bioihbjkbjnl/mcl2 huggingface dataset:
Haemochromatosis and Periodontitis
Condition: to Evaluate the Prevalence of Periodontal Diseases in Patients With Hemochromatosis at the Time of Diagnosis and / or Their Usual Therapeutic
MeSH terms: Periodontitis; Periodontal Diseases; Hemochromatosis; Hemosiderosis
Study type: Interventional

Summary: 
      Periodontitis is a chronic inflammatory disease that affects tissues surrounding the teeth.
      It is strongly associated with the major pathogenic "red complex", including Porphyromonas
      gingivalis, Tannerella forsythia and Treponema denticola1 and thus is considered an
      infection. Recent advances in the pathogenesis of periodontal disease have suggested that
      polymicrobial synergy and microbiota dysbiosis together with a dysregulated immune response
      can induce inflammation-mediated damage in periodontal tissues2-4. Interestingly, currently
      periodontitis is associated with a growing number of systemic diseases, including
      cardiovascular diseases, adverse pregnancy outcomes, diabetes5-7 and hereditary
      haemochromatosis8.
    


Intervention name(s): dental probes
Intervention type(s): Diagnostic Test
Intervention description(s): Measurement of the depth of the periodontal pockets and clinical loss
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Gluten Digestion With ALV003
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      This is a Phase 0, Double-blind study that will assess the effect of in vitro treatment of
      gluten with ALV003 or with placebo when ingested by CD Subjects.
    

Detailed description: 
      The primary objective of this study is to compare the effects of gluten treated with ALV003
      vs placebo:

        -  The clinical response by symptom measurement before and after oral challenge

        -  The immune response measured by ELISPOT testing and serology The secondary objective of
           the study is to

        -  Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with
           placebo
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The target population for this study is patients with celiac disease with HLA DQ2 phenotype
        who have well controlled celiac disease without significant co-morbidities and are
        previously on a gluten free diet for at least 8 weeks prior to study entry.
      
Biospecimen description: 
      The enzyme linked immunospot (ELISPOT) assay is used in vaccine development, cancer research,
      infectious disease diagnosis and monitoring, autoimmune disease studies and allergy and
      transplantation research. The ELISPOT enables determination of the frequency of cytokine
      secreting cells. The ELISPOT is a combination of both immunoassay and bioassay because live
      cells are cultured in plates. This enables a very high sensitivity to detect cytokine
      secretion at a single cell level as secreted cytokine does not diffuse into media but is
      immediately membrane bound.
    
Keywords: Celiac Disease
The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection
Condition: Dermal Fillers; Lidocaine; Hyaluronic Acid
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm Lidocaine
      to the correction of nasolabial folds wrinkle and reduction of pain immediately after
      treatment. The main questions it aims to answer are:

        1. The pain score assessed using Visual Analog Pain Scale(VAS) and Thermometer Pain
           Scale(TPS).

        2. The facial wrinkle assessed using Wrinkle Severity Rating Scales(WSRS).

        3. The treatment improvement assessed using Global Aesthetic Improvement Scale (GAIS).

        4. Safety Indicators of which incidences on the day of the injection or after the
           injection.

      Participants will be self-controlled and randomized for same period,

        -  received both trial product and control product at the same time.

        -  re-visited on Day 14 and Day 30 after injection.

      The researchers will compare whether Formaderm Lidocaine is superior to Formaderm Dermal
      Filler Injection (without lidocaine) in terms of pain relief experienced by subjects during
      injection.
    

Detailed description: 
      This is a two-center, randomized, self-controlled, double-blind trial. Each subject received
      the trial product and control product injections at the same time to assess the safety and
      efficacy of Formaderm Lidocaine, which is a hyaluronic acid dermal filler injection with
      lidocaine.
    

Intervention name(s): Formaderm Lidocaine; Formaderm Dermal Filler Injection
Intervention type(s): Device; Device
Intervention description(s): Dermal filler injection to facial areas; Dermal filler injection to facial areas
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
Condition: Nosocomial Infections; Sepsis; Staphylococcal Infections; Candidemia
MeSH terms: Infections; Communicable Diseases; Sepsis; Toxemia; Cross Infection; Candidemia; Staphylococcal Infections; Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human
      immune globulin intravenous (IGIV), can prevent an infection in the blood caused by
      staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth.

      Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or
      placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study
      Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.
    


Intervention name(s): Veronate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: late onset sepsis; premature infants; staphylococcus; candida; prevention
Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and effectiveness of HEALOS compared
      with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
    


Intervention name(s): HEALOS and Leopard Cage; Leopard Cage and Autograft
Intervention type(s): Device; Device
Intervention description(s): Placement in interbody space; Placement in the interbody space
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: One or Two Level Degenerative Disc Disease
Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500
Condition: Metabolic Disorders
MeSH terms: Metabolic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose
      study to assess the safety, tolerability, pharmacokinetic (PK), immunogenicity, and
      pharmacodynamic (PD) effects of REGN1500 in patients with a metabolic disorder.
    


Intervention name(s): REGN1500; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability
Condition: Preoperative Vegetative Stress
Study type: Observational

Summary: 
      The purpose of the study is to investigate whether there is a correlation between the
      vegetative stress evaluated by the State-Trait-Anxiety-Inventory (STAI-Test) and the
      measurement of heart rate variability (HRV). A subgroup analysis will also be performed to
      determine whether premedication contributes to a lower STAI score and/or heart rate
      variability. The primary outcome will be the parameter of frequency-based analysis Low
      Frequency (LF) and High Frequency (HF), and the STAI score. Secondary outcomes are the
      parameters Low Frequency/High Frequency-ratio (LF/HF-ratio), Standard deviation of
      normal-to-normal (NN) intervals (SDNN), Root Mean Square of successive differences" (RMSSD)
      and mean heart rate, age, gender, if they are smokers and if they work in shifts.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects are recruited after the anesthesia interview with the anesthesiologist.

        anesthesiologist. Subjects with elective surgery associated with a low risk of bleeding
        will be included. This includes procedures such as knee arthroplasties, cruciate
        ligamentoplasties, or metal removals.
Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design
Condition: Hip Arthrosis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The investigators want to examine if specific acetabular liner designs can be a contributing
      factor to audible squeaking associated with CoC bearings. The aim of the present study is to
      compare two different designed and well documented acetabular component systems with
      reference to squeaking and other noises from the hip.
    


Intervention name(s): THA with ABG II / Trident; THA with CLS / Trilogy
Intervention type(s): Device; Device
Intervention description(s): Surgery with total hip arthroplasty in the form of ABG II / Trident; Surgery with total hip arthroplasty in the form of CLS / Trilogy
Intervention MeSH terms: Tacrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy of 2 Probiotics During Nicotine Replacement Therapy on Withdrawal Symptoms Associated With Smoking Cessation
Condition: Smoking Cessation
MeSH terms: Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Quitting smoking is a big decision, a decision to achieve better health. Trying to quit
      smoking can be stressful. The prospect of dealing with withdrawal symptoms, fear or failure
      to change the routine, can also be sources of stress.

      Withdrawal from nicotine is characterized by symptoms that include anxiety, irritability,
      hunger and cravings for more tobacco. Nicotine creates a dependency so that the body develops
      a need for a certain level of nicotine at all times. Unless that level is maintained symptoms
      of withdrawal appear.

      For tobacco users trying to quit, symptoms of withdrawal from nicotine are unpleasant and
      stressful, but they are temporary.

      Research has demonstrated the relative effectiveness of pharmacotherapy treatments in smoking
      cessation but no studies have examined the effects of the probiotics on the withdrawal
      symptoms associated with the tobacco cessation during nicotine replacement therapy (NRT).

      The purpose of this study is to assess the effectiveness of two probiotic products during NRT
      for managing withdrawal symptoms associated with smoking cessation.
    


Intervention name(s): Probiotic L008-1; Probiotic L008-2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Dosing regimen of 2 capsules daily, once per day, for 14 weeks; Dosing regimen of 2 capsules daily, once per day, for 14 weeks; Dosing regimen of 2 capsules daily, once per day, for 14 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Determine the characteristics of symptoms and functional impairment associated with
      chemotherapy induced peripheral neuropathy.
    

Detailed description: 
      Taxanes, a type of chemotherapeutic agent prescribed to breast cancer patients, have a known
      physical side effect of chemotherapy induced peripheral neuropathy (CIPN). The purpose of
      this qualitative study is to understand the experience and physical functional side effects
      of taxanes. This is the first of a two phase study. The overall goal is to identify existing
      objective physical performance measures to assess functional side effects of taxanes.
    

Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        The semi-structured interviews will be conducted with breast cancer patients of the Rena
        Rowan Breast Center of the Abramson Cancer Center of the University of Pennsylvania. A
        purposive sampling strategy in which study participants are recruited based on a particular
        characteristic of experience of interest, will be used to select breast cancer patients
        (N=30). Participants will be recruitedwith the goal of having a balanced sample of women
        who experience documented CIPN (per Common Toxicity Criteria for Adverse Events CTCAE -
        grading criteria, details below) and those who received a taxane but did not have
        documented CIPN.
      
Keywords: Breast Cancer patients
Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?
Condition: Postoperative Oxygen Therapy
Study type: Interventional

Summary: 
      The purpose of this study by automated control of oxygen supply in the immediate
      postoperative period is to show the possibility of immediate weaning in the postoperative
      period in case of remifentanil use and complete reversion of curarization.
    

Detailed description: 
      The main hypothesis of this study is that classical oxygen therapy at 3l/min is futile in the
      postoperative period of a so-called modern anaesthesia and that a total weaning within one
      hour after arrival in the ICU is possible whatever the postoperative position of the patient.
      The aim is therefore to include patients who have to undergo a scheduled surgery under
      anaesthetic sedation (analgesia with remifentanil) or general anaesthesia (combining
      remifentanil, propofol rocuronium) for ambulatory surgery. The trial is interventional,
      randomized, monocentric to demonstrate the absence of interest of prolonged postoperative
      oxygen therapy under specific intraoperative conditions.
    

Intervention name(s): automated oxygenation with a sitting patient position in the ICU; Automated oxygenation with the patient lying down in the ICU; Oxygenation is controlled with the patient in a sitting position in the ICU.
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Oxygenation will be done with the Free O2 device via oxygen goggles or a face mask and with an O2 prescription to obtain a SpO2> 94%. The patient's position in the ICU will be a sitting position with the chest raised at an angle greater than 45°.; Oxygenation will be done with the Free O2 device via oxygen goggles or a face mask and with an O2 prescription to obtain a SpO2> 94%. The patient's position in the ICU will be a recumbent position with the head elevated to a maximum of 10; ICU. Oxygenation will be done via the same interface in manual mode where the post-interventional monitoring room nurse modifies the flow to maintain oxygen saturation above 94%. The patient's position in the ICU will be a sitting position with the chest raised at an angle greater than 45°.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: interventional study with 4 paralel arms ; randomization is realised according to a centralized and balanced 2x2 factorial design
Masking: None (Open Label)
Primary purpose: Other
Short-term Caregiver Psychotherapy
Condition: Caregiver Burden of People With Dementia
MeSH terms: Dementia; Caregiver Burden
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to test the feasibility (pilot part) and efficacy (phase IIa part) of a
      specifically on the needs of caregivers of people with dementia composed new short-term
      psychotherapeutical intervention.
    

Detailed description: 
      This prospective study will be offered to caregivers from the out patient clinic of the
      Department of Psychosomatic Medicine of the University Rostock Medical Center. In a first
      pilot study with 10 participants without control group, we tested the feasability and
      acceptance of the program (completed 2/2015). From 4/2015 a phase IIa study started with 10
      participants in the intervention group and 10 in the control groups (will be organized by
      waiting list). The program consists of two modules of caregiver education followed by ten
      psychotherapeutic group modules. Duration of each module is planned to be 90 minutes
      including a relaxation exercise at the end of each module. Primary outcomes are the
      feasibility, acceptance and the effect on caregiver burden.
    

Intervention name(s): Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): The program is designed for 10 participants and consists of two modules of caregiver education followed by ten psychotherapeutic group modules. The major overarching topics will be (i) caregiver´s emotional and physical limits, (ii) conscious and unconscious feelings and emotions towards the people with dementia and (iii) activation of caregivers´ social resources. Duration of each module is planned to be 90 minutes including a relaxation exercise at the end of each module.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: caregiver burden; stress; depression; dementia
HIV-1 Resistance at Screening for HIV Prevention Studies
Condition: HIV
Study type: Observational

Summary: 
      MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the
      prevalence of ARV resistance in the population of women who present to study sites to be
      pre-screened or screened for participation in an HIV prevention trial. To date, a
      comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive
      age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV
      drug resistance mutations among women who test HIV-positive when presenting to screen for
      participation in HIV prevention trials.
    

Detailed description: 
      MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the
      prevalence of ARV resistance in the population of women who present to study sites to be
      pre-screened or screened for participation in an HIV prevention trial. To date, a
      comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive
      age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV
      drug resistance mutations among women who test HIV-positive when presenting to screen for
      participation in HIV prevention trials. Secondary aims include the identification and
      evaluation of behavioral indicators including self or sexual partner(s) exposures to
      antiretroviral (ARV) drugs as risk factors for drug resistant HIV infection, as well as the
      characterization of the degree of immunodeficiency and risk of disease progression by
      quantifying plasma HIV-1 RNA and CD4-positive T cells among women who test HIV-positive when
      presenting to screen for participation in an HIV prevention trial. Exploratory aims include
      the identification of polymorphic or subtype-specific sequence changes in HIV-1 that may
      impact susceptibility to ARVs, and the estimation of the proportion of HIV-positive women who
      have chronic versus recent HIV infection.

      The finding of significant resistance, or lack thereof, to ARV-based study products delivered
      vaginally or taken orally may guide decisions related to future microbicide and PrEP studies.
      In addition, MTN-009 will provide valuable comparison data for the resistance data obtained
      in MTN-015, the MTN seroconverter study.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women of reproductive age who are interested in participating in HIV prevention trials
      
Biospecimen description: 
      Blood Plasma
    
Keywords: HIV; Drug resistance; mutations; ARV's
Administrative Claims Analysis of Metanx® in Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy (DPN)
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Observational

Summary: 
      This study will be an observational cohort study utilizing administrative claims data with
      100 patients randomly selected taking Metanx® meeting the inclusion and exclusion criteria
      and 400 propensity score matched patients meeting the same criteria to serve as a control
      cohort for analyses. This data includes medical, and pharmacy claims from the HealthCore
      Integrated Research Database for claims submitted during the time period of 01/01/2002
      through 06/30/2007.
    

Detailed description: 
      The control patients will be matched at a ratio of 4:1 with the Metanx® patients. Covariates
      used to select the propensity matched patients will include: age; gender; health plan type
      and region; DCI score; presence/absence of nephropathy; ischemic heart disease;
      cerebrovascular disease; neoplasm; insulin use; and all-cause health plan costs in the 6-mont
      pre-index period.

      Claims information about patients selected for the study will be followed longitudinally to
      the end of data availability. This data stream will be used to determine treatment patterns
      for Metanx®, healthcare resource utilization, and cost.
    

Intervention name(s): Metanx® (a medical food); Not treated with Metanx®
Intervention type(s): Other; Other
Intervention description(s): Patient cohort compliant on Metanx® BID therapy for >120 days; Non-treated comparative cohort
Intervention MeSH terms: Vitamin B 12
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with Diabetes and Peripheral Neuropathy or Peripheral Circulatory Disorder with
        Lower Limb Ulceration Who Have Been Treated with Metanx® or Not Treated with Metanx®.

        Patients selected for the study will be identified from a review of available medical and
        pharmacy data during the period from 01/01/2003 to 06/30/2006. The date of the first
        pharmacy claim of interest within the intake period will be defined as the index date.
      
Keywords: Metanx®; diabetes; neuropathy; peripheral neurological disorder; peripheral circulation disorder; folic acid; folate; L-methylfolate; vitamin B6; Pyridoxal 5'-phosphate; vitamin B12; methylcobalamin