bioihbjkbjnl/mcl2 huggingface dataset:
Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Condition: Stone Clearance
MeSH terms: Calculi
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the usefulness of saline solution irrigation in
      decreasing residual common bile duct (CBD) stones.
    

Detailed description: 
      In recent years, ERCP is the standard procedure to remove the bile duct stones. The big
      stones(>1.2 cm) require additional lithotripsy procedures for complete stone removal.
      Nevertheless, small stone fragments still remain in the common bile duct when the
      cholangiogram shows normal. The fragments are too small to be verified. These retained
      fragments may cause recurrence of stones. Another way to demonstrate residual CBD stones is
      to use intraductal ultrasonography (IDUS). However, IDUS has limited availability in clinical
      practice. The single-operator cholangioscopy (SOC)-system Spyglass gains widespread
      acceptance because of its independent washing channels and direct viewing. The investigators
      used Spyglass to detect if saline(50 or 100ml) infusion might clear the bile duct fragments
      after ERCP. Saline irrigation has many advantages such as easy stone removal, no additional
      cost and rare side effects. The purpose of this study is to evaluate the usefulness of saline
      solution irrigation in decreasing residual CBD stones.
    

Intervention name(s): CBD stone removal via lithotripsy; Saline 50ml; Saline +50ml
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.; If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.; If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ERCP; Common bile duct stone; Cholangitis; Residual stone; Irrigation
Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up
      and broken down by the body when given by short infusion into a vein and when given by the
      mouth in the form of a capsule or tablet.
    


Intervention name(s): GLPG1205 film-coated tablets; [14C]-GLPG1205 solution for infusion; GLPG1205 capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of GLPG1205; A 15-minute IV infusion of [14C]-GLPG1205; Single oral dose of GLPG1205 as solid formulation
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)
Condition: HPV; Cervical Cancer; Premalignancy Anogenital Warts
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This dose-ranging study is to evaluate an investigational vaccine with the following
      objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate
      immune responses in women who are between 16 and 23 years of age at enrollment.
    


Intervention name(s): Comparator: Gardasil; Comparator: octavalent HPV Vaccine - dose formulation 1; Comparator: octavalent HPV Vaccine - dose formulation 2; Comparator: octavalent HPV Vaccine - dose formulation 3
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Evaluation of Visual Performance With Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      This study will evaluate the influence of contact lens optical design on visual performance
      using standard and multifocal soft contact lenses (MFCLs).
    

Detailed description: 
      The study will examine visual acuity with various contact lenses, with and without glare
      source, in myopes between the ages of 18-39 years old (inclusive) to determine the effect of
      different multifocal optical designs on visual performance in the post-fit period.
    

Intervention name(s): Single Vision Contact Lens; Multifocal Contact Lens 1; Multifocal Contact Lens 2
Intervention type(s): Device; Device; Device
Intervention description(s): Spherical Contact Lens worn on non-dispensing basis; Multifocal Contact Lens worn on non-dispensing basis; Multifocal Contact Lens worn on non-dispensing basis
Other intervention name(s): comfilcon A; comfilcon A; etafilcon A
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects between the ages of 18-39 (inclusive) without significant ocular disease.
      
Keywords: Multifocal Contact Lens; Myopia; Visual Performance
Ahmed Glaucoma Valve Surgery With Mitomycin-C
Condition: Glaucoma; Primary Open Angle Glaucoma; Secondary Glaucoma; Neovascular Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Glaucoma, Neovascular
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed
      valve implantation. Approximately 100 patients will be enrolled, with half receiving the
      Mitomycin-C treatment and the other half receiving placebo treatment.
    

Detailed description: 
      Glaucoma is a leading cause irreversible blindness worldwide. Glaucoma valve surgeries such
      as Ahmed valve implantation, which are conventional surgeries performed to control
      intraocular pressure in eyes, are sometimes associated with complications due to fibrosis.
      Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will
      evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively.
    

Intervention name(s): Mitomycin-C; Balanced Salt Solution; Ahmed Glaucoma Valve Implant
Intervention type(s): Drug; Other; Procedure
Intervention description(s): Intraoperative and postoperative injections of mitomycin-c/Mitosol; Intraoperative and postoperative injections of BSS; Implantation of Ahmed Valve in study eye
Other intervention name(s): Mitosol; BSS
Intervention MeSH terms: Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521,
      given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension
      (CTEPH).
    

Detailed description: 
      Adverse event data will be covered in Adverse events section.
    

Intervention name(s): Riociguat (Adempas, BAY63-2521); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BAY63-2521: 1 mg tid - 2,5 mg tid orally for 16 weeks.; Matching Placebo tid orally for 16 weeks
Intervention MeSH terms: Riociguat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic thromboembolic pulmonary hypertension; PH; soluble Guanylate Cyclase Stimulator; sGC
Follow-up of a Study Examining Sleep Management in United States Veterans
Condition: Insomnia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The first part of the pilot study, as detailed in Unique Protocol ID No. 27522, is a
      randomized clinical trial that compares the effects of a mind-body bridging program with a
      sleep hygiene program to improve sleep quality in patients suffering from sleep disturbances.
      In Part II of the study, the investigators will perform a six month follow-up on the same
      subjects.
    

Detailed description: 
      In this follow-up, we ask subjects to answer the same questionnaires that they completed at
      the beginning of the study. In addition we will ask subjects to complete a survey reflecting
      their medical history over the past 6 months and a second survey establishing their
      behavioral patterns and whether they continued practicing techniques of the intervention they
      were assigned to.
    

Intervention name(s): Mind-Body Bridging Program; Sleep Hygiene
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.; treatment as usual
Other intervention name(s): MBBP; SH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sleep problems; Awareness training program; Mind body bridging
Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior
Condition: Monopolar Depression, Single Episode or Unspecified; Suicidal and Self-injurious Behaviour
MeSH terms: Self-Injurious Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to combine and adapt Mindfulness-Based Cognitive Therapy (MBCT)
      + Safety Planning Intervention (SPI) for individuals with suicidal behavior and to determine
      its feasibility, acceptability, safety and preliminary effectiveness. An exploratory aim is
      to collect data on the cognitive changes underlying treatment gains.
    

Detailed description: 
      -  The study is a nine-week clinical trial combining Safety Planning Intervention plus
           Mindfulness-Based Cognitive Therapy for patients with a recent history of suicidal
           thoughts or behavior and current or past depressive symptoms.

        -  These treatments work for depression and some preliminary data suggest they may work to
           prevent suicidal behavior.

        -  Participation includes:

             -  Nine weeks of free treatment

             -  Clinical assessments

             -  An opportunity to offer your views on treatment and suggestions for improving the
                treatment in focus groups
    

Intervention name(s): MBCT+SPI
Intervention type(s): Behavioral
Intervention description(s): Safety Planning Intervention (SPI), a very brief intervention focused on identifying personalized coping strategies to manage acute suicidality, is combined with Mindfulness-Based Cognitive Therapy (MBCT), a group intervention comprised of mindfulness training and cognitive therapy techniques. Treatment lasts 9 weeks.
Other intervention name(s): Mindfulness-Based Cognitive Therapy; Safety Planning Intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?
Condition: Habituation
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a
      significant pain relief and decrease of evoked potentials and has been used to analyze
      conditioned pain modulation (CPM). However, it is unknown whether the pain relief results
      from habituation to the repeated painful electric stimulation. We compared the effects of CPM
      and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether
      increased attention by a random change of electric intensities amplifies the habituation
      effects.
    


Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        healthy subjects
      
Keywords: Painful cutaneous electrical stimulation; Conditioned Pain Modulation
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
Condition: Anti-Infective Agents
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over
      design was used with a washout of 7 days between the two study periods. Treatment groups
      balanced with the same number of healthy volunteers who were randomly (in two strata: male
      and female) assigned to the study drug administration sequences.
    


Intervention name(s): Cephalexin suspension (Optocef, BAYO5448); Cephalexin suspension (Keflex)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 500 mg / 10 mL; Single dose of 500 mg / 20 mL
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
Condition: Venous Thromboembolism; Menstruation
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A large proportion of women with menstruating potential with newly diagnosed VTE or atrial
      fibrillation, treated with apixaban will have less menstrual blood loss than patients
      randomized to rivaroxaban.
    

Detailed description: 
      Heavy menstrual bleeding (HMB) complicates the treatment of approximately 9-25% of patients
      treated with orally administered anti-Xa anticoagulants for venous thromboembolism (VTE,
      including either pulmonary embolism or deep vein thrombosis). In particular, recent evidence
      has suggested an increase in length and severity of menstrual bleeding for women treated with
      rivaroxaban, and this effect may be less severe apixaban treatment.(1;2) Increase in uterine
      bleeding with rivaroxaban has necessitated hysterectomy in rare cases.(3) Other complications
      of HMB include reduced drug adherence, decreased perception of wellness (quality of life) and
      anemia.(4;5) The anti-Xa agents may increase HMB more than vitamin K antagonists.(1) However,
      in the principal investigators' experience treating over 100 women of menstruating age with
      rivaroxaban for VTE with varying degree of HMB, no woman has expressed desire to switch to a
      VKA even when offered this option (unpublished data). We have successfully reduced perception
      of HMB by switching from rivaroxaban to apixaban in six patients. Comparison of published and
      supplemental data from AMPLIFY and AMPLIFY Extend to EINSTEIN and EINSTEIN extend trials also
      support a lower rate of uterine bleeding with apixaban compared with rivaroxaban, although
      exact comparisons are difficult to make.(6;9) Myers et al recently reported a 9.4% rate of
      HMB with apixaban, compared with a 25% rate of HMB with rivaroxaban.(2) Accordingly, we
      hypothesize that women with menstruating potential with newly diagnosed VTE or atrial
      fibrillation/flutter, treated with apixaban will have less menstrual blood loss than patients
      randomized to rivaroxaban.
    

Intervention name(s): Apixaban; Rivaroxaban
Intervention type(s): Drug; Drug
Intervention description(s): 10mg BID for 7 days, then 5mg BID for three months; 15mg BID for 7 days, then 20mg daily for three months
Other intervention name(s): Eliquis; Xarelto
Intervention MeSH terms: Rivaroxaban; Apixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Laser Therapy on Proximal Hamstring Tendinopathy
Condition: Tendinopathy; Lasers
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      Proximal hamstring tendinopathy (PHT) is tendinopathy of the semimembranosus and/or biceps
      femoris/semitendinosus complex. Previous studies have shown the efficacy of laser therapy in
      the treatment of tendinopathy. To the best of the investigator's knowledge, no study has
      compared the effects of high-power LASER therapy with conventional physiotherapy programs in
      proximal hamstring tendinopathy patients. Therefore, this study aimed to assess the effects
      of high-power laser therapy on pain and muscle power in proximal hamstring tendinopathy
      patients.
    

Detailed description: 
      2 arms comparative pretest-posttest experimental research design with random allocation of
      subjects into groups (experimental and control group) using the lottery method. A total of
      thirty-six participants aged between 18-35 (mean age) years, were recruited in the present
      study. The selected participants were randomly allocated into experimental and control groups
      using the lottery method and website randomization.com with eighteen participants in each
      group. The participants and outcome assessor were kept blinded to the allocation. In the
      experimental group, the high-power laser was given whereas in the control group conventional
      physiotherapy treatment was given for 4 weeks. Conventional physiotherapy treatment included
      the US, moist heat pack, and home exercises. Home exercises include nordic hamstring
      exercises - 2 sets of 5 repetitions, 3 days/week for 3 weeks.
    

Intervention name(s): Laser Therapy; Ultrasound + Moist Heat pack + Exercises
Intervention type(s): Radiation; Other
Intervention description(s): Therapeutic laser therapy was applied.; Ultrasound therapy, a moist heat pack, and a home exercise program were given.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm parallel-groups
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Proximal hamstring tendinopathy; laser therapy; Pain; Muscle power
Post-Treatment Effects of Naltrexone
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with
      two psychotherapies that differ in scope and intensity. The effect of these treatments will
      be assessed with patients who differ in their psychosocial need and resources at their
      disposal, and in their level of cravings for alcohol.
    


Intervention name(s): naltrexone (Revia); broad spectrum treatment; motivational enhancement therapy
Intervention type(s): Drug; Behavioral; Behavioral
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects
Condition: Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of
      three different strengths of resiquimod gel applied to common wart(s) three times a week for
      up to twelve weeks.

      A second purpose is to evaluate the safety of the drug.
    


Intervention name(s): Resiquimod
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Wart(s); Common Wart(s); Children; Pediatric; 3M Pharmaceuticals; Resiquimod
The Psychometric Properties of the Turkish Version of Interpersonal Communication Questionnaire
Condition: Educational Problems
Study type: Observational

Summary: 
      In a study conducted by Lewis et al. in 2008, an "interpersonal communication" questionnaire
      was developed to measure the perceived interpersonal skills of physiotherapy and
      rehabilitation students regarding patient interaction. It was determined that the
      questionnaire used especially after the simulated patient training increased the
      communication of physiotherapy and rehabilitation students after the simulated patient
      training. However, the questionnaire was not translated into Turkish and its validity and
      reliability were not investigated. Therefore, in this study, the authors aim to investigate
      the Turkish validity and reliability of the Interpersonal Communication Questionnaire as the
      primary purpose. Secondly, to investigate the effect of simulated patient experience on the
      perceived interpersonal skills of physiotherapy and rehabilitation students regarding patient
      interaction at the time of the clinical trial.
    


Intervention name(s): simulated patient
Intervention type(s): Other
Intervention description(s): In the last month of the Measurement and Evaluation course in Physiotherapy, a simulated patient session will be held four times (with disease in the cervical-lumbar-shoulder and knee region). Students will be evaluated by the methods they learned about patients. 10 days before and after the simulated patient sessions, the questionnaire will be applied in Turkish for validity and reliability, and then the questionnaire will be repeated after the simulated patient sessions are over, and the effect of the smile patient sessions on the perceived communication skills of the patient will be examined.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 second year students aged 18-23 studying at the physiotherapy and rehabilitation
        department of Acibadem mehmet ali aydınlar university are planned to participate in the
        research.