bioihbjkbjnl/mcl2 huggingface dataset:
Immune Response to Varicella Vaccination in Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Chickenpox; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      Atopic dermatitis (AD) causes people to be susceptible to skin infection and inflammations.
      The purpose of this study is to determine the immune response to chicken pox vaccine in
      children with or without AD who received the vaccine 2 to 16 weeks prior to the study visit.
    

Detailed description: 
      AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections.
      Children with AD given the smallpox vaccine could develop a life-threatening condition known
      as eczema vaccinatum. This immune response is not currently understood. The purpose of this
      study is to understand the immune response to a viral vaccine in children with AD. This will
      be accomplished by studying immune response to the chicken pox vaccine in children with AD in
      comparison to those without AD.

      This study will consist of one study visit occurring about 2 to 16 weeks after the child
      received the chicken pox vaccination. During this visit, physical and skin exams will occur.
      Personal and family medical histories and blood collection will also occur. The chicken pox
      vaccine will not be given as a part of this study. Subjects will receive the results of
      radioallergosorbent (RAST) testing that will tell if they are allergic to some common items
      (e.g., mold, grass).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with or without AD who received the chicken pox vaccine including a group of AD
        subjects with eczema herpeticum (ADEH+)
      
Biospecimen description: 
      Blood collected for endpoint measurements.
A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720
Condition: Multiple Sclerosis; Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will assess the patients' satisfaction of treatment after 12 months treatment with
      fingolimod It also will assess the tolerability profile of fingolimod in a small population.
    


Intervention name(s): Fingolimod
Intervention type(s): Drug
Intervention description(s): Fingolimod 0.5mg orally once a day without food.
Intervention MeSH terms: Fingolimod Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Relapsing remitting multiple sclerosis; Fingolimod; FTY720
A Study in People With High Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purposes of this study are to determine:

        -  The safety of the study medication and any side effects that might be associated with it

        -  Whether the study medication can help patients with high levels of "bad" cholesterol
           (low-density lipoprotein-cholesterol [LDL-C]), alone or in combination with additional
           study medication
    


Intervention name(s): PPAR alpha; atorvastatin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
9 Minutes for Tandem Colonoscopy Withdrawal
Condition: Colon Polyp; Colorectal Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      A mean withdrawal time of at least 6 minutes has been considered to be one of the critical
      quality criterions of colonoscopy. Recently, our group completed a multicenter randomized
      controlled trial, which proved that prolonging the withdrawal time to 9 minutes could
      significantly improve the adenoma detection rate of colonoscopists, especially for young
      colonoscopists and proximal colon. However, it has some limitations in included participates
      (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on
      adenoma miss rate in a parallel randomized design. It is necessary to include tandem
      colonoscopy and adopt strict criteria of the screening population to confirm the effect of
      the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to
      conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma
      miss rate of 6-minute and 9-minute withdrawal in screening population.
    


Intervention name(s): 6-minute then 9-minute withdrawal; 9-minute then 6-minute withdrawal
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 2 minutes then in 3 minutes during each colonic segment.
In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 2 minutes, then reentered the cecum and withdrawn to the splenic curvature in 3 minutes.; Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 3 minutes then in 2 minutes during each colonic segment.
In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 3 minutes, then reentered the cecum and withdrawn to the splenic curvature in 2 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: withdrawal time; adenoma miss rate; tandem colonoscopy; adenoma detection rate
BIA Guided-fluid Management in Postinjury Open Abdomen
Condition: Damage Control; Trauma Abdomen; Acute Compartment Syndrome
MeSH terms: Compartment Syndromes; Abdominal Injuries
Study type: Interventional

Summary: 
      Fluid overload (FO), resulting from high volume fluid therapy, is frequent and contributes to
      excessive visceral edema, delayed fascial closure, and adverse outcomes among postinjury open
      abdomen (OA) patients. Bioelectrical impedance analysis (BIA) is a promising tool in
      monitoring fluid status and FO. Thus, we sought to investigate the efficacy of BIA-directed
      resuscitation among postinjury OA patients.
    


Intervention name(s): BIA-guided fluid resuscitation protocol; Traditional fluid resuscitation protocol
Intervention type(s): Other; Other
Intervention description(s): In both groups, a multi-frequency BIA with eight tactile electrodes (Inbody S10 Biospace, Biospace Co. Ltd., Seoul, Korea) was used to assess body fluid status every 6h within the first 72h after admission to the ICU and daily for a period of 4 days.
BIA recording was not adjusted by clinicians in fluid restrict, pharmacological and mechanical means of therapy.
In contrast, in group BIA, fluid resuscitation protocol with adjustment determined according to HL measured by BIA.; Traditional fluid resuscitation strategy determined by treating clinicians according to usual clinical parameters.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Trauma; Open abdomen; Fluid resuscitation; Fascial closure; Bioelectrical impedance analysis
Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
Condition: Inguinal Hernia; Femoral Hernia
MeSH terms: Hernia; Hernia, Inguinal; Hernia, Femoral
Study type: Interventional
Phase: Phase 3

Summary: 
      Does corticosteroid (dexamethasone) have an effect on the postoperative period after
      laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and
      convalescence. This randomized, double-blinded study compares dexamethasone versus placebo.
      The patients are recommended one day of convalescence. The medicine or placebo is given
      before operation. The patients fill out questionnaire before operation and three hours after
      operation and in the following three days. The patients also register when they return to
      normal activities and work.
    


Intervention name(s): Dexamethasone; Saline
Intervention type(s): Drug; Drug
Intervention description(s): single use of dexamethasone IV 8 mg/2 ml; 2 ml IV
Other intervention name(s): Fortecontin; Natriumchlorid, B. Braun 9 mg/ml
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Inguinal hernia; Transabdominal preperitoneal hernia repair; TAPP; Dexamethasone; Pain
Diagnostic Biomarkers for Adult Hemophagocytic Lymphohistiocytosis in Critically Ill Patients (HEMICU)
Condition: Hemophagocytic Lymphohistiocytosis
MeSH terms: Lymphohistiocytosis, Hemophagocytic; Critical Illness
Study type: Observational

Summary: 
      Hemophagocytic lymphohistiocytosis in adults (HLH) is at 68% mortality whereas 78% of all
      cases remain undiagnosed though therapies are available which clearly reduce mortality. The
      investigators aim to systematically investigate this life-threatening hyperinflammatory
      syndrome in intensive care units (ICU) in order to detect biomarkers that are highly
      sensitive and highly specific for HLH in ICU compared to patients with sepsis.
    

Detailed description: 
      The investigators will draw blood samples of 100 patients at the time of diagnosis (each 50
      with suspected or diagnosed HLH/sepsis) to determine a cytokine panel (c reactive protein
      (CRP), procalcitonin (PCT), interleukin (IL) 1β, IL-6, IL-8, IL-10, IL-18, IL-33, tumor
      necrosis factor (TNF) α, interferon (IFN) ɣ, soluble IL-2 receptor (sIL-2R), the EBV and CMV
      viral loads, human immunodeficiency virus (HIV) antibodies and -antigen, perforin,
      fibrinogen, triglycerides, bilirubin, lactate dehydrogenase, liver transaminases, sodium,
      serum albumin, electrophoresis, glycosylated ferritin, the microRNAs miR-205-5p, miR-194-5p
      and miR-30c-5p, perforin, CD107a and high immune status (differential blood count, T cells, B
      cells, NK cells, T helper cells, cytotoxic T cells, CD4 / CD8 ratio, HLA-DR of CD8 +, CD11a
      of CD8, CD57 of CD8, CD28 of CD8 +, HLA-DR of monocytes, CD56bright and CD69 of NK cells).
      The results of this study serve the development of new clinical concepts in order to safely
      diagnose HLH at an early stage, to distinguish from sepsis and to reduce the fatal
      consequences.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female critically ill patients admitted to any ICU of the Charité -
        Universitätsmedizin Berlin.
      
Biospecimen description: 
      6 ml of blood samples of each patient will be stored in the Biobank of the Berlin Institute
      of Health, Clinical Research Unit, Charité - Universitätsmedizin Berlin, Campus
      Virchow-Klinikum, Augustenburger Platz 1, D-13353 Berlin
    
Keywords: Hemophagocytic Lymphohistiocytosis (HLH); Hemophagocytic syndrome (HPS); critically ill; Intensive care unit (ICU)
Drug Utilization Study on Diane-35 (and Generics) in Three European Healthcare Databases
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Observational

Summary: 
      The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol
      (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics,
      previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne
      treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases
      in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).
    


Intervention name(s): Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics
Intervention type(s): Drug
Intervention description(s): Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg
Intervention MeSH terms: Cyproterone Acetate; Ethinyl Estradiol; Cyproterone; Cyproterone acetate, ethinyl estradiol drug combination
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women who are new users of CPA/EE in 2011/2012 and in 2014
A Study of LY3025876 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and
      tolerability of the study drug in healthy people and investigate how much of the study drug
      gets into the blood stream and how long it takes the body to get rid of it. Information about
      any side effects that may occur will also be collected.
    


Intervention name(s): LY3025876; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Given as a subcutaneous injection; Given as a subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Combination Therapy in Patients With Hypertension Not Controlled With Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      CS-8635 combines three widely prescribed antihypertensive medications, olmesartan
      medoxomil(OM), amlodipine (AML), and hydrochlorothiazide (HCTZ), to lower blood pressure. The
      purpose of the study is to evaluate the efficacy and safety of triple therapy with CS-8635
      compared with dual therapy in Korean patients with hypertension not controlled with dual
      fixed dose combination therapy (Olmetec® Plus). The treatments that will be used in this
      study are as follows: Run-in period -OM/HCTZ 20/12.5 mg (Olmetec® Plus 20/12.5 mg) ; Double
      blind treatment period - OM/AML/HCTZ 20/5/12.5mg (CS8635 20/5/12.5mg) + its matching placebo
      vs.OM/HCTZ 20/12.5mg (Olmetec® Plus 20/12.5 mg) + its matching placebo; Open label extension
      period - OM/AML/HCTZ 40/5/12.5mg (CS8635 40/5/12.5mg) or OM/AML/HCTZ 20/5/12.5mg (CS8635
      20/5/12.5mg).
    

Detailed description: 
      Please refer to arms, outcome measures and eligibility criteria for details.
    

Intervention name(s): CS8635 20/5/12.5mg and placebo; Olmetec® Plus 20/12.5mg and placebo
Intervention type(s): Drug; Drug
Intervention description(s): Run-in period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day.
Double-blind period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine (AML)-Hydrochlorothiazide(HCTZ) 20-5-12.5mg, oral placebo tablet. All tablets are given once a day.
Open-label period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine(AML)-Hydrochlorothiazide(HCTZ) 40-5-12.5mg, given once a day.; Run-in period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day.
Double-blind period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, oral placebo tablet. All tablets are given once a day.
Open-label period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine(AML)-Hydrochlorothiazide(HCTZ) 20-5-12.5mg, given once a day.
Intervention MeSH terms: Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the PK of single dose of vedolizumab SC 108 milligram
      (mg) administered as PFS vs investigational device.
    

Detailed description: 
      The drug being tested in this study is called vedolizumab SC. This study will compare the PK
      of a vedolizumab SC dose in PFS to an investigational device in healthy participants.

      This study will include 2 different device delivery presentations in 2 treatment groups.
      Participants in each treatment group will be randomized to one of the three administration
      sites: Abdomen, thigh, or arm. The study will enroll approximately 24 participants, including
      4 participants allocated to each administration site within each treatment group.
      Participants will be randomly assigned (per randomization schedule) to one of the two
      treatment groups:

        -  Group A: Vedolizumab SC PFS

        -  Group B: Vedolizumab SC Investigational Device

      All participants will receive a single dose of study drug on Day 1.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 196 days. Participants will be contacted by
      telephone on Day 168 after their last dose of study drug for a long-term follow-up (LFTU)
      assessment which will involve the progressive multifocal leukoencephalopathy (PML)
      questionnaire survey.
    

Intervention name(s): Vedolizumab SC
Intervention type(s): Drug
Intervention description(s): Vedolizumab SC liquid.
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
Alcohol Monitor Validation
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      This study will validate a wrist-worn alcohol monitor (BACtrack Skyn) in both laboratory and
      real-life settings.
    

Detailed description: 
      The overarching goal of this research program is to improve alcohol intervention and
      eventually related clinical outcomes (e.g., liver function) among HIV+ drinkers through
      biosensor-assisted intervention. Research shows HIV infection can influence alcohol
      metabolism (i.e., higher blood alcohol levels), so it's necessary to validate the new alcohol
      biosensor in HIV+ drinkers rather than in general population. The primary goal of this
      project, as a step toward the development and evaluation of a biosensor-assisted alcohol
      intervention, is to validate the newly available wrist worn transdermal alcohol biosensor
      (BACtrack Skyn). The two specific aims are: (1) To assess validity and reliability of the
      Skyn biosensor using fixed-dose lab administration of alcohol through comparison with
      laboratory grade breathalyzer, and (2) To validate Skyn biosensor in daily life using a
      2-week ecological momentary assessment (EMA) to compare self-reported drinking and the Skyn
      derived transdermal alcohol concentration (TAC) readings.
    

Intervention name(s): Skyn Monitor Lab Session 1; Skyn Monitor Field Test with EMA App; Skyn Monitor Lab Session 2
Intervention type(s): Device; Device; Device
Intervention description(s): Participants will be instructed to wear the Skyn wrist-worn alcohol monitor and drink 3 beers over the course of an hour and a half. BrAC will be measured every 15 minutes throughout the session.; After Skyn Monitor Lab Session 1, participants will be instructed to wear Skyn monitor for the rest of the day and the following two weeks. Participants will also enter information on each drinking session during the two week time using a mobile-based ecological momentary assessment (EMA) to collect real-time data in daily life.; Participants will be instructed to wear the Skyn wrist-worn alcohol monitor and drink 3 beers over the course of an hour and a half. BrAC will be measured every 15 minutes throughout the session. Participant will also complete device acceptability and usability survey.
Other intervention name(s): BACtrack Skyn; Skyn Alcohol Monitoring Device; BACtrack Skyn; Skyn Alcohol Monitoring Device; BACtrack Skyn; Skyn Alcohol Monitoring Device
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: alcohol consumption
Computed Tomography-guided Brachytherapy Plus Chemotherapy for Locally Recurrent Rectum Cancer
Condition: Rectum Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of CT guided 125I seeds
      implant plus systemic chemotherapy for locally recurrent rectum cancer.
    

Detailed description: 
      The primary aim of this study is to determined the safety and efficacy of CT guided 125I
      seeds implant plus systemic chemotherapy for locally recurrent rectum cancer.The patients
      with recurrence in pelvic or on pelvic wall after rectal resection were treated with 125I
      seeds implant plus chemotherapy or chemotherapy alone. The side-effect, tumor response and
      survival data were recorded.
    

Intervention name(s): Computed tomography guided radioactive seeds implant; Systemic chemotherapy (FOLFIRI)
Intervention type(s): Procedure; Drug
Intervention description(s): Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.; irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks
Other intervention name(s): Brachytherapy; FOLFIRI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Condition: Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of long-term treatment
      with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's
      disease (CD)
    


Intervention name(s): 25 mg Ontamalimab; 75 mg Ontamalimab
Intervention type(s): Drug; Drug
Intervention description(s): Ontamalimab sterile aqueous buffered solution will be administered in dose of 25 mg subcutaneously.; Ontamalimab sterile aqueous buffered solution will be administered in dose of 75 mg subcutaneously.
Other intervention name(s): PF-00547659; SHP647; SHP647; PF-00547659
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Immunosuppressants; Mesalamine; Ulcerative Colitis; Crohn's disease; Gastroenteritis