bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation
Condition: Lumbar Disc Herniation; Balance; Distorted
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period
      in Individuals With Lumbar Disc Herniation
    

Detailed description: 
      This study was carried out to examine the effect of core stabilization exercises on balance
      and quality of life in the chronic period in individuals with lumbar disc herniation. Forty
      patients aged 45-65 years who had been diagnosed with lumbar disc herniation at least one
      year ago were included in the study. By randomization, they were divided into 2 groups of 20
      people, each being the treatment and the control group. A self-prepared form for patient
      demographic information, McGill Pain Scale and Visual Analog Scale(VAS) for pain assessment;
      Diasu Gait Analysis Device and Berg Balance Scale for static balance assessment; Timed Up and
      Go Test, Y Balance Diagram, Functional Reach Test to evaluate dynamic balance; Tinetti Fall
      Efficiency Scale for assessing falls; The Oswestry Disorder Scale and Nottingham Health
      Profile were used to assess quality of life and functionality; to evaluate proprioceptive
      sensation, ankle joint position sense was measured in standing, neutral position (0˚) and
      angular measurement in 10˚ dorsiflexion. After the questionnaires and measurement tools were
      completed, the patients were included in the program. While the patients in the control group
      continued their routine lives, the modified pilates exercise program focused on core
      stabilization was applied to the patients in the treatment group for 8 weeks, 2 days a week
      for 50 minutes and in 4 groups. After the treatment process was completed, the questionnaires
      and measurements were repeated.
    

Intervention name(s): exercise treatment
Intervention type(s): Other
Intervention description(s): core stabilization exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two group. one of group for exercise and the other group is for control
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lumbar Disc Herniation,; Chronic Period, Balance,; Core Stabilization,; Proprioceptive Sense
GSK618334 Repeat Dose Study
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.
    

Detailed description: 
      GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being
      developed as an innovative treatment for substance dependence. This study will evaluate the
      safety, tolerability, blood concentrations and effect following repeated oral doses of
      GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of
      GSK618334 will also be evaluated. Another portion of this study will investigate dopamine
      type 3 receptor binding in the human brain by PET scan before and after repeated doses of
      GSK618334.
    

Intervention name(s): GSK618334 Low Dose; GSK618334 PET subjects; GSK618334 Medium Dose; GSK618334 High Dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK618334 low dose; PET subjects; Medium Dose; GSK618334 High Dose
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: compulsive discorders; addiction
Liking Adaptation to Beverages With Varying Sweetness Levels After Prolonged Exposure
Condition: Sweetness Liking Adaptation
Study type: Interventional

Summary: 
      This is a double-blind, controlled, parallel, randomized sensory study. The study will
      consist of two cohorts; habitual regular full-calorie Carbonated Soft Drink (CSD) consumers
      and habitual low-calorie CSD consumers. Each cohort will be randomized to one of 3
      interventions for six months (24 weeks):

        -  Intervention 1: Control (full sweetness) beverage

        -  Intervention 2: Step-wise sweetness reduction series of beverages

        -  Intervention 3: Moderate sweetness (reduced sweetness) beverage

      The primary outcome is to assess the perception changes in sweetness (magnitude scale) and
      sweetness liking (Likert scale) of a test product and a control product over a period of six
      months. The study endeavors to explore whether consumers of sweetened carbonated beverages
      can adapt liking to lower sweetness beverages after prolonged exposure of daily consumption
      of beverages with step-wise reduction of sweetness, or maintenance at reduced (moderate)
      sweetness.

      Additional analysis will be to assess dietary compensation for sweetness in the step-wise and
      moderate reduction arms compared to the control arms (the full calorie and low calorie
      control beverages). Dietary analysis of calories and intakes of total sugar, added sugar, and
      servings of low-/non-calorie sweeteners will be assessed using a 3-day diet record
      pre-intervention and monthly for 6 months.
    


Intervention name(s): Flavored carbonated soft drink (CSD)
Intervention type(s): Other
Intervention description(s): Beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: sweetness; liking; adaptation; intensity; low calorie sweetener; full sugar; carbonated soft drink; sensory; taste; dietary compensation; beverage; perception
Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects
Condition: Idiopathic Thrombocytopenic Purpura; Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of romiplostim (AMG 531)
      in the treatment of thrombocytopenia in pediatric subjects with chronic ITP. We will also
      evaluate the efficacy of romiplostim (AMG 531) and characterize the pharmacokinetics of
      romiplostim (AMG 531). It is anticipated that romiplostim (AMG 531), when given at an
      effective dose and schedule, will be well tolerated treatment for thrombocytopenia among
      pediatric subjects with chronic ITP.
    


Intervention name(s): Placebo; AMG 531
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.; Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.
Other intervention name(s): romiplostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Immune (Idiopathic) Thrombocytopenic Purpura; Pediatric Idiopathic Thrombocytopenic Purpura
Study of a Novel Microlens Array Device for Skin Rejuvenation
Condition: Wrinkles; Scars
Study type: Interventional

Summary: 
      A single-center prospective, open-label uncontrolled pilot study. Subjects will receive laser
      treatments and will be followed at 12 weeks post-final treatment.
    


Intervention name(s): Microlens Array
Intervention type(s): Device
Intervention description(s): Treatment with Cutera Microlens Array Device used with the enlighten™ 532nm /1064nm/670nm laser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Conventional Versus Posterior Approach in Ultrasound-Guided Parasagittal In-Plane Infraclavicular Brachial Plexus Block
Condition: Brachial Plexus Block; Infraclavicular; Ultrasound Guided
Study type: Interventional

Summary: 
      The lateral parasagittal in-plane is the current conventional approach in ultrasound-guided
      infraclavicular brachial plexus block. However this technique is less popular because
      brachial plexus at the infraclavicular level runs deeper compared to its course proximally,
      often give rise to impaired needle visualisation due to its steep angle of needle trajectory
      to the ultrasound beam. A new posterior parasagittal in-plane approach was introduced to
      improve needle visibility. This approach proved feasible from our case series hence the
      investigators would like to compare it with the conventional method in this study
    

Detailed description: 
      This study compared the conventional lateral and posterior approach parasagittal in-plane
      ultrasound guided infraclavicular brachial plexus block for upper limb surgery. A cadaveric
      study was also performed to complement the findings.

      After obtaining approval from the Medical Ethics Committee, University Malaya Medical Centre
      (IRB reference no. 949.14 dated 17 October 2012), 46 patients undergoing upper limb surgery
      were prospectively recruited and randomized. A cadaveric dissection was also performed.

      DESIGN: Prospective randomized study

      SETTING: Single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia; November
      2012 to October 2013

      INTERVENTION: Ultrasound guided, lateral or posterior parasagittal in-plane infraclavicular
      brachial plexus blocks were performed on patients, depending on randomization. All blocks
      were performed using 21G x 4 inch Stimuplex A (B Braun Medical) without nerve stimulation
      plus SonoSite M-Turbo with HFL38x/ 13-6 MHz linear transducer probe. A 25-ml local
      anaesthetic admixture [Lignocaine 2% (100mg) plus Ropivacaine 0.75% (150mg)] were injected to
      all patients. A total volume of normal saline 0.9% 25ml mixed with methylene blue (0.2ml) was
      used for cadaveric study.
    

Intervention name(s): Posterior approach; Conventional approach
Intervention type(s): Procedure; Procedure
Intervention description(s): The needle insertion point was over the trapezius muscle sufficiently posterior to allow the needle to pass between the clavicle and the scapula in the direction of the axillary artery. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique.; The needle insertion point would be at the cephalad (lateral) aspect of the ultrasound probe, beneath the clavicle and medial to the coracoid process. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg Twice Daily, As Needed In The First Menstrual Cycle Day And Then Once A Day, And Piroxicam 40 Mg Once A Day In The Treatment Of Patients With Primary Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the analgesic efficacy, safety, and tolerability of valdecoxib versus piroxicam in
      subjects with moderate to severe menstrual cramping pain associated with primary
      dysmenorrhea.
    


Intervention name(s): piroxicam; valdecoxib
Intervention type(s): Drug; Drug
Intervention description(s): piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle; valdecoxib 40 mg capsule twice a day (BID), taken as required, on the first day of treatment in the menstrual cycle followed by oral valdecoxib 40 mg once a day (QD) for up to the first 3 days of the menstural cycle
Intervention MeSH terms: Valdecoxib; Piroxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect Of Oral And Dental Health Education In Pregnant Women
Condition: Pregnancy
Study type: Interventional

Summary: 
      The study was conducted as a randomized controlled experimental study to determine the effect
      of the education given to pregnant women on their oral and dental health behaviors and
      knowledge levels.
    

Detailed description: 
      In line with these results, it is recommended that midwives should determine the behaviors
      and knowledge levels of pregnant women regarding oral and dental health within the scope of
      primary health care services, provide trainings to increase their knowledge and awareness on
      the subject, refer them to treatment in the presence of problems, and expand these services
      within the health system.
    

Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): Before the training was given to the pregnant women in the experimental group who agreed to participate in the study, the Introductory Information Form, the Form for Assessing Pregnant Women's Behaviors Towards Oral and Dental Health, and the Form for Assessing Pregnant Women's Knowledge Levels Towards Oral and Dental Health were applied by face-to-face interview method. The application of the forms took 20-30 minutes. Then, a training time was planned on a suitable date for the pregnant women.
In order to ensure the effectiveness of the training, to answer the questions of the pregnant women effectively and to be able to direct them to the dentist in line with their needs, the training was applied in groups of maximum five people. Lecture, question and answer and demonstration methods were used in the training.
One month after the training, the necessary forms were applied to the pregnant women and the study was terminated.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels. With the power analysis, α = 0.05, β = 0.20, 1-β = 0.80, a total of 60 pregnant women, 30 in the experimental group and 30 in the control group were included (the power of the test was found as p = 0.8056).
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Prengnancy; oral and dental health; Education; knowledge and behavior
12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to examine the safety and efficacy and dose-response relationship
      of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation;
      including post-treatment follow-up of smoking status to one year from randomization. A small
      satellite protocol (A3051048) investigated safety of a second course of therapy in subjects
      who did not quit.
    


Intervention name(s): CP-526,555 (varenicline)
Intervention type(s): Drug
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Pethidine Analgesia and Neonatal Hearing Screening Test
Condition: Hearing Loss; Newborn Complication
MeSH terms: Hearing Loss
Study type: Observational

Summary: 
      Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well
      known that false positivity in newborn hearing screening increases cost and maternal anxiety
      and anxiety. There is still widespread concern about the use of opoid analgesics to relieve
      pain during labor. The aim of this study was to determine the effects of pethidine
      administered during labor on neonatal hearing screening test false positivity rates.
    

Detailed description: 
      The study group consisted of patients receiving 50 mg intramuscular (I.M) pethidine at the
      beginning of the active phase of labor and the control group consisted of patients not
      receiving pethidine. Newborns were evaluated by otoacoustic emission (OAE) test. The OAE test
      was performed before the patients were discharged. Perinatal and neonatal variables and test
      results were recorded and the relationship between false positivity and pethidine use was
      evaluated.
    

Intervention name(s): Neonatal Hearing Screening Test
Intervention type(s): Diagnostic Test
Intervention description(s): neonatal hearing screening test results will be evaluated.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        term singleton pregnancy,Gave birth at 37-41 weeks of gestation, without chronic internal
        disease,Pregnant women were included in the study.
      
Keywords: Newborn Hearing Screening; Otoacoustic emissions; Pethidine; False positive
Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD
Condition: Attention Deficit Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of modafinil administered
      once daily for 9 weeks at doses of 255, 340, 425, and 510 mg as treatment for adults with
      ADHD.
    

Detailed description: 
      The primary objective of the study is to determine whether modafinil at 255, 340, 425, or 510
      mg'day is more effective than a placebo in alleviating the symptoms of
      Attention-Deficit/Hyperactivity Disorder (ADHD) in adults as determined by the change from
      baseline in the total score from the investigator-completed Adult ADHD Investigator Symptoms
      Rating Scale (AISRS) the at endpoint (last post-baseline observation [week 9 or early
      termination]).
    

Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ADHD
Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
Condition: Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective of this study is to determine if, in the era of novel drugs, high dose therapy
      (HDT) is still necessary in the initial management of multiple myeloma in younger patients.
      HDT as compared to conventional dose treatment would be considered superior if it
      significantly prolongs Progression-free survival (by at least 9 months).
    

Detailed description: 
      Study design Phase III, multicenter, randomized, open-label study designed to evaluate the
      clinical benefit from the drug combination RVD without immediate high-dose therapy (HDT)
      followed by lenalidomide maintenance (Arm A) versus RVD plus HDT and PBSCT followed by
      lenalidomide maintenance (Arm B).
    

Intervention name(s): Lenalidomide, Bortezomib; Lenalidomide, Bortezomib
Intervention type(s): Drug; Drug
Intervention description(s): Lenalidomide/Bortézomib/Dexamethasone cycles:
Number of cycles: 8 cycles for arm A
Cycle length
Dosage:
Lenalidomide: 25 mg/day on days 1-14 of each cycle
Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle
Maintenance phase (12 months):
Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed; Lenalidomide Bortezomib Dexamethasone cycles:
Number of cycles: 5 cycles for arm B
Cycle length
Dosage:
Lenalidomide: 25 mg/day on days 1-14 of each cycle
Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle
Maintenance phase (12 months):
Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed
Other intervention name(s): Lenalidomide (REVLIMID®); Bortezomib (VELCADE®); Lenalidomide (REVLIMID®); Bortézomib (VELCADE®)
Intervention MeSH terms: Lenalidomide; Bortezomib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Progression free survival prolongation; Disease Progression; Overall survival
Phase Ib Study AZD1775 in Combination With Carboplatin and Paclitaxel in Adult Asian Patients With Solid Tumours
Condition: Advanced Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase Ib, open-label, multicentre study of AZD1775 administered orally in
      monotherapy and in combination with carboplatin and paclitaxel to Asian patients with
      advanced solid tumours.
    

Detailed description: 
      This is a phase Ib, open label, multicentre study of AZD1775 administered orally in
      monotherapy and in combination with carboplatin and paclitaxel in Asian patients with
      advanced solid tumours. The study design allows escalation or de-escalation of AZD1775 in
      combination with carboplatin and paclitaxel with intensive safety monitoring to ensure the
      safety of the patients. Approximately 12 evaluable patients will be enrolled in the
      dose-finding portion of this study. The total number of patients will depend upon the number
      of combination dose level evaluations necessary to define the recommended dose for further
      clinical evaluation. The proposed combination doses are : Dose level-1; Dose level 1; Dose
      level 2 (if Dose Level 1 tolerated). All combination doses other than Combination Dose level
      1 may be subject to change by the SRC in light of emerging data. At least 3 and up to 6
      evaluable patients will be required for each dose finding cohort. Once the recommended dose
      for further clinical evaluation is established, additional 3 to 6 patients may be enrolled to
      the cohort where the recommended dose has been defined to further characterise the safety,
      tolerability, pharmacokinetics, and efficacy profiles of AZD1775 in combination with
      paclitaxel and carboplatin. If this dose is subsequently found to be non-tolerated,
      alternative doses and/or schedules may be explored. This will be determined by the SRC.
    

Intervention name(s): AZD1775; Paclitaxel; carboplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small-molecule inhibitor of the WEE1 kinase that sensitizes tumour cells to cytotoxic agents and is being developed for the treatment of advanced solid tumours and p53 pathway deficient malignancies. Gemcitabine is a nucleoside analog used as chemotherapy.; Paclitaxel is a mitotic inhibitor used in cancer chemotherapy ; it and docetaxel represent the taxane family of drugs.; Carboplatin is a chemotherapy drug used against some forms of cancer (mainly ovarian carcinoma, lung, head and neck cancers as well as endometrial, esophageal, bladder, breast and cervical; central nervous system or germ cell tumors; osteogenic sarcoma, and as preparation for a stem cell or bone marrow transplant.).
Other intervention name(s): MK1775
Intervention MeSH terms: Paclitaxel; Carboplatin; Adavosertib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment