bioihbjkbjnl/mcl2 huggingface dataset:
Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair
Condition: Cleft Palate
MeSH terms: Cleft Palate
Study type: Interventional

Summary: 
      to study the benefical audiological and/or otological effect by mordified restoration of
      tensor veli palatini in cleft palate repair compared to traditional Langenbeck's repair and
      merely levator veli palatini restoration.
    

Detailed description: 
      71 patients with cleft palate received surgery were divided into 3 groups. Group 1: patients
      who received Langenbeck surgery without specific restoration of levator veli palatini or
      tensor veli palatini. Group 2: patients who received palate surgery with special levator veli
      palatini restoration. Group 3: patients who received palate surgery with modified tensor veli
      palatini restoration. The conductive auditory brainstem response and 226 Hz tympanometry were
      used to test the audiological and otological status of the three groups. Preoperative and
      postoperative results were compared intragroup and intergroup.
    

Intervention name(s): cleft palate repair
Intervention type(s): Procedure
Intervention description(s): restoration of tensor veli palatini for the purpose of the muscle function recovery.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting
      with the polycystic ovary syndrome - in association with insulin resistance, obesity, and
      other metabolic disorders.

      The present clinical trial intends to compare the effects of oral contraceptives and
      metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers
      and indexes of cardiovascular performance, in order to whether or not, as suspected by
      previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the
      cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter
      actually ameliorates such a risk.
    


Intervention name(s): Metformin; Ethynyl-estradiol plus cyproterone acetate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Cyproterone Acetate; Ethinyl Estradiol; Estradiol; Cyproterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; Hyperandrogenism; Hirsutism; Cardiovascular risk; Chronic inflammation; Metformin; Cyproterone acetate; Oral contraceptives
A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2-part, single center, open-label, randomized, single-dose, 4-sequence, 4-period
      cross-over study will compare the bioequivalence of three test RO5424802 capsule formulations
      with the reference capsule formulation in healthy adult volunteers. All participants in both
      fasted (Part 1) and fed (Part 2) conditions of the study will receive each of 4 treatments
      (Ro542-4802/F03 [RO5424802 with 50 percentage (%) sodium lauryl sulfate (SLS) (reference)],
      Ro542-4802/F07 [RO5424802 with 25% SLS (test)], Ro542-4802/F14 [RO5424802 with 12.5% SLS
      (test)] and Ro542-4802/F08 [RO5424802 with 3% SLS (test)] in a randomized sequence. Each
      treatment will be given as a single 600 milligrams (mg) oral administration in an upright
      position on Day 1 after an overnight fast, followed by a 10-day washout period. Total time on
      study is expected to last up to 75 days, for each enrolled participant.
    


Intervention name(s): Ro542-4802/F03 (Reference); Ro542-4802/F07 (Test); Ro542-4802/F08 (Test); Ro542-4802/F14 (Test)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive Ro542-4802/F03 (containing 50% SLS) 600 mg capsules orally on Day 1.; Participants will receive Ro542-4802/F07 (containing 25% SLS) 600 mg capsules orally on Day 1.; Participants will receive Ro542-4802/F08 (containing 3% SLS) 600 mg capsules orally on Day 1.; Participants will receive Ro542-4802/F14 (containing 12.5% SLS) 600 mg capsules orally on Day 1.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Examine the Effectiveness of Aspirin and/or Vitamin D3 to Prevent Prostate Cancer Progression
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To demonstrate the acceptability and feasibility of recruitment to a randomised
      chemoprevention study of standard (300mg) or low dose (100mg) aspirin vs. placebo and/or
      Vitamin D3 vs. placebo in patients enrolled on an Active Surveillance programme for prostate
      cancer.
    

Detailed description: 
      The PROVENT study is a randomised, double blind, placebo controlled feasibility study to
      examine the clinical effectiveness of aspirin and/or Vitamin D3 to prevent disease
      progression in men on Active Surveillance for prostate cancer

      The main outcome measure of the trial is the rate of patient recruitment to a randomised
      chemoprevention study in men enrolled on an Active Surveillance programme for prostate cancer

      Secondary outcomes include the response to treatment as determined by serial multi-parametric
      magnetic resonance imaging (MRI) of the prostate, biochemical disease progression and
      histological disease progression after 12 months of therapy and finally toxicity and/or
      allergy to both aspirin and Vitamin D3.
    

Intervention name(s): High dose Aspirin & Vitamin D; High dose Aspirin, Vitamin D placebo; Low dose Aspirin , Vitamin D; Low dose Aspirin, Vitamin D placebo; Aspirin Placebo, Vitamin D; Aspirin placebo, Vitamin D placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Aspirin 1 x 300mg tablet daily & Vitamin D 4,000IU daily. (8 drops).; Aspirin 1 x 300mg tablet daily & Vitamin D placebo (8 drops).; Aspirin 1 x 100mg tablet daily & Vitamin D 4,000IU daily. (8 drops).; Aspirin 1 x 100mg tablet daily & Vitamin D placebo 8 drops daily.; Aspirin 1 x 300mg placebo tablet daily & Vitamin D 4,000IU daily. (8 drops).; Aspirin 1 x 100mg placebo tablet daily & Vitamin D 4,000IU daily. (8 drops).
Other intervention name(s): Aspirin - acetylsalicylic acid; Vitamin D - Vigantol® Oil; Aspirin - acetylsalicylic acid; Vitamin D placebo - Miglyol®812 Oil; Aspirin - acetylsalicylic acid; Vitamin D - Vigantol® Oil; Aspirin - acetylsalicylic acid; Vitamin D placebo - Miglyol®812 Oil; Vitamin D - Vigantol® Oil; Aspirin Placebo, Vitamin D; Vitamin D placebo - Miglyol®812 Oil
Intervention MeSH terms: Aspirin; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prostate Cancer; Active Surveillance; Chemo-prevention
Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Hematopoietic reconstitution defined by a neutrophils number > 500/mm3 at day 7 after
      injection of ex vivo amplified graft and by a platelets number > 20000/mm3, at day 15 after
      the injection of ex vivo amplified graft, without transfusion.
    

Detailed description: 
      To check that injection of autologous peripheral blood stem cell CD34(+) "amplified ex vivo
      in the presence of SCF, G-CSF and TPO in HP01 Maco pharma medium culture. ": Allows to obtain
      a hematopoietic reconstitution:

        1. Rapid : 7 days or less after the injection, regarding neutrophils and 15 days or less
           regarding platelets

        2. Complete: numbers neutrophils and platelets respectively higher than 500/mm3 and
           20000/mm3 within the times mentioned

        3. Stable: no secondary neutropenia or thrombocytopenia during the year following the
           injection, in the absence of recurence of the myeloma.
    

Intervention name(s): autologous peripheral blood stem cell transplantation, ex vivo amplified
Intervention type(s): Procedure
Intervention description(s): autologous peripheral blood stem cell transplantation, ex vivo amplified
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Symptomatic Multiple Myeloma; first line treatment; first autologous Stem Cell Transplantation; ex vivo amplified autologous peripheral blood stem cells
Combined STN/SNr-DBS for the Treatment of Refractory Gait Disorders in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      12 patients with idiopathic Parkinson's disease and refractory gait disturbances under best
      individual subthalamic nucleus stimulation and dopaminergic medication will be included into
      this randomised double-blind cross-over two-armed clinical trial. The treatment consists of
      two different stimulation settings using (i) conventional stimulation of the subthalamic
      nucleus [STNmono] and (ii) combined stimulation of distant electrode contacts located in the
      subthalamic nucleus and caudal border zone of STN and substantia nigra pars reticulata
      [STN+SNr].
    

Detailed description: 
      A composite 'axial score' including the major clinical and anamnestic items on gait, posture
      and balance function from UPDRSII (items 13-15) and UPDRS III (items 27-31) constitutes the
      primary outcome measure. Secondary outcome measures include specified clinical and anamnestic
      assessments on freezing of gait, balance, quality of life, non-motor symptoms, impulsivity,
      impulse control and neuropsychiatric symptoms. The aim of the present trial is to investigate
      the efficacy and safety of combined stimulation on subthalamic and nigral electrode contacts
      [STN+SNr] in refractory hypokinetic gait disturbances compared with [STNmono] (active
      comparator). The results will clarify, whether the combined [STN+SNr] stimulation improves
      otherwise refractory gait disturbances in PD.
    

Intervention name(s): deep brain stimulation (ACTIVA PC, Medtronic)
Intervention type(s): Device
Intervention description(s): High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude)
Other intervention name(s): Neurostimulation with ACTIVA PC, Medtronic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; gait; deep brain stimulation; substantia nigra pars reticulata; subthalamic nucleus
Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-blind study looking at the efficacy and satisfaction of Concerta
      substitution in adult subjects with ADHD receiving immediate release methylphenidate.
      Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or
      Concerta. The specific hypotheses of this study are:

      Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled
      in patients switched from MPH IR TID to Concerta.

      Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to
      Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with
      MPH IR TID.
    

Detailed description: 
      Concerta was specifically developed to replace three times a day immediate release (IR)
      methylphenidate (MPH). The clinical advantages offered by this novel compound go beyond ease
      of administration. By avoiding the peaks and valleys of serum levels associated with IR MPH,
      treatment with Concerta minimizes adverse effects at peaks and break through symptoms at
      valleys securing clinical coverage throughout the day, minimizing the risks of adverse
      effects from serum fluctuations that can occur with multiple dosing of the IR formulation of
      MPH. This unique pharmacokinetic and pharmacodynamic profile of Concerta is potentially
      particularly advantageous in the treatment of adults with ADHD because a) adults with ADHD
      tend to be forgetful; b) forgetfulness makes the self administration of treatment three times
      a day difficult; c) forgetfulness can lead to poor compliance and drop off of effects over
      time with its attendant detrimental effect on clinical control and quality of life. Subjects
      will be randomized by the pharmacy to CONCERTA or to continue MPH IR TID in a ratio of 4:1.

      This study includes: 1) a six-week design to document the response rate 2) assessment of the
      impact of either MPH IR or Concerta on functional capacities 3) careful assessment of safety
      and tolerability
    

Intervention name(s): methylphenidate hydrochloride; OROS methylphenidate hydrochloride (CONCERTA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to test the efficacy of an investigational influenza vaccine, in
      children compared to Havrix®, a licensed Hepatitis A virus vaccine.

      This study will also evaluate the immunogenicity and safety of the investigational vaccine.
    


Intervention name(s): FluLaval® Quadrivalent; Havrix™
Intervention type(s): Biological; Biological
Intervention description(s): One intramuscular dose for primed subjects. Two intramuscular doses for unprimed subjects.; Two intramuscular doses for primed subjects. Three intramuscular doses for unprimed subjects.
Other intervention name(s): Quadrivalent seasonal influenza vaccine GSK2282512A
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza
CA 125 and VAS Pain Score Changes to Diagnose Endometriosis
Condition: Pelvic Pain; Endometriosis
MeSH terms: Endometriosis; Pelvic Pain
Study type: Observational

Summary: 
      To assess the diagnostic accuracy for the noninvasive detection of pelvic endometriosis of
      the combination of two simple parameters: modifications of serum CA 125 and VAS pain score
      following one dose of GnRH-analog (GnRH-a).
    

Detailed description: 
      Between January 2010 and January 2014, women scheduled for a diagnostic laparoscopy for CPP
      at our Department will be enrolled in the current prospective observational study. For these
      patients, laparoscopy represents the last diagnostic step after medical history negative for
      gastrointestinal, urological, musculoskeletal and psychoneurological disorders related to
      pelvic pain, physical examination, ultrasonographic assessment and laboratory testing. From
      all patients, at enrollment, blood samples for serum CA125 determination will be taken during
      the early follicular phase (2nd-3rd day of the menstrual cycle) and VAS score for menstrual
      pain will be assessed. Electrochemiluminescence immunoassay (Immunoassay Elecsys Systems,
      Roche Diagnostics, Italy) for serum CA125 assay will be used (kit coefficient of variation
      between-run 0.0% and within-run 2.0%).

      During the time passed on surgery waiting list, patients will received leuprolide acetate
      depot (LAD) at a dose of 3.75 mg IM at the 21st day of the menstrual cycle. One month later
      LAD administration, serum CA125 levels and VAS score will be assessed again, and then the
      surgical procedure will be performed in all these patients.

      After laparoscopy and definitive histological examination, the population initially enrolled
      will be sub-grouped according to endometriosis diagnosis in two groups, i.e. group 1
      (subjects with endometriosis) and group 2 (subjects without endometriosis).
    

Intervention name(s): GnRH-analogue
Intervention type(s): Drug
Other intervention name(s): LAD
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic pelvic pain
      
Keywords: GnRH-a; endometriosis; chronic pelvic pain; VAS score; diagnostic accuracy
A Study of Dulaglutide in Chinese Participants
Condition: Diabetes Mellitus, Type 2; Healthy Volunteers
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study of dulaglutide in Chinese participants. The purpose of the study is to
      determine how the body processes dulaglutide and how dulaglutide affects the body. This study
      has 2 parts: Part A - single dose of dulaglutide administered to healthy participants in 2 of
      3 study periods. There is a minimum 28-day washout between periods. Part A will last
      approximately 16 weeks. Part B - multiple doses of dulaglutide administered to participants
      with Type 2 diabetes mellitus (T2DM). Part B will last approximately 15 weeks.

      Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this
      study.
    


Intervention name(s): Dulaglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
Other intervention name(s): LY2189265
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessing Uniqueness of Inflammatory Bowel Disease Related Microbiome-derived Biomarkers
Condition: Irritable Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      To assess the differential expression of IBD-related microbiome-derived biomarkers including
      bacterial strains and peptides such as antimicrobial peptides (AMP) found in inner-colonic
      samples (HygiSample™) in comparison to home collected stool samples in patients with active
      IBD colonic disease.

      The HygiSample will be collected during a defecation-inducing high-volume (>40 L) colon
      irrigation bowel prep (HygiPrepⓇ).
    

Detailed description: 
      This study is a preliminary study aimed to assess the ability to differentially detect
      IBD-related microbiome-derived biomarkers in colon effluent samples collected using the
      Hygieacare System. The proposed sample size of 20 patients (10 in the control arm, 10 in the
      IBD arm), where each patient provides both stool and three inner-colonic samples is
      sufficient to provide preliminary results for such an assessment.

      Categorical variables will be summarized by frequencies and percentages, while quantitative
      variables will be summarized by descriptive statistics (mean, median, standard deviation,
      minimum, and maximum).

      The investigators will compare taxonomy and phylogeny biodiversity between the control and
      the IBD arms and between stool and colon effluent samples.
    

Intervention name(s): Hygieacare System
Intervention type(s): Device
Intervention description(s): The device is an FDA cleared colon irrigation device, it will be used according to clearance. The sampling of the colon effluent sampled is the are of study.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Study Arm = 10 patients diagnosed with colonic IBD (5 diagnosed with Ulcerative Colitis and 5 diagnosed with Crohn's Disease) scheduled for a surveillance colonoscopy
Control Arm = 10 patients scheduled for a routine screening colonoscopy who do not have a history of IBD symptoms or IBD diagnosis
Masking: None (Open Label)
Primary purpose: Health Services Research
The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
Condition: Colon Cancer
MeSH terms: Adenoma
Study type: Observational

Summary: 
      Colonoscopy is clinically used as the gold standard for detection of colon cancer (CRC) and
      removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related
      deaths, there exists a disappointing level of adenomas missed at colonoscopy. "Back-to-back"
      colonoscopies have indicated significant miss rates of 27% for small adenomas (< 5 mm) and 6%
      for adenomas of more than 10 mm in diameter. Studies performing both CT colonography and
      colonoscopy estimate that the colonoscopy miss rate for polyps over 10 mm in size may be as
      high as 12%. The clinical importance of missed lesions should be emphasized because these
      lesions may ultimately progress to CRC8.

      Limitations in human visual perception and other human biases such as fatigue, distraction,
      level of alertness during examination increases such recognition errors and way of mitigating
      them may be the key to improve polyp detection and further reduction in mortality from CRC.
      In the past years, a number of CAD systems for detection of polyps from endoscopy images have
      been described. However, the benefits of traditional CAD technologies in colonoscopy appear
      to be contradictory, therefore they should be improved to be ultimately considered useful.
      Recent advances in artificial intelligence (AI), deep learning (DL), and computer vision have
      shown potential to assist polyp detection during colonoscopy.
    


Intervention name(s): AI
Intervention type(s): Other
Intervention description(s): Artificial intellignece colonoscopy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Based on the observed prevalence of adenomas (35%) among patients undergoing colonoscopies
        at our center within the last 12 months, a sample size of 322 subjects per arm could allow
        for a 90% power to show the non-inferiority (primary end-point) of the AI-aided arm by
        excluding that the one-side 95% CI will exclude a difference of 10% in favour of the
        standard group. Such sample size will also have a 80% power to detect as statistical
        significant (α=0.05; two-sided test) a 10% absolute increase in the detection rate of
        adenomas in the AI-aided arm (secondary end-point).
      
Keywords: Artificial Intelligence