bioihbjkbjnl/mcl2 huggingface dataset:
Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid After a Single Subcutaneous Administration of 300 mg
Condition: Healthy; Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed exploratory study aims to understand the in vivo skin distribution properties of
      subcutaneously (s.c.) administered AIN457 in psoriatic and healthy skin using open flow
      microperfusion (OFM). The data of this study will help to understand the mode of action of
      AIN457 in its target tissue.

      It aims to establish a technique assessing in vivo distribution of AIN457 and its metabolites
      in human dermal interstitial fluid (ISF) and exploring a potential pharmacodynamic effect in
      situ. In addition, the study will further evaluate safety and local tolerability of
      subcutaneously administered AIN457 and explore dermal interstitial fluid skin levels of
      potential disease relevant biomarkers.

      The study is divided into two parts - Part I with 8 healthy volunteers (HV) to validate the
      method is completed and Part II with 8 psoriasis patients will start based on the outcome of
      Part I.
    


Intervention name(s): secukinumab (AIN457)
Intervention type(s): Drug
Intervention description(s): anti-IL-17 antibody
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Psoriasis; interstitial fluid; open flow microperfusion; IL-17; inflammatory skin disease; scaly patches; Healthy volunteers and psoriasis patients
US Ovulation Inhibition Study in Obese Women
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      Birth Control Patch Study
    


Intervention name(s): Ethinylestradiol/Gestodene (BAY86-5016)
Intervention type(s): Drug
Intervention description(s): 0.55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 3 cycles
Intervention MeSH terms: Ethinyl Estradiol; Gestodene; Femovan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy prevention; female contraception; patch
Effects of Aripiprazole (LAI) on Phychosocial/Cognitive Functioning, pt Reported AcceptabilityofTreatment in Sch
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Nautralsitic, Open-label, Single Arm, Uncontrolled Study Evaluating the Effects of Long
      Acting Injectable (LAI) on Phychosocial Functioning Congitive Functioning and Patient
      Reported Acceptability of Treatment 'Reported Acceptability of Treatment' Regarding Quality
      of Life Subjective Well-being Under Neuroleptic Medication in Schizophrenia Patients
    

Detailed description: 
      Primary Objective

        -  To evaluate the efficacy of aripiprazole long acting injectable form in Turkish patients
           with schizophrenia on psychosocial functioning, quality of life and patient reported
           acceptability of treatment. Secondary Objective(s)

        -  To evaluate the cognitive functioning of the patients

        -  To evaluate positive and negative symptoms of the Aripiprazole Long Acting Injectable
           (LAI),

        -  To evaluate adherence of Aripiprazole Long Acting Injectable (LAI) treatment,

        -  To evaluate tolerability of Aripiprazole Long Acting Injectable (LAI).
    

Intervention name(s): Aripiprazole 400mg LAI
Intervention type(s): Drug
Intervention description(s): Aripiprazole 400mg, IM, Once a month
Other intervention name(s): ABILIFY
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Quality of Life; Functionality; Long Acting Injectable; Aripiprazole; Naturalistic; Open-label; Single Arm; Uncontrolled Study
Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) Vaccine
Condition: Infections, Cytomegalovirus
MeSH terms: Cytomegalovirus Infections
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the persistence of the vaccine induced immune
      responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy subjects who received 3 doses
      of GSK Biologicals' candidate CMV vaccine according to a 0-1-6 month schedule during the
      primary study 108890 (NCT00435396) (vaccine group). The immune response to CMV infection in
      naturally infected subjects who participated in the screening visit of the primary study
      108890 (NCT00435396) and who were tested CMV-seropositive, will be used as a reference value
      (seropositive reference group). In addition, this study will continue to assess the
      occurrence of CMV infections as well as the continued development and validation of read-outs
      in the CMV project.

      The primary vaccination phase and Year 2 follow-up were posted as a separate protocol posting
      (NCT00435396).
    

Detailed description: 
      During the long-term follow-up study, all subjects who received 3 doses of GSK Biologicals'
      candidate CMV vaccine according to a 0-1-6 month schedule during the primary study 108890
      (NCT00435396) will be invited to participate at Visit 8 (Year 4) and Visit 9 (Year 5) as the
      vaccine group. In addition, the healthy subjects who participated in the screening visit of
      the primary study 108890 (NCT00435396) and who were tested CMV-seropositive will be invited
      to Visit 9 (Year 5) of this study as the seropositive reference group.This Protocol Posting
      has been updated following Protocol Amendment 1, March 2012, leading to the update of brief
      summary, intervention model, enrolment, outcome measures, eligibility and arms.
    

Intervention name(s): Blood sampling; GSK149203A
Intervention type(s): Procedure; Biological
Intervention description(s): Blood samples will be collected at 2 time points:
At the long-term follow-up at approximately Month 48 of study (= ± 42 months post dose 3) from all subjects in the vaccine group.
At the long-term follow-up at approximately Month 60 of study (= ± 54 months post dose 3) from all subjects.; GSK Biologicals' Recombinant CMV glycoprotein B Vaccine, Intramuscular injection, 3 doses
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cytomegalovirus; Vaccine
A 2 Year Trial of Patients With Type 2 Diabetes Focusing on Cardiovascular Diagnostics and Metabolic Control
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purposes of this study are:

        -  to investigate the extent of cardiovascular complications in a representative cohort
           (n=135) of adult patients with type 2 diabetes;

        -  to examine if modern non-invasive assessment can replace invasive assessment;

        -  to determine the effects of a 6 month lifestyle interventional program on weight,
           glycemic control and lipids in 60 patients;

        -  to determine the effect of a 2-year prospective, randomised multi-interventional program
           (n=120) on cardiovascular risk, anthropometric measures and glycometabolic control; and

        -  to investigate inflammatory markers in this setting.
    

Detailed description: 
      As cardiovascular disease often is silent in type 2 diabetic patients, ways of detecting this
      early is of potential benefit, as is probably an aggressive treatment regimen trying to
      achieve goals for factors such as blood pressure, glycemic control, lipids, smoking, physical
      activity and weight.

      This study compares traditional non-invasive tests such as stress-ecg, modern non-invasive
      tests such as holter-analysis, modern ECG analysis, stress-ecco cardiography and tissue
      Doppler against the gold standard today for assessing coronary artery disease, coronary
      angiography, in patients with type 2 diabetes and at least one cv-risk factor (i.e smoking,
      premature familial coronary artery disease (CAD)), hypertension) irrespective of symptoms or
      signs of CAD.

      The participants are included in a randomized-control trial for 2 years where one arm
      receives standard treatment and one receives treatment after a multi-interventional program.

      End-points include: glycemic control, lipid control, weight control, blood pressure control,
      and effects on inflammatory parameters.
    

Intervention name(s): Combined lifestyle intervention and optimisation of pharmacological treatment
Intervention type(s): Drug
Intervention description(s): 6 months non-pharmacological treatment, 18 months with polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin)
standard care
Other intervention name(s): Combination of drugs (predefined) to reach treatment targets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Type 2 diabetes mellitus; Cardiovascular; Coronary artery disease; Glycemic control; Treatment; Diabetes Mellitus
Reminder Modality for CRC Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a randomized controlled trial that will evaluate the effectiveness of different
      reminder modalities for a population-based mailed FIT program at the VA Puget Sound among
      average risk Veterans who are due for annual colorectal cancer (CRC) screening.
    

Detailed description: 
      This is a prospective, randomized controlled trial that will evaluate the effectiveness of
      two different reminder modalities in improving adherence to annual CRC screening.

      Veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation
      using permuted block randomization (with random block sizes of 3 and 6) to the following
      interventions:

        1. Control arm: No reminder

           a. Intervention Type: No intervention

        2. Arm 2: Automated phone reminder

           a. Intervention Type: Standard reminder via phone (audiocare)

        3. Arm 3: Text reminder a. Intervention Type: Standard reminder via text (VEText)

      Randomization will be stratified within arms by prior screening status (prior screener vs.
      never screener)
    

Intervention name(s): Reminder Phone; Reminder Text
Intervention type(s): Other; Other
Intervention description(s): Standard reminder via phone (audiocare); reminder via text (VEText)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: Cancer screening; Adherence
Supplementation in Adolescent Girls With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether dietary supplementation with Vitamin D or
      Fish Oil can help to reduce physical and emotional symptoms in adolescent girls with
      endometriosis.
    

Detailed description: 
      This is a randomized controlled trial designed to evaluate the effect of dietary
      supplementation on endometriosis symptom remediation. Adolescent and young adults females
      aged 12 to 25 years with a surgically-confirmed diagnosis of endometriosis will be eligible
      for study participation. Subjects will be excluded if they have concurrent chronic illnesses
      that affect gastrointestinal absorption of nutrients (e.g., celiac disease, IBD, cystic
      fibrosis), a history of renal stones, are pregnant, or non-English speaking. Once consented,
      subjects will be randomized to one of 3 treatment assignments: 1) vitamin D3 2000 IU daily
      (n=30), 2) fish oil 1000 mg daily (n=30), 3) placebo (n=30) and will take these daily for 6
      months. Baseline nutrient intake from food and supplements will be assessed using the Food
      Frequency Questionnaire (FFQ). The 142 item survey assesses usual dietary intake during the
      past year. Validated rating scales including the visual analog scale (VAS), SF-36, and the
      World Endometriosis EPHect questionnaires will be used to measure pain and overall quality of
      life. The SF-36 measures 8 health concepts relevant across disease groups, including
      limitations to physical or social activities because of health problems, vitality, and
      general health perception. Patients will complete a full review of medication usage, past
      medical history, family history, and other lifestyle factors. Anthropometrics will be
      measured, and vital signs obtained. Measures will be repeated at 3-month intervals for a
      total of 6 months. Blood will be drawn at baseline, and at 6 months to measure levels of
      fatty acids, vitamin D, parathyroid hormone (PTH), and calcium.
    

Intervention name(s): Vitamin D3; Fish Oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Nature Made Vitamin D 2000IU, 1 softgel taken daily; Nature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily; Placebo capsule, 2 taken daily
Other intervention name(s): Nature Made Vitamin D 2000IU Liquid softgels; Nature Made ultra omega-3 mini fish oil 500mg, 2 daily; Placebo capsule
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adolescent; Endometriosis; Diet; Nutrition; Pain
Kalogon Pilot Fatigue and Comfort Study
Condition: B52 Pilot Fatigue and Comfort
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The goal of this experimental study is to compare 2 different seat cushions in B52 cockpit
      seats to see if they affect pilot fatigue and comfort. The main questions it aims to answer
      are:

        1. Does the Kalogon AF Prototype seat cushion improve pilot comfort compared to the
           standard seat cushion?

        2. Does the Kalogon AF Prototype seat cushion reduce pilot fatigue compared to the standard
           cushion?

      Participants will spend 8 hours in a simulated cockpit playing a flight simulator. They will
      fill out multiple questionnaires and take 2 attention/reaction time tests throughout the
      8-hours.
    

Detailed description: 
      Participants will be screened for eligibility and if they qualify will be asked to provide
      informed consent and sign a photo release. Participants will be asked to avoid caffeine
      consumption on the day of testing, wear comfortable clothing with no back pockets on the
      pants/shorts, and bring food and water for them to consume during testing.

      Once informed consent is given, they will be measured and weighed. They will then be given a
      flight suit to wear. Once they are in the flight suit, the first 5-minute Psychomotor
      Vigilance Task test (PVT) will be administered. Once completed, the participant will be
      strapped into the pilot seat.

      Once the participant is properly secured to the pilot seat, the 8-hour timer will be started
      and the first Subjective Fatigue Survey will be administered. Once the questionnaire is
      completed they will begin playing the flight simulator. Participants will be encouraged to
      minimize bathroom breaks and will be given specific times to eat. At the 4-hour mark, the
      second Subjective Fatigue Survey will be administered. At the end of the 8 hours, a second
      PVT will be administered, followed by the final Subjective Fatigue Survey.
    

Intervention name(s): Kalogon AF Prototype Smart Cushion; Standard Seat Cushion from Air Force
Intervention type(s): Device; Device
Intervention description(s): The Kalogon cushion is a dynamic smart cushion that utilizes a combination of foam and 5 adjustable air cells to intelligently redistribute weight and increase comfort for users. The air cells are used to modulate interface pressures and adjust where support or pressure reductions are provided based on input from the controller's pressure sensing system.; This is the standard seat cushion that was provided by the United States Air Force to use for this study. It is a high-density, molded polyurethane foam.
Other intervention name(s): Kalogon; Standard
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: B52 Pilot; US Air Force; Comfort; Fatigue; Dynamic cushion
Microparticles, Vector of Genetic Information During HIV Infection
Condition: HIV,
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The aim of the investigators study is to demonstrate in healthy subjects and a cohort of
      patients infected with HIV, the presence of miRNAs in circulating peripheral blood
      microparticles (MPs).
    


Intervention name(s): Blood samples
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to investigate meal-related treatment with either premixed Insulin
      Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free
      fatty acids excursions after a standard breakfast and lunch.
    

Detailed description: 
      Whereas the effects of each of the established types of insulin (remixed Insulin Aspart 30,
      Aspart 70 and Aspart) have been shown before, their specific glucose and lipid lowering
      capacities have so far not been investigated in a simulated physiological situation.
    

Intervention name(s): Insulin Aspart; Insulin Aspart 30; Insulin Aspart 70
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients received insulin aspart before breakfast and before lunch.; Patients received biphasic insulin aspart 30 before breakfast and before lunch.; Patients received biphasic insulin aspart 70 before breakfast and before lunch.
Other intervention name(s): Novorapid; Novomix 30; Novomix 70
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insulin aspart 30; insulin aspart 70; insulin aspart; postprandial glucose and lipid metabolism; consecutive mixed meals
A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma
Condition: Hodgkin Disease
MeSH terms: Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate if the addition of Bortezomib (Velcade) to IGEV
      combination (Ifosfamide, Gemcitabine and Vinorelbine) in patients with relapsed/refractory
      Hodgkin's lymphoma increases the rate of complete remission (PET negativity) at
      transplantation.
    


Intervention name(s): Ifosfamide, Gemcitabine, Vinorelbine; Bortezomib + IGEV
Intervention type(s): Drug; Drug
Intervention description(s): Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.; Bortezomib 1,3 mg/sqm, day 1, 4, 8; Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.
Intervention MeSH terms: Gemcitabine; Bortezomib; Vinorelbine; Ifosfamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin disease; Salvage therapy; Bortezomib; Transplantation
The CBF Study Evaluating the Effect of Betahistine on the Cerebral Blood Flow
Condition: Gait or Balance Disorder Problems
Study type: Interventional
Phase: Phase 4

Summary: 
      Betahistine may provide benefit by enhancement of Cerebral Blood Flow (CBF). This
      placebo-controlled pharmacodynamic treatment study will primarily explore the effect of
      betahistine on cerebral blood flow measured by dynamic contrast-enhanced MRI imaging, in a
      patient population with MRI evidence of cerebrovascular compromise. Also it will be measured
      if CBF changes correlate with gait and cognitive changes.
    


Intervention name(s): betahistine dihydrochloride; placebo
Intervention type(s): Drug; Other
Intervention description(s): betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment; placebo tablets b.i.d., six weeks treatment
Other intervention name(s): Agiserc®
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: interventional,placebo controlled
Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD) Who Received Anti-vascular Endothelial Growth Factor (VEGF) Agents (Komodo Health)
Condition: Age-related Macular Degeneration (AMD)
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      This was the cross-sectional study to assess the period prevalence of IOI in patients with
      wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year
      period in 2019.
    

Detailed description: 
      In this cross-sectional study of patients with wet AMD who received ≥1 anti-VEGF injection
      (excluding brolucizumab), evidence was generated to describe the period prevalence of
      specific ocular AEs. The study was conducted using the Komodo Healthcare Map, and all results
      were based on the study period from 01/01/2018 to 12/31/2019.

      Komodo Healthcare Map data from 01/01/2018 to 12/31/2019 for patients with a diagnosis of wet
      AMD who were treated with ≥1 anti-VEGF agent (excluding brolucizumab) were included.

        -  Identification period: Patients fulfilling the selection criteria during the period from
           01/01/2019 to 12/31/2019 were identified

        -  Index date: 01/01/2019

        -  Study Period: 01/01/2018 to 12/31/2019

        -  Pre-index period: 01/01/2018 to 12/31/2018

        -  Post-index period: 01/01/2019 to 12/31/2019
    

Intervention name(s): Aflibercept; Ranibizumab; Bevacizumab
Intervention type(s): Other; Other; Other
Intervention description(s): intravitreal injection; intravitreal injection; intravitreal injection
Other intervention name(s): EYLEA®; LUCENTIS®; AVASTIN®; off-label use
Intervention MeSH terms: Bevacizumab; Ranibizumab; Aflibercept
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study included patients with wet AMD who received ≥1 anti-VEGF injection (excluding
        brolucizumab)
      
Keywords: AMD,; brolucizumab,; anti-VEGF switchers,; treatment-naive