bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
Condition: Infections, Rotavirus; Rotavirus Vaccines
MeSH terms: Rotavirus Infections; Gastroenteritis
Study type: Observational

Summary: 
      The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing
      rotavirus severe gastroenteritis among hospitalized infants, in Belgium.
    


Intervention name(s): Sample collection
Intervention type(s): Procedure
Intervention description(s): Stool sample
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The confirmed cases are children born after 01 October 2006, at least 14 weeks of age,
        hospitalized for SGE during the designated study period and whose stool samples have been
        tested positive for RV by polymerase chain reaction (PCR). The controls are those children
        hospitalised or visiting the hospital outpatient clinic for non-GE causes at the study
        hospitals during the same time-period as the case and will be included after matching by
        age.
      
Biospecimen description: 
      Stool samples
    
Keywords: Hospitalized; Rotavirus; Children; effectiveness; Gastroenteritis
Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera
Condition: Polycythemia Vera
MeSH terms: Polycythemia Vera; Polycythemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is the identification of the maximum tolerated dose (MTD) of the
      investigational medicinal product. Moreover the safety and tolerability will be assessed and
      an exploratory analysis of efficacy and biomarker modulation will be performed.
    


Intervention name(s): PEG-P-INF alpha-2b (P1101)
Intervention type(s): Drug
Intervention description(s): µg (starting with 50 µg), subcutaneously, 2-weekly administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults
Condition: Focus of Study of Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      This proposal hypothesizes that oral supplementation with sodium nitrite or nitrate will
      result in in vivo conversion of nitrate to nitrite and nitrite to nitric oxide with limited
      toxicity in the doses proposed in healthy adult normal volunteers. We utilize a powerful in
      vivo technique (pharmacokinetic testing) and are the first to design inorganic nitrate and
      nitrite capsules for cardiovascular disease.
    

Detailed description: 
      Preclinical and clinical research over the last decade has revealed the important
      vasoprotective effects of nitrates and nitrites with regards to reduction in blood pressure,
      vascular inflammation and endothelial dysfunction. New findings suggest an effect of nitrate
      and nitrite therapy in the regulation of glucose-insulin homeostasis. Development of an oral
      formulation of nitrate and nitrite salts is attractive, whereby nitrite would ensure rapid
      acting effects upon absorption, while the nitrate would continuously provide a slow formation
      of nitrite over a prolonged period of time via the enterosalivary circulation pathway.

      For this reason, development of an oral formulation of nitrate and nitrite salts is
      attractive, whereby nitrite would ensure rapid acting effects upon absorption, while the
      nitrate would continuously provide a slow formation of nitrite over a prolonged period of
      time via the enterosalivary circulation pathway. This study aims to establish the
      pharmacokinetics, metabolism and interconversion of nitrate to nitrite and nitrite to nitric
      oxide in vivo in healthy adult normal volunteers.
    

Intervention name(s): 15Nitrogen(15N)-labeled sodium nitrite; 15Nitrogen(15N)-labeled sodium nitrate
Intervention type(s): Drug; Drug
Intervention description(s): 15Nitrogen(15N)-labeled sodium nitrite 20 mg once; 15Nitrogen(15N)-labeled sodium nitrate 1,000 mg once
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Treatment of Pilonidal Sinus Disease Using Surgiflo as a Sealant: A New Concept
Condition: Pilonidal Sinus Disorder
MeSH terms: Pilonidal Sinus; Paranasal Sinus Diseases
Study type: Interventional

Summary: 
      Assessment of surgiflo injection for treating pilonidal sinus disease
    

Detailed description: 
      Evaluation of injection of Surgiflo as a sealent in treatment of pilonidal sinus, evaluation
      includes recurrence, infection, complications and patient satisfaction over 2 years of follow
      up
    

Intervention name(s): Surgiflo injection
Intervention type(s): Procedure
Intervention description(s): Curettage of sinus cavity then injection of surgiflo material
Intervention MeSH terms: Surgiflo
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing Balance Changes Following an Exercise Program Among Middle-Aged Adults
Condition: Balance Changes
Study type: Interventional

Summary: 
      This graduate student research study has two purposes; the first purpose is to examine the
      criterion validity of the Y Balance Test (YBT) with the Limits of Stability Test (LOS) in
      healthy middle-aged adults. The second purpose is to examine balance changes using the YBT
      following a home-based exercise program.
    

Detailed description: 
      4. "Subjects will be healthy female or male middle-aged adults who are able to walk and move
      independently.

      5. "Subjects will be between 45 and 64 years of age." 6. "In total, subject participation
      will last approximately eight weeks. Visit 1 (baseline): 90 minutes, visit 2 (week 4): 30
      minutes, and visit 3 (week 8): 60 minutes.

      7. "Subjects will be recruited by distributing flyers in the Loma Linda Community, sending
      emails to school staff, students, and faculty, and word of mouth.

      8. "Consent will take place at Loma Linda University, Nichol Hall rooms A620 -A640 by
      investigators." 9. If Multi-center: N/A 10. If Single center or investigator-initiated: "70
      subjects will participate in the study."
    

Intervention name(s): home exercise program; non exercise program
Intervention type(s): Other; Other
Intervention description(s): Subjects in the exercise group will be instructed to follow the intervention protocol for eight weeks. The intervention consists of five exercises: standing on one foot, walking heel to toe, heel walking, side kicks, and wall squats. Each exercise will be repeated three times per week for eight weeks.; continue usual lifestyle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep
Condition: Nonorganic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      A randomized, controlled trial to explore whether warm footbaths with added ginger powder can
      improve the sleep quality of adults with self-perceived insomnia symptoms. Participants
      receive daily footbaths either with warm water alone or with added ginger powder over a
      period of 2 weeks.
    

Detailed description: 
      This is a randomized controlled trial with parallel group design to explore the effects of
      warm water footbaths with added ginger powder (experimental) compared to footbaths with warm
      water alone (active comparator) on sleep quality in adults with self-perceived insomnia
      symptoms. Participants receive daily footbaths 1-3 hours before bedtime over a period of two
      weeks. The footbaths are prepared by the participants themselves and carried out at their
      homes. Outcome measures are assessed at baseline (pre intervention) and two weeks after
      baseline (post intervention). The main focus is on change in subjective quality of sleep as
      assessed by the Pittsburgh Sleep Quality Index (PSQI). The statistical analysis comprises
      analyses of variance based on linear mixed effects models.
    

Intervention name(s): Ginger powder footbath; Warm water only footbath
Intervention type(s): Other; Other
Intervention description(s): 40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level; 40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Renal Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
Condition: Clinical Pharmacology
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      BAY 63-2521 is intended to be used for a disease that affects the blood flow through the
      lungs. Renal impairment is a common condition in patients with this disease. The goal of the
      study is to learn more about the safety of BAY 63-2521, how it is tolerated and the way the
      body absorbs, distributes and gets rid of the study dug given as a single oral dose of 1 mg
      tablet in participants with renal impairment and healthy participants matched for age-,
      gender-, and weight
    


Intervention name(s): Riociguat (Adempas, BAY 63-2521)
Intervention type(s): Drug
Intervention description(s): 0.5 mg riociguat as an immediate-release (IR) tablet
Intervention MeSH terms: Riociguat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evidence of Spreading Vasodilation in Human Gingiva
Condition: Nitric Oxide; Vasodilation; Oral Soft Tissue Conditions
Study type: Interventional

Summary: 
      The aim of this study is to observe the mechanism of spreading vasodilatation on human
      healthy gingiva. Nitric-oxide donor solutions in lower and higher concentration are used to
      trigger the vasoactivity.
    

Detailed description: 
      Spatial regulation of gingival microcirculation has not been revealed yet. Although this
      could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical,
      thermal etc. irritation during whole life. It is especially important during flap surgery.
      Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal
      resolution, therefore it allows us to study remote effect of local vasodilation such as
      spreading vasodilation in human gingiva.

      The vasodilatator nitric-oxide (NO) donor will be used to trigger remote effect on gingiva.
      NO donor solutions will be applied in 1 mg/ml and 8 mg/ml nitroglycerin concentrations.
      Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well
      attached to 2mm above the marginal gingiva. The change on blood flow will be monitor at the
      test well with surrounding gingival area spanning 3 tooth and at the contralateral side by
      LSCI.
    

Intervention name(s): nitroglycerin
Intervention type(s): Drug
Intervention description(s): Vasodilatator solution is dropped on the gingiva.
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: spreading vasodilation; gingival microcirculation
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, non-randomized study will assess the absorption, metabolism, and excretion
      of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a
      single dose of [14C]-GDC-0973.
    


Intervention name(s): GDC-0973
Intervention type(s): Drug
Intervention description(s): Single oral dose of [14C]-GDC-0973
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Amniotic Membrane in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal Tunnel Syndrome (CTS) is the most frequent mononeuropathy. CTS is more frequent in
      females than in males, it has been associated to work activities, hormone exposure and
      obesity. Although its primary treatment is conservative, there is strong evidence that
      patients who retard surgery are more prone to develop worse outcomes. Surgery to treat CTS
      consists in liberating carpal tunnel in order to ameliorate median nerve symptoms; however,
      more than 20% of patients who undergo surgery have recurrent CTS (RCTS). RCTS is due to a
      fibrotic process in the site of the surgery. Amniotic membrane (AM) is the inner layer of the
      placenta which has been used to treat different pathologies. AM transplantation (AMT) has
      demonstrated to significantly inhibit inflammation and fibrosis. Therefore, the aim of the
      present study was to determine the effect of AMT in CTS surgery. The present is a randomized,
      open labeled, controlled clinical study. The investigators included patients with recent
      diagnosis of CTS and divided into two groups. The experimental group received AMT
      concomitantly with conventional surgery; whilst, the control group received only the
      conventional surgery. Clinical status of patients measured with the BCTQ questionaire was the
      main outcome. Both groups showed similar BCTQ punctuation at the beginning of the study.
      However, the results of the experimental group were significantly better than those from the
      control group through time, until the finish of the study. None of the patients presented
      complications or adverse effects related to the AMT. These results indicate that AMT is a
      secure and suitable treatment for CTS presenting better clinical outcomes at one-year
      follow-up.
    


Intervention name(s): Amniotic membrane transplantation
Intervention type(s): Other
Intervention description(s): Amniotic membrane was located over median nerve during surgery of CTS, prior of closing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amniotic membrane transplantation
Safety and Efficacy Study of Single Doses of TT-034 in Patients With Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is a first in man, dose escalation study that will measure the safety and efficacy
      of TT-034 in the treatment of patients with chronic hepatitis C. The study is divided into 5
      dose levels. Subjects will be given a single dose delivered by IV infusion. The subjects will
      be monitored and the data analyzed. After a set time, between 6 and 10 weeks depending on the
      dose level, the next set of subjects will be dosed. The study drug is a gene therapy
      treatment that produces molecules that destroy the Hepatitis C virus (HCV) in infected cells.
      Once the study drug is given, it cannot be withdrawn. Additionally, once an individual
      receives a dose, he or she will not be able to receive a second dose, but will remain
      eligible to receive most other HCV treatments.
    

Detailed description: 
      This is a first-time use of a method of therapy designed to transfer anti-HCV genetic
      sequences into the hepatocytes of subjects infected with HCV. The anti-HCV sequences will be
      comprised of three different short hairpin RNAs (shRNA) that have the ability to directly
      cleave the RNA genome of HCV by a process known as RNA interference. The transfer of the
      anti-HCV sequences will be accomplished using a "vector" that was made from an
      adenovirus-associated virus (AAV) by removing the viral genes and replacing them with a
      non-replicating genetic sequence that produces three different shRNA that target three
      different regions within the HCV genes. This type of vector has been used in other clinical
      trials in order to transduce the hepatocytes of subjects who suffer from hemophilia.
    

Intervention name(s): TT-034
Intervention type(s): Drug
Intervention description(s): The study drug will be given as a single dose IV infusion on Day 1. 5 different dose levels corresponding to the 5 cohorts of the study will be given.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genotype 1; Chronic Hepatitis C; CHC; HCV; Hepatitis; RNAi; shRNA; ddRNAi; AAV8; AAV; Adeno-associated virus; Adeno-associated viral vectors
Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab
      ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of
      gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.
    


Intervention name(s): Gemtuzumab Ozogamicin
Intervention type(s): Drug
Intervention MeSH terms: Gemtuzumab
Primary purpose: Treatment
Keywords: Acute; Myeloid; Leukemia
Catechin Containing Mask for the Prevention of Influenza Infection
Condition: Influenza Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of catechin extracts containing mask on
      prevention of influenza infection.
    

Detailed description: 
      Catechins are the major components of tea flavonoids and are reported to possess
      physiological activities such as antiviral effects. Recent in-vitro experimental studies have
      revealed that tea catechin extracts possess the effects on the prevention of influenza
      infection. However, a limited number of studies have been conducted on the clinical effects.
      Based on these backgrounds, we designed a prospective randomized controlled study to evaluate
      the effects of tea catechin extracts containing mask on the prevention of influenza
      infection.
    

Intervention name(s): tea catechin extracts
Intervention type(s): Dietary Supplement
Intervention description(s): catechins are composed of tea catechin extracts available in grren tea supplements
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prophylaxis; influenza infection; catechins; prophylaxis of influenza infection
Differences in Rate of Recovery Between Young and Middle-aged Men After Downhill Running
Condition: Exercise
Study type: Interventional

Summary: 
      The aim of this study is to evaluate differences in rate of recovery between young and
      middle-aged men after prolonged (downhill) running. Thirty healthy young (n=15, 18-30 y) and
      middle-aged (n=15, 35-50y) men will be recruited for this study. Participants will perform 60
      minutes of downhill run at 65% of their maximal oxygen consumption (VO2max). Recovery
      parameters will be evaluated during 48 hours following the downhill protocol, and will
      include changes in performance tests, inflammatory markers, muscle integrity and heart-rate
      variability. Questioners will be used to evaluate muscle soreness and fatigue. We
      hypothesized that middle-aged males will have longer rate of recovery following the downhill
      running protocol, as compared to younger age males.
    


Intervention name(s): Downhill running
Intervention type(s): Other
Intervention description(s): 60 minutes downhill running in 10% grade, in an effort of 65% of VO2max.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Young (18-30 y) and middle aged (35-50 y) men will perform 60 min of downhill running
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety and Effectiveness of the AcuFocus Corneal Inlay ACI7000PDT in Presbyopes
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will
      provide an effective method of for the correction of presbyopia in patients who have normal
      distance vision but need correction such as glasses or contact lenses to see clearly at near.
    

Detailed description: 
      The design and mechanism of action of the AcuFocus™ Corneal Inlay (ACI 7000PDT) is based on
      the well-established concept of small-aperture optics. In cameras, depth of focus is
      controlled by reducing the aperture through which light enters; the smaller the aperture, the
      greater the depth of focus. This concept also applies to the human eye. In the eye of an
      emmetropic presbyope, the natural lens cannot fully accommodate to focus the light rays from
      a near object onto a single point on the retina. Thus, a point object is imaged as a blur
      circle on the retina, and images of extended objects are degraded as well. If an opaque disc
      with a small aperture in the center is placed in front of the eye, the peripheral rays will
      be obscured while the central rays pass unaffected. Since peripheral rays enter the eye at a
      larger angle, they create a larger blur circle at the retinal image plane. Eliminating these
      peripheral rays reduces the size of the blur circle, improving image resolution.

      When the inlay is implanted in one eye, the increased depth of focus provides near and
      intermediate visual acuity while having a minimal effect on distance acuity. Under binocular
      conditions, the effect of having an inlay eye with a range of vision from distance to near
      combined with the uncorrected vision in the fellow presbyopic eye, which will essentially
      have good distance acuity with reduced near acuity, is similar to the contact lens modality
      known as "modified monovision."

      The ACI is expected to provide presbyopic patients with improvement in near and intermediate
      vision.
    

Intervention name(s): AcuFocus Corneal Inlay ACI 7000PDT
Intervention type(s): Device
Intervention description(s): corneal inlay
Other intervention name(s): AcuFocus KAMRA inlay
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Presbyopia; Accommodation; Near visual acuity; LASIK