bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
Condition: Upper Respiratory Tract Infection; Nasal Congestion; Rhinorrhea; Sneezing
MeSH terms: Respiratory Tract Infections; Rhinorrhea; Sneezing
Intervention: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets; Paracetamol (500 mg) tablets
Intervention description: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets; Paracetamol (500 mg) tablets
Intervention MeSH terms: Acetaminophen; Dimethindene; Phenylephrine; Oxymetazoline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Paracetamol; dimethindene maleate; phenylephrine hydrochloride; cold and flu symptoms

Summary:

      The study is a clinical evaluation of an over the counter (OTC) combination product
      containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10
      mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea,
      sneezing and other symptoms due to upper respiratory tract infection (URTI).
    

Eligibility criteria:

        -  Inclusion criteria:

             • acute URTI, diagnosed by a health care professional at the study site, with the
             following symptoms having started within 72 hours before the screening/baseline Visit:
             nasal congestion, sneezing, and rhinorrhea.

          -  Exclusion criteria:

               -  Use of other investigational drugs within 30 days or 10 half-lives before
                  enrollment, whichever is longer.

               -  History of or known hypersensitivity to any of the study drugs, excipients or to
                  drugs of similar chemical classes.

        Other protocol-defined inclusion/exclusion criteria may apply
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Apremilast 20mg; Apremilast 30mg; Placebo + 20 mg Apremilast; Placebo + 30 mg Apremilast
Intervention description: Apremilast 20 mg twice daily, orally; Apremilast 30 mg twice daily, orally; Placebo + 20 mg Apremilast; Placebo + 30 mg Apremilast
Intervention MeSH terms: Thalidomide; Apremilast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 504.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Psoriasis; Arthritis; inflammation; skin condition; inflammatory cells; apremilast; CC-10004; phosphodiesterase type 4

Summary:

      The purpose of this study is to determine whether apremilast is safe and effective in the
      treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms
      of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, aged ≥ 18 years at time of consent.

          -  Have a diagnosis of Psoriatic Arthritis (PSA, by any criteria) of ≥ 6 months duration.

          -  Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at time of
             screening.

          -  Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)

          -  May not have axial involvement alone

          -  Concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine

          -  Have ≥ 3 swollen AND ≥ 3 tender joints.

          -  Males & Females must use contraception

          -  Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose
             oral corticosteroids allowed.

        Exclusion Criteria:

          -  Pregnant or breast feeding.

          -  History of allergy to any component of the investigational product.

          -  Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.

          -  Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF)
             blocker
Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Lavender Essential Oil
Intervention description: Lavender essential oil will be applied topically and by inhalation to the lavender group.
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized study with control group and test group. Using a 1:1 treatment allocation ratio, the total of 60 patients (30 per arm) will be randomly assigned to control or treatment arm. The Statistical Investigator will generate the randomization scheme and monitor the randomization process over the course of the trial. The study will use randomization with random permuted blocks. The test group will receive 50% lavender oil diluted in fractionated coconut oil and the control group will have the current standard of care with no essential oil intervention. Fractionated coconut oil is being used because it is colorless, odorless, does not stain clothing, and has a long shelf life. It also serves as a carrier oil for the essential oil to absorb into the skin instead of evaporating off the skin due to essential oils volatile nature.
Masking: None (Open Label)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This project will evaluate the integration of lavender essential oil in surgical patients
      during the perioperative and postoperative phase of care. The study will assess patients'
      pain, sleep quality, and mood. The goal is to support that lavender oil will decrease pain
      scores and narcotic use, increase sleep quality, and decrease anxiety by improving overall
      patient satisfaction and supporting their natural sense of well being. This research project
      will help support the use of complementary medicine in a hospital setting. The increased
      awareness and use of complementary medicine in a hospital setting will strengthen the patient
      centered care model that all hospitals strive to achieve.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing any form of breast reconstruction therapy

          -  Ages 18-85

          -  At least a one night stay in hospital after surgery

        Exclusion Criteria:

          -  Use of sleeping aide drugs

          -  Use of benzodiazepines

          -  History of any of the following: asthma, eczema, allergy to flowers, smell disorders

          -  Sensitivity to lavender oil or any of its ingredients

          -  Pregnant women will be excluded from the study. During routine preoperative testing
             the patient's menstrual history or urine pregnancy test will be performed to identify
             any patient who is pregnant.
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
Condition: Paget's Disease of Bone
MeSH terms: Bone Diseases; Osteitis Deformans
Intervention: Zoledronic Acid; Risedronate; Placebo to Risedronate; Placebo to Zoledronic Acid; Calcium and Vitamin D
Intervention description: Zoledronic acid 5 mg in 5 mL of sterile water intravenous infusion.; Oral risedronate 30 mg capsules.; Oral placebo of risedronate capsules.; 5 mL of sterile water one dose intravenous infusion.; Calcium and vitamin D supplements were supplied.
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Risedronic Acid; Etidronic Acid; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Bisphosphonate; SAP; SAP excess; non-inferiority; therapeutic response; extended observation period

Summary:

      The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.)
      infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone.
      The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The
      extended observation period included participants of the core study who responded to
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  30 years or older

          -  Serum alkaline phosphatase (SAP) 2 times upper limit normal (ULN)

          -  Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance
             imaging, computerized tomography, radioisotope imaging, etc.).

          -  90 days washout calcitonin

          -  180 day washout bisphosphonate

        Exclusion Criteria:

          -  Allergic reaction to bisphosphonates

          -  History of upper gastrointestinal disorders

          -  History of iritis, uveitis

          -  Calculated creatinine clearance < 30 ml/min at baseline

          -  Evidence of vitamin D deficiency

        Other protocol-defined inclusion/exclusion criteria applied.
A Study of Ruxolitinib in Pancreatic Cancer Patients
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Ruxolitinib; Placebo; Capecitabine
Intervention description: 5 mg tablets to be administered by mouth twice daily (BID); 5 mg matching placebo tablets to be administered by mouth twice daily (BID); 150 mg or 500 mg tablets to be administered by mouth twice daily (BID)
Intervention MeSH terms: Capecitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic pancreatic cancer

Summary:

      This was to determine the efficacy, based upon overall survival, of ruxolitinib added to
      capecitabine for the treatment of metastatic pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas.

          -  Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

          -  Received 1 prior chemotherapy regimen for advanced or metastatic disease (not
             including neoadjuvant and/or adjuvant therapy).

          -  ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants
             must have recovered or be at a new stable baseline from any related toxicities.

          -  Radiographically measurable or evaluable disease

          -  An modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

               -  Criteria:

                    1. mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin ≥ 35 g/L

                    2. mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L

        Exclusion Criteria:

          -  Received more than 1 prior regimen for advanced or metastatic disease.

          -  Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment

          -  Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery,
             immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor
             embolization).

          -  Current or previous other malignancy within 2 years of study entry without sponsor
             approval

          -  Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase
             deficiency (DPD), or other known hypersensitivity to active substances, including
             fluorouracil (5-FU), ruxolitinib, or any of their excipients.

          -  Prior treatment with a JAK inhibitor for any indication.
Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.
Condition: Sore Throat Due to a Common Cold
MeSH terms: Respiratory Tract Infections; Pharyngitis; Common Cold
Intervention: Lidocaine 8mg + CPC 2mg; Lidocaine 1mg + CPC 2mg
Intervention description: one single dose; one single dose
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sore throat, upper respiratory tract infection, lozenge with lidocaine and cetylpyridinium chloride.

Summary:

      This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg +
      cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg
      lozenge in the treatment of sore throat due to a common cold.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with sore throat due to an upper respiratory tract infection, with recent
             onset (within 48 hours)

          -  Sore throat of at least moderate pain intensity

        Exclusion Criteria:

          -  - History of hypersensitivity to any of the study drugs and listed excipients or to
             drugs of similar chemical classes

          -  Evidence of mouth breathing or severe coughing

          -  Evidence of overt oropharyngeal bacterial or fungal infection or evidence of lower
             respirator tract infection

          -  Severe renal, liver or cardiac impairment

          -  Severe lung disease
Zanamivir Versus Trivalent Split Virus Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluviral; Zanamivir
Intervention description: One dose; 10 mg, OD, for duration of influenza season (10-23 weeks)
Intervention MeSH terms: Zanamivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: antiviral drugs; influenza vaccines

Summary:

      This unblinded pilot study is intended to assess the feasibility of a larger double-blind,
      randomized control trial. For the larger trial the investigators are interested in
      understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors
      for influenza infection in healthy adults, and in assessing the safety and tolerability of
      seasonal antiviral prophylaxis in healthcare workers.

      The pilot study will be assessing the rate of infection with influenza and the rate of
      adherence to long-term zanamivir in 60 healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-69 years old as of 01/Nov/2008

          -  have an understanding of the study, agree to its provisions, and give written informed
             consent prior to study entry

          -  available for follow-up during the study period

          -  if a women of child-bearing years, must meet criteria to prevent pregnancy

        Exclusion Criteria:

          -  allergy to any component of influenza vaccine or zanamivir

          -  previous serious adverse event associated with influenza vaccination

          -  receipt of influenza vaccine between 01/Mar/2008 and start of study

          -  previous adverse event associated with the use of antiviral medications

          -  expecting to be unable to take zanamivir for more than 72 hours during study period

          -  planning to spend more than 2 consecutive weeks outside Canada or more than 100 km
             from the study site during study period

          -  pregnant, or planning to become pregnant, during study period

          -  breastfeeding, or planning to breastfeed, a child under 12 months of age during study
             period

          -  receipt of immunoglobulin within six months of study entry

          -  immunocompromising condition or therapy that would be expected to reduce the efficacy
             of vaccination

          -  plans to receive cytotoxic or radiation therapy during study period

          -  history of cardiovascular or pulmonary disease that has required hospital admission
             within the past year

          -  history of asthma or other chronic respiratory disease

          -  participating in a trial that will result in the receipt of an investigational
             medication during the period that zanamivir may be taken (15/Nov/2008 to 30/Apr/2009)
Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: PRO-067; GAAP Ofteno®
Intervention description: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.; 1 drop QD during 30 days Active comparator, reference medication.
Intervention MeSH terms: Latanoprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Latanoprost; Glaucoma; Ocular hypertension; Crossover study

Summary:

      Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by
      Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensive
      therapy in subjects with primary open angle glaucoma or ocular hypertension.

      Study design: a multicentric, prospective, crossover (2x2), double blind clinical study.
      Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension.
      Patients in the period 1: In the first sequence 60 patients will be assigned to receive the
      ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop per day (QD) during 30 days
      and the second sequence 60 patients will be assigned to receive the ophthalmic solution:
      PRO-067 1 drop QD during 30 days in the same period. Washout period: 21 hours. Patients in
      the period 2: the pharmacological intervention change to the opposite therapy for 30 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male

          -  Age: ≥18 years old

          -  Patients with primary open angle glaucoma with mild to moderate damage or ocular
             hypertension that were sufficiently controlled with GAAP Ofteno® (latanoprost 0.005%)
             within the last 60 days

          -  Signed Informed Consent Form

        Exclusion Criteria:

          -  Subjects with unique eye

          -  Subjects with visual acuity < 20/200

          -  Another kind of glaucoma disease different to primary open angle glaucoma

          -  corneal disturbances with impossibility to measure the intraocular pressure

          -  retinal alterations without control or progressive retinal disease with high risk to
             lost vision
18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 18F-fluciclovine PET CT
Intervention description: Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 221.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent
      prostate cancer after curative-intent primary therapy and negative or equivocal findings on
      standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine
      PET/CT. Site clinicians will manage study subjects per standard practices and will document
      any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants
      will be followed for up to 6 months, with clinical data collected for this study. An
      interdisciplinary panel will provide expert guidance to local readers on request. The final
      reporting of the PET/CT scan will be a single report by the local reader following any such
      discussion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of histologically confirmed adenocarcinoma of the prostate post
             curative-intent local treatment (radical prostatectomy, local radiotherapy,
             brachytherapy).

          -  Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy
             for organ confined disease defined as :

          -  Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second
             confirmatory level of >0.2 ng/mL

          -  Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir

          -  Negative or equivocal findings on standard-of-care imaging for restaging of disease in
             the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT;
             and either CT or MRI of the pelvis (or the abdomen and pelvis).

          -  Being considered for salvage therapy

          -  Any non-surgical local treatment such as previous cryotherapy, external beam
             radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.

          -  Previous brachytherapy treatment will have occurred at least 2 years in the past

          -  Ability to understand and the willingness to sign a written informed consent.

        Exclusion Criteria:

          -  Ongoing treatment with any systemic therapy intended for the treatment of prostate
             cancer (e.g., antiandrogen or LHRH agonist or antagonist)

          -  Androgen deprivation therapy (ADT) in the past 3 months

          -  History of bilateral orchidectomy

          -  Inability to tolerate 18F-fluciclovine PET/CT