bioihbjkbjnl/mcl2 huggingface dataset:
Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to describe the safety and antibody response to revaccination
      with Menactra vaccine in persons who received their first dose at ≥11 years of age.

      Primary Objective:

      - To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured
      by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in
      subjects who were first vaccinated with Menactra 4-6 years ago.

      Secondary Objective:

      - To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens
      collected 6 days post-vaccination in a subset of study population.

      Observational Objective:

      - To describe the rates of immediate reactions, solicited injection-site and systemic
      reactions, unsolicited adverse events and serious adverse events following vaccination.
    

Detailed description: 
      All participants will receive one dose of Menactra vaccine at their first clinic visit. There
      will be a telephone safety follow-up contact at six months post-vaccination.
    

Intervention name(s): Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): Menactra®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Infection; Menactra®
Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Study type: Interventional

Summary: 
      Abnormal cervical cytology was the most common reason for women being referred to the
      colposcopy unit. We prospectively included the women with negative cytology (negative for
      intraepithelial lesions or malignancy (NILM)) and positive High RiskHPV test other than HPV
      16 or HPV 18. Comparing the immediate colposcopy findings among women with High Risk HPV
      other than HVPV16/18 and negative cytology and determine positive predictive values for CIN2+
      of other high risk HPV genotypes
    


Intervention name(s): Colposcopy
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective cohort study comparing the immediate colposcopy findings among women with HrHPV other than HVPV16/18 and negative cytology
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Human Papilloma Virus; negative for intraepithelial lesions or malignancy; HPV16; HPV18
Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Bone Fractures
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Fractures, Bone
Study type: Observational

Summary: 
      This multicenter, prospective, observational cohort study will assess bone differences in
      women and men with type 2 diabetes mellitus (T2DM) with and without fragility fractures.
    

Detailed description: 
      Cross-sectional evaluation of clinical, biochemical and microstructural measures of bone in
      patients with type 2 diabetes and age-matched healthy controls. Longitudinal assessment of
      clinical, biochemical and microstructural measures of bone in study participants without
      prevalent fragility fractures.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Female and male diabetics (aged between 50 and 75 years; BMI between 18 and 37 kg/m2) Age-
        and sex-matched non-diabetic controls
      
Biospecimen description: 
      Bone trunover markers, parameters re calcium metabolism, HbA1c, Insulin, pentosidine, markers
      of inflammation
    
Keywords: Intra-cortical pore volume; HR-pQCT; DXA; bone mineral density; bone turnover markers; urinary pentosidine
Self-Management for Youth and Families Living With SCD - SMYLS
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The purpose of this proposal is to integrate family-centered self-management strategies with
      mobile health (mHealth) technology to improve reach, self-management behaviors, and child and
      caregiver physical and psychosocial symptoms and quality of life. Specifically, the
      investigators propose to conduct feasibility testing of SMYLS, which has been adapted based
      on user feedback in the first phase of this study. First the investigators will work with the
      Medical University of South Carolina (MUSC) Pediatric Sickle Cell Clinic to identify and
      recruit families with children with sickle cell disease (SCD) in the community, statewide.
      Next, the investigators will test the feasibility of the intervention with 30 dyads of
      children ages 8 - 17 with sickle cell disease and their parent or primary caregiver, (N=60)
    


Intervention name(s): Voice Crisis Alert V2
Intervention type(s): Behavioral
Intervention description(s): Intervention consists of a mHealth app delivered via smartphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
Condition: Non Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to find out whether treatment with rosiglitazone improves the state of
      the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).
    

Detailed description: 
      Phase one : A double blind randomized placebo controlled trial of rosiglitazone

        -  64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8
           mg/day or placebo for one year.

        -  after one year of treatment patients will undergo a liver biopsy then a 4 month follow
           off treatment

      Primary endpoint: improvement of at least 30% of the histological score of steatosis
      Secondary endpoints: improvement in ALT values, in necrosis and inflammation and fibrosis

      Phase II extension open label trial

      All participants to the phase one regardless of the drug received in the first year will be
      treated with rosiglitazone for 2 additional years. A liver biopsy will be performed at the
      end of these two additional years in order to find out whether prolonged rosiglitazone
      therapy further results in improvement of liver injury in NASH patients.
    

Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: steatosis,; fibrosis,; diabetes,; obesity
EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to test the experimental reproducibility and within-subject
      variability of qEEG (quantitative electroencephalogram) using two probe compounds: MK3134 and
      lorazepam.

      This study will test the hypothesis that EEG (Electroencephalogram) theta power, averaged
      across a topographical region of interest is decreased 6 hours after administration of MK3134
      compared to placebo.

      The objective of this study is to test the experimental reproducibility and within-subject
      variability of qEEG using two probe compounds: MK3134 and lorazepam.
    


Intervention name(s): MK3134; Comparator: Lorazepam; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK3134, 25 mg tablets (5 x 5 mg capsule), orally; Lorazepam, 2 mg (2 x 1 mg tablet), orally; Placebo, to match MK3134, and placebo to match Lorazepam
Other intervention name(s): Lorazepam
Intervention MeSH terms: Lorazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: EEG Standardization
Role of Lung Ultrasonography in Detecting Extravascular Lung Water in Major Oncosurgeries
Condition: Extravascular Lung Water
Study type: Interventional

Summary: 
      During major surgeries optimal intravenous fluid administration is essential , conventional
      method may cause fluid overload , increased extravascular Lung water can lead to
      postoperative cardio-respiratory complications , this study was designed to detect immediate
      postoperative EVLW with Lung Ultrasonography in patients receiving Central venous pressure
      Guided and Pleth variability Index (PVI) guided fluids intraoperatively .
    

Detailed description: 
      Standard General Anaesthesia with Endotracheal Tube and Intermittent Positive Pressure
      Ventilation (IPPV) was given to all patients,Monitoring included 5 lead ECG, Oxygen
      Saturation (SPO2), End tidal Carbon di oxide (ETCO2), Invasive Blood Pressure (IBP) , Central
      venous Pressure (CVP), Pleth variability Index (PVI) in study group and Bispectral Index
      (BIS) , Core temperature .Postintubation before commencement of surgery baseline Lung
      Ultrasonography will be performed with non-linear probe in 4 zones on Right and Left Lung--
      Zone I Right Midclavicular in second intercostal space , Zone II Right Parasternal in third
      intercostal space, Zone III Anterior axillary line in fourth intercostal space Zone IV
      Posterior axillary line in the V intercostal space. Zone V to VIII in Corresponding spaces on
      the Left side . In the control Group CVP Guided IV fluids were given during surgery CVP will
      be maintained between 10-16 cms H20 , for CVP values < 10 cms H20 colloid bolus 200ml was
      given.In the Study Group PVI guided IV Fluids will be given to maintain PVI <12 for increase
      in PVI value > 12 Colloid bolus 200 ml will be given. After the completion of surgery and
      before extubation Lung Ultrasonography will be performed in all 8 Zones in both lungs to
      identify B Lines and total number of B lines will be calculated , Extra Vascular Lung Water
      (EVLW) Grading will be done as B Lines <5 Mild, between 5-15 moderate , > 15 severe .Total IV
      Fluids along with colloid boluses will be calculated , Postintubation as Baseline and after
      the completion of surgery Arterial blood gas analysis will be done for Alveolar-Arterial
      Oxygenation Pa02 (A-a) and blood Lactate values . After completion of surgery neuromuscular
      blockade will be reversed and trachea extubated .
    

Intervention name(s): PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .; CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): PVI probe attached to finger in PVI Group; Placement of central venous catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Lung Ultrasonography Extravascular Lung Water Plethysmography variability Index
A Study to Evaluate the Whitening Effect of Mineral Sunscreens in Multi-Cultural Skin Tones
Condition: Sunscreen
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the whitening potential effect of different mineral
      sunscreens across multi-cultural skin tones through instrumentation, imaging, and
      self-assessment and also evaluate the relationship between self-perception and objective
      measurement of whitening.
    


Intervention name(s): Sunscreen A; Sunscreen B; Sunscreen C; Sunscreen D; Sunscreen E; Sunscreen F
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Participants will topically apply Sunscreen A at Visit 1.; Participants will apply Sunscreen B at Visit 1.; Participants will apply Sunscreen C at Visit 1.; Participants will apply Sunscreen D at Visit 1.; Participants will apply Sunscreen E at Visit 1.; Participants will apply Sunscreen F at Visit 1.
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Evaluation of Delefilcon A and Verofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear
Condition: Ocular Physiology
Study type: Interventional

Summary: 
      This is a bilateral-wear, dispensing, randomized, controlled, double-masked, 2-sequence ×
      2-period crossover study to evaluate ocular physiology following contact lens wear.
    


Intervention name(s): TEST LENS; CONTROL LENS
Intervention type(s): Device; Device
Intervention description(s): DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA); PRECISION1™ for Astigmatism Contact Lenses (P1fA)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Gastric Plication and Banding
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical
      procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.
    


Intervention name(s): Plication
Intervention type(s): Procedure
Intervention description(s): Plication of the stomach will be performed in conjunction with placement of a gastric band.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: morbid obesity; bariatric surgery; gastric banding; gastric plication
Impact of Slowly Digestible Carbohydrates on the Gut-brain Axis
Condition: Appetitive Behavior; Obesity; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Our laboratory is investigating the physiological outcomes and health benefits of the
      consumption of high-quality carbohydrates. One important aspect of the high-quality
      carbohydrate characteristics is a slow and sustained digestion and glucose release to the
      blood. In the proposed study, the investigators will evaluate the consumption of different
      types of slowly digestible carbohydrates (SDCs) and their beneficial effects including
      moderation of the glycemic response profile (postprandial glycemic response, PPGR) and
      stimulation of the gut-brain axis, which controls appetite and food intake. This stimulation
      will be evaluated in terms of second-meal food intake and the circulatory level of
      appetite-suppressing gut hormones (such as glucagon-like peptide-1).
    


Intervention name(s): Rice flour; Alternanoligosaccharide 15; Inulin; Waxy potato starch; Waxy potato starch + epigallocatechin gallate (EGCG); Chickpea flour + epigallocatechin gallate (EGCG)
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Rice flour made into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.; Alternanoligosaccharide 15 incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.; Inulin incorporated into rice porridge will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.; Retrograded waxy potato starch made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.; A combination of retrograded waxy potato starch and EGCG made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.; A combination of chickpea flour and EGCG made into porridge meal will be tested for postprandial glycemic response, gut hormone levels, gastric emptying rate, appetitive response, and fermentability.
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Phase 3 Study to Compare the Efficacy and Safety of Gemigliptin and Vildagliptin as Add-on Therapy to Metformin in People With Type 2 Diabetes Inadequately Controlled With Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To compare the clinical efficacy of gemigliptin and vildagliptin as add-on therapy to
      metformin in terms of change in Hemoglobin A1c (HbA1c) reduction.

      Secondary Objectives:

      To compare the safety and tolerability of gemigliptin and vildagliptin:

        -  Number of patients who experience at least one episode of hypoglycemia.

        -  Number of patients experiencing adverse event (AE), serious adverse event (SAE).

        -  Assessment of patients compliance defined as number tablets returned by patients.
    

Detailed description: 
      The study consists of 2 weeks screening and 24 weeks of treatment (a total of 26 weeks).

      The protocol includes a screening period of two weeks, after which they will be randomized to
      receive gemigliptin or vildagliptin.

      Patients will be evaluated through 4 mandatory visits during the study. Visit 1: Week -2
      (screening) Visit 2: Week 0 (randomization) Visit 3: Week 12 (efficacy and safety evaluation)
      Visit 4: Week 24 (efficacy and safety evaluation)
    

Intervention name(s): GEMIGLIPTIN LS15-0444; vildagliptin; metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:tablet
Route of administration: oral; Pharmaceutical form:tablet
Route of administration: oral; Pharmaceutical form:tablet
Route of administration: oral
Other intervention name(s): Zemiglo; Galvus
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC)
Condition: Gastrointestinal Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate a low-dose of bowel preparation for Computed Tomography
      Colonography (CTC) versus free laxative CTC with regard to performance, feasibility, patient
      tolerability and acceptance.
    

Detailed description: 
      Computed Tomography Colonography (CTC) is a valid alternative to colonoscopy in the detection
      of cancer, polyps and other colon lesions.

      High volume cathartic preparations, low volume cathartic solutions with oral tagging agent
      and tagging agent only are the procedures available for CTC.

      High volume preparations are a considerable burden for patients. Low volume cathartic
      solutions are more accepted by the patients, reduce the amount of tagging agent and the
      waiting time to the exam. Tagging agent only preparations represent a risk if they are taken
      without medical supervision.
    

Intervention name(s): Bisacodyl & PEG-CS; Iopamidol
Intervention type(s): Drug; Drug
Intervention description(s): the day before the CTC:
low fiber diet
at 15.00: 2 tablets of bisacodyl (5 mg)
at 17.00: 1 litre of PEG-CS
liquid diet
the day of the exam:
at home: 2 tablets of bisacodyl (5 mg)
at the Hospital (3 hours after tablets intake): 90 ml of Iopamidol in 500 ml of water
at the Hospital (5 minutes after Iopamidol intake): 10 mg of Metoclopramide mono chlorohydrate monohydrate im; the day before CTC:
low fiber diet
at 15.00: 90 ml of Iopamidol in 250 ml of water
at 17.00: 90 ml of Iopamidol in 250 ml of water
at 20.00: start liquid diet
Other intervention name(s): Lovoldyl (Bisacodyl); Lovolesse (PEG-CS); Gastromiro (Iopamidol); Plasil (Metoclopramide mono chlorohydrate monohydrate); Gastromiro (Iopamidol)
Intervention MeSH terms: Metoclopramide; Bisacodyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CT colonography
The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      The present study aims to verify the analgesic potential of a transcutaneous electrical nerve
      stimulation (TENS) device using patients with primary dysmenorrhea and compare it with a
      control period without usage.
    


Intervention name(s): One Unit TENS; Two Unit TENS
Intervention type(s): Device; Device
Intervention description(s): TENS was administered by the participant at home. Application was limited to the abdominal area and instructed to be placed at the location of pain. Single unit TENS was administered via 2 channels. Participants chose an intensity of comfort and continued the treatment for 30-90 minutes per session with unlimited sessions allowed per day.; TENS was administered by the participant at home. Application was limited to the abdominal area and instructed to be placed at the location of pain. Double unit TENS was administered via 4 channels. Participants chose an intensity of comfort and continued the treatment for 30-90 minutes per session with unlimited sessions allowed per day.
Other intervention name(s): PowerDot; PowerDot
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a randomized cross-over design over the course of 3 menstrual cycles. Each menstruation phase begins on the first day of menstruation until the last day of menstruation (disappearance of bleeding). Each participant will participate in 3 randomized conditions: control (no TENS), one-unit TENS, and two-unit TENS.
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Investigation of the F-Composite 2 System in Direct Filling Therapy
Condition: Dental Caries; Unsatisfactory or Defective Restoration of Tooth
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the clinical performance of F-Composite 2 system
      in Class I and Class II cavities in permanent teeth.

      The materials of the system can be polymerized in short time with a curing light which is
      part of the system.

      The study will be carried out as a prospective study, with evaluation of the restorations
      after 7-10 days (baseline), at 6 months, at 12 months, at 24 months and 60 months according
      to defined criteria.
    


Intervention name(s): F-Composite 2 system
Intervention type(s): Device
Intervention description(s): Procedures will be done using local anesthesia (if the patients wants that). The cavity is prepared according to the principles of the adhesive technique. First the adhesive will be applied and polymerized, afterwards the flowable resin-based restorative material will be applied and polymerized and then the sculptable resin-based restorative material will be applied and polymerized; all materials will be light-cured within short time with an experimental curing light.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: filling material, polymerization