bioihbjkbjnl/mcl2 huggingface dataset:
Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study will be a multicenter, prospective phase II-study investigating safety and
      efficacy of the combination of auto-allo tandem stem cell transplantation in patients with
      multiple myeloma and age of >_60 years, followed by maintenance therapy with low-dose
      Thalidomide and Donor Lymphocyte Infusions.
    


Intervention name(s): Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI; auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
Intervention type(s): Procedure; Procedure
Intervention description(s): *Multiple myeloma
-> Induction Therapy (max. 8 cycles)
-> Registration of patient, stem cell mobilization, start of donor search
-> Melphalan (200mg/qm) plus autologous PBSCT
-> 2 months later: Melphalan plus allogeneic PBSCT
-> day 120 after allogeneic PBSCT: Thalidomide, 100mg (max. 2 years or until progress or non-tolerable toxicity, respectively)
-> day 180 after allogeneic PBSCT (if CsA discontinued): First DLI (1 x 10^6 (MRD) or 5 x 10^5 (MUD) CD3+ cells per kg BW)
-> day 250 after allogeneic PBSCT: second DLI (if no signs of GvHD: dose escalation by 0,5 Log)
-> Day 320 after allogeneic PBSCT: Third DLI (if no signs of GvHD: dose escalation by 0,5 Log)
-> Further DLI depending on MRD-measurement; *Multiple myeloma
-> Induction Therapy (max. 8 cycles)
-> Registration of patient, stem cell mobilization, start of donor search
-> Melphalan (200mg/qm) plus autologous PBSCT
-> if no donor available (max 4 weeks after autologous PBSCT) or if patients declines allogeneic PBSCT): 2 months: Melphalan (200mg/qm) plus autologous PBSCT
-> day 120 after autologous PBSCT: Thalidomide, 100mg (max. 2 years or until progress or non-tolerable toxicity, respectively)
Intervention MeSH terms: Ferrous fumarate; Thalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Stem Cell Transplantation; Thalidomide; DLI
Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      An interventional phase 3 study to evaluate efficacy and safety of a new dilution and
      injection volume of AbobotulinumtoxinA treatment for glabellar lines
    


Intervention name(s): AbobotulinumtoxinA; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA; Treatment of glabellar facial lines with placebo
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Maqui Berry Extract and Omega-3 Fatty Acids for Cytokine Reduction
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this trial is to determine the effect of maqui extract plus omega-3 fatty
      acids compared to a placebo for reducing inflammatory cytokine levels in older, obese adults.
    

Detailed description: 
      Anthocyanins, a subclass of flavonoids, are plant pigments that provide the rich color of
      many plants, fruits, and flowers. Health benefits of anthocyanins have been widely reported
      in the research literature, particularly for disease conditions associated with oxidative
      stress, such as cardiovascular and neurodegenerative diseases. Emerging evidence suggests
      that anthocyanins may also modulate gut microbiota, which can impact a wide variety of health
      conditions. Maqui berries (Aristotelia chilensis), indigenous to Chile, have one of the
      highest concentrations of anthocyanins in the plant world; moreover, the dominant anthocyanin
      in maqui berries is delphinidin. Delphinidin is more bioavailable than most flavonoids, with
      intact molecules absorbed in appreciable amounts in less than an hour after consumption.
      Systemic effects of delphinidin include reduced inflammation due to downregulation of NF-kB,
      the transcription factor that initiates the generation of pro-inflammatory cytokines. The
      omega-3 fatty acid eicosapentaenoic acid [EPA], a component of omega-3 fatty acid
      concentrates, also has anti-inflammatory properties. There is much empirical evidence
      demonstrating beneficial effects of EPA supplementation, linked mainly to reductions in
      inflammation. It has been demonstrated the dietary supplementation with EPA-rich marine oil
      concentrations reduces cytokine levels up to 15%.
    

Intervention name(s): Maqui berry/omeg-3 fatty acids; Placebos
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules BID per day containing a total of 600 mg of Maqui extract; 4 capsules per day supplying a total of 2000 mg EPA and 1000 mg DHA; 4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, controlled trial
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: maqui berry extract; omega-3 fatty acids; cytokines; blood lipids
Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation
Condition: Facial Rhytides
MeSH terms: Facies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A prospective, non-randomized study to evaluate the performance of the MyoScience Tissue
      Remodeling Device for the treatment of glabellar lines (frown lines), lateral orbital lines
      (crow's feet), and frontalis lines (horizontal forehead lines).
    


Intervention name(s): MyoScience Tissue Remodeling Device
Intervention type(s): Device
Intervention description(s): Percutaneous treatment with the MyoScience device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Doxycycline on Persistent Symptoms Post-neuroborreliosis
Condition: Fatigue; Radicular Pain; Cognitive Dysfunction; Paresthesia; Paresis
MeSH terms: Paresis; Paresthesia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The aim of this randomised, double-blind crossover study was to determine whether Doxycycline
      has an impact on the persistent symptoms post-neuroborreliosis, through alterations in the
      immune response and whether such an effect could influence the clinical outcome.
    

Detailed description: 
      Persistent symptoms after treatment of neuroborreliosis (NB) are not uncommon. There is
      currently no evidence for improvement of symptoms after repeated or prolonged antibiotic
      treatment. However, clinical observations have indicated that some patients improve during
      treatment with doxycycline (DOX), but regain the symptoms some time after completed
      treatment. This may be due to an immunomodulatory effect of the drug. The aim of this
      randomised, double-blind crossover study was to determine whether DOX has an impact on the
      persistent symptoms through alterations in the immune response and whether such an effect can
      influence the clinical outcome.

      A total of 15 patients from South-East Sweden with previously adequately diagnosed NB with
      diverse persistent symptoms ≥6months after antibiotic treatment were randomised in a
      double-blind, crossover fashion to receive either DOX 200 mg or placebo (PBO) once daily for
      three weeks, followed by a wash-out period of six weeks and a further three-weeks treatment
      with either DOX 200 mg or PBO once daily for three weeks. The primary outcome measures were
      improvement of the persistent symptoms and physical and mental health, evaluated using the
      visual analogue scale (VAS), the 36-item Short-Form General Health Survey (SF-36) and through
      physical examination with special emphasis on neurologic status at the follow-up visits.
      Secondary outcome measures were changes in drug-induced antigen-stimulated and unstimulated
      cytokine responses.
    

Intervention name(s): Doxycycline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.; Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
Other intervention name(s): Doxyferm; Vibramycin; Tetracycline; Sugar pill
Intervention MeSH terms: Doxycycline; Tetracycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Persistent symptoms; Doxycycline; Placebo; Neuroborreliosis
Arousal Training for Social Anxiety Disorder
Condition: Social Anxiety
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The primary objective of the study is to examine the safety, usability and preliminary
      efficacy of a novel arousal-based biofeedback system in alleviating social anxiety. The
      investigators hypothesize that after 4 weeks of hour-long interventions, participants will
      show reductions pre- and post-intervention in their Liebowitz Social Anxiety Scale scores.
    

Detailed description: 
      The investigators plan to conduct a waitlist control trial.

      Intervention consists of a combination of computerized cognitive behavioral therapy and
      arousal-based Virtual Reality Exposure Therapy. During the latter component, the
      physiological variables of participants, such as pulse rate and EEG, will be continuously
      monitored and presented as feedback to them. Participants will have to deliver speeches to
      videotaped audiences while striving to regulate their physiological arousal.
    

Intervention name(s): Arousal-based biofeedback system
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality Exposure Therapy; Computerized Cognitive Behavioral Therapy; Public Speaking; Social Phobia; Biofeedback
The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat in the Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in
      women with PCOS. The purpose of this study therefore is to examine the effects of fish oils
      on blood pressure, heart rate variability and liver fat content in obese women with the
      polycystic ovary syndrome.
    

Detailed description: 
      The prevalence of abnormalities of blood pressure (ABP), variability of heart rate (HRV) and
      liver fat content is increased in women with the polycystic ovary syndrome (PCOS). We
      hypothesise that fish oils will have a beneficial effect on these endpoints and other
      cardiometabolic parameters such as cholesterol and liver function in women with PCOS. This
      crossover study of 40 obese women with PCOS will therefore examine the effects of fish oils
      on the above parameters compared with placebo (olive oil). Subjects with PCOS who have
      participated in previous studies with this research group will be approached for recruitment,
      as will eligible subjects within the endocrine clinics of the chief and co-investigators.
    

Intervention name(s): Ocean Nutrition 2050; Olive oil capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1000mg capsules, 4 capsules/day for 8 weeks; Olive oil capsules, 4 per day for 8 weeks
Other intervention name(s): Code name: 2050
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: polycystic ovary syndrome; cardiovascular risk; metabolism; blood pressure; liver fat; heart rate variability
MRI to Characterize and Predict CF Liver Disease in PUSH Cohort
Condition: Cystic Fibrosis Liver Disease; Pancreatic Insufficiency
MeSH terms: Cystic Fibrosis; Liver Diseases; Exocrine Pancreatic Insufficiency; Fibrosis
Study type: Observational

Summary: 
      Specific Aim 1. Determine if valid results of non-sedated MRI based assessments of liver
      stiffness and lipid content can be obtained in more than 90% of children and young adults
      with cystic fibrosis.

      Specific Aim 2. Determine hepatic lipid content using the HepaFat sequence and liver
      stiffness using MRE. Investigators will compare the results obtained by MRI with PUSH study
      grayscale ultrasounds in CF patients with normal, heterogeneous, homogeneous or nodular
      (cirrhotic) pattern on ultrasound.

      Specific Aim 3. Creation of an imaging core lab to centralize evaluation of MR imaging data,
      allow for remote image upload, electronic data storage, and remote image
      viewing/interpretation. This infrastructure will be utilized to standardize image post
      processing.

      Specific Aim 4. Using the longitudinal PUSH study, determine if MRI based imaging improves
      discrimination of subjects at risk for progression to advanced CF liver disease (development
      of cirrhosis) compared to using US imaging alone
    

Detailed description: 
      This proposal will be a cross sectional study of the current well-characterized PUSH cohort.
      Patients will receive an MRI at the time of their scheduled PUSH ultrasound. Ideally, the MRI
      will be performed the same day or a similar time point near liver ultrasound (+/-90 days, but
      Investigators will allow a larger window due to the slow progression of fibrosis).

      Blinded radiology review of imaging sequences will be performed by a local study radiologist
      with central review performed by the Imaging Core. Analysis by the Imaging Core will include
      calculation of the liver stiffness, liver and spleen volume, and hepatic and lipid content
      for all MRI studies.
    

Intervention name(s): MRI
Intervention type(s): Procedure
Intervention description(s): non-invasive assessment of hepatic fibrosis and steatosis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 3 through 12 years of age at time of enrollment diagnosed with Cystic
        Fibrosis and pancreatic insufficiency and enrolled in the CFLD PUSH longitudinal study.
      
Keywords: Cystic Fibrosis Liver Disease; Pancreatic Insufficiency
Vestibular Cortex and TMS
Condition: Cortical Organisation of Vestibular Integration
Study type: Observational

Summary: 
      In human, the cerebral cortex forms a network of vestibular cortical areas which functional
      role remains unknown. In patients with localised cortical lesions the investigator has
      previously demonstrated that the parieto-temporal cortex could regulate the inertial
      component of the vestibulo-ocular (VOR) responses whereas more ventral regions including the
      temporo-occipital cortex would be associated with gain regulation of these VOR responses.

      The investigator's main purpose is to investigate the modalities of vestibular integration in
      these posterior parieto-temporal et temporo-occipital cortical regions. Thus, by using
      repetitive ttranscranial magnetic stimulation (rTMS) the investigator will induce a
      transitory inhibition of one of these 2 cortical regions and register its effect on VOR
      responses. Based on theta burst stimulation (TBS) paradigm, the investigator will stimulate
      the region of interest by applying on the scalp repetitive burst (at 50 HZ) during 44sec.
      Then, during the consecutive cortical inhibition lasting for the 15 minutes poststimulation,
      the investigator will record the subject's VOR responses. The VOR gain will be calculated and
      the time constant and phase will provide an estimation of the inertial component of the VOR
      responses. The healthy subjects recruited on the basis of inclusion criteria during medical
      examination will be divided into two groups of 20 subjects each depending of their sites of
      stimulation, temporo-parietal or temporo-occipital. Each subject will perform three
      experimental sessions (of 1h in average each) separated by at least one week and
      corresponding to : (1) the right cortical stimulation, (2) the left stimulation and (3) the
      vertex stimulation serving as the control session.

      The TMS paradigm is used in routine in hospital and research field and had very few negative
      consequences (mainly transitory and occasional headache).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Subjects
Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed.
      EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does
      not contain corticosteroids or other anti-inflammatory drugs. The objective of the present
      study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to
      severe atopic dermatitis as compared to mid-strength topical steroid cream following twice
      daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients
      lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as
      shown in previous studies and eliminate or reduce the requirement for supplemental topical
      steroid administration.
    


Intervention name(s): Epiceram(r); Fluticasone Propionate 0.05%
Intervention type(s): Device; Drug
Intervention description(s): Topical barrier repair emulsion cream; Topical mid-strength steroid
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Atopic; Dermatitis; eczema; skin barrier; ceramide; topical; inflamation; steroid; SCORAD; glucocorticoids; EpiCeram; Cutivate; fluticasone
Efficacy of 24-hour Intraocular Pressure Fluctuation Recording With the SENSIMED Triggerfish Contact Lens Sensor
Condition: Primary Open Angle Glaucoma; Healthy Subjects
MeSH terms: Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      The objectives of this study are to assess the safety and effectiveness of the SENSIMED
      Triggerfish® (TF) device in continuous recording of relative fluctuation in intraocular
      pressure (IOP). Safety will be assessed by recording of AEs during the 24 hours of continuous
      TF recording.

      TF efficacy will be evaluated by demonstrating TF ability to detect:

        1. The known phenomenon of increase in IOP when moving from waking state to going to bed,
           as reflected in pneumotonometer measurements

        2. Ocular Pulse frequency relative to direct measurement of Heart Rate (HR).

      A screening visit and one 24-hour IOP fluctuation recording session are planned for each
      patient. IOP fluctuation recording sessions will be carried out in a sleep unit. An
      ophthalmological examination of the eyes will be done at screening and prior to and following
      the device recording.
    


Intervention name(s): SENSIMED Triggerfish
Intervention type(s): Device
Intervention description(s): Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)
Condition: Dietary Modification
Study type: Interventional

Summary: 
      This survey is a multicenter, double-blind, randomized, controlled, parallel-designed,
      prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance,
      gut health, fecal flora and immune function.
    


Intervention name(s): GOS; B-GOS 3%; B-GOS 2%; Mother's breast milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3); Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2); Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3); exclusively breastfed infants for at least 7 days prior to enrollment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Osteopathic Manipulative Treatment in Oncology Patients' Management
Condition: Geriatric Oncology; Osteopathy in Other Diseases Classified Elsewhere
MeSH terms: Neoplasms; Disease
Study type: Interventional

Summary: 
      The aim of present study was to study the osteopathic manipulative effects on pain relief and
      quality of life improvement on hospitalized oncology geriatric patients. A non-randomized
      comparison trial was performed in Unit of Oncology Rehabilitation, Palazzolo Institute, Don
      Carlo Gnocchi Foundation ONLUS, Milan, Italy, from September 2015 to March 2016. 23 older
      oncology patients were unrolled and allocated in two experimental groups: study group (OMT
      group, N=12) underwent to osteopathic manipulative treatment associated to physiotherapy and
      control group (PT group, N = 11) underwent only physiotherapy. At enrollment (T0), 23
      recruited oncology patients completed the socio-demographic forms and were evaluated, from
      external examiner, pain intensity and quality of life. All patients were revaluated at the
      end of treatment (T4) for quality of life and every week (T1, T2, T3 and T4) for pain
      intensity. Standard level of significance was p<0.05.
    


Intervention name(s): Osteopathic manipulative treatment; Physiotherapy
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: geriatric oncology; pain; osteopathic manipulative treatment; quality of life