bioihbjkbjnl/mcl2 huggingface dataset:
Non-surgical Treatment of Peri-implant Mucositis
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      This a Randomized Controlled Clinical Trial comparing two techniques for the nonsurgical
      treatment of peri-implant mucositis. The main objective of the present randomized controlled
      clinical trial is to determine whether the application of a novel treatment strategy for
      peri-implant mucositis could lead to significantly improved clinical parameters as compared
      to standard treatment. Half of the patients receives treatment with manual instruments and
      chlorhexidine gel 1%, half receives treatment with submucosal biofilm removal by erythritol
      powder.
    


Intervention name(s): Chlorhexidine; Air-powder
Intervention type(s): Drug; Device
Intervention description(s): Chlorhexidine gel 1% one single application after mechanical biofilm removal through manual instruments; Erythritol powder using air-powder device
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Hydrodissection as a Treatment for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This is a pilot study designed to acquire data on the added value of hydrodissection when
      using a corticosteroid injection as a treatment for patients with carpal tunnel syndrome.
      Hydrodissection is part of a standard clinical care injection under ultrasound guidance in
      which the fluid is used to separate the nerve from surrounding structures.
    


Intervention name(s): Hydrodissection; Regular Injection
Intervention type(s): Procedure; Procedure
Intervention description(s): Additional 3cc's of saline is used to establish an increase in hydrodissection during routine treatment.; Corticosteroid and lidocaine injection without additional saline is used as routine treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized blinded study looking at two different ways of drug administration rather than the drug itself. We will compare ultrasound guided injection with hydrodissection to ultrasound guided injection without hydrodissection. In both groups, the active drug is the same in type and amount.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety Skills Training: Parents of School-Aged Children
Condition: Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Injuries are the leading cause of death and disability in children in America. Most injuries
      can be prevented when parents implement effective child safety practices. This project will
      create a behaviorally based program to teach parents what to do to prevent injuries to their
      school aged child, in an effort to reduce the number of injuries, hospitalizations, medical
      costs, and missed work days.
    

Detailed description: 
      This project will produce a comprehensive, interactive multimedia (IMM) program to teach
      childhood injury prevention skills to parents of children 6 through 11 years of age. This is
      one of a four-part series of funded programs to address injury prevention issues for three
      age groups of children (birth through 24 months, 2-5 years of age and 6-11 years of age). The
      program will be created in three formats: Internet/intranet, CD-ROM, and linear video (DVD)
      suitable for use in homes, worksites, medical settings, service agencies, and health
      information Web sites. On-screen narrators will guide the user through program material
      comprised of short video presentations, modeling vignettes demonstrating desired behaviors,
      supportive testimonials, and suggestions for modifications to home and recreational
      environments.
    

Intervention name(s): Am Academy of Pediatrics print materials; Family safety 1-2-3
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Print materials of injury prevention content.; Theoretically based school-aged childhood injury prevention videos for families
Other intervention name(s): The Injury Prevention Program; tip sheets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: child safety; injury; prevention; computer; internet
The Role of Sodium Chloride and the Treg/Th17 Axis in Autoimmune Hepatitis
Condition: Autoimmune Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Autoimmune
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a salt restriction diet improves immune
      parameters in patients with autoimmune hepatitis.
    

Detailed description: 
      The etiology of autoimmune hepatitis (AIH) is unknown although both genetic and environmental
      factors are thought to be involved. A defect in immune regulation affecting regulatory T
      cells (Tregs) has been demonstrated in AIH. Tregs function in the maintenance of immune
      homeostasis by controlling autoreactive immune responses to self-antigens.

      Rationale: the western diet has been postulated as a potential environmental risk factor for
      the increasing incidence of autoimmune diseases in developed countries. Data from the
      investigators' laboratory also suggests that increased dietary salt intake might represent an
      environmental risk factor for the development of autoimmune diseases through the induction of
      pathogenic Th17 cells. The dramatic in vitro effects of high salt on the induction of
      pathogenic Th17 cells from naïve human CD4 cells {Kleinewietfeld, Hafler. Nature. 2013 Apr
      25;496(7446):518-22. doi: 10.1038/nature11868.}, and block of in vitro Treg suppression, in
      line with in vivo effects on worsening murine experimental autoimmune encephalomyelitis
      (EAE), have prompted the investigators to examine the effects of increased dietary sodium
      chloride in a human in vivo system.

      The investigators hypothesize that excess dietary salt may function as an environmental
      trigger that favors induction and expansion of pathogenic Th17 cells and leads to functional
      impairment of Tregs, thereby favoring development of autoimmunity. The investigators aim to
      study their established in vitro model in humans by altering the salt intake in patients over
      a 20-day period.
    

Intervention name(s): Low Salt Diet; Liberal salt diet
Intervention type(s): Other; Other
Intervention description(s): On Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet.; On Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Autoimmune hepatitis; Liver dysfunction; Elevated serum auto antibodies
A First-in-Human Study of CEE321 in Adult Subjects
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      Open label, non-randomized, uncontrolled, First-in-Human Phase 1 Study in Healthy Subjects
      and Subjects with Atopic Dermatitis
    


Intervention name(s): CEE321
Intervention type(s): Drug
Intervention description(s): CEE321 administered to all subjects
Other intervention name(s): CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a FIH study of CEE321 in Adult Healthy Subjects (Part A) and Subjects with Atopic Dermatitis (Part B).
Enrollment started with Healthy Subjects in Feb 2020. The protocol was amended Jul 2020 to include Atopic Dermatitis (AD) Subjects (Part B).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: First-in-Human; Healthy Volunteers; Atopic Dermatitis; CEE321; Safety; Tolerability; Pharmacokinetics
4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer
      (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. West German
      Study Group and "Arbeitsgemeinschaft Gynäkologische Onkologie" (WSG-AGO) EC-Doc is a large
      trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3
      involved lymph nodes (LN).
    


Intervention name(s): Epirubicin; Cyclophosphamide; Docetaxel; Methotrexate; 5-fluorouracil
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Fluorouracil; Methotrexate; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
Condition: Onychomycosis of Toenail
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal
      infections in patients who wear polish compared to those who do not.
    

Detailed description: 
      Topical efinaconazole 10% solution is known to be an efficacious and safe treatment modality
      for toenail onychomycosis. This study will examine the compatibility of topical efinaconazole
      and nail polish in patients with distal and lateral subungual onychomycosis (DLSO). It is
      hypothesized that the treatment of DLSO with efinaconazole 10% solution will not be adversely
      affected by the application of nail polish.
    

Intervention name(s): Efinaconazole 10% Topical Application Solution [JUBLIA]; Application of Nail Polish
Intervention type(s): Drug; Other
Intervention description(s): Topical efinaconazole 10% solution (Jublia); Application of Nail Polish
Other intervention name(s): Jublia
Intervention MeSH terms: Efinaconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Microsatellite Analysis of Urinary Sediment in Detecting Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Observational

Summary: 
      RATIONALE: New diagnostic procedures such as microsatellite analysis of sediment in the urine
      may improve the ability to detect bladder cancer without invasive procedures.

      PURPOSE: Diagnostic trial to study the effectiveness of microsatellite analysis of sediment
      in the urine in detecting bladder cancer in healthy participants, participants who have
      genitourinary conditions requiring cystoscopy, and patients who have bladder cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the sensitivity and specificity of microsatellite analysis (MSA) of urine
           sediment with cystoscopy and urine cytology for detecting bladder cancer in participants
           undergoing cystoscopy.

      Secondary

        -  Determine the temporal performance characteristics of MSA in urine sediment from these
           participants.

        -  Determine which of the 15 individual markers or combination of markers that make up the
           MSA test are most predictive of the presence of bladder cancer in these participants.

      OUTLINE: This is a single-blind, multicenter, cohort study.

      Urine and blood specimens are collected from all participants at baseline. Urine specimens
      are examined using microsatellite analysis, urine cytology, and urinalysis. Patients in
      groups 2 and 3 also undergo cystoscopy at baseline.

      Patients in group 3 undergo cystoscopy, upper tract imaging (e.g., abdominal CT scan),
      microsatellite analysis, urine cytology, and urinalysis every 3 months for 2 years in the
      absence of progressive disease.

      Microsatellite analysis, which identifies loss of heterozygosity using polymerase chain
      reaction technique, is conducted for 15 markers: D4S243, D21S1245, FGA, D17S695, D16S476,
      D9S171, IFN-A, D20S48, D13S802, D17S654, D16S310, THO1, D9S162, D9S747, and MBP.

      PROJECTED ACCRUAL: A total of 500 participants (100 each for groups 1 and 2 and 300 for group
      3) will be accrued for this study.
    

Intervention name(s): loss of heterozygosity analysis; microarray analysis; microsatellite instability analysis; cytology specimen collection procedure; laboratory biomarker analysis; computed tomography; cystoscopy
Intervention type(s): Genetic; Genetic; Genetic; Other; Other; Procedure; Procedure
Observational model: Cohort
Time perspective: Cross-Sectional
Keywords: bladder cancer; stage 0 bladder cancer; stage I bladder cancer; transitional cell carcinoma of the bladder
577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy
Condition: Acute Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether micropulse laser (MPL) is different to
      half-dose photodynamic therapy on acute central serous chorioretinopathy.
    

Detailed description: 
      Central serous chorioretinopathy(CSC) is characterized by serous detachment of neurosensory
      retina which can cause lose in visual acuity.Some studies have shown that Half-dose
      photodynamic therapy(PDT) is effective on CSC,although accompanied with side-effects,such as
      choroidal ischemia, retinal pigmental epithelium(RPE) atrophy,and RPE rip,and with exorbitant
      price.Recent retrospective studies suggest micropulse laser (MPL) therapy may also be
      effective without obvious complications in this disease. But to date, there is no study on
      effectiveness of CSC between PDT and MPL.

      The study is the first prospective randomized controlled trial about 577nm micropulse laser
      versus half-dose photodynamic therapy on acute central serous chorioretinopathy.The null
      hypothesis of the study is that there is difference between MPL and half-dose photodynamic
      therapy on acute central serous chorioretinopathy at first month after treatment.The primary
      outcome measures is the proportion of eyes with complete absorption of subretinal fluid at 1
      month after treatment.
    

Intervention name(s): 577-MPL; HD-PDT
Intervention type(s): Device; Device
Intervention description(s): All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle.; 5 minutes after the start of the half-dose verteporfin infusion, the PDT treatment will been performed in HD-PDT arm. The treatment is performed with standard fluency (50 J/cm2), a PDT laser wavelength of 689 nm, and a standard treatment duration of 83 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
AF Ablation for HF With Reduced EF
Condition: Persistent Atrial Fibrillation; Heart Failure With Reduced Ejection Fraction
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This is an open label, multi-center, randomized parallel control clinical trial, to examining
      thethe clinical outcomes of AF ablation on HFrEF patients with persistent atrial
      fibrillation.
    

Detailed description: 
      This is an open label, multi-center, randomized parallel control clinical trial. HFrEF
      patients with persistent atrial fibrillation are 1:1 randomized into the AF ablation group or
      the medical therapy (rate or rhythm control) group. Markers of HFrEF severity, including
      composite of death from any cause or worsening of heart failure that led to an unplanned
      overnight hospitalization,exercise hemodynamics, natriuretic peptide levels, and patient
      symptoms. and other indicators are analyzed to demonstrate the role of AF ablation in
      comparing the effects of AF ablation vs usual medical therapy for HFrEF patients with
      persistent atrial fibrillation.
    

Intervention name(s): AF ablation; medical therapy
Intervention type(s): Procedure; Other
Intervention description(s): The aim of the ablation procedure was to achieve isolation of all pulmonary veins and to restore sinus rhythm.Additional ablation strategies were made at the discretion of the operators.; The medical therapy for atrial fibrillation was administered in accordance with the guidelines that were available at the time of the trial.Efforts to maintain sinus rhythm were recommended. The aim of the treatment was a ventricular rate of 60 to 80 beats per minute at rest.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dental Anaesthesia Affects Pain Level
Condition: Dental Anxiety; Anesthesia, Local
Study type: Interventional

Summary: 
      Background: Needles are the most feared tools, making anaesthetic injection a worrying
      practice.

      Aim: To compare intraosseous (IOA) and needle-free dental anaesthesia (NFA) methods that
      painless anaesthesia.

      Design: Twenty patients aged 8-10 years were included in this cross-over study. To determine
      the anxiety levels and pain experienced by the patients, visual and behavior scales were
      used. The pulse rate (PR) and opiorphin levels (OL) determined. The Friedman and Wilcoxon
      signed-rank tests were used. p<0.05 was considered significant.
    


Intervention name(s): DENTAL LOCAL ANESTHESİA
Intervention type(s): Device
Intervention description(s): doing local and topical anesthesia with two different device
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women
Condition: 24-hour Pad Test Weight Gain With and Without Activity
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      We hypothesised that in women with stress urinary incontinence, the severity of leakage on a
      24 hour pad test was affected by activity.
    

Detailed description: 
      We asked women to perform two separate pad tests, one with normal activity, and another with
      decreased activity.
    

Intervention name(s): minimal activity
Intervention type(s): Behavioral
Intervention description(s): Pad test with minimal activity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 24-hour pad test; Activity; Stress urinary incontinence
Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      The objective of this study was to assess the bioequivalence of a potential generic
      6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol®
      (mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the
      fasted state.
    


Intervention name(s): 6-Mercaptopurine
Intervention type(s): Drug
Intervention MeSH terms: Mercaptopurine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risk Reduction Intervention for Vulnerable Young Adult Males
Condition: Sex; Substance Use; HIV
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The primary aim of this study is to test a brief 4-session risk reduction intervention, based
      on Motivational Enhancement Therapy (MET) to reduce the co-occurrence of club drug use and
      sexual risk taking behaviors among non-treatment seeking young men who have sex with men
      (YMSM) in NYC.
    

Detailed description: 
      This study is a randomized clinical trial. A sample of 300 non-treatment seeking YMSM (ages
      18-24) who report risky sex and club drug use in the past 90 days are being enrolled using
      active and passive community-based recruitment strategies in NYC. After baseline assessment,
      participants are being randomly assigned to one of two study arms: a Brief Risk Reduction
      Intervention Condition - a four session MET intervention piloted for feasibility and
      acceptability among YMSM, designed to increase readiness to change club drug use and
      unprotected sex; or an Education Comparison Condition - four sessions of facilitated
      education regarding the effects of club drugs and unprotected sex. Participants undergo
      follow-up assessments 3, 6, 9, and 12 months after baseline.
    

Intervention name(s): HIV prevention intervention randomized control trial
Intervention type(s): Behavioral
Intervention description(s): Substance using HIV-negative young MSM who engage in sexual risk are randomized to either a motivational interviewing or an education condition to reduce sexual risk and drug use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sexual risk; substance use; HIV; prevention; intervention; Motivational Enhancement Therapy; young men who have sex with men
Safety and Tolerability Study of BIBF 1120 as Intravenous Infusion and Absolute Bioavailability of BIBF 1120 as Soft Gelatine Capsule in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial was to assess the safety and tolerability of BIBF 1120
      administered as intravenous (iv) infusions of 1, 3, 10, and 20 mg, and to assess the absolute
      bioavailability of orally administered 100 mg BIBF 1120 as soft gelatine capsules. A
      secondary objective was the exploration of the pharmacokinetic (PK) of BIBF 1120 after single
      iv dosing, including dose proportionality.
    


Intervention name(s): BIBF 1120 soft gelatine capsule; BIBF 1120 intravenous solution; Placebo ampoule
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Nintedanib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment