bioihbjkbjnl/mcl2 huggingface dataset:
Does the Femoral Head Size Can Predict the Cup Size?
Condition: Total Hip Arthroplasty
Study type: Observational

Summary: 
      This study had four aims:

        1. To evaluate the correlation between the planned preoperative cup size and the actual cup
           size that was implanted in surgery.

        2. To examine the absolute difference between the implanted cup size diameter and the
           actual femoral head size diameter.

        3. To examine the absolute difference between the planned cup size diameter and the actual
           femoral head size diameter

        4. To suggest an additional online monitoring tool on the accuracy of the preoperative
           process and implant selection. We hypothesized that high accuracy rates will be found
           between the preoperative planned cup size and the actual implanted cup size.
           Furthermore, we hypothesized that strong correlations will be found between the planned
           and actual implanted cup size and the actual femoral head diameter size.
    

Detailed description: 
      Methods This is a retrospective study , that will include patients who underwent primary
      cementless THA due to end-stage hip osteoarthritis during 2011 and 2013 . Inclusion criteria
      were: Patients that underwent primary THA due to end-stage primary osteoarthritis; Males and
      females between 15-90 years of age.

      Data collection The following data will be collected: patients' characteristic including
      gender, age at surgery and side of surgery; implant information including cup model, planed
      cup size, actual cup size, shell type and outer diameter size (mm); actual femoral head
      diameter size (mm); the difference between the planned cup size and the actual cup size that
      was used; the difference between the actual femoral head diameter size measured at the end of
      surgery and the cementless implanted cup outer diameter size; the difference between the
      actual femoral head diameter size and the planed cup size..
    

Intervention name(s): There are no specific Intervention
Intervention type(s): Other
Intervention description(s): are no specific Intervention
Other intervention name(s): are no specific Intervention
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that underwent primary Total hip arthroplasty due to end-stage primary
        osteoarthritis; Males and females between 15-90 years of age.
      
Keywords: femoral head size; cup size; Total hip arthroplasty
A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary
      purpose of this study is to help answer the following research questions, and not to provide
      treatment for diabetes :

        -  The safety of LY2409021 and any side effects that might be associated with it following
           4 weeks of doses

        -  How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks

        -  How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other
           naturally occurring substances before and after a meal

        -  How LY2409021 works when given with metformin

        -  How daily dosing of LY2409021 affects the cells that produce insulin
    


Intervention name(s): Placebo; LY2409021
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally (capsule); Administered orally (capsule)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional
      therapy using digital subtraction angiography（DSA）for breast cancer.
    

Detailed description: 
      By enrolling patients with breast cancer adapted to enrolled criteria, this study will
      document for the first time the safety and the short and long term efficacy of HepaSphere
      interventional therapy using digital subtraction angiography（DSA）for breast cancer.
    

Intervention name(s): interventional therapy
Intervention type(s): Procedure
Intervention description(s): breast cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; HepaSphere
Alternate Day Micafungin: A PK Study in Pediatric Patients
Condition: Fungal Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the pharmacokinetics of micafungin when it is given
      on an every other day schedule. The study will determine if every other day micafungin will
      provide drug exposure equivalent to daily dosing while reducing administration costs and
      improving patient convenience. Fifteen patients will be enrolled on this study. Blood samples
      for PK measurements will be obtained for 48 hours following a single dose of micafungin (3
      mg/kg).
    

Detailed description: 
      Disseminated fungal infection is a major cause of morbidity and mortality in
      immunocompromised children. Many of the drugs used for fungal prophylaxis have been
      associated with kidney and liver toxicity. Also, breakthrough infections have been reported
      with the use of some of the oral agents due to poor oral absorption. An alternative approach
      is the use of intravenous micafungin for fungal prophylaxis. Micafungin has a distinct
      advantage due to its better safety profile, specifically in terms of liver and kidney
      toxicity. Currently, children who receive micafungin are given daily dosing. This study will
      examine the pharmacokinetics of micafungin when it is given on an every other day schedule.
      It will examine whether every other day micafungin will provide drug exposure equivalent to
      daily dosing while reducing administration costs and improving patient convenience. Both
      animal and adult human data support the use of this approach. Fifteen patients will be
      enrolled on this study and will be given a single dose of micafungin (3 mg/kg). Blood samples
      will be drawn for pharmacokinetic measurements after administration of micafungin.
    

Intervention name(s): Micafungin
Intervention type(s): Drug
Intervention description(s): 3 mg/kg IV once over 1 hour
Other intervention name(s): MYCAMINE
Intervention MeSH terms: Micafungin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Anti-fungal; Immunocompromised; Pharmacokinetic; Prophylaxis; Pharmacokinetics
A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, parallel group study will evaluate the
      pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.

      Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or
      placebo. In-unit period is 6 days.
    


Intervention name(s): Placebo; RO5508887
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Single oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Evaluation of a Cognitive Behavioral Smoking Reduction Program
Condition: Tobacco Reduction
Study type: Interventional

Summary: 
      The aim of this study is to evaluate a new cognitive behavioral smoking reduction program for
      ambulant patients in a three-armed study design. Study participants will be randomized to one
      of the following three study groups: experimental group: 5-week lasting cognitive behavioral
      reduction program ("smoke_less"); active comparator: 15 minutes counseling interview; waiting
      group: no intervention.

      The three follow-up measures take place after the reduction program in week 6, 17 an 29.
      After the finalisation of the last follow-up, participants from the active comparator and
      waiting group get the chance to take part at the smoking reduction program at no charge.
    


Intervention name(s): Cognitive behavioral smoking reduction program "Smoke_less"; 15 minute counseling interview
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Duration: 5 weeks, 4 sessions over 2,5 hours and 2 phone calls
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mass Balance Study of NV-5138 in Healthy Male Subjects.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the mass balance and routes of excretion of total
      radioactivity after a single oral dose of 1600 mg [14C]-NV-5138.
    


Intervention name(s): [14C]-NV-5138
Intervention type(s): Drug
Intervention description(s): Single dose, given as oral solution, 1600 mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Explore the PK and PD of INV-202 in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      INV-202-CL-105 is a phase 1B study to examine the safety and tolerability, as well as the
      pharmacokinetics (PK) pharmacodynamic (PD) effects of INV-202 in subjects with metabolic
      syndrome over 28 days.
    

Detailed description: 
      INV-202-CL-105 is a phase 1B study to examine the safety and tolerability, as well as the
      pharmacokinetics (PK) pharmacodynamic (PD) effects of INV-202 in subjects with metabolic
      syndrome over 28 days.

      Subjects with metabolic syndrome as defined as an increased waist circumference,
      hypertriglyceridemia, and glucose intolerance will be randomized to INV-202 or placebo for 28
      to assess PK/PD relationships and other biomarkers.
    

Intervention name(s): INV-202; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablet; matching tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety and Effectiveness of S-adenosyl-l-methionine (SAMe) for the Treatment of Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and effectiveness of
      s-adenosyl-l-methionine (SAMe) in treating major depression.
    

Detailed description: 
      SAMe is a substance that is naturally produced by the body and is also sold as an
      over-the-counter drug. Although SAMe has not yet been approved for treating depression,
      evidence suggests that it has antidepressant properties. This study will determine whether
      SAMe is safe and effective in treating major depression.

      This study will last 24 weeks. Participants will be randomly assigned to receive either the
      antidepressant escitalopram, SAMe, or placebo for 12 weeks. Participants who respond to
      treatment at the end of 12 weeks will stay on their regimen for an additional 12 weeks.
      Participants who do not respond to treatment will enter an open treatment phase where they
      will receive SAMe and escitalopram for 12 more weeks. Depression scales and self-report
      questionnaires will be used to assess participants. All participants will receive 3 months of
      follow-up care, including free medication and clinic visits as necessary.
    

Intervention name(s): S-adenosyl-l-methionine; Escitalopram; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1600 mg per day with possibility of increasing to 3200 mg per day at 6 weeks; 10 mg per day, with possibility of increasing to 20 mg/day at 6 weeks; placebo capsules look like escitalopram capsules and SAMe capsules
Other intervention name(s): SAMe; Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Depression; Antidepressive Agents; Complementary Therapies
CSD190401: A Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products
Condition: Smoking; Smoking Behaviors; Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      This is a single site, open-label, randomized, cross-over study designed to evaluate elements
      of abuse liability (AL) including subjective effects and physiological measures
      (pharmacodynamics [PD]) and plasma nicotine uptake (pharmacokinetics [PK]) during and
      following ad libitum use of the study investigational products (IPs) by generally healthy
      subjects.
    

Detailed description: 
      Cigarette smokers (SMK) and smokers who also use smokeless tobacco (SST) [e.g., snus, moist
      snuff] will be recruited into the study. An attempt will be made to have approximately one
      third of the study population made up of SST.

      Potential subjects may complete a pre-Screening telephone interview and will complete a
      Screening Visit to assess their eligibility within 45 days prior to check-in and
      enrollment/randomization.

      Starting on Day -1, eligible subjects will begin confinement at the clinical site for 6 days.
      Subjects will be randomized to evaluate one investigational product (IP) in each of five
      separate Test Sessions, such that each subject will evaluate five IPs, including three
      strengths of the nicotine pouches, and both a high- and a low-AL comparator.

      Each Test Session will last for approximately 4 hours during and following IP use and will
      include collection of both PD measures (subjective and physiological) and PK measures.

      On Day -1, subjects will participate in an IP acclimation period where they will be
      instructed on how to use the nicotine pouch IP and the nicotine gum (low-AL comparator IP).
      At the end of the acclimation period, subjects will have access to their usual brand (UB)
      cigarettes for ad libitum use until the 12-hour tobacco abstinence begins prior to the Day 1
      Test Session.
    

Intervention name(s): Product A; Product B; Product C; Product D; Product E
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Usual brand (UB) filtered, combustible cigarette; Nicorette® White Ice Mint 2 mg nicotine gum; CSD1904-01, a nicotine pouch, 2 mg nicotine; CSD1904-02, a nicotine pouch, 4 mg nicotine; CSD1904-02, a nicotine pouch, 8 mg nicotine (simultaneous use of two 4 mg nicotine pouches)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Birth Environment and Childbirth-stress, Control & Outcome
Condition: Childbirth Problems; Birth; Delayed
Study type: Interventional

Summary: 
      This research improves the correlation between birth control and birth outcomes by
      understanding the childbirth environment and birth stress. A Quasi Experiment research . The
      sample size was calculated using a two-tailed test, the significance level α was 0.05, the
      power was 80%, three groups of repeated measurements were taken three times, the effect size
      (effect size) was set to medium.25, and the required number of samples was 108 people,
      resulting in a 20% wastage rate, a total of 129 people are needed, so each of the three
      groups is expected to accept 43 people.
    


Intervention name(s): Positive Birth Environment
Intervention type(s): Other
Intervention description(s): The intent is to surround the woman and her caregivers with specific types of auditory, visual, and tactile stim uli. One key feature of the ambient room is what is missing-the standard hospital bed. As an alternative, a portable double-sized mattress with several large pillows is set up in a corner of the room. The intent is to allow the woman freedom in positioning and to permit close contact with support people, and to limit the routine use of continuous elec tronic fetal heart rate monitoring and other technologies during normal labor. Lighting is dimmed. A wide variety of music selections are also available.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: birth Environment; childbirth-stress; birth control; outcomes
Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients
Condition: Post-Menopausal Bleeding; Post-Menopausal Endometrial Thickness
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Hysteroscopic endometrial biopsy is usually performed through the classic spoon grasper.
      Recently, a new hysteroscopic grasper with knurled terminal end and cutting jaws was
      designed, in order to improve feasibility of the procedure, reduce its duration and the
      discomfort for the patients.

      This study aims to compare the outcomes of the three hysteroscopic graspers for endometrial
      biopsy in post-menopausal patients.
    

Detailed description: 
      Diagnostic hysteroscopy is currently the gold standard method to evaluate uterine cavity and
      tubal ostia, allowing also the visualization of vaginal walls and the cervical canal.
      Compared to the other available diagnostic techniques, hysteroscopy has the advantage of
      directly visualization the anatomical area to be investigated and allows to perform biopsy.
      The possibility of hysteroscopy-guided biopsy sampling is particularly important in order to
      get histological diagnosis. As recently suggested, the hysteroscopic biopsy of the
      endometrium has diagnostic accuracy of 90% for post-menopausal endometrial cancer.

      Currently, most diagnostic hysteroscopies are performed in outpatient setting, without
      anesthesia, using modern hysteroscopes with a 1.67 mm working channel. In particular,
      endometrial biopsy is usually performed through the classic spoon grasper or alligator
      grasper. Recently, a new hysteroscopic grasper with knurled terminal end and cutting jaws was
      designed, in order to improve feasibility of the procedure, reduce its duration and the
      discomfort for the patients.

      This study aims to compare the outcomes of the three hysteroscopic graspers for endometrial
      biopsy in post-menopausal patients.
    

Intervention name(s): Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws; Endometrial biopsy with the hysteroscopic spoon grasper; Endometrial biopsy with the hysteroscopic alligator grasper
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws.; Hysteroscopic endometrial biopsy performed through the spoon grasper.; Hysteroscopic endometrial biopsy performed through the alligator grasper.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hysteroscopy; Endometrial biopsy; Menopause
Healthy Effects of an Innovative Probiotic Pasta
Condition: OBESITY; INFLAMMATION; DYSLIPIDEMIA; CONSTIPATION
MeSH terms: Dyslipidemias; Inflammation; Constipation
Study type: Interventional

Summary: 
      The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of
      a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus
      coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized
      controlled trial.
    

Detailed description: 
      Epidemiological evidences indicate that consumption of whole grains products is associated to
      a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity,
      hypertension and metabolic syndrome. In the present study a whole grain pasta was
      supplemented with prebiotics and probiotics 'ad hoc' formulated. In detail, pasta was
      industrially developed after the identification of particular cultivars of wheat and barley,
      rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants.
      Further, pasta was supplemented with spores of Bacillus coagulans, a putative probiotic
      microorganism, belonging to Lactobacillus family. It is well demonstrated the ability of this
      microorganism to survive to technological processes and to upper gastro-intesinal tract, in
      order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing
      immunological defences as well as improvements in intestinal regularity. Conversely, the
      control pasta was made from the same cultivar of grain and by the same technological process,
      but without any supplementation.

      In this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly
      allocated for the consumption of the two kind of pasta once a day, for 12 weeks. At the
      beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and
      feces for the evaluation of:

        -  blood inflammation markers;

        -  blood lipid and carbohydrate profile;

        -  blood and urine markers of cardiovascular risk;

        -  feces profile of microbiota and detection of markers for the healthiness of the gut.

      In addition, volunteers filled in different questionnaires regarding their dietary habits,
      the physical activity and the gut healthiness.
    

Intervention name(s): whole grain pasta
Intervention type(s): Dietary Supplement
Intervention description(s): Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Infant phase: To determine the safety of and production of antibodies by a group C
      meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine
      vaccines.

      Booster phase: To compare the safety of and production of antibodies by MnCC with and without
      MMR and to compare the antibody response to that produced by a low dose of plain
      polysaccharide vaccine as a way of investigating immune memory
    


Intervention name(s): Meningococcal C; DTP/Hib
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Infant; Conjugate vaccine; Meningococcal; Antibody; Immune memory; Health; Meningococcal Vaccines