bioihbjkbjnl/mcl2 huggingface dataset:
Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children
Condition: Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
MeSH terms: Influenza, Human; Tetanus; Epiglottitis; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the persistency of immune response against Haemophilus influenzae type b by
      assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT
      booster vaccine approximately 4 years before.
    


Intervention name(s): Hib-CRM197; Hib-TT
Intervention type(s): Biological; Biological
Intervention description(s): No vaccine administered in V37_07E2 study; No vaccine administered in V37_07E2 study
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haemophilus influenzae type b; persistency; children; CRM197; anti-PRP antibody
Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects
Condition: Aplastic Anemia
MeSH terms: Anemia; Anemia, Aplastic
Study type: Interventional
Phase: Phase 2

Summary: 
      This was an open label, non-randomized, phase II study of eltrombopag in combination with
      rabbit ATG/CsA in subjects with moderate or more severe AA who did not received prior
      ATG/ALG-based immunosuppressive therapy. The objective was to assess additive effects of
      eltorombopag on overall response rate (ORR) at 6 months (Week 26) of treatment with ATG/CsA.
      Subjects were assessed at least weekly for safety during the period from the start of ATG/CsA
      to 4 weeks after the start of administration of eltrombopag. After that, subjects had visits
      every 2 weeks until Week 26. Subjects in whom the treatment was assessed as effective at Week
      26 could continued treatment with eltrombopag after 6 months when clinically indicated at the
      discretion of the investigator. There were five follow-up visits: at discontinuation of the
      treatment of eltrombopag, and Weeks 1, 2, 3, 4 and 26 after treatment discontinuation. As
      this study was the first Japanese phase II study in which this product was administered in
      combination with ATG/CsA to subjects with naive moderate or more severe AA, the subject
      number of this study was determined to be 10 based on the feasibility survey.
    


Intervention name(s): Eltrombopag; Rabbit ATG; CsA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Eltrombopag was provided as white round film-coated tablets containing 12.5 mg or 25 mg of eltrombopag free acid (SB-497115-GR, eltrombopag).; Rabbit ATG, as an intravenous drip infusion, diluted by 500 mL of saline or 5% glucose injection was administered at a dose of 2.5 to 3.75 mg per kg per day as a slow intravenous infusion over 6 hours.; CsA as capsules, oral solution, or fine granule, was administered at a dose of 3 mg per kg twice a day.
Intervention MeSH terms: Thymoglobulin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eltrombopag; rabbit anti-thymocyte globulin; additive effect; cyclosporine A; bone marrow; hematopoietic stem cells; pancytopenia; leukopenia; platelets; throbocytopenia; mature blood cells; bone marrow biopsy
Effect of Modulated Auditory Stimulation on Interaural Auditory Perception
Condition: Asymmetric Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      This study analyzes the effect of an equalizer-modulated auditory intervention on the
      asymmetry of interaural auditory perception in groups with different emotional states such as
      well-being, anxiety, depression and mixed anxiety-depression.
    

Detailed description: 
      The present study follows a randomized, double-blind (investigator and outcome assessor),
      parallel and controlled design. The auditory intervention consisted of listening to classical
      music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3
      hours, for 10 days (Monday to Friday for 2 weeks). Participants assigned to the control group
      are cited to the Health centre, but they do not received any intervention. These subjects
      follow the same evaluation and data collection process.

      Once randomized, all participants will make a first control visit in which a pure-tone
      audiometry was carry out and completed the various psychiatric evaluation tests to classify
      into different groups: Goldberg Anxiety and Depression Scale (GADS), Hamilton Anxiety Rating
      Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), and Sociodemographic variables (age,
      gender, nationality, education, working status, noise exposure, use of ear protection, and
      present or past use of any analgesic, anxiolytic or antidepressant for longer than a week).

      The study variables collected at 3 months were pure-tone audiometry (air conduction).
    

Intervention name(s): Auditory intervention filter-modulated group
Intervention type(s): Other
Intervention description(s): Intervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks).
The musical intervention was always performed with the same songs and in the same order using original CDs, heard through headphones (Beyerdynamic, DT 250 / 80 ohm. GMBH & Co. KG, Theresienstr. 8 D-74072 Heilbronn, Germany). The music was played with a sound system (Panasonic MASH, No. SA-PM24. Hamburg, Germany). and filtered through an equalizer called Earducator (Hollagen Designs, PÍO. Box 43 7864 Bergvliet W.Cape - South Africa) that modulates music by alternating low and high tones with an unpredictable cadence, preventing habituation. It also allows very narrow band complementary filters to attenuate (by about 40 dB) abnormally perceived frequencies (hyper-hearing peaks): filters in: 1 kHz - 1,5 kHz - 2kHz - 3 kHz - 4 kHz - 8kHz.
Other intervention name(s): Bérard´s method
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, parallel, pre-post study design
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: hearing asymmetry; mental disorders
A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the relative efficacy and safety of the test
      formulation Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) to the
      marketed formulation Duac® Topical Gel (Clindamycin 1%/Benzoyl Peroxide 5%) (Stiefel) in the
      treatment of the inflamed lesions of acne vulgaris. Both the test and reference formulations
      will also be compared to a placebo formulation to test for superiority.
    


Intervention name(s): Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel; Duac® Topical Gel; Placebo Topical Gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks); Duac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel) applied once a day in the evening for 77 days (11 weeks); Placebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acne vulgaris; Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel; Duac® Topical Gel
Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol
Condition: Severe Distal Tibia Injury; Severe Ankle Injury; Severe Foot Injury; Major Soft Tissue Loss; Major Bone Articular Surface Loss; Major Ankle Articular Surface Loss
MeSH terms: Wounds and Injuries; Ankle Injuries; Foot Injuries
Study type: Observational

Summary: 
      The primary aim this prospective longitudinal observational outcomes study is to compare 18
      month functional outcomes and health related quality of life (HRQoL) of patients undergoing
      salvage versus amputation following severe distal tibia, ankle and/or foot fractures with
      major soft tissue, bone and/or ankle articular surface loss. Functional outcomes and HRQoL
      will be measured using well established self reported measures, including the Veterans Rand
      Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA).

      Hypothesis 1: As a group, salvage patients with severe distal tibia, ankle and/or foot
      injuries with major soft tissue, bone and/or ankle articular surface loss will have similar
      functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of
      injury).

      Hypothesis 2: The subgroup of salvage patients who have either (1) a soft tissue injury that
      requires tissue transfer; (2) articular damage requiring arthrodesis of the ankle joint; or
      (3) bone loss at the distal tibia or ankle will have better functional outcomes and HRQoL had
      they undergone a transtibial amputation (within 6 weeks of injury).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will be patients aged 18-60 with severe open or crushed distal tibia,
        ankle and/or foot injury that go on to limb salvage or receive a below the knee amputation.
Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305
      versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate
      therapy.
    


Intervention name(s): LX3305 low dose; LX3305 mid dose; LX3305 high dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A low dose of LX3305; daily oral intake for 12 weeks; A mid dose of LX3305; daily oral intake for 12 weeks; A high dose of LX3305; daily oral intake for 12 weeks; Matching placebo dosing with daily oral intake for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial Comparing Breakfast Versus no Breakfast Prior to Colonoscopy
Condition: Clinically Indicated Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      In addition to bowel cleansing agents, the current practice of bowel preparation for
      colonoscopy involves a low residue diet 48 hours prior to and a clear fluid diet the day
      before the procedure. This study aims to test whether patients who consume a low residue
      breakfast the day prior to colonoscopy have a difference in the quality of their bowel
      preparation. Patients requiring outpatient colonoscopies will be asked to participate. They
      will be randomized to either breakfast or no breakfast the day before the procedure. Colon
      cleanliness, patient hunger, and tolerance will be assessed.

      The investigators hypothesize that there will be no difference in bowel preparation scores
      and will be better tolerated
    

Detailed description: 
      Colon cleansing prior to colonoscopy is essential for an adequate examination. Research has
      shown that preparation prior to colonoscopy remains one of the biggest deterrents for
      patients considering colon screening (1).

      In addition to the bowel cleansing agents another important aspect of the preparation is the
      diet consumed prior to the procedure. Currently 48 hours prior to colonoscopy patients are
      asked to consume a low residue diet. The day before the procedure they are switched to a
      clear fluid only diet which many patients find difficult to follow due to hunger and can lead
      to non-compliance with the preparation.

      There have been no trials to date which have answered the question whether the consumption of
      breakfast alters colon cleansing with the cleansing agents currently used in Canada.
      Investigators found that in patients receiving sodium phosphate preparations, a full
      breakfast or low residue lunch had no effect on colon cleansing scores and improved hunger
      and energy levels (2). Several studies have looked at the result of low residue diet kits
      taken the day prior to the procedure and showed no difference in colon cleansing or
      tolerability compared to the traditional clear fluid regime (3,4).

      This study aims to test whether patients who consume a low residue breakfast the day prior to
      colonoscopy have a difference in the quality of their colon cleansing or tolerability of the
      preparation compared to those who consume a clear fluid diet. The investigators hypothesize
      that there will be no difference in bowel preparation scores and will be better tolerated.
    

Intervention name(s): breakfast
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Monitoring Pre-exposure Prophylaxis for Young Adult Women
Condition: HIV/AIDS; Adherence
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      Next generation real-time monitoring for PrEP adherence in young Kenyan women
    

Detailed description: 
      This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who
      will be offered HIV pre-exposure prophylaxis (PrEP) for up to two years. Adherence will be
      monitored in all women with the next generation Wisepill; half will be randomized to receive
      short message service (SMS) reminders. The technical function, acceptability, cost, and
      validity of the next generation Wisepill device coupled to SMS reminders will be determined
      among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal
      assessment of risk perception and its alignment with PrEP adherence.
    

Intervention name(s): SMS Reminders
Intervention type(s): Behavioral
Intervention description(s): Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV/AIDS; adherence; women; real time monitoring; risk; SMS; mHealth
Intravitreal Aflibercept for Therapy of Patients With Pseudoxanthoma Elasticum (PXE)
Condition: Pseudoxanthoma Elasticum
MeSH terms: Choroidal Neovascularization; Pseudoxanthoma Elasticum
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Aflibercept (Eylea) is effective in the
      treatment of choroidal neovascularization and fibrovascular proliferation in patients with
      pseudoxanthoma elasticum (PXE) in terms of preservation or improvement of visual acuity.
    


Intervention name(s): Aflibercept
Intervention type(s): Drug
Intervention description(s): Intravitreal injection
Other intervention name(s): Eylea
Intervention MeSH terms: Aflibercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Choroidal neovascularization; Angioid streaks; Pseudoxanthoma Elasticum; vascular endothelial growth factor; aflibercept
Dose-finding Study of MT-1303
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of the study are:

        -  To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a
           period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI
           parameters

        -  To evaluate the safety and tolerability of three oral doses of MT-1303 compared to
           placebo given for a period of 24 weeks in subjects with RRMS.
    


Intervention name(s): MT-1303-Low; MT-1303-Middle; MT-1303-High; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: relapsing-remitting multiple sclerosis; RRMS
Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones
Condition: Common Bile Duct Stones.
MeSH terms: Gallstones; Calculi
Study type: Interventional

Summary: 
      ERCP plays an important role in management of common bile duct stones. Herein the
      investigators compare preoperative against intraoperative ERCP.

      210 were included but only 198 patients were randomly divided into two groups; PES/LC (100
      patients) and LC/IOES (98 patients).

      The total hospital stay were significantly shorter in the group of LC/IOES
    


Intervention name(s): preoperative ERCP and LC; Intraoperative ERCP and LC
Intervention type(s): Procedure; Procedure
Intervention description(s): preoperative ERCP followed by LC; LC and intraoperative ERCP
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Choledocholithias; Common bile duct stones; Endoscopic retrograde cholangiopancreatography; endoscopic sphincterotomy; Preoperative; intraoperative; Laparoscopic common bile duct exploration
Lacidipine in Medical Practice in Patients With Mild to Moderate Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to
      provide long-term data on its impact on liver function, glucose homoeostasis and lipid
      metabolism. Additionally, its adverse drug reactions and antihypertensive effects were to be
      studied.
    


Intervention name(s): Lacidipine
Intervention type(s): Drug
Intervention MeSH terms: Lacidipine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sun Protection Factor Assay
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987517
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z12-030)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      single doses of MK1006
    


Intervention name(s): MK1006; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK1006 capsules: 1 mg, 10 mg, and 20 mg.
Panel A: MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg
Panel B: MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg.
Panel C: MK1006 capsules in five doses beginning at 140 mg and rising to 260 mg.
There will a 7-day interval between each dose; Placebo capsule to match MK1006 1, 10, and 20 mg.
Panel A: Placebo to MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg
Panel B: Placebo to MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg.
Panel C: Placebo to MK1006 capsules in 5 doses beginning at 140 mg and rising to 260 mg.
There will a 7-day interval between each dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fingerprinting of Impulsivity
Condition: Impulse Control Disorders
MeSH terms: Impulsive Behavior; Disruptive, Impulse Control, and Conduct Disorders
Study type: Observational

Summary: 
      The study aims to examine a battery of behavioral and questionnaire measures in 4 disorders
      clinically associated with impulsivity and in health controls, to: 1) investigate if the
      different populations have a distinct behavioral profile, and 2) to investigate if there are
      specific measures that are reliable and sensitive measures of impulsivity across diagnoses.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        subjects meeting criteria for one of the described cohorts
Constraint Induced Movement Therapy on Infantile Hemiplegia
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      The purpose of this study is to assess the functionality of the affected upper limb in
      infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.
    


Intervention name(s): mCIMT; Unimanual therapy without constraint UTWC
Intervention type(s): Procedure; Procedure
Intervention description(s): affected upper limb use with constraint of the healthy hand; affected upper limb use without constraint of healthy hand
Other intervention name(s): Modified constraint-induced movement therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Upper extremity; Physical therapy modalities
Manual Acupuncture Using Acupuncture Needle vs Press Needle for COVID-19 Healthcare Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study would like to compare manual acupunture treatment for anxiety in COVID Health
      workers population in Cipto Mangunkusumo Hospital using filiform needles and press needle.
    

Detailed description: 
      This study wanted to know would press needle be having better outcome for anxiety treatment,
      compared with filiform needles, because press needle taken home and could be manipulated as
      needed at home, unlike filiform needle where an acupuncturist must be available to do the
      treatment. Furthermore, the press needle needed to be changed once within 5 days, that is 2-3
      times in week. So we hope to have better acupuncture option (in effectivity and timewise) for
      COVID healthcare workers anxiety treatment. There are no study to compare the usage of the
      two types of needles for anxiety treatment to date.
    

Intervention name(s): Manual Acupuncture
Intervention type(s): Procedure
Intervention description(s): Manual acupuncture treatment using different types of needle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; press needle; anxiety