bioihbjkbjnl/mcl2 huggingface dataset:
ToleroMune Grass Exposure Unit Study
Condition: Grass Allergy; Rhinoconjunctivitis
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Grass pollen allergens are recognised as a major cause of allergic diseases in humans and
      animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen
      allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass
      pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising
      vaccine, currently being developed for the treatment of grass allergy.

      This study will look at the efficacy, safety and tolerability of three doses of ToleroMune
      Grass in grass allergic subjects following challenge with with grass in an Environmental
      Exposure Unit (EEU).
    

Detailed description: 
      This study is designed as a randomised, double-blind, placebo-controlled, parallel group
      study to evaluate the safety and tolerability of ToleroMune Grass in grass allergic subjects
      with allergic rhinoconjunctivitis. The efficacy of ToleroMune Grass will be explored in
      subjects using an EEU (Environmental Exposure Unit).

      The study will consist of 3 study periods. In Period 1, Screening will be performed up to a
      maximum of 16 weeks before randomisation and may consist of one or two visits to the clinic,
      at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEU at
      least 3 days before randomisation.

      In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be
      randomised to one of four groups and will receive treatment every 2 weeks (±2 days) for 14
      weeks.

      In Period 3, Post Treatment Challenge will consist of 4 visits to the EEU about 25 weeks
      after the first administration in the treatment period and assessments will be performed
      identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after
      PTC.
    

Intervention name(s): ToleroMune Grass; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal injection 1 x 8 administrations 2 weeks apart; Intradermal injection 1 x 8 administrations 2 weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Grass allergy; Rhinoconjunctivitis; Environmental Exposure Unit; Immunotherapy; ToleroMune Grass
Occupational Performance Problems in Individuals With Rheumatoid Arthritis
Condition: RheumatoId Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      Aim: To identify the main occupational performance problems reported by individuals with
      rheumatoid arthritis and the relationship between these activities with work status of
      participants . Methods: the investigators conducted a cross-sectional study with 81 patients
      with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data was
      described in frequencies and percentages, and the Pearson's chi-square test was used to
      determine the asymptotic association between the occupational performance problems with work.
    

Detailed description: 
      For this cross-sectional study, 81 patients were recruited by convenience at the Clinical
      Hospital (HC) of the Universidade Federal de Minas Gerais (UFMG), in Brazil.

      COPM was applied to identify the main occupational performance problems reported by
      participants. The COPM is an individual measure of self-awareness about the problems faced
      when carrying out the activities. It identifies problems in the areas of self-care,
      productivity, and leisure, and measure the individual's performance and satisfaction
      regarding these activities
    

Intervention name(s): Observational study
Intervention type(s): Other
Intervention description(s): Canadian Occupational Performance Measure (COPM) was applied to identify the main occupational performance problems
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        For this cross-sectional study, 81 patients treated between 2009 and August 2010 in
        clinical Hospital, at the Universidade Federal de Minas Gerais (UFMG) in Brazil werw
        recruited by convenience sampling
      
Keywords: Rheumatoid arthritis; human activity; Canadian Occupational Performance Measure
A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label study will investigate the pharmacokinetics and elimination of
      a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers
      will receive a single oral dose of RO4602522.
    


Intervention name(s): RO4602522
Intervention type(s): Drug
Intervention description(s): Single radiolabeled dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Does Vaginal Washing Affect the Success Rate of the Labour Induction?
Condition: Labor Induction; Dinoprostone Vaginal Insert; Vaginal Infection; Effect Increased
Study type: Interventional

Summary: 
      Investigators will use dinoprostone(Propess TM) for cervix ripening and labor induction in
      term pregnant women.Vaginal pH base is achieved with the effect of hormones in pregnancy and
      associated with this, vaginal infections rates increase. With the vaginal application of
      Propess, the preparate remains in the vagina for a long time, with controlled
      release,creating a film layer against bacteria and especially fungal infections and it was
      thought that this could be a reason for unsuccessful birth induction by preventing release of
      this ovule.

      The aim of this study is to observe whether or not the rate of caesareans with the indication
      of unsuccessful induction was reduced in patients by reducing the density of vaginal bacteria
      and fungi with vaginal lavage and thereby increasing the effect of the drug and decreasing
      the rate of unsuccessful inductions.
    

Detailed description: 
      The study will include patients meeting the study criteria monitored in the delivery .

      Verbal and written informed consent will be obtained from all patients before starting the
      study. The patients will be randomised to 2 groups. In one group, vaginal lavage (the vagina
      will first be washed with saline in a 20cc injector) will be applied then Propess will be
      used and in the other group Propess will be used without any lavage.

      It is planned to include 70 patients in each group.
    

Intervention name(s): vaginal lavage group; Control Group
Intervention type(s): Procedure; Procedure
Intervention description(s): vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.; vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia
Condition: Hypertriglyceridemia; Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      IONIS ANGPTL3-LRx (ISIS 703802) given to healthy volunteer subjects with elevated
      triglycerides and subjects with familial hypercholesterolemia.
    


Intervention name(s): IONIS ANGPTL3-LRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.9%NaCl, water, riboflavin
Other intervention name(s): ISIS 703802
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: ANGPTL-3
Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase Ⅱ trial of fixed dose rate gemcitabine and cisplatin chemotherapy followed by
      chemoradiation with capecitabine in patients with locally advanced pancreatic cancer.
    

Detailed description: 
      The main purpose of this study is to evaluate the efficacy and safety of fixed dose rate
      gemcitabine and cisplatin chemotherapy followed by chemoradiation with capecitabine in
      patients with locally advanced pancreatic cancer.
    

Intervention name(s): gemcitabine, cisplatin, capecitabine
Intervention type(s): Drug
Intervention description(s): Gemcitabine: 1000mg/㎡ (day 1, 8), cisplatin 60mg/㎡ (day 1) Capecitabine: 650mg/㎡ twice a day, during radiotherapy Gemcitabine: 1000mg/㎡ (day 1, 8)
Intervention MeSH terms: Gemcitabine; Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: locally advanced
Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      To compare between outcome of Express implant and subscleral trabeculectomy (SST) in
      management of glaucoma after previous trabeculectomy with a fibrotic bleb.
    

Detailed description: 
      Trabeculectomy is the main glaucoma surgery. Despite the good decline in intraocular pressure
      (IOP) that occur rapidly after the procedure, there is still failure occurring due to
      progressive subconjunctival fibrosis, with associated increased IOP.

      If the bleb is revived by needling with adjunctive 5-fluorouracil (5FU) and mitomycin C (MMC)
      that used intraoperatively for the majority of these cases , the associated rise in IOP was
      controlled if the revision occured early within the first three months after surgery. But
      less success occurred if the bleb revision was delayed.

      If these interventions fail, alternative approaches include new augmented trabeculectomy or
      aqueous shunt implantation.

      Express shunt allows aqueous to pass from anterior chamber to subconjunctival space like
      trabeculectomy .Express shunt is a non valved shunt, It has an advantage of less traumatic,
      less complications, low diffuse bleb and high success rate.
    

Intervention name(s): Express implant device
Intervention type(s): Procedure
Intervention description(s): Operative technique in group I (Express implant) was as in group II (trabeculectomy) except with no sclerectomy or peripheral iridectomy , the steps included conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva.
While in group II, Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock.
Other intervention name(s): Trabeculectomy with Mitomycin-C
Intervention MeSH terms: Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Express valve; Failed Trabeculectomy
Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea
Condition: Acute Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a medical nutrition product, PTM202, along
      with standard of care, enhances recovery and reduces diarrhea morbidity in young children
    


Intervention name(s): PTM202; Placebo
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma affects about 10% of children and 6% of adults in industrialized countries.
      Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are
      broadly involved in this pathology in experimental models and in humans. Many studies show
      that the signaling pathways activated by the commitment of T receiver differ depending LT.
      The identification of specific signaling pathways links to Th2 offer new therapeutic
      approaches. Precedent study showed that mouse Th2 selectively expressed related to calcium
      channels sensitive channels Cav1 voltage, normally found in excitable cells where they are
      defined as receivers dihydropyridine (DHP).

      The goal of the present study is to show the presence of Cav1 channels in inflammatory cells
      in allergic asthmatics and show overexpression of these channels in the peripheral blood
      mononuclear cells from asthmatic subjects before and / or after stimulation with the TCR in
      comparison with controls.
    


Intervention name(s): Induced sputum method using hypertonic serum
Intervention type(s): Procedure
Intervention description(s): Collection of expectoration in sterile vial, conserved in ice all along the examination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Lymphocytes Th2; Cav1 channels
A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a
      single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.
    

Detailed description: 
      This is a randomized (study medication assigned by chance), placebo controlled, double-blind
      (neither physician or subject knows the name of the assigned study medication) study to
      assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the
      drug), and pharmacodynamics (what the drug does to the body) of CNTO 5825. The study
      population will consist of 48 healthy volunteers and 16 healthy atopic volunteers. Five dose
      levels of study agent will be assessed. Participants will be required to stay at the research
      center after study agent administration for the inpatient portion of the study and then
      return for out-patient visits. Safety assessments will be performed throughout the study and
      include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and
      the occurrence and severity of adverse events. Placebo (containing inactive substances only)
      or one of five dose levels of CNTO 5825 will be given. Healthy volunteers will be given a
      single IV infusion (directly into a vein) or a single dose of up to 3 injections under the
      skin. Healthy atopic volunteers will be given one dose as as an IV infusion. There will be a
      screening period of up to 4 weeks. All participants will be in the study for 17 weeks after
      dose administration.
    

Intervention name(s): CNTO 5825; CNTO 5825; CNTO 5825; CNTO 5825; CNTO 5825; CNTO 5825; CNTO 5825
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 10 mg/kg single dose IV or matching placebo; 3 mg/kg single dose IV or matching placebo; For atopic patient:10 mg/kg single IV dose or matching placebo; For atopic patient: 3 mg/kg single dose SC or matching placebo; 0.3 mg/kg single dose IV or matching placebo; 0.1 mg/kg single dose Intravenously (IV) or matching placebo; 1 mg/kg single dose IV or matching placebo
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CNTO 5825; Safety; Phase I; Healthy adults; Healthy Atopic adults
Neural Mechanisms for Appetitive Responses to High Reward Foods
Condition: Appetitive Behavior; Obesity
Study type: Observational

Summary: 
      This study is aimed at understanding neuroendocrine responses to different types of sugars
      and how this influences feeding behavior among lean, overweight, and obese individuals.
    

Detailed description: 
      The investigators have previously combined functional magnetic resonance imaging (fMRI) with
      hormonal and behavioral assessments to better understand the impacts of glucose and fructose
      on appetite and its central regulation in humans and have made important observations in lean
      individuals linking fructose consumption to overeating and obesity. The investigators now
      propose to expand this work by examining the impacts of glucose and fructose ingested
      together (sucrose), as occurs in real life, and by examining effects of a common
      non-nutritive sweetener, sucralose, on brain and appetitive response. The investigators
      propose a random-order crossover design to determine the effects of caloric and non-nutritive
      sweeteners among lean, overweight, and obese participants. The investigators will measure
      circulating levels of hormones involved in satiety signaling, quantify food intake, and
      measure brain activity using blood-oxygen level dependent and arterial spin labeling methods
      and functional connectivity analyses.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in the greater Los Angeles area will be recruited. Lean, overweight, and obese
        participants will be recruited.
      
Biospecimen description: 
      Blood Samples
    
Keywords: functional magnetic resonance imaging; eating behavior; sugar
Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula
Condition: Obstetric Fistula
MeSH terms: Fistula
Study type: Observational

Summary: 
      This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic
      and hormonal characteristics of women and without obstetric fistula.

      Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is
      at least 10 mm shorter than the mean cervical length measurement of similar women without
      obstetric fistula.

      Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with
      obstetric fistula will allow us to assess the cause of amenorrhea in these women.
    

Detailed description: 
      This study is a cross-sectional study of 110 Malawian women who present for medical
      evaluation at the Fistula Care Centre in Lilongwe, Malawi. If a woman enrolls in the study,
      her demographic, medical history, physical exam, and lab data will be abstracted from her
      medical records at the Fistula Centre. She will also a pelvic ultrasound on each participant
      so that the characteristics of her cervix, uterus, and ovaries (such as the cervical length,
      endometrial thickness and ovarian volume) can be evaluated. If the participant has an
      obstetric fistula, she will also complete an additional blood draw for lab testing. The
      laboratory tests will evaluate three hormones that are associated with amenorrhea and
      infertility: follicle stimulating hormone, estradiol, and antimullerian hormone.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We will be enrolling 100 Malawian women with obstetric fistula and 10 Malawian women
        without obstetric fistula.
Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168)
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate whether the within-subject variation in duration of
      action and time-action profile of glargine measured by isoglycemic clamp will be below
      prespecified levels.
    


Intervention name(s): Isoglycemic Clamp; Comparator: insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2); Insulin glargine at 0.4 U/kg
Other intervention name(s): LANTUS
Intervention MeSH terms: Insulin Glargine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin
Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to
      subjects with chronic hepatic impairment and in matched healthy subjects.
    

Detailed description: 
      This is a nonrandomized, open-label, parallel-group, single oral dose study in subjects with
      chronic hepatic impairment and matched (age, sex, weight, BMI) healthy subjects. Subjects
      will be enrolled into 1 of 3 groups based on hepatic impairment grade: mild, moderate and
      normal hepatic function. An optional severe hepatic impairment group will enroll based on
      data from the mild and moderate hepatic impairment groups in comparison to matched healthy
      group. All subjects will receive a single oral dose of IPI-145 25 mg.
    

Intervention name(s): IPI-145
Intervention type(s): Drug
Intervention description(s): 25 mg single oral capsule
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; hepatic impairment
Comparison of Compact 3T, Conventional 3T, and 7T Scanners Using Task Based and Resting State fMRI
Condition: Healthy
Study type: Observational

Summary: 
      Comparison of 3 MRI scanners.
    

Detailed description: 
      Comparing the strengths and weaknesses of 3 different MRI scanners in their performance of a
      functional MRI (an MRI that shows which areas in the brain are active during some sort of
      task).
    

Intervention name(s): Functional MRI (fMRI)
Intervention type(s): Diagnostic Test
Intervention description(s): fMRI will be done on 3 separate MRI scanners to compare.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young healthy volunteers ages 18-55, English must be primary language