bioihbjkbjnl/mcl2 huggingface dataset:
Does the Application of a Bilateral-dual Transverse Abdominal Plane (TAP)Block Have an Influence on Lung Function?
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      TAP-block (Transverse Abdominal Plane) block is a method of regional anesthesia used after
      abdominal surgery. The method is often applied ultra-sound guided.

      In our department, the so-called bilateral dual TAP-block (BD-TAP-block) has been developed.
      This includes injection of local anesthetics at four sites on the abdominal wall, aiming at
      the best possible spread of the nerve block.

      Clinical experience shows satisfying results on pain relieve using the nerve block, i.e the
      sensory nerves of the abdominal wall are successfully blocked. However, to our knowledge,
      clinical investigations regarding the effect on the muscles of the abdominal wall has never
      been executed.

      Patients with chronic lung diseases, who are prone to catch pneumonia post surgery, may have
      to be able to use accessory muscle groups to prevent pulmonary phlegm stagnation. Therefore
      it would be inappropriate if the motor nerves supplying these muscles were too, affected by
      the nerve block.

      Our clinical experience has so far not given us suspicion or indication that the motor nerves
      become blocked, although these nerves are situated in the same muscle layer as the sensory
      branches.

      Hence the investigators would like to examine on healthy, male subjects, whether application
      of a bilateral-dual TAP-block effects their ability to perform peak-flow and inspiratory and
      expiratory pressure. Our study hypothesis is:

      There is no clinically relevant difference in the spread of results of pulmonary tests (peak
      flow et.c.) before and after application of bilateral dual TAP-block.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Young (18-45 yrs), healthy males with no history of lung diseases.
      
Keywords: pulmonary function; BD-TAP-block
Controlling Myopia Progression With Soft Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study is to investigate whether novel soft contact lens optical designs can slow myopia
      progression.
    


Intervention name(s): Test Soft Contact Lens B; Test Soft Contact Lens C; Active Comparator
Intervention type(s): Device; Device; Device
Intervention description(s): Test lenses to be worn in daily wear modality; Test lenses to be worn in a daily wear modality; Control spectacle lenses to be worn in a daily wear modality
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Improving Colon Cancer Screening for Diverse Populations
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      This study is a multi-site randomized, controlled trial testing the effect of a combined
      intervention that includes a colorectal cancer (CRC) screening decision aid plus patient
      navigation in a diverse, primary care patient population in clinical sites in North Carolina
      and New Mexico.

      Our primary aim is to determine the effect of the intervention on CRC screening completion
      six months after the index visit among all enrolled participants and among Latinos.
      Secondarily, we will determine how this intervention affects screening-related knowledge,
      self-efficacy, intent, and clinical communication, and examine whether these factors mediate
      the effect of the intervention on screening test completion. Lastly, we will explore whether
      insurance status, ethnicity, and patient language preference moderate the effect of the
      intervention on screening.
    


Intervention name(s): Decision aid and navigation
Intervention type(s): Behavioral
Intervention description(s): Patients in the intervention group will receive a combined intervention consisting of a CRC screening decision aid and assistance from a trained patient navigator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and effectiveness of Depakote ER
      compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.
    


Intervention name(s): Divalproex Sodium (Depakote ER)
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar Disorder (manic or mixed type)
Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects
      of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in
      Healthy Subjects
    


Intervention name(s): EDP-938; EDP-938; EDP-938; Itraconazole; Rifampin; Quinidine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 1); Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 2); Subjects will receive EDP-938 once daily on Day 1 and 8 (Part 3); Subjects will receive itraconazole once daily from Day 5 to Day 18; Subjects will receive rifampin once daily from Day 5 to Day 16; Subjects will receive quinidine once daily from Day 5 to Day 12
Intervention MeSH terms: Itraconazole; Rifampin; Quinidine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 3-Part Single Group study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug-drug interaction
Observational Study to Determine the Efficacy and Safety of Potenfill for Temporary Penile Enhancement
Condition: Penile Enhancement
Study type: Observational

Summary: 
      This is an observational study to determine the efficacy and safety of Potenfill for
      temporary penile enhancement.

      The pivotal study of Potenfill has already been completed and this observational study
      determines the long-term efficacy and safety for up to 24 months in subjects who have been
      participated and treated in the pivotal study.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males over 19 and under 65 who have participated in the previous clinical investigation
        (pivotal) and were treated with the investigational medical device and completed all the
        anticipated visits.
Study to Assess Food Effect on Sativex Bioavailability
Condition: Food Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess effect of food on the bioavailability of a single dose of Sativex and to
      measure its' pharmacokinetics after a single and multiple doses.
    

Detailed description: 
      This was an open-label, randomised, ascending dose, 2-way crossover food-effect study
      incorporating a parallel single and multiple dose components in healthy subjects.
    

Intervention name(s): Sativex; Sativex; Sativex; Sativex
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 sprays Sativex in fasted state on Day 1. 4 sprays Sativex in fed state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.; 4 sprays Sativex in fed state on Day 1. 4 sprays Sativex in fasted state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.; 2 sprays Sativex daily in fasted state Days 4-13.; 8 sprays Sativex daily in fasted state Days 4-13.
Intervention MeSH terms: Nabiximols
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sativex; bio-availability; cannabinoid; pharmacokinetics
The Effect of Different Treatment Modalities of Class II Malocclusion on Upper Third Molars.
Condition: Third Molar Impaction
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Observational

Summary: 
      What is the effect of the different treatment modalities (distalization versus upper premolar
      extraction) of class II malocclusion on the position, inclination and incidence of impaction
      of the upper third molars?
    

Detailed description: 
      What is the effect of the different treatment modalities (distalization versus upper premolar
      extraction) of class II malocclusion on the position, inclination and incidence of impaction
      of the upper third molars? Pico P: Adolescent patients with class II malocclusion having
      bilateral developing upper third molars.

      I: bilateral upper first premolar extraction orthodontic treatment with moderate anchorage.

      C: distalization orthodontic treatment. O: Primary: angulation of the maxillary third molars.
    

Intervention name(s): extraction orthodontic treatment
Intervention type(s): Other
Intervention description(s): bilateral upper first premolar extraction orthodontic treatment with moderate anchorage.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        • Egyptian Adolescent males and females (16 -18 years)
      
Keywords: distalization; premolar extraction; upper third molar; impaction of third molar
Afatinib in Subjects With Kidney Dysfunction
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the influence of moderate to
      severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in
      comparison to a control group with normal renal function.

      The assessment of safety and tolerability will be an additional objective of this trial and
      will be evaluated by descriptive statistics.
    


Intervention name(s): Afatinib healthy; Afatinib severe renally impaired; Afatinib moderate renally impaired
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Afatinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Device for Hair Removal
Condition: Hair Removal
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR
      ultrasound device for hair removal.
    

Detailed description: 
      The purpose of this study is to evaluate the Cutera UHAIR device for safety and efficacy for
      removal and long term reduction of unwanted hair on subjects with Fitzpatrick skin types I-IV
      and dark (black or brown), red, and blonde colored hair.

      At investigator's discretion, each subject will receive treatments and will be scheduled for
      follow-up visits after the final treatment. The treated area(s) will be photographed at each
      visit for analysis.
    

Intervention name(s): Cutera Ultrasound Device
Intervention type(s): Device
Intervention description(s): Pulse duration 10-100 ms, fluence greater or equal to 50 J/cm2, contact tip temperature 5-30 celsus, frequency 5-20 MHz.
Other intervention name(s): UHAIR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hair Reduction Arm Leg; Unwanted hair
Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis
Condition: Spontaneous Bacterial Peritonitis; Hepatorenal Syndrome; Cirrhosis
MeSH terms: Peritonitis; Liver Cirrhosis; Hepatorenal Syndrome; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Advanced liver disease and low ascitic fluid protein concentration have been identified as
      risk factors for spontaneous bacterial peritonitis in cirrhosis. Moreover, renal impairment
      and hyponatremia increase mortality rate of this infection. Aims: To investigate if oral
      administration of norfloxacin prevents the first episode of SBP, hepatorenal syndrome and
      improves survival in cirrhotic patients with ascites and low protein concentration in ascitic
      fluid (<15 g/L) and at least one of the following inclusion criteria: functional renal
      failure (serum creatinine ≥ 1,2 mg/dl or BUN ≥ 25 mg/dl), hyponatremia (serum sodium ≤ 130
      mEq/L) or advanced liver disease (Child ≥ 9 points with serum bilirubin ≥ 3 mg/dl). Methods:
      Prospective, multicenter, randomized, double-blind placebo controlled trial comparing oral
      norfloxacin (400 mg/d; n=35) with placebo (n=35).
    


Intervention name(s): Oral norfloxacin
Intervention type(s): Drug
Intervention MeSH terms: Norfloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Norfloxacin, primary prophylaxis, SBP
Combined Use of Er:YAG and Nd:YAG Laser
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      The aim of the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG
      laser therapy to that of scaling and root planning with hand instruments in nonsurgical
      treatment of chronic periodontitis.
    

Detailed description: 
      The aim of the present study was to compare the effectiveness of combined Er:YAG and Nd:YAG
      laser therapy to that of scaling and root planning with hand instruments in nonsurgical
      treatment of chronic periodontitis.Twenty-ﬁve systemically healthy patients with
      moderate-to-advanced periodontal destruction were selected for this study. The quadrants were
      randomly allocated in a split-mouth design to either combined Er:YAG (160 mj/pulse, and 10
      Hz) and Nd:YAG laser (100 mJ/pulse, and 20 Hz) therapy (test group) or scaling root planning
      using hand instruments (control group). At baseline, 1 month, and 3 months after treatment,
      clinical measurements, including plaque index (PI), gingival index (GI), probing depth (PD),
      clinical attachment level (CAL), and bleeding on probing (%) (BOP), were performed and
      gingival crevicular fluid and subgingival plaque samples were taken. The gingival crevicular
      fluid levels of interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α) were analyzed by
      enzyme-linked immunosorbent assay. Total antioxidant status (TAS)/total oxidant status (TOS)
      were analyzed by high-performance liquid chromatography and a novel automatic colorimetric
      method. Quantitative analysis of Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf),
      and Treponema denticola (Td) was performed using real-time polymerase chain reaction (PCR)
      procedures.
    

Intervention name(s): Periodontal curettes; Er-YAG+Nd-YAG lasers
Intervention type(s): Device; Device
Other intervention name(s): Hu-Friedy, Gracey curets No. 1/2, 3/4, 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA; AT Fidelis Fotona, Ljubljana, Slovenia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: split-mouth
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Er-YAG lasers; Nd-YAG lasers; chronic periodontitis; nonsurgical periodontal debridement
The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients
Condition: Intraocular Pressure
Study type: Interventional
Phase: Phase 1

Summary: 
      This an interventional study looking at two different sequences of pre-operative eye drops,
      to determine which order is more effective in reducing intraocular pressure with pupil
      dilation.
    

Detailed description: 
      Twenty healthy participants will be separated into two groups of 10 volunteers each. In both
      groups, the participant's right eye will serve as a control with only
      Tropicamide/phenylephrine given. In one group of 10 participants the left eyes will receive
      Alphagan prior to Tropicamide/phenylephrine. In the other group of 10 eyes, the left eyes
      will have Tropicamide/phenylephrine administered prior to Alphagan. The investigator will
      observe the intraocular benefits of the addition of Alphagan over the
      Tropicamide/phenylephrine alone and determine if pre-treating is any better than
      post-treating. In addition, the investigator will monitor pupil response, as it is known that
      Alphagan may have some effect on the pupil dilation.
    

Intervention name(s): Alphagan; Phenylephrine; Tropicamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.; Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.; Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one.
Other intervention name(s): Brimonidine
Intervention MeSH terms: Brimonidine Tartrate; Phenylephrine; Oxymetazoline; Tropicamide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mydriasis; Cycloplegics
A Study to Determine the Signs and Symptoms That Impact Daily Life of Participants With Irregular Sleep-Wake Rhythm Disorder
Condition: Irregular Sleep Wake Rhythm Disorder
Study type: Observational

Summary: 
      The primary purpose of this study is to determine the signs and symptoms of irregular
      sleep-wake rhythm disorder (ISWRD) that are important to patients and caregivers of patients
      with Alzheimer's disease dementia (AD-D), AD-D with cerebrovascular disease (CVD), and/or
      vascular dementia (VaD) and ISWRD, and to draft an instrument or instruments to assess them.
    

Detailed description: 
      The study is comprised of an interview with patients and caregivers to determine the signs
      and symptoms of ISWRD that are important to patients and caregivers of patients.
    

Intervention name(s): Non-interventional
Intervention type(s): Other
Intervention description(s): No intervention will be administered.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with AD-D, AD-D with CVD and/or VaD and ISWRD and caregivers of patients.
      
Keywords: Irregular Sleep-Wake Rhythm Disorder; Alzheimer's disease dementia; Vascular dementia; Circadian Rhythm Sleep Disorder
Bioequivalence Study Comparing Two Test Products With One Reference Product, All Containing 5 mg Yohimbine
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      -  Type: Bioequivalence study in male healthy volunteers, therapeutical indication
           (erectile disfunction) not studied

        -  Products, dosage, and route of administration:

             -  Test 1: Yohimbin "Spiegel"® (Desma GmbH, Germany), tablet containing 5 mg yohimbine
                hydrochloride, oral administration

             -  Reference: Yocon-Glenwood® (Glenwood GmbH, Germany), tablet containing 5 mg
                yohimbine hydrochloride, oral administration

        -  Duration of treatment:

           2 single-dose administrations of 5 mg yohimbine hydrochloride each under fasting
           conditions separated by a wash-out period of at least one week i.e. 6 treatment free
           days between all administrations
    

Detailed description: 
      Study objectives

      Primary Objectives:

        -  Characterisation of relative bioavailability of Test 1 in comparison to Reference after
           single dose administration under fasting conditions

        -  Assessment of bioequivalence of Test 1 vs. Reference after single dose administration
           under fasting conditions, determined by use of area under the concentration time curve
           AUC0-tlast and maximal concentration Cmax obtained for yohimbine

      Secondary Objective:

        -  Descriptive characterisation of safety and tolerability of the investigational products
           in the study population

        -  Descriptive characterisation of blood pressure and pulse rate around Cmax of the
           investigational products in the study population

      Analytical methodology:

      Yohimbine in plasma samples will be analysed by use of a validated HPLC-MS/MS; intended LLOQ
      for yohimbine is 0.5 ng/ml
    

Intervention name(s): Yohimbine; Yohimbine
Intervention type(s): Drug; Drug
Intervention description(s): yohimbine 5 mg, one tablet, single dose only; yohimbine 5 mg, one tablet, single dose only
Intervention MeSH terms: Yohimbine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalency
Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
Condition: Syncope, Vasovagal
MeSH terms: Syncope; Syncope, Vasovagal
Study type: Interventional

Summary: 
      This is a randomized controlled open-label trial. During the study, adolescents scheduled to
      receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy®
      and Music intervention(s) in addition to standard care to evaluate the feasibility and
      acceptability of these interventions prior to being used in a larger study to assess the
      effectiveness of the interventions in preventing post-vaccination presyncope and syncope.
      Feasibility will be assessed according to study staff ability to successfully administer the
      protocol specified clinic-based interventions and per both study staff and healthcare
      provider responses to written feasibility assessments. Acceptability will be assessed
      according to the participant's self-report. In addition, baseline needle phobia and anxiety,
      post-vaccination pain and presyncope symptoms, and pre- and post- vaccination state anxiety
      will be assessed per participant written self-report to standardized survey questions.
    


Intervention name(s): Buzzy®; Music
Intervention type(s): Device; Behavioral
Intervention description(s): Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.; Music will be selected and listened to as a distraction before and during vaccination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: vaccination; pre-syncope; syncope prevention