bioihbjkbjnl/mcl2 huggingface dataset:
Platelet Rich Plasma in Levator Ani Muscle Trauma
Condition: Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma
      injection after delivery showed reduced hiatal area and maintain levator muscle strength.
    

Detailed description: 
      This study aims to see if PRP has a beneficial effect on the repair of pelvic floor muscle
      damage in primipara. Therefore, this single-blinded randomized clinical trial compares the
      pelvic floor muscle repair in primipara following labor between the interventional group who
      received intramuscular PRP injection in levator ani muscle and the control group, as assessed
      by ultrasonography, perineometry. The ultrasonography outcome measures include lower hiatal
      area during Valsalva. The assessments are performed at multiple time points, which are before
      labor, 24-48 hours post-labor, 40 days post-labor, and 3 months post-labor.
    

Intervention name(s): Platelet Rich Plasma
Intervention type(s): Biological
Intervention description(s): Platelet rich plasma is an autologous blood with high amount of platelet. It produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.
Other intervention name(s): PRP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: platelet rich plasma; levator ani muscle; post-partum trauma; ballooning trauma; levator ani muscle strength
Fear Conditioning Paradigm in Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Fear processing in obesity and specifically the ability to i) learn and remember threatening
      stimuli, and ii) implicitly (i.e., unconsciously) and explicitly (consciously) discriminate
      them from neutral ones, will be investigated in affected individuals through the
      fear-conditioning paradigm.
    


Intervention name(s): Fear Conditioning
Intervention type(s): Behavioral
Intervention description(s): It is a 2-day paradigm. Participants will undergo an auditory fear conditioning task in 3 phases: (1) pre-conditioning habituation, (2) unconditioned stimulus (US) calibration, where USs will be delivered to set the individual stimulation intensity threshold, and (3) fear conditioning, in which participants will be exposed to the conditioned stimulus (CS) associated with the US with an 80% pairing rate. 24 hours later, the (1) implicit recognition of the CS and novel stimuli (NSs), and the (2) explicit recognition, through an alternative forced-choice task will be assessed. Also, (3) the perceptual discrimination (among the CS and NSs) will be tested.
Event-related skin conductance responses (SCRs) will be collected as an implicit index of defensive fear responses, while the accuracy in detecting and discriminating the CS from NSs as the explicit index. Psychological questionnaires about anxiety symptoms will be also administered.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants with obesity will be recruited at the beginning of a rehabilitative treatment
        at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be
        recruited out of the hospital.
      
Keywords: fear conditioning; fear processing; anxiety
Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses
Condition: Age Related Cataracts
MeSH terms: Cataract
Study type: Interventional

Summary: 
      On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA
      Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated
      receives the other IOL type.

      A complete biomicroscopic examination, visual acuity testing using autorefractometer,
      contrast sensitivity testing, and standardised retroillumination photography for PCO
      evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months)
      years postoperatively.
    


Intervention name(s): Alcon SN60WF; Hoya Vivinex
Intervention type(s): Device; Device
Intervention description(s): Implantation of an intraocular lens Alcon SN60WF; Implantation of an intraocular lens Hoya Vivinex
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee
Condition: Meniscus Tears; Loose Bodies; Articular Osteoarthritis; Articular or Capsular Trauma
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of the study is to accumulate efficacy data on VisionScope Imaging (VSI) for
      pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage injuries).
      The study will compare VSI's accuracy to MRI's in diagnosing the same injuries.

      The hypothesis is the VisionScope Imaging system will be able to provide direct visualization
      and diagnostic images of inside the joint capsule space without fluid distention in the knee.
      This study will provide valuable feedback on the ability of the VisionScope system to provide
      physicians with the information they need to make a definitive diagnosis.
    

Detailed description: 
      The primary objective of this study is to accumulate efficacy data on the VisionScope Imaging
      System (VSI) for pre-operative diagnoses when it is used to provide illumination and
      visualization of articular cavities. The study will analyze the VisionScope system's accuracy
      compared to MRI in diagnosing and confirming meniscus tears, chondral defects, loose bodies,
      minor arthritis, and/or any articular or capsular trauma.

      The hypothesis of the study is that the VisionScope System will be able to obtain direct
      visualization and diagnostic images of the intercapsular space without fluid distention in
      the knee. This study will provide feedback on the ability of the VisionScope system to
      potentially eliminate the need for MRI scans. Additionally, a cost-analysis comparison
      between the use of VSI vs. MRI for the diagnosis of orthopaedic knee injuries will be
      conducted. Finally, the study will help develop an algorithm of potential use for the VSI
      system in the management of knee pathologies.
    

Intervention name(s): VisionScope Imaging (VSI) Exam
Intervention type(s): Procedure
Intervention description(s): The VisionScope Imaging (VSI) Exam [the system itself] is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization, and the capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Knee Injuries; Meniscus Injuries; Articular Cartilage Injuries; Orthopaedic Diagnostic; Magnetic Resonance Imaging
Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India
Condition: Iron Deficiency; Zinc Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      In this study, iron- and zinc-biofortified pearl millet will be fed to young children in
      Mumbai, Maharashtra, India over a period of nine months to measure growth and immune function
      in comparison to children receiving non-biofortified pearl millet.
    

Detailed description: 
      Iron and zinc deficiency remain a major worldwide public health problem, especially in
      developing countries such as India. In this randomized study, 700 children aged 12-18 months
      from Mumbai, Maharashtra, India will be fed either iron and zinc biofortified pearl millet or
      control pearl millet three times per day, six days per week, for nine months. The goal of
      this study is to examine the effects of iron and zinc biofortified millet on immune function,
      growth, and cognitive function in this age group. The key outcome measures are biomarkers of
      iron and zinc status, growth, and immune function. Serum concentrations of hemoglobin,
      ferritin, serum transferrin receptor, and zinc will be assessed at enrollment (baseline), at
      an intermediate time point (midline; random serial sampling) and after 9 months of follow-up
      (endline). Additionally, we will measure concentrations of C-reactive protein (CRP) and alpha
      1-acid glycoprotein (AGP), as iron and zinc biomarkers can be influenced by inflammation. To
      assess cognitive function in a subset, multiple specific aspects of memory, attention, and
      processing speed will be assessed. Higher-level, integrative cognitive abilities that require
      the coordination of multiple specific functions, such as problem-solving and exploratory
      behavior and global aspects of attention during free play with toys, will also be assessed.
    

Intervention name(s): FeZnPM; CtrlPM
Intervention type(s): Other; Other
Intervention description(s): Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.; Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
Other intervention name(s): biofortified pearl millet, bajra, ICTP8203-Fe; bajra, pearl millet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: iron; zinc; pearl millet; India; children; trial; randomized
A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with
      diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.
    


Intervention name(s): YM060; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ramosetron, Irribow
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diarrhea; IBS; Colonic disease; YM060; Ramosetron
Using Technology to Promote Mental Acuity
Condition: Mental Acuity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study plans to test the effectiveness of behavioral economics based incentives to promote
      the daily use of computer programs designed to improve memory and mental acuity. Subjects
      will be recruited from the Pittsburgh metropolitan area. The primary objective is to
      determine the impact of structured financial incentives on the number of computer-based
      cognitive exercises completed during a 3 month intervention period.
    


Intervention name(s): Financial incentives; No incentives
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are eligible for incentives if they participate in at least 30 games per day.; Participants will be given training and access to the software to participate in mental exercises but will not be given financial incentives for participation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Senior citizens; mental acuity; memory
Effectiveness of TheraNeem Lip Therapy for Herpes Simplex Labialis
Condition: Herpes Simplex
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study intends to test the efficacy of the TheraNeem Lip Therapy balm for Herpes Simplex.
      The study will include a total of 5 people.
    

Detailed description: 
      Qualified candidates will be officially enrolled into the study within 24 hours of their
      subsequent outbreak of Herpes Simplex Labialis. They will be given all of the Neem Therapy
      products to use, and photographs and questionnaires will be taken to assess their progress.
    

Intervention name(s): Neem Based External Application Cream
Intervention type(s): Other
Intervention description(s): Apply externally 3-4 times per day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal Carcinoma Patients
Condition: Target Volume Delineation; Early-stage Nasopharyngeal Carcinoma; Intensity Modulated Radiation Therapy
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      To analyze the long-term results and toxicities of the reducing clinical target volume (CTV)
      delineation method in early-stage nasopharyngeal carcinoma (NPC) patients treated with
      intensity modulated radiation therapy (IMRT).
    

Detailed description: 
      The investigators designed a prospective phase II study for early-stage NPC patients, and
      proposed a reasonable delineation method of reducing CTV according to the clinical
      characteristics and tumor infiltration patterns, performing therapeutic dose to tumor and
      prophylactic dose to CTV while protecting as much normal tissues as possible, in order to
      ensure a long-term survival with good quality of life.
    

Intervention name(s): Reducing CTV
Intervention type(s): Radiation
Intervention description(s): CTVs were delineated in line with tumor stage, i.e. tumor invasion.
Intervention model: Single Group Assignment
Intervention model description: The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Locoregional Failure Pattern; Toxicity
Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 21 to 64 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of different
      formulations of GSK Biologicals H7N1 influenza vaccine in subjects 21 to 64 years of age. The
      study will evaluate safety related events and antibody immune responses to different
      formulations of study vaccine and placebo.
    


Intervention name(s): Investigational H7N1 vaccine GSK2789869A; Investigational H7N1 vaccine GSK2789868A; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while second dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21; One dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21; One dose of placebo administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of placebo administered intramuscularly at the deltoid region of the dominant arm at Day 21
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immunogenicity; H7N1; Influenza; Safety; AS03 adjuvant; Adults
Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study
Condition: Spinal Cord Injuries; Deglutition Disorders
MeSH terms: Spinal Diseases; Deglutition Disorders; Spinal Cord Injuries
Study type: Observational

Summary: 
      This study is part of a larger grant, for which the overall goal is to collect measurements
      of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing.The focus of
      this study is to evaluate the flow of liquids of varying consistency in the spinal disorder
      population.
    

Detailed description: 
      Thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment).
      However, the field lacks a clear understanding of how liquids of different consistencies
      behave during swallowing. In order to improve understanding of the effectiveness of altered
      liquid consistency for improving dysphagia, the investigators are studying liquid flow
      through the oropharynx. This study explores this question in individuals with spinal cord
      injury. Participants will swallow 20% w/v barium thickened to different consistencies (thin,
      slightly thick, mildly thick, moderately thick and extremely thick). Swallowing will be
      observed under videofluoroscopy. Simultaneous measures of airflow via nasal cannula will be
      used to study respiratory-swallow coordination in this study sample.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We will recruit participants from the inpatient SCI program at the Toronto Rehabilitation
        Institute Lyndhurst Center.
Letigen® and Cardiovascular Morbidity
Condition: Stroke; Myocardial Infarctions; Sudden Death
MeSH terms: Myocardial Infarction; Infarction; Death, Sudden
Study type: Observational

Summary: 
      Letigen® was a combination drug containing ephedrine, an adrenergic agonist with lipolytic
      and appetite-inhibiting properties. The drug was used as adjuvant treatment of obesity from
      1990 and up to 2002 when it was withdrawn from the market by the manufacturer. The basis for
      this was a number of spontaneous reports about patients that died during treatment with
      Letigen®.

      The causal relation has never been addressed. There are only sparse data from randomised
      studies and the above-mentioned reports are not conclusive.

      We propose a controlled study based on data from Statistics Denmark that hold a complete copy
      of the Prescription Register of the Danish Medicines Agency and the Danish Hospital Discharge
      Register. The aim of the study would be to determine whether there is an excess frequency of
      deaths and serious cardiovascular events that can not be explained by particular
      characteristics of users of the drug. A well-known problem in such observational studies is a
      fundamental incomparability between users and non-users of drugs. In the present setting, it
      should be expected that use of Letigen® is associated with high BMI, smoking, alcohol abuse,
      type-2 diabetes, mild hypertension, low physical activity and other indicators of unhealthy
      lifestyle. Thus, an uncritical comparison between users and non-users of Letigen® regarding
      serious cardiovascular events will probably show an excess frequency that can not necessarily
      be attributed to the drug. This problem can be addressed by a special epidemiological
      technique - the case-crossover design - which is particularly robust to such comparability
      problems. In brief, only cases should be included. Controls are the same persons at an
      earlier time, , where the case-defining disease has not yet developed. The exposure of cases
      will be compared with the exposure of the same persons' case history.

      To account for the effect of chronic exposure, we also perform, as a secondary analysis, a
      conventional case-control study nested within the cohort of Letigen users, and employing a
      risk-set sampling technique.
    


Time perspective: Retrospective
Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172-013)
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered
      to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria
      of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy
      participants.
    


Intervention name(s): Grazoprevir
Intervention type(s): Drug
Intervention description(s): Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days
Intervention MeSH terms: Grazoprevir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
Condition: Eosinophilic Chronic Rhinosinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy and safety of SC administrations of
      Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a
      multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and
      immunogenicity will be assessed secondarily.
    

Detailed description: 
      Screening Period (maximum 4 weeks) , Randomized Treatment Period (24 weeks)
    

Intervention name(s): benralizumab; benralizumab; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SC administration; SC administration; SC administration
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment