bioihbjkbjnl/mcl2 huggingface dataset:
Preoperative Bath in Patients Submitted to Hip Arthroplasty
Condition: Surgical Wound Infection
MeSH terms: Wound Infection; Surgical Wound Infection; Surgical Wound
Study type: Interventional

Summary: 
      Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms
      which purpose is verify the effects of nursing intervention preoperative bathing with 4%
      chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the
      prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.
    

Detailed description: 
      Despite the recommendation in several guidelines of preoperative bathing with 4%
      chlorhexidine gluconate as a measure for the prevention of SSI, there is no evidence in the
      literature that support this practice. The objective of this study is to evaluate the effect
      of nursing intervention: preoperative bath using 4% chlorhexidine gluconate solutions, 10%
      povidone iodine degermante or soap without antiseptic for the prevention of SSI in patients
      undergoing elective hip arthroplasty surgery. The specific objectives are to compare the
      incidence of SSI in the three interventions, to assess the most effective intervention for
      the prevention of surgical infection and to estimate the frequency of allergic reactions
      caused by the use of the solutions. Two intervention groups (4% Chlorhexidine gluconate and
      PVPI10%) and a control group (without antiseptic soap) composed of 52 patients undergoing hip
      arthroplasty in each group will be randomized to perform the baths in the period from may
      2015 to june 2017. Before the intervention, nasal swabs will be collected of patients to
      investigate colonization by Staphylococcus aureus.

      The expected result is lower ISC rate with the proposed measures.
    

Intervention name(s): 4% Chlorhexidine gluconate; 10% PVPI degermante; Soap without antiseptic
Intervention type(s): Device; Device; Device
Intervention description(s): Cationic biguanide - antimicrobial action rubbing in the skin.; Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.; Liquid soap with glycerin, neutral pH. Skin cleansing
Other intervention name(s): HiBiScrub; 4% Chlorhexidine degermante; Betadine; 10% Povidone iodine degermante; Non-medicated soap; Soap
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Anti-Infective Agents, Local; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preoperative Care; Baths; Chlorhexidine; Soaps; Povidone-Iodine; Arthroplasty, Replacement, Hip; Surgical Wound Infection
Alterations in Subgingival Microbiota and Hypoxia in Occlusal Trauma
Condition: Chronic Periodontitis; Occlusal Trauma
MeSH terms: Periodontitis; Chronic Periodontitis; Hypoxia; Wounds and Injuries
Study type: Observational

Summary: 
      Present study suggests that excessive occlusal forces did not cause a significant change in
      hypoxia and vascular markers, however a slight alteration in subgingival microbiota was
      observed.
    

Detailed description: 
      Occlusal trauma is defined as tissue destruction and/or injury resulting in tissue changes in
      the periodontium as a consequence of excessive occlusal forces or hyper-occlusion. Previous
      studies suggested accelerated periodontal destruction around teeth with occlusal trauma and
      increased mobility, however, the evidence is lacking. Recent animal studies found that
      occlusal trauma increased osteoclastic activity and alveolar bone loss. One possible
      mechanism suggested for the progression of periodontal destruction with occlusal trauma is
      that tooth mobility creates a subgingival environment conducive to overgrowth by periodontal
      pathogens. However, the association of occlusal trauma and subgingival microbiota was not
      evaluated in previous studies. Therefore, present study aimed to evaluate subgingival dental
      plaque components and compare with healthy individuals and periodontitis patients without
      occlusal trauma.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study population consisted of 80 participants and 4 study groups were created as
        follows:

        Group 1; healthy individuals without occlusal trauma (Group 1, n=20), 6 men and 14 women,
        mean age 32.06±2.90 Group 2; periodontitis patients without occlusal trauma (Group 2,
        n=20), 6 men and 14 women, mean age 36.90±4.67 Group 3; healthy individuals with occlusal
        trauma (Group 3, n=20), 5 men and 15 women, mean age 34.89±7.51 Group 4; periodontitis
        patients with occlusal trauma (Group 4, n=20) 7 men and 13 women, mean age 36.76±4.40.
      
Biospecimen description: 
      Gingival crevicular fluid, serum
    
Keywords: hyper-occlusion; hypoxia; occlusal trauma; periodontitis; subgingival microbiota
A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -
Condition: Healthy Male Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to evaluate the safety and plasma pharmacokinetics of DE-117
      ophthalmic solution (one drop once daily for 7 days) in healthy male adults.
    


Intervention name(s): DE-117
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Condition: Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
MeSH terms: Otitis Media with Effusion
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the safety and tolerability of two dose levels of
      OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with
      bilateral middle ear effusion who require tympanostomy tube placement.
    


Intervention name(s): OTO-201; Placebo; Sham
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single intra-operative injection; Single intratympanic injection; Simulated single intratympanic injection
Other intervention name(s): ciprofloxacin
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      Based on EMA (European Medicines Agency) new guidelines on the clinical development of
      products for immunotherapy for the treatment of allergic disease the aim of this study was to
      assess safety and tolerability of three different subcutaneous immunotherapy dose escalations
      in patients allergic to the pollen of Phleum pratense.
    


Intervention name(s): Subcutaneous immunotherapy with Phleum pratense pollen extract
Intervention type(s): Biological
Intervention description(s): Increasing doses up to a maximum dose of 500 TSU
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic rhinitis; Phleum pratense; Timothy grass pollen allergy; subcutaneous immunotherapy
The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis
Condition: Cholangitis; Choledocholithiasis
MeSH terms: Cholangitis; Choledocholithiasis
Study type: Interventional

Summary: 
      In expert comment, performing the sphincterotomy for choledocholithiasis with acute
      cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore,
      investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for
      stone removal later. However, in the recent study, single-stage endoscopic treatment may be
      still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis
      associated with choledocholithiasis. Investigators will carry out a prospective trial to
      analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate
      cholangitis with choledocholithiasis to determine the safety, successful rate, and
      complications in these two groups.
    

Detailed description: 
      Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed
      with mild to moderate cholangitis associated with choledocholithiasis. The method of
      one-stage: performing the stone removal at the first session of ERCP. The pancreas duct stent
      will be placed for preventing post ERCP pancreatitis (PEP) if necessary. The indomethacin
      100mg anal route will be administered for all patients without allergy history. All
      participants will receive the empiric antibiotics treatment for cholangitis.
    

Intervention name(s): One stage treatment for mild and moderate cholangitis with choledocholithiasis
Intervention type(s): Behavioral
Intervention description(s): one stage of stone removal in mild or moderate cholangitis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild or moderate cholangitis associated with choledocholithiasis for one-stage procedure to remove CBD stone.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute cholangitis; choledocholithiasis; ERCP; One-stage treatment
A Study to Evaluate Absolute Bioavailability, Absorption, Metabolism, and Excretion of Genz-112638 in Healthy Male Participants
Condition: Gaucher's Disease Type I
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives:

      To determine pharmacokinetic (PK) variables, including absolute bioavailability (F), of
      Genz-99067, the free base of the L-tartaric acid salt of Genz-112638 as it exists in plasma,
      after a single intravenous (IV) dose and after a single oral dose of Genz-112638 (unlabeled).

      To determine the PK, total recovery, routes and rates of excretion, and the metabolic profile
      of Genz-99067 after 5 days of BID oral dosing with unlabeled Genz-112638 followed by a single
      dose of [14C]-Genz-112638.
    

Detailed description: 
      The maximum study duration for an individual subject was approximately 65 days from the
      beginning of Screening through the Safety Follow-up visit.
    

Intervention name(s): Genz-112638; Genz-112638; [14C]-Genz-112638
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:Solution-Route of administration:IV; Pharmaceutical form:Capsule-Route of administration:Oral; Pharmaceutical form:Solution-Route of administration:Oral
Other intervention name(s): GZ385660/ eliglustat; Cerdelga; GZ385660/ eliglustat; GZ385660/ eliglustat
Intervention MeSH terms: Eliglustat
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficiency of Diode Laser Activated Irrigation on Healing of Periapical Tissues
Condition: Periapical Diseases
MeSH terms: Periapical Diseases
Study type: Interventional

Summary: 
      Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university
      Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing
      ability of diode laser activated irrigation versus conventional root canal treatment using
      CBCT
    

Detailed description: 
      Sample size is 24 , 24 Patients were randomly distributed in 2 groups , one group of patients
      received laser activated irrigation LAI during root canal treatment and the other group
      received no treatment just conventional RCT. • Patients were equally divided into 2 groups
      (n=12 in each group ) The study in a Single blinded RCT , Numbers for patients will be
      generated and distributed randomly in a table on an Excel sheet, and in front of each number
      either a letter (C) for control or (I) for intervention will be typed After patients were
      selected in the study they will be asked to fill in a consent form , that states that they
      are part of a clinical trial and that they may or may not receive a laser activated
      irrigation Group A LAI :Disinfection were done by using 5 ml of 2.5% sodium hypochlorite
      irrigation for 1 minute. Irrigation will be performed with a 30-gauge needle side vented The
      irrigation needles were introduced passively up to 2 mm away the working length. After
      irrigation Laser treatment will be performed with a diode laser, at a wavelength of 980 nm
      with a repeated pulse mode using a pulse duration of 5sec per canal and a pulse interval of
      0.2 ms. The laser irradiation were delivered for 1 minute into the canal up to 1 mm short of
      the working length, with circling movements from the apical part moving towards the coronal
      part Group B : received mock laser intervention , conventional Root canal treatment with 2.5%
      sodium hypochlorite CBCT was taken pre-operative and another one was taken after 12 month ,
      both volumetric and linear measurements were calculated
    

Intervention name(s): Diode laser; Placebo
Intervention type(s): Device; Other
Intervention description(s): Diode laser activated irrigation; mock Laser activated irrigation
Other intervention name(s): LAI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diode laser; CBCT; low level laser therapy
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of BI 1358894
      in plasma when given as oral single dose together with multiple oral doses of itraconazole
      (Test, T) as compared to when given alone as oral single dose (Reference, R).
    


Intervention name(s): BI 1358894; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): tablet; oral solution
Intervention MeSH terms: Itraconazole
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Relapsed Acute Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      peripheral stem cell transplantation in treating children who have relapsed acute lymphocytic
      leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of autologous peripheral blood stem cell (PBSC) transplantation
           for marrow reconstitution after high-dose carmustine, cytarabine, etoposide, and
           cyclophosphamide in children with relapsed acute lymphocytic leukemia.

        -  Determine the dose effect of autologous PBSC on engraftment in this patient population.

      OUTLINE: Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours
      on days 1-5. When blood counts recover, autologous peripheral blood stem cells (PBSC) are
      harvested and selected for mononuclear cells, granulocyte-macrophage colony-forming units,
      and CD34+ cells.

      Patients receive preparative regimen comprising carmustine IV on days -8 and -3, cytarabine
      IV every 12 hours and etoposide IV every 12 hours on days -7 to -4, and cyclophosphamide IV
      on days -2 and -1. PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) or
      sargramostim (GM-CSF) beginning after PBSC transplantation. Male patients undergo
      radiotherapy to the testes before transplantation. Patients with a history of CNS leukemia
      undergo craniospinal irradiation before transplantation.

      Patients are followed at 100 days, 6 months, and 1 year.

      PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 5 years.
    

Intervention name(s): filgrastim; sargramostim; carmustine; cyclophosphamide; cytarabine; etoposide; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cytarabine; Cyclophosphamide; Carmustine; Etoposide; Sargramostim
Primary purpose: Treatment
Keywords: recurrent childhood acute lymphoblastic leukemia
AZD1390 Administration of a Microdose [11C]AZD1390 to Healthy Volunteers
Condition: Healthy Volunteer Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single centre exploratory study to analyse brain exposure of AZD1390
      in healthy volunteer males.
    

Detailed description: 
      Up to 12 healthy male volunteers, 20 to 65 years of age will participate in the study. The
      study population chosen is sufficient to examine variability in pharmacokinetic and imaging
      measurements. All male volunteer subjects will have a baseline brain magnetic resonance
      imaging (MRI) for eligibility and anatomical delineation of brain regions to be applied in
      positron emission tomography (PET) image analysis. An arterial line will be inserted on day
      the healthy volunteer arrives for the administration of study drug and PET imaging (Day 1).
      The arterial line will be placed in the opposite arm than the one being used to administer
      the single intravenous microdose of [11C]AZD1390. Blood samples will be collected after the
      administration of microdose [11C]AZD1390 bolus injection and during the PET imaging
      procedure. The arterial line will be removed at the conclusion of the PET imaging study after
      the last blood sample has been collected. Standard institutional procedures will be followed
      for arterial line removal. The study will conclude with a telephone follow-up call within 7
      business days after the PET measurement.
    

Intervention name(s): [11C]AZD1390
Intervention type(s): Drug
Intervention description(s): [11C]AZD1390
Other intervention name(s): Radiolabeled AZD1390
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Volunteer Male Subjects
"Outcome of Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia
Condition: Varicocele; Pain; Fertility Issues
MeSH terms: Varicocele; Infertility
Study type: Interventional

Summary: 
      varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of
      varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes
      and others do not.

      Most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those
      studies dont report on postoperative semen.

      This study will focus on the effect of operation on the semen postoperatively .
    


Intervention name(s): varicocelectomy
Intervention type(s): Procedure
Intervention description(s): operation for varix ligation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Can we Train Patients With Chronic Stroke Out of Abnormal Hand Synergy?
Condition: Cerebral Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study plans to determine whether training can change abnormal flexion synergy in chronic
      stroke patients.
    

Detailed description: 
      The aim of the current study is to investigate whether motor training in chronic stroke
      patients can change their abnormal flexion synergy. The investigators will study chronic
      stroke patients , who are defined as patients that sustained a stroke at least 6 months prior
      to our testing date.

      Three functional aspects of each finger will be tested: maximal voluntary contraction (MVC),
      finger dexterity, and hand posture.

      Prior to intervention, participants will have a baseline assessment including clinical tests,
      MVC, the individuation task, and the configuration task. Following the baseline assessment
      patients will receive intervention, training on the configuration task for 5 consecutive
      days. On the sixth day and as a one week follow-up after, subjects will have a
      post-intervention assessment containing the same tests performed in baseline.

      This design will allow us to determine speed and accuracy during the configuration task, the
      individuation index, and possible changes in abnormal flexion synergy.

      We initially registered the study as two arms (anodal tDCS and sham tDCS groups) but decided
      to make it one arm due to the number of participants we were able to recruit.
    

Intervention name(s): Configuration task
Intervention type(s): Behavioral
Intervention description(s): Training the impaired hand on a configuration task
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: motor recovery; motor learning; ischemic Stroke
Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix - Compatibility
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of irritation potential (primary
      dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the
      product Dermacyd PHDETINLYN Tangerine Mix.None.
    


Intervention name(s): Dermacyd PH_DETINLYN (Lactic Acid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care