
      that provides support for early intervention before severe symptoms arise.

      The patient carries a smartphone that records physical activity real-time, daily lung
      function measures, lung disease related symptoms, and use of medication.

      The experimental phase, the first part of the project, covers 25 COPD patients followed up to
      12 weeks where the primary objective is to examine and verify both new investigational
      methodology and technology.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients
A Comparison of Two Metal Surface Finishes on Femoral Components in Hip Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to compare metal surface finishes (proximal-coated titanium
      surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.
    

Detailed description: 
      In younger patients femoral components are most often implanted without the use of cement. A
      direct ingrowth of bone to the implant is crucial to the attainment of good results in those
      cases where cement is not employed.

      The construction of a femoral implant, Versys Fiber Metal Taper®, by Zimmer includes a more
      extensive coating than previous femoral implants. The improved surface coating has been shown
      to provide these implants with better properties than those demonstrated by implants
      currently in general use.

      Theoretically, the greater porous surface of mid-coated implants should:

        -  Encourage bone ingrowth through improved osteoconductive properties, however more
           extensive coating might change the loss of bone due to stress shielding later in time

        -  Improve anchorage of the implant due to the higher friction coefficient

        -  Result in fewer postoperative complaints measured with the Harris Hip Score and visual
           analog scale scores

      The migration of femoral components will be evaluated by RSA, performing radiostereometric
      analyses at the Orthopaedic Center, Aarhus University Hospital. The follow-up RSA will be
      scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral
      density around the implanted femoral component will be examined by DEXA scan at week 1, as
      well as 1 year and 2 years after surgery.
    

Intervention name(s): Femoral implant (Versys Fiber Metal Taper®)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: RSA; Osteoarthritis; Hip arthroplasty; DEXA
Drug Drug Interaction Study Of Crizotinib With Esomeprazole.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, cross-over, single dose study in healthy volunteers to
      evaluate the potential effect of esomeprazole, a proton pump inhibitor, on the
      pharmacokinetics of crizotinib. Each subject enrolled will receive two single oral doses of
      crioztinib with or without esomeprazole separated by a washout period of at least 14 days.
    


Intervention name(s): crizotinib; esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Each subject in Treatment A will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 1 and each subject in Treatment B will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 5; Each subject in Treatment B will receive 40 mg daily dose of esomeprazole from Day 1 to Day 5
Intervention MeSH terms: Crizotinib; Esomeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: crizotinib; pharmacokinetics; esomeprazole; proton pump inhibitor; drug drug interaction; healthy volunteers
Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this three-armed randomized controlled trial is to establish the relative roles
      of treatment of hyperandrogenism versus obesity (as the largest modifiable factor
      contributing to insulin resistance) in treating infertility and improving pregnancy outcomes
      among obese PCOS women. The investigators hypothesize that the key to restoring ovulation
      leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the
      key to avoiding later pregnancy complications is to improve insulin sensitivity with weight
      loss.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among
      women, and women with PCOS are at increased risk for pregnancy complications such as
      gestational diabetes and pre-eclampsia. Both hyperandrogenism (HA) and obesity exacerbated
      insulin resistance (IR) are characteristics of the syndrome, and are targets for treatment,
      but which should be the predominant focus is still unknown. Phase 1 of this study will be a
      randomized trial of three preconception interventions in infertile women with PCOS. The first
      arm will be a combined intervention of medication, meal replacements, and lifestyle
      modification to improve IR. Orlistat is a gastric lipase inhibitor that reduces the
      absorption of fat contained in a meal by about 30%. The second arm will be the use of a
      continuous OCP for 4 months to improve HA. Lo-Estrin 1/20 will be used in a continuous method
      for 4 months to suppress the ovary. The third arm is the combination of both to improve HA an
      IR. Phase II of this study will involve ovulation induction with clomiphene citrate with
      hopeful outcome of pregnancy. Finally, Phase III involve following the pregnancies for
      outcomes and complications.
    

Intervention name(s): Orlistat/Meal Replacement/Lifestyle Modification; Loestrin 1/20; Combination of treatments
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.; Patients will be started on a low dose containing OCP for a continuous 4 month period.; Medications will be administered as described for the other 2 arms.
Other intervention name(s): Orlistat; Alli; Lifestyle Intervention; Weight Loss; OCP; Oral Contraceptive; Orlistat; Alli; OCP; Oral Contraceptive; Weight Loss; Lifestyle Intervention
Intervention MeSH terms: Orlistat; Contraceptive Agents; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome
Understanding the Relationship Between Inflammation and Insulin Resistance in the Adipose Tissue
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance; Inflammation
Study type: Interventional

Summary: 
      This study is being done to better understand the relationship between inflammation and
      insulin resistance in your Adipose (fat) Tissue .
    

Detailed description: 
      This study is being done to determine whether eosinophils (a type of white blood cell) play
      an important role in human fat metabolism and inflammation.

      This study is being done to determine if fish oil supplement could play a role in reducing
      inflammation and improving insulin sensitivity in your fat tissue.
    

Intervention name(s): Fat biopsy during scheduled abdominal surgery; Fat Aspiration; Fish Oil Supplement
Intervention type(s): Procedure; Procedure; Dietary Supplement
Intervention description(s): Physical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Fat tissue biopsy during a scheduled abdominal surgery.; Physical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Subcutaneous fat tissue biopsy.; Fish Oil supplementation for three months.
Other intervention name(s): Fat Aspiration; Tissue Biopsy; Fat Sample; Adipose Tissue; Dietary Supplement
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Obesity; Insulin Resistance
Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhinoconjunctivitis With or Without Asthma: A Study in Daily Clinical Practice
Condition: Allergic Rhinitis; Rhinoconjunctivitis; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Conjunctivitis
Study type: Observational

Summary: 
      This is an observational prospective study to assess the tolerability and safety of treatment
      of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be
      administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at
      initiation period till maintenance dose is reached) The study population is both: adult and
      child, polysensitized to at least 2 allergen sources with rhinitis or allergic
      rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.

      The assignment of a patient to a particular therapeutic strategy will not be decided in
      advanced by a trial protocol but will be determined by routine clinical practice. The
      decision of the investigator to prescribe a particular treatment will be clearly dissociated
      from the decision to include the patient in the study. The patients will not suffer any
      intervention, whether diagnostic or monitoring, other than the usual in clinical practice.
    


Intervention name(s): Allergovac Poliplus
Intervention type(s): Biological
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Polisensitized patients with allergic rinitis and rhinoconjunctivitis with or without
        associated mild or moderate asthma
      
Keywords: mild or moderate
Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed the clinical performance of a resin-modified glass ionomer cement
      containing different concentrations of chlorhexidine digluconate and doxycycline hyclate.
    

Detailed description: 
      This study aimed to evaluate the in vivo microbiologic action of the best concentration of
      chlorhexidine and doxycycline associated with the resin-modified glass ionomer cement applied
      on remaining dentine after indirect pulp treatment.
    

Intervention name(s): Indirect pulp treatment
Intervention type(s): Other
Intervention description(s): Carious dentine was sampled from the mesial portion of the cavity floor and the pulpal wall was entirely covered with one of the randomly selected materials: GIC containing 4.5% DOX; GIC containing 1.25% CHX or GIC as a control group. The antimicrobial concentrations were chosen based in the previous in vitro results obtained in this study. The cavities were then temporarily restored using a conventional GIC. Within 3 months after the initial treatment,the materials were carefully and completely removed, a new dentine sample was collected, and the teeth were then restored with a light-cured composite resin using a bonding system, after a new placement of the initial liner material.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Glass ionomer cement; Indirect pulp therapy
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC585 in Healthy Male and
      Female Subjects
    


Intervention name(s): HEC585; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single or Mulltiple doses up to 10 days; single or Mulltiple doses up to 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Efficacy β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists
Condition: Supplementation; Cyclists
Study type: Interventional

Summary: 
      A double-blind, placebo-controlled, randomised, with two arms (product and placebo)
      unicentric clinical trial to analyse the efficacy on physical performance parameters of a
      product designed for sport during a lapse of two weeks (7 days).
    

Detailed description: 
      After recruitment, subject will be randomised and allocated to one group of the 2 study arms:
      treatment group or control group (placebo).

      A simple randomisation will be performed using software by a random number generator, and
      assigned to participants.
    

Intervention name(s): β-alanine; wheat semolina
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 7 days of consumption; 7 days of consumption
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment