bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Immunogenicity And Efficacy Of Vaccination In Military Personnel
Condition: Vaccination Adverse Events; Vaccination Failure; Specific Antibody Response
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if multiple vaccination in military personnel may
      be correlated with the appearance of poorly defined diseases as symptomatic multisyndrome,
      autoimmune or lymphoproliferative disorders. At the same time, considering possible
      interference between different vaccines, proteins and polysaccharides, living and
      inactivated, the study aims to assess the immunogenicity and efficacy also in relation to the
      specific Human Leucocyte Antigens (HLA) genetic structure.
    


Intervention name(s): biological monitoring
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with
      non-small cell lung cancer who have failed first-line chemotherapy for advanced disease.
      Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no
      preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated
      time on study treatment is until disease progression or intolerable toxicity, and the target
      sample size is 100-500 individuals.
    


Intervention name(s): Doxycline; erlotinib [Tarceva]
Intervention type(s): Drug; Drug
Intervention description(s): 100mg po daily; 150mg po daily
Intervention MeSH terms: Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD
Condition: Chronic Obstructive Pulmonary Disorder
MeSH terms: Lung Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung
      function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320
      μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
    

Detailed description: 
      This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung
      function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320
      μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to
      4-week Screening Period. Subjects who successfully complete the Screening Period will be to
      one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg
      BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following
      randomization, subjects will enter the Treatment Period and undergo additional treatment
      visits over 24 weeks.
    

Intervention name(s): BFF MDI 320/9.6 μg; BFF MDI 160/9.6 μg; FF MDI 9.6 μg; BD MDI 320 μg; Symbicort® TBH 400/12 μg BID
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Blinded Treatment; Blinded Treatment; Blinded Treatment; Blinded Treatment; Open Label
Other intervention name(s): Budesonide and Formoterol Fumarate Inhalation Aerosol; Budesonide and Formoterol Fumarate Inhalation Aerosol; Formoterol Fumarate Inhalation Aerosol; Budesonide Inhalation Aerosol; Symbicort® Turbuhaler
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
Condition: Amblyopia; Strabismus
MeSH terms: Amblyopia; Strabismus
Study type: Observational

Summary: 
      The purpose of this project is to compare the performance of the Pediatric Vision Scanner
      (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at
      detecting amblyopia and strabismus.
    


Intervention name(s): Pediatric Vision Scanner
Intervention type(s): Device
Intervention description(s): Subject is scanned with a 2.5 second pediatric vision scanner device test.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children presenting for ophthalmic exam at eye clinic.
Clinical Reminder Changes to Increase Smoking Cessation Treatment in Outpatient Psychiatry
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      This study will use a scientifically robust, mixed-methods, two-arm cluster-randomized study
      design. Investigators will implement a tobacco use clinical reminder for outpatient
      psychiatrists practicing at the VA New York Harbor Healthcare System (N = 20). Half of the
      psychiatrists will receive a reminder that encourages the psychiatrist to offer cessation
      medications and referral to cessation counseling to patients interested in quitting (Opt-In
      Reminder). The other half will receive a clinical reminder that includes a standing nicotine
      replacement therapy (NRT) order and a referral to cessation counseling that will
      automatically generate unless the provider actively opts-out (Opt-Out Reminder). Prior to
      implementation of the reminders, psychiatrists in both arms will receive a one-hour training
      on tobacco treatment and individual education outreach to demonstrate the clinical reminder
      and answer questions (academic detailing).
    


Intervention name(s): Opt-Out Reminder; Opt-In Reminder
Intervention type(s): Behavioral; Behavioral
Intervention description(s): half will receive a clinical reminder that includes a standing NRT order and a referral to cessation counseling that will automatically generate unless the provider actively opts-out; Half of the psychiatrists will receive a reminder that encourages the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arm cluster randomized study design
Masking: None (Open Label)
Primary purpose: Treatment
Early Detection of COVID-19 Using Breath Analysis
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY
    

Detailed description: 
      Primary objective- to identify and evaluate a set of biomarkers that represent both the
      genetic expression of the virus itself (SARS-CoV-2) and the metabolic activity of the immune
      system's response to the virus.
    

Intervention name(s): Breath biopsy sampling using the ReCIVA Breath Sampler
Intervention type(s): Diagnostic Test
Intervention description(s): Breath biopsy sampling using the ReCIVA Breath Sampler
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Argireline in Treatment of Periorbital Wrinkles
Condition: Wrinkles
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether La Jolie gel is effective in the treatment
      of periorbital wrinkles.
    

Detailed description: 
      Argireline has mechanism of action that significantly inhibited neurotransmitter release with
      a potency similar to that of BoNTA. Inhibition of neurotransmitter release was due to the
      interference of the hexapeptide with the formation and/or stability of SNARE complex.
      Notably, this peptide did not exhibit in vivo oral toxicity nor primary irritation at high
      doses. These findings demonstrate that Argireline is a anti-wrinkle peptide that emulates the
      action of currently used BoNTs.

      In vivo study, Topical Argireline 10% is applied on lateral preorbital area twice daily for
      30 days. The result demonstrates a significant anti-wrinkle activity by decreased skin
      wrinkle 30%. These findings demonstrate a significant anti-wrinkle activity for Argireline,
      in agreement with its in vitro and cellular activities. Topical Argireline represents a
      bio-safe alternative to BoNTs in anti-wrinkle therapy.
    

Intervention name(s): 10% Argireline
Intervention type(s): Drug
Intervention description(s): 10% Argireline (La jolie gel®, Pacific health care, Thailand) were instructed to apply the gel over the face and periorbital area twice daily for a period of 3 months.
Other intervention name(s): 10% Argireline (La jolie gel®)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periorbital wrinkles; Efficacy and safety
IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD
Condition: GVHD; Ocular Rosacea; Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Rosacea
Study type: Interventional

Summary: 
      The purpose of this study was to see if Intense Pulsed Light (IPL) can be used safely and
      effectively to help treat dry eyes from ocular rosacea after chronic graft-versus-host
      disease (GVHD). Current treatment options for this disease are limited.
    

Detailed description: 
      Ocular rosacea and meibomian gland disease are major contributors to keratoconjunctivitis
      sicca after chronic GVHD. Rosacea exacerbates the aqueous deficiency caused by damage to
      lacrimal and accessory lacrimal glands similar to cholestasis damage in the biliary system.

      Subjects who had inactive chronic GVHD after allogeneic bone marrow transplantation and
      severe dry eye symptoms related to ocular rosacea were recruited and treated with 4 monthly
      sessions of IPL and meibomian gland expression. Their charts were reviewed prior to treatment
      to confirm quiescence of active systemic disease. Symptom scores were quantified with Ocular
      Surface Disease Index (OSDI) and Standard Patient Evaluation of Eye Dryness questionnaire
      (SPEED2). Baseline complete eye exam was performed, and subjects received an eyes assessment
      score based on the Chronic Graft-Versus-Host Disease (GVHD) Assessment and Scoring Form.

      Symptoms, exam, and diagnostic data were obtained at baseline (month 0, month 1, month 2,
      month 3, month 4, month 5, month 6, month 9 and month 12). IPL treatment and meibomian gland
      expression was performed at baseline (month 0), month 1, month 2, and month 3.
    

Intervention name(s): IPL; Meibomian Gland Expression
Intervention type(s): Device; Procedure
Intervention description(s): Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.; After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of ARTISS for Flap Adherence in Abdominoplasty
Condition: Seroma; Hematoma
MeSH terms: Hematoma; Seroma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of
      care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing
      abdominoplasty.
    


Intervention name(s): FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma); Standard of care
Intervention type(s): Biological; Procedure
Intervention description(s): Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.; Standard of care
Other intervention name(s): ARTISS
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Abdominoplasty; Flap adherence in subjects undergoing abdominoplasty to eliminate dead space and reduce seroma/hematoma formation
A Study to Evaluate the Safety and Tolerability of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, randomized, blinded, placebo-controlled study in up to 20 overweight or
      obese participants with type 2 diabetes mellitus. The participants will participate in the
      study for approximately 18 weeks, including screening, run-in and treatment periods and a
      safety follow-up.
    


Intervention name(s): MEDI0382; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous dose of MEDI0382 will be up-titrated weekly once daily up to 8 weeks during the uptitration period and thereafter once daily in 3-week TEP.; Subcutaneous dose of placebo matched to MEDI0382 will be administered once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week TEP.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MEDI0382, diabetes, obesity, overweight, type 2 diabetes mellitus
Perineal Preparation for Pregnant Ladies.
Condition: Delivery; Trauma; Pelvic Floor; Perineal Rupture, Obstetric; Pelvic Floor Muscle Weakness
MeSH terms: Muscle Weakness; Rupture
Study type: Interventional

Summary: 
      Pregnant participants will be recruited at the obstetrics outpatient clinic during their
      visits 4 weeks before the due date. They are randomized into two groups. The first group will
      be educated to do digital perineal massage. They will be also educated to do pelvic floor
      muscle exercises and will receive the usual education program for strengthening the pelvic
      floor. The second group will receive the usual education program for strengthening the pelvic
      floor. Occurrence of perineal laceration will be reported at time of delivery.
    

Detailed description: 
      Pregnant participants will be recruited at the obstetrics outpatient clinic during their
      visits 4 weeks before the due date. They are randomized into two groups. The first group will
      be educated to do digital perineal massage. They will be also educated to do pelvic floor
      muscle exercises and will receive the usual educational pelvic floor dysfunction prevention
      program for strengthening the pelvic floor. The second group will receive the usual education
      program for strengthening the pelvic floor. Occurrence of perineal laceration will be
      reported at time of delivery.
    

Intervention name(s): 3 program; one program
Intervention type(s): Other; Other
Intervention description(s): The participants will receive 3 programs.The educational pelvic floor dysfunction prevention program, pelvic floor muscle exercise program and perineal massage program will be educated by an investigator during the participant visit 4 weeks before her due date; The participants will receive one program. That is the educational pelvic floor dysfunction prevention program.The instructions of the program will be given by an investigator once during the participant visit 4 weeks before her due date.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: perineal massage; health education; perineal tear; episiotomy; pelvic floor muscle exercise
Physiologic Interactions Between the Adrenal- and the Parathyroid Glands
Condition: Osteoporosis; Vitamin D Deficiency; Cardiovascular Disease
MeSH terms: Osteoporosis; Cardiovascular Diseases; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate possible physiologic interactions between the adrenal- and the parathyroid
      glands in patients with secondary hyperparathyroidism.
    

Detailed description: 
      In primary hyperparathyroidism, chronic-elevated PTH levels seem to stimulate the
      renin-angiotensin-aldosterone system (RAAS) which may explain the increased risk of
      cardiovascular disease. In addition to increased PTH levels, vitamin D has been shown to
      inhibit the RAAS. However, a possible physiologic interaction needs further investigation.

      The purpose of the study is to investigate changes in the RAAS in otherwise healthy
      postmenopausal women with secondary hyperparathyroidism due to vitamin D deficiency when
      p-PTH is normalized.

      Furthermore, we will evaluate whether an angiotensin 2 receptor blocker can lower PTH in
      patients with secondary hyperparathyroidism.
    

Intervention name(s): Valsartan; Placebo Valsartan; Cholecalciferol; Placebo cholecalciferol
Intervention type(s): Drug; Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): 2 weeks of Valsartan 80 mg per day; 2 weeks of Placebo Valsartan, one tablet per day. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.; 12 weeks of daily cholecalciferol treatment, 70 microgram per day; 12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.
Other intervention name(s): Vitamin D3; Placebo D3
Intervention MeSH terms: Vitamin D; Cholecalciferol; Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB086550
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the absorption, metabolism, and excretion of 86550-106 in healthy males.
    

Detailed description: 
      The purpose of this study is to determine the absorption, metabolism, and excretion of a
      single oral dose of 400 mg (4x100 mg tablets) of INCB086550 followed by an oral dose solution
      of approximately 100 μCi (3.7 MBq) [14C]-INCB086550 and to characterize and determine the
      metabolites present in plasma, urine, and, where possible, feces in healthy male participants
      .
    

Intervention name(s): INCB086550
Intervention type(s): Drug
Intervention description(s): INCB086550 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteers; male only
Assess the Feasibility of Cone Beam CT to Localize Liver Metastases Immediately Prior to Radiotherapy
Condition: Localize Liver Metastases
MeSH terms: Neoplasm Metastasis; Liver Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to test a new and possibly more accurate method of positioning
      patients with liver tumors in preparation for radiation treatment.

      The positioning of patients with liver cancer is important because the tumor moves a bit when
      you breathe and makes it hard to determine the right position of the tumor at the time of
      treatment. Also, depending upon what is in your stomach at the time of treatment, it may
      change the shape of the liver and make it difficult to plan the radiation treatment. As part
      of this study, we will take a new type of image of your liver in addition to the standard
      portal images. This new type of image is called a cone-beam image. It shows a much more
      detailed picture of the liver tumors than the standard portal images. Normally, marker seeds
      need to be placed near the liver metastasis for radiation treatment. If the results of this
      study show that the tumor can be positioned as accurately with the new images as with the old
      images, then future patients with liver tumors would not have to have marker seeds placed
      into their liver. The use of cone beam imaging for the setup of patients with liver tumors is
      new.
    


Intervention name(s): cone beam imaging
Intervention type(s): Radiation
Intervention description(s): All study patients will undergo simulation, treatment planning and verification as currently practiced. The contrast injection and cone beam imaging will be added to the standard procedure just prior to treatment delivery on the first and last days of treatment only.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Radiation Therapy
Relative Bioavailability of Epinastine Syrup Compared to Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of two galenic formulations for epinastine (Flurinol®): syrup
      and 20 mg tablets
    


Intervention name(s): Epinastine syrup; Epinastine tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Epinastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Uphold LITE Post-Market Surveillance Study
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      The purpose of this study is to compare transvaginal mesh repair to traditional native tissue
      repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
    

Detailed description: 
      The primary objective is to evaluate clinical effectiveness of transvaginal repair with mesh
      (Uphold LITE) against traditional native tissue repair in women surgically treated for
      anterior and/or apical pelvic organ prolapse. Secondary objectives are to evaluate Uphold
      LITE-related complications and subject reported outcomes.

      The primary endpoint of the study is to achieve superiority of transvaginal repair with mesh
      (Uphold LITE) over native tissue repair at 36 months as compared to baseline. Success will be
      based on a composite of objective and subjective measures.

      Additionally, a co-primary endpoint of the study is to achieve non-inferiority of
      transvaginal repair with mesh (Uphold LITE) to native tissue repair for safety by comparing
      rates of serious device or serious procedure related complications between baseline and the
      36 month time point.

      The secondary endpoints of the study include assessments of complications and subject
      reported outcomes.
    

Intervention name(s): Uphold Lightweight Vaginal Support System; Traditional native tissue repair
Intervention type(s): Device; Procedure
Intervention description(s): Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE); Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Other intervention name(s): Uphold LITE
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: POP; Transvaginal; Native Tissue Repair; Repair Augmented with Mesh; Pelvic Organ Prolapse