bioihbjkbjnl/mcl2 huggingface dataset:
Prevalence of Eosinophilic Esophagitis in Children With Celiac Disease
Condition: Celiac Disease; Eosinophilic Esophagitis
MeSH terms: Esophagitis; Celiac Disease; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      Celiac disease (CD) and eosinophilic esophagitis (EE) are distinct diseases of the
      gastrointestinal tract with specific clinico-pathological characteristics. In recent years,
      in the literature, several children who underwent upper gastrointestinal endoscopy for
      suspected CD, which was confirmed histologically, were also found to have coexistent EE.
      There are reports of coexistent CD and EE. We would like to see the prevalence of EE in
      children with CD and the prevalence of CD in children with EE in our population, and to do so
      would like to review medical records. Our objectives are to determine if children with celiac
      disease have a high prevalence of eosinophilic esophagitis.and to determine if children with
      eosinophilic esophagitis have increased risk of developing celiac disease.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children seen in the Pediatric Gastroenterology clinic at St. John Hospital & Medical
        Center and diagnosed with celiac disease or eosinophilic esophagitis or both based on the
        endoscopic and histopathological findings.
A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the absorption,
      metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male
      subjects.
    


Intervention name(s): somapacitan
Intervention type(s): Drug
Intervention description(s): All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing [3H]-somapacitan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of BFH772 in Psoriasis Patients
Condition: Psoriasis; Arthritis
MeSH terms: Arthritis; Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety
      after multiple dosing.
    


Intervention name(s): BFH772; Placebo; BFH772; Placebo; calcipotriol/betamethasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Betamethasone; Calcipotriene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stable plaque Psoriasis; inflammatory skin; with or without arthritis
A Study to Investigate the Effect of JNJ-63623872 on Pitavastatin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady-state concentrations of
      JNJ-63623872 on the single-dose pharmacokinetics of pitavastatin in healthy participants.
    

Detailed description: 
      This is a Phase 1, open-label (identity of study drug will be known to participant and study
      staff), sequential study in healthy volunteers to investigate the potential Pharmacokinetics
      (PK) effects of JNJ-872 on pitavastatin. The study consists of Screening Phase (28 days),
      Treatment Phase (Day 1 - Day 12), Follow up (10-14 days and 30-35 days after last study drug
      intake or drop). The total duration of the study will be approximately 2 months. Participants
      will sequentially receive the following treatment: a single oral dose of pitavastatin 1
      milligram (mg) on Day 1; JNJ-63623872 600 mg twice daily on Days 4 through 12, with a single
      oral dose of pitavastatin 1 mg administered in the morning of Day 9. All study drug intakes
      will be taken orally, under fed conditions (within approximately 10 minutes after completion
      of a meal). Blood samples will be collected to assess pharmacokinetic parameters.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Pitavastatin; JNJ-63623872
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single oral dose of pitavastatin 1 milligram (mg) on Day 1 and Day 9.; Participants will receive JNJ-63623872 600 mg twice daily on Days 4 through 12.
Intervention MeSH terms: Pitavastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy; Pitavastatin; JNJ-63623872
Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy
Condition: Hypertriglyceridemia
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons with Elevated
      Triglycerides (200-499) on Statin Therapy. The study is to determine progression rates of low
      attenuation plaque under influence of Vascepa as compared to placebo.
    

Detailed description: 
      Residual cardiovascular (CV) risk remains in dyslipidemic patients despite intensive statin
      therapy, underscoring the need for additional intervention. Eicosapentaenoic acid (EPA), an
      omega-3 polyunsaturated fatty acid, is incorporated into membrane phospholipids and
      atherosclerotic plaques and exerts beneficial effects on the pathophysiologic cascade from
      onset of plaque formation through rupture. EPA also improves atherogenic dyslipidemia
      characterized by reduction of triglycerides without raising low-density lipoprotein
      cholesterol. All of this data supports the biologic plausibility of EPA as an
      anti-atherosclerotic agent. The goal of this study is to evaluate whether treatment with
      Vascepa (4 grams) results in a greater change from baseline in low attenuation plaque than
      placebo in subjects with elevated triglycerides (200-499 mg/dl).
    

Intervention name(s): Vascepa; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.; placebo
Other intervention name(s): icosapent ethyl
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ultrasound Guided Sciatic Nerve Block
Condition: Sciatic Nerve
Study type: Interventional

Summary: 
      The primary purpose of this study is to determine whether the leg positioning or distal
      tourniquet used during the injection of local anesthetic may decrease the onset time and
      prolong the duration of analgesia of ultrasound-guided Sciatic Nerve Block (SNB) with
      popliteal approach. Patients will be divided randomly into three groups: group 1 will receive
      sciatic nerve block, with leg kept in a neutral position after anesthesia (control group);
      group 2 will receive the same anesthesia, with leg raised 30° by placing the back of the foot
      over a support placed on the OR table and maintained in that position for 15 min; and
      patients in group 3 will receive the same anesthesia, and distal tourniquet placed on the
      lower part of the leg (upper part of the tourniquet being about 4-6 inches from the ankle)
      with the leg in a neutral position
    


Intervention name(s): Sciatic Nerve block; Leg raised 30°; Distal tourniquet placed on the lower part of the leg; Leg in a neutral position
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the immune response and safety of AdCOVID administered as an intranasal
      spray in healthy adults.
    


Intervention name(s): AdCOVID; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Administered intranasally; Administered intranasally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; SARS-CoV-2; Intranasal Vaccine
Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females
Condition: Pain
Study type: Interventional

Summary: 
      The primary purpose of this study to assess patient pain scores comparing rigid to flexible
      cystoscopy in females; to assess post procedural complications, including frequency, urgency,
      infection and time to resolution of these symptoms between the two procedures; to assess
      physician perception of patient pain or discomfort with flexible or rigid cystoscopy.
    

Detailed description: 
      This will be a prospective randomized trial study in order to determine to compare rigid and
      flexible cystoscopy in female patients. Patients will be recruited from OU Physicians Pelvic
      and Bladder Health clinic. Patients receive an information leaflet describing the procedure
      prior to their appointment. All procedures are performed by the attending physician.
      Procedures performed by residents and/or fellows are excluded from this study. The vulva is
      cleaned with antiseptic solution and 10 ml of Xylocaine 2% is be instilled into the urethra
      before the endoscope was introduced. A 16 F flexible cysto urethroscope (Storz, Culver city,
      CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope
      (Storz, Culver city, CA) is used to enable optimal visualization of the lateral bladder wall
      in those with previous continence surgeries. The investigator may choose to use a 30° scope
      when appropriate. Cystoscopy is commenced by recording a postvoid residual ensuring
      appropriate bladder emptying prior to filling. Filling is performed with continuous saline
      infusion until the maximum tolerated capacity or 300 ml. (whichever was reached first). A
      standard systematic approach was adopted to ensure global assessment of the vesical surface.
      This included the bladder dome, the bladder neck, bladder trigone, sidewalls and ureteral
      orifices. The urethroscopy portion of the procedure is performed last. When performing rigid
      cystoscopy, a 0° degree lens is used for this portion of the procedure.
    

Intervention name(s): Cystoscopy
Intervention type(s): Device
Intervention description(s): A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: flexible cystoscopy; rigid cystoscopy; bladder; outcome assessment; pain measurement
Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma
Condition: Diffuse Large B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

Summary: 
      CD20, the protein which is expressed on the surface of all mature B cells, is active in many
      B-cell lymphomas that express this molecule such as Diffuse Large B Cell Lymphoma (DLBCL),
      the most frequently occurring subtype of non-Hodgkin lymphomas. In clinical practice,
      Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone combination chemotherapy (CHOP) is
      still considered one of the standard treatment to DLBCL. CMAB304(Retuxira), the chimeric
      monoclonal antibody is designed to targeted against CD20 for treatment of lymphoma diseases.
      This trial aimed to observe the safety and efficacy of CMAB304, by added CMAB304 to CHOP
      chemotherapy regimen compared with CHOP chemotherapy alone.
    

Detailed description: 
      Rituximab, a chimeric anti-CD20 monoclonal antibody, has been proved valuable treatment for
      CD20-positive DLBCL. The combination of rituximab with CHOP has been shown to increase both
      survival and response rate, in comparison to CHOP alone. CMAB304(Retuxira), a biosimilar of
      rituximab, was developed by Shanghai CP Guojian Pharmaceutical Co.,Ltd. Previous Phase I
      study showed that CMAB304 was well tolerated as monotherapy and the pharmacokinetic data
      exhibited a non-linear profile over the dose range of 250 to 500 mg/m2. In this study,
      efficacy and safety of CMAB304 were evaluated in DLBCL patients.
    

Intervention name(s): CHOP combined with CMAB304; CHOP, CMAB304
Intervention type(s): Drug; Drug
Intervention description(s): Patients treated with CHOP-304 undergo 1 cycle every 3 weeks, received CMAB304 at a dose of 375 mg/m2 on day 1 and CHOP on day 2 of each of the 6 cycles.; First standard CHOP, then sequential CMAB304 in patients who reached a complete response or undocumented complete response at the end of treatment of 6 cycles.
Other intervention name(s): cyclophosphamide, doxorubicin, vincristine, prednisone; cyclophosphamide, doxorubicin, vincristine, prednisone
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Vincristine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: untreated, CD20-positive
A Study to Evaluate the Pharmacokinetics of Benzoic Acid and Hippuric Acid After Topical Administration of GSK2585823 in Japanese Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, open-label study to evaluate the pharmacokinetics of the
      BPO metabolites benzoic acid and hippuric acid with 7-day repeat application of GSK2585823 in
      subjects with acne vulgaris
    


Intervention name(s): GSK2585823
Intervention type(s): Drug
Intervention description(s): CLDM1%/BPO3%
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: GSK2585823, benzoic acid, hippuric acid, acne vulgaris, pharmacokinetics
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914
Condition: Gonococcal (GC) Infection
MeSH terms: Gonorrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of orally administered
      AZD0914 in healthy adult subjects.
    

Detailed description: 
      A Phase I, Randomized, Placebo-controlled, Single-center Study to Assess the Safety,
      Tolerability, and Pharmacokinetics of AZD0914 After a Single Oral Administration and to
      Assess the Effect of Food in Healthy Adult Volunteers
    

Intervention name(s): Part A; Part B
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending doses; Single doses food effect. Subjects to receive 2 single doses, one in fed and one in fasted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy Volunteers; First Time in Man; Pharmacokinetics
An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)
Condition: Contraception
MeSH terms: Uterine Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind
      trial of three different doses of etonogestrel releasing medicated intrauterine systems
      (ENG-MIUS) in healthy parous women in need for contraception.

      The primary trial objective is to explore safety and acceptability of three doses of an
      ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.
    


Intervention name(s): Etonogestrel-releasing IUS; Etonogestrel-releasing IUS; Etonogestrel-releasing IUS; Multiload-cu 375®
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): Low dose; treatment duration of 6 months with a possible extension to 12 months; Intermediate dose; treatment duration of 6 months with a possible extension to 12 months; High dose; treatment duration of 6 months with a possible extension to 12 months; Duration of 6 months with a possible extension to 12 months
Other intervention name(s): SCH 900342; ORG 299001; SCH 900342; ORG 299001; SCH 900342; ORG 299001
Intervention MeSH terms: Etonogestrel; Desogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Immunopathology of Loeys-Dietz Syndrome
Condition: Loeys-Dietz Syndrome
MeSH terms: Loeys-Dietz Syndrome; Syndrome
Study type: Interventional

Summary: 
      Loeys-Dietz syndrome (LDS) is a rare vascular genetic disorder (estimated prevalence
      1/25,000-1/100,000) due primarily to mutations in the Transforming growth factor beta (TGF-β)
      cytokine receptor 1 and 2 genes. In addition to a common vascular phenotype with Marfan
      syndrome (dilatation of the ascending aorta, arachnodactyly, lens dislocation), patients
      present specific malformations (bifid uvula, hypertelorism, tortuous arteries) and
      immuno-allergic manifestations (asthma, eczema, food allergy, eosinophilic esophagitis,
      chronic inflammatory bowel disease).

      Pathophysiologically, LDS appears to be associated with hyperactivation of the intracellular
      TGF-β signaling pathway in a manner similar to Marfan syndrome, as evidenced by increased
      intracellular phosphorylated Smad2/3 (pSmad2/3) in lymphocytes. The immuno-allergic
      complications appear paradoxical because of the major immunosuppressive role of this cytokine
      on lymphoid and myeloid immune lineages.

      The biological description of immunological abnormalities associated with LDS is based on a
      single 2013 study that found increased regulatory T (Treg) and Th2 lymphocyte polarizations,
      as well as increased circulating eosinophil and total IgE levels.

      In order to better understand the underlying mechanisms, the investigators propose to perform
      a descriptive clinical-biological study to identify and study the immune subpopulations most
      impacted by the causative mutations of LDS.
    


Intervention name(s): blood samples; blood samples
Intervention type(s): Biological; Biological
Intervention description(s): Only one visit for each participant: A large majority of visits will be part of patients' usual care.
Medical examination : weight, gender, blood pressure, medical history
Blood samples : 1 EDTA tube (3 mL) for CBC, 3 heparin tubes (3 × 7 mL) for frozen PBMC, 1 EDTA tube (3 mL) for frozen plasma; Only one visit for each participant:
Medical examination : weight, gender, blood pressure, medical history
Blood samples : 1 EDTA tube (3 mL) for CBC, 3 heparin tubes (3 × 7 mL) for frozen PBMC, 1 EDTA tube (3 mL) for frozen plasma
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Loeys-Dietz Syndrome; immunology; T-Lymphocytes
Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis
Condition: Proctitis
MeSH terms: Proctitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy and safety of budesonide suppository
      for the treatment of acute ulcerative proctitis.
    


Intervention name(s): Budesonide 2 mg suppository; Budesonide 4 mg suppository; Mesalazine 1 g suppository; Budesonide 2 mg suppository/Mesalazine 1 g suppository
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): per day; per day; per day; per day
Intervention MeSH terms: Budesonide; Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose
      Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product
      CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg
      of each product to healthy male subjects
    

Detailed description: 
      This study is a double-blind, three-arm, parallel group, single-dose study. A total of 141
      subjects will be enrolled; 47 subjects in each of the 3 arms of the clinical study. In each
      arm, all subjects will receive a single dose (5 mg/kg) of either CT-P16, EU-approved Avastin,
      or US-licensed Avastin by intravenous (IV) infusion for 90 min (±5 min) on Day 1 followed by
      15 weeks during which the PK, safety, and immunogenicity measurements will be made. The
      randomization will be stratified by body weight and site.
    

Intervention name(s): CT-P16; EU-approved Avastin; US-licensed Avastin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CT-P16 is a biosimilar product for Avastin; EU-approved Avastin; US-licensed Avastin
Other intervention name(s): bevacizumab; bevacizumab; bevacizumab
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: safety; Pharmacokinetics; Immunogenicity
Prevalence of Nasal Hyperreactivity in Chronic Upper Airway Inflammation
Condition: Hyperactivity; Chronic Rhinosinusitis (Diagnosis); Chronic Rhinitis; Upper Respiratory Disease
MeSH terms: Rhinitis; Respiratory Tract Diseases; Respiration Disorders; Inflammation
Study type: Observational

Summary: 
      Rhinitis, or inflammation of the nasal mucosa, can present with nasal obstruction, nasal
      discharge, itch or sneezing. If the sinusal mucosa is involved as well, it is called
      rhinosinusitis and facial pain or loss of smell is possible. Several causes are known, such
      as an underlying allergy ("allergic rhinitis", AR). If at least 2 symptoms are present for at
      least 12 weeks, it is called "chronic rhinosinusitis" (CRS).

      Up to 2/3 of the AR and CRS patients have symptoms upon exposure to triggers such as sudden
      temperature changes, smoke, fragrances… a phenomenon called "nasal hyperreactivity" (NHR). It
      is currently not clear why some patients suffer NHR while others do not.

      In this study, the investigators want to determine the prevalence and severity of nasal
      hyperreactivity in patients with chronic upper airway inflammation. To this end, patients and
      healthy controls will be asked to fill out a questionnaire inquiring presence and severity of
      nasal symptoms upon exposure to particular environmental triggers.
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Patients and healthy controls will fill out a questionnaire
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic inflammation of the upper airways. Controls without chronic
        inflammation of the upper airways.