bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this single-dose, open-label, randomized, two-treatment, two-period
      crossover study was to compare the relative bioavailability of a test formulation of KADIAN
      (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the
      commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma
      Branded Products Inc.. Following an overnight fast of at least 10 hours, subjects consumed a
      standard high-calorie, high-fat breakfast meal that began 30 minutes prior to each dose.
    


Intervention name(s): morphine sulfate extended-release capsules; KADIAN (morphine sulfate extended-release) capsules
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 10 mg, single-dose capsule; 1 x 20 mg, single-dose capsule
Other intervention name(s): Treatment A; Test product; Treatment B; Reference product
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: 10 mg; KADIAN capsules; 20 mg; fed conditions; bioequivalence
Early Peanut Introduction: Translation to Clinical Practice
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Observational

Summary: 
      The recent finding that early introduction of peanut can prevent ~70-90% of peanut allergy is
      a major step towards prevention of food allergy. However, because that finding was from a
      clinical trial in a very select population, there are several major questions that must be
      answered in order to implement these findings into clinical practice without causing more
      harm than good. These questions include who, if anyone, should be screened prior to early
      introduction for peanut allergy, how this screening should be done, and what quantity of
      peanut ingestion is needed to prevent peanut allergy. The goal of this project is to answer
      these critical questions so that the potential of these recent findings can be realized. To
      that end, 400 infants at high-risk of peanut allergy will be enrolled. These infants will be
      given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of
      peanut IgE, and then will be followed for assessment of peanut consumption and development of
      peanut allergy until 3 years of age.
    

Detailed description: 
      400 infants aged 4-11 months from three high risk groups will be enrolled in a prospective
      observational study. All subjects will have a baseline research clinic visit, where they will
      be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement
      of peanut immunoglobulin E (IgE). Based on the baseline oral food challenge, the participants
      will be advised to begin introducing peanut following the current practice guidelines.
      Participants will then be followed until 30 months of age with two clinic visits and regular
      monitoring of peanut consumption.
    

Intervention name(s): Peanut in diet
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants age 4 monhts to 11 months
      
Biospecimen description: 
      Bloods, skin swabs, skin tape strips
    
Keywords: peanut allergy; food allergens; atopic dermatitis; eczema; infant food allergy testing; skin prick testing; peanut IgE; early peanut introduction; food allergy prevention
Drug Interaction Study of Isavuconazole and Midazolam
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Midazolam; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of isavuconazole at steady state on the
      pharmacokinetics of midazolam in healthy adult subjects.
    

Detailed description: 
      Subjects will check-in on Day -1 and remain confined to the study center until the completion
      of study procedures on Day 14. Subjects will return to the study center for an outpatient
      follow-up visit on Day 21. Blood and urine samples will be taken at various times during the
      study.

      Subjects will receive a single dose of oral midazolam syrup on Day 1. On Days 3 and 4,
      isavuconazole will be dosed orally three times daily (TID). On Days 5 through 13,
      isavuconazole will be dosed orally once daily (QD). A single dose of oral midazolam syrup
      will be administered on Day 12.
    

Intervention name(s): Isavuconazole; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): oral; Oral
Other intervention name(s): ASP9766; BAL8557
Intervention MeSH terms: Isavuconazole; Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Isavuconazole; ASP9766; BAL8557; Midazolam; Healthy volunteers
The Effects of Lowering Dialysate Sodium in Hypertensive Hemodialysis Patients
Condition: Hypertension; Arteriosclerosis; Left Ventricular Hypertrophy
MeSH terms: Hypertension; Arteriosclerosis; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional

Summary: 
      Unfavorably high sodium intakes remain prevalent around the world. A negative sodium gradient
      in hemodialysis treatment results in absolute sodium removal via diffusive transport of
      sodium from the blood to the dialysate, and it may be a potentially useful tool to improve
      sodium loading due to excess dietary sodium intake.

      The purpose of this study is to determine whether a in small negative sodium gradient could
      improve blood pressure level, arterial stiffness and left ventricular hypertrophy in
      hypertensive hemodialysis patients, who had been achieving and maintaining their dry weight
      assessed by bioimpedance spectroscopy.
    

Detailed description: 
      A number of studies have shown that lowering dialysate sodium concentration could improve
      blood pressure (BP) control, and the lower BPs are considered to be a result of an
      improvement in volume status via increasing sodium removal. However, sodium, apart from
      volume, may have an independent effect on BP regulation. It is speculated that a reduction in
      exchangeable sodium, even without a change in body water content, may improve BP control.
      Unfortunately, as of yet, no clinical studies have actually provided the evidence in this
      field.

      In general population, dietary salt loading produces significant increase in aortic pulse
      wave velocity, which is reversed by lowering sodium intake. To the investigators knowledge,
      the effect of sodium on arterial stiffness has not been investigated in hemodialysis
      patients.

      A regression of left ventricular hypertrophy (LVH) has been achieved through strict dietary
      sodium restriction in hemodialysis patients. Lack of effect on LVH was observed in low sodium
      dialysis which may be due to the shorter time interval.
    

Intervention name(s): Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L
Intervention type(s): Other
Intervention description(s): After 1-month period of dialysis with standard dialysate sodium concentration 138mmol/L, patients were followed up over a 1-year period with dialysate sodium set at 136mmol/L, without changes in instructions to patients about dietary sodium.
Intervention MeSH terms: Dialysis Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; arterial stiffness; left ventricular hypertrophy
Changes in Skin Autoflouresence Following Weight Loss and Maintenance Using Liraglutide in Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      This is sub-study to a randomised, double blind, placebo-controlled, parallel group, and
      single-centre trial investigating the effect of liraglutide on body weight and pain in
      overweight or obese patients with knee osteoarthritis (NCT02905864).

      In the parent trial patients will be subjected to a run-in diet intervention phase (week -8
      to 0) including a low-calorie diet and dietetic counselling. At week 0 patients will be
      randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to
      dietetic guidance on re-introducing regular foods and a focus on continued motivation to
      engage in a healthy lifestyle.

      This sub-study of the parent trial only involves an additional assessment of skin auto
      fluorescence (AGE concentration) in the preallocation phase and in the main trial phase, i.e.
      from enrollment (defined as signature of informed consent) to treatment allocation (visits
      -Tx and T0 in the parent trial visit schedule) and from allocation to end of trial (visits T0
      and T15 in the parent trial visit schedule).
    


Intervention name(s): Liraglutide 3 mg (Saxenda); Liraglutide 3 mg placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks; Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adenomyosis and Ulipristal Acetate
Condition: Adenomyosis
MeSH terms: Adenomyosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal
      acetate) on bleeding control and pain for patients with adenomyosis and wish to keep
      fertility.
    

Detailed description: 
      After inclusion according to criteria, 2 arms : placebo and Ulipristal acetate (UA) 10mg with
      randomisation, 1 patient with placebo for 3 patients with UA.

      48 patients will be included in this trial. The end point will be the bleeding evaluated by
      Pictorial Blood-loss Assessment Chart (PBAC) score, the amenorrhea rate and the pain
      evaluated with visual analogic scale.
    

Intervention name(s): Ulipristal acetate; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): ESMYA®
Intervention MeSH terms: Ulipristal acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: adenomyosis; ulipristal acetate; sonography; Magnetic resonance imaging [MRI]; Pictorial Blood-loss Assessment Chart [PBAC]
Study to Investigate the Relative Bioavailability of Ibuprofen in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Study to demonstrate average bioequivalence between a 400 mg ibuprofen extrudate tablet
           (Test) and a 400 mg ibuprofen lysinate tablet (Dolormin extra ®; reference 1) under
           fasted conditions.

        -  Study to determine the relative bioavailability of ibuprofen following single
           administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg
           ibuprofen tablet (Brufen® 400mg, Denmark; Reference 2) under fasted conditions.

        -  Study to determine the relative bioavailability of ibuprofen following single
           administration of a 400 mg ibuprofen extrudate tablet (Test) compared to a 400 mg
           ibuprofen lysinate tablet (Dolormin extra ®; reference 1) or a 400 mg ibuprofen tablet
           (Brufen® 400mg, Denmark; Reference 2), respectively, under fed conditions.

        -  Study to evaluate the effect of food on the pharmacokinetics of ibuprofen for all three
           formulations.
    


Intervention name(s): Ibuprofen extrudate; Ibuprofen lysinate; Ibuprofen
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of RM Technology in Pediatric BAI Recipients
Condition: Hearing Loss, Unilateral
MeSH terms: Hearing Loss; Hearing Loss, Unilateral
Study type: Observational

Summary: 
      The purpose of this research study is to learn about the hearing outcomes of children with
      conductive hearing loss who are treated with bone conductive devices and their outcomes with
      remote microphone technology.
    

Detailed description: 
      The purpose of this research study is to learn about the hearing outcomes of children with
      unilateral conductive hearing loss who are treated with bone conductive devices and their
      outcomes with remote microphone technology. It has been shown that the use of intervention
      (hearing aids, cochlear implants, bone conduction devices) alone does not alleviate the
      difficulties children with hearing loss encounter in noisy environments such as a classroom
      or restaurant. One of the most common methods to help children hear better in these types of
      environments is the use of a personal remote microphone (RM) system. This study will evaluate
      how much benefit children are getting from their bone conduction device alone compared to the
      bone conduction device with a personal RM system.
    

Intervention name(s): Personal remote microphone (RM) system; Subjective Questionnaire
Intervention type(s): Device; Other
Intervention description(s): Speech perception in noise performance will be evaluated in the unaided, bone conduction device (BAHA) aided, and bone conduction device (BAHA) + RM conditions. All test measures are non-experimental and commercially available.; These subjective questionnaires will be given pre- and post-evaluation to both the subject and their guardian in order to determine the impact of RM on subject and guardian perceptions of listening in noise.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        English speaking pediatric conduction device users ages 5 to 18 and their parent/guardian
        will be included for study. These pediatric patients have a unilateral conductive hearing
        loss with a minimum of a 30 dB air-bone gap.
Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas
Condition: Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the protocol is to estimate the complete response rate of three
      courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone
      in relapsed aggressive non hodgkin's B-cell lymphoma
    

Detailed description: 
      Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide,
      mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma.

      The study intervention is an administration of 3 courses of the abovementioned drugs, witch
      doses are detailed below. Remission is assessed and the investigator is free to proceed with
      any kind of consolidation , he decides best for the patient( high dose or standard
      chemotherapy).

      The addition of Rituximab the the NIMP protocol is warranted on the basis of previous
      publications wtich have shown a significant advantage in addition to chemotherapy in complete
      remission rate and in overall survival.

      Navelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good
      toxicity profile for patients who have prevously received anthracyclines, and there is not so
      much cross resistance between the two drugs.

      Ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of
      its low hematologic toxicity profile and good antitumor activity.
    

Intervention name(s): rituximab; vinorelbine; ifosfamide; Mitoxantrone; Prednisone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 6 courses every 28 days; 6 courses every 28 days; 6 courses every 28 days; 6 courses every 28 days; 6 courses every 28 days
Other intervention name(s): (Mabthera ® )Rituximab IV 375 mg/m²day; (Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 5; (Holoxan®)Ifostamide 1000mg/m² day 1 to day 5; (Novantrone®) Mitoxantrone 10mg/m² day1; (Cortancyl®)Prednisone 1m/kg day 1 to day 5
Intervention MeSH terms: Prednisone; Rituximab; Vinorelbine; Ifosfamide; Mitoxantrone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: relapsed aggressive B-cell lymphoma; Chemotherapy
Cukurova University Faculty of Medicine Non-interventional Clinical Research Institutional Ethics Committe
Condition: Menopause; Sleep; Fatigue; Therapeutic Touch
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      This research was carried out to determine the effect of therapeutic touch on sleep quality
      and fatigue in menopausal women.
    

Detailed description: 
      Methods: This randomized controlled experimental study was conducted with 48 (24 in the
      intervention group and 24 in the control group) women who sought treatment in the
      gynecological outpatient clinic of a public hospital. According to the study procedure, while
      the intervention group received therapeutic touch, the control group received SHAM
      therapeutic touch for 10 minutes a day for five consecutive days. Data were collected through
      the Personal Information Form, the Pittsburgh Sleep Quality Index, and the Piper Fatigue
      Scale.

      Results: The median post-test total sleep quality score was significantly lower in the
      intervention group than in the control group (p=0.010). However, the mean total fatigue
      scores did not differ significantly between the groups (p=0.917).

      Conclusions: The results of this study showed that therapeutic touch was effective in
      improving sleep quality, but it did not affect fatigue in menopausal women.
    

Intervention name(s): Therapeutic Touch; Sham Therapeutic Touch
Intervention type(s): Behavioral; Other
Intervention description(s): Therapeutic Touch performed in line with the Therapeutic Touch Practice Procedure included the following steps: centering, assessing, rebalancing, reassessing, reexamining, grounding, and closure.; The control group was administered STT instead of TT for 10 minutes for successive 5 days. The practice was implemented in line with STTPP. The practice was implemented by not centering or intending to help to heal, by moving at a longer distance, and by imitating the TT practice protocol visually.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was conducted as a parallel randomized-controlled, single-blind, single-centered, interventional study with a pre-test and post-test design
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Menopause; Sleep; Fatigue; Therapeutic touch
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of
      Meniere's disease.
    


Intervention name(s): OTO-104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intratympanic injection of 12 mg OTO-104; Single intratympanic injection of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meniere's Disease; Vertigo
Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis
Condition: Adhesive Capsulitis of Shoulder
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      Adhesive capsulitis refers to the occurrence of pain and a gradual decline in the range of
      motion (ROM) due to slow increases in synovial hypertrophy and the adhesion between the
      synovial membrane and articular surface. It leads to the loss of flexibility and difficulties
      with the activities of daily living (ADLs) due to chronic inflammation accompanied by
      intra-articular fibrosis. The real cause of this syndrome is unknown but there are some
      predisposing factors involved such as synovial cell hyperplasia, fibrosis of the capsule due
      to cytokines or other inflammatory factors. In the current study investigator will compare
      the effects of Extracorporeal Shockwave Therapy (ESWT) along with conventional therapy to
      treat the adhesive capsulitis.
    

Detailed description: 
      This study will be a Randomized Controlled Trail conducted at Horizon hospital, Lahore. The
      study will be completed within the time duration of Six months. Consecutive sampling
      technique will be used to collect the data. The sample size of 44 patients will be taken in
      this study to find the effects of ESWT on pain, ROM, functional mobility. Patient will be
      divided into two groups. Group A will be treated with ESWT with conventional therapy and
      Group B will be treated with conventional therapy. Constant Shoulder Score (CSS) and the
      Oxford Shoulder Score (OSS) tools will be used to measure the outcomes of the study.

      One session of treatment per week for four weeks will be given. Pretest, posttest at 4th week
      and followup of 24th weeks will be evaluated.
    

Intervention name(s): Extracorporeal Shockwave Therapy; Conventional Treatment
Intervention type(s): Device; Other
Intervention description(s): ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder; hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder
Other intervention name(s): Experimental Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a local, multicenter, randomized, active comparator, double-blind, parallel group
      study with extension will be conducted to evaluate the efficacy and safety of celecoxib
      versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS).
    


Intervention name(s): Celecoxib; Diclofenac SR
Intervention type(s): Drug; Drug
Intervention description(s): capsule, 200 mg QD, 6-12 weeks; tablet, 75 mg QD,6-12 weeks
Intervention MeSH terms: Celecoxib; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment