bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-118 Lotion
Intervention description: IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 555.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the long-term safety of IDP-118 lotion.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Has an area of plaque psoriasis appropriate for topical treatment that covers a Body
             Surface Area (BSA) of at least 3 percent (%), but no more than 12%. The face, scalp,
             palms, soles, axillae and intertriginous areas are to be excluded in this calculation.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigators
             Global Assessment (IGA) score of 3 or 4 (The face, scalp, palms, soles, axillae and
             intertriginous areas are to be excluded in this assessment).

        Key Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             Investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently
             participating in another clinical study with an investigational drug or device.
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel
Condition: Adult Male Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone gel (FE 999303)
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone
      concentrations <300 ng/dL. The purpose of this study is to evaluate the safety and efficacy
      of testosterone gel (2%) delivered using an applicator.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males between 18-75 years of age

          2. Two screening serum testosterone values less than 300 ng/dL

          3. One or more symptoms of testosterone deficiency

        Exclusion Criteria:

          1. Previous use of the investigational product

          2. Use of any investigational product within 30 days prior to screening and during the
             study

          3. BMI less than 18 kg/m^2 or more than 35 kg/m^2

          4. Prostatic mass(es)

          5. Generalized skin irritation or skin disease

          6. Lower urinary tract obstruction

          7. Myocardial infarction or cerebrovascular accident in the last 6 months

          8. Unstable angina or congestive heart failure

          9. Thromboembolic disorders

         10. Sleep apnea

         11. Hyperparathyroidism or uncontrolled diabetes

         12. Untreated moderate to severe depression

         13. History of testicular, prostate, or breast cancer

         14. HIV, Hepatitis B, or Hepatitis C positive

         15. PSA more or equal to 3 ng/mL

         16. Use of any medications that could be considered anabolic

         17. Use of estrogens, Gonadotropin Releasing Hormone agonists/antagonists, antiandrogens,
             or human Growth Hormone

         18. Chronic use of any drug of abuse

         19. Involvement in a sport in which there is a screening for anabolic steroids

         20. Not willing to use adequate contraception during the study

         21. Partner is pregnant and/or breast feeding

         22. Partner has a history of breast, uterine or ovarian cancer
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CT-P17 SC AI (adalimumab)
Intervention description: Subcutaneous Injection of Adalimumab 40mg once every two weeks
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With
      Active Rheumatoid Arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient aged 18 to 70 years, inclusive.

          -  Patient must be able and willing to self-administer subcutaneous (SC) injections via
             auto injector (AI).

        Exclusion Criteria:

          -  Patient who has previously received investigational or licensed product; biologic or
             targeted synthetic disease-modifying antirheumatic drugs for the treatment of
             rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any
             purposes.

          -  Patient who has allergies to any of the excipients of study drug or any other murine
             and human proteins, or patient with a hypersensitivity to immunoglobulin products.
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: fostamatinib; fostamatinib; placebo
Intervention description: fostamatinib 100 mg twice daily; fostamatinib 100 mg twice daily/150 mg once daily; Placebo twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The purpose of the study is to evaluate the effectiveness of two dosing regimens of
      fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking
      methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study
      will last for approximately six months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active rheumatoid arthritis (RA) diagnosed after the age of 16

          -  Currently taking methotrexate

          -  6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and
             either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or
             C-Reactive Protein (CRP) blood result of 10mg/L or more

          -  At least one of the following: documented history of positive rheumatoid factor (blood
             test), current presence of rheumatoid factor (blood test), radiographic erosion within
             12months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide
             antibodies (blood test)

        Exclusion Criteria:

          -  Females who are pregnant or breast feeding

          -  Poorly controlled hypertension

          -  Liver disease or significant liver function test abnormalities

          -  Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue
             diseases or chronic pain disorders

          -  Recent or significant cardiovascular disease

          -  Significant active or recent infection including tuberculosis

          -  Previous failure to respond to anakinra or previous treatment with biological agent
             (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)

          -  Severe renal impairment

          -  Neutropenia
To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
Condition: RA
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Sarilumab; Auto-Injector Device (AID); Pre-filled Syringe (PFS); Methotrexate; Sulfasalazine; Leflunomide; Hydroxychloroquine
Intervention description: Pharmaceutical form: Solution Route of administration: Subcutaneous; Dispensed according to local practice.; Dispensed according to local practice.; Dispensed according to local practice.; Dispensed according to local practice.
Intervention MeSH terms: Hydroxychloroquine; Sulfasalazine; Methotrexate; Leflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid
      arthritis (RA) participants.

      Secondary Objective:

      To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus
      prefilled syringes (PFS).
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of RA, ≥3 months disease duration;

          -  Participant willing and able to self-inject;

          -  Continuous treatment with 1 or a combination of non-biologic disease modifying
             antirheumatic drugs (DMARDs) (except leflunomide in combination with methotrexate);

          -  Moderate-to-severely active RA.

        Exclusion criteria:

          -  Participants <18 years;

          -  Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonists;

          -  Treatment with tumor necrosis factor (TNF) antagonists;

          -  Treatment with RA-directed biologic agents other than with a TNF-α antagonist
             mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent;

          -  Prior treatment with a Janus kinase inhibitor.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Sildenafil in HFpEF (Heart Failure With Preserved Ejection Fraction) and PH
Condition: Heart Failure, Diastolic; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Heart Failure; Heart Failure, Diastolic
Intervention: Sildenafil; Placebo
Intervention description: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks; Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HFpEF; PH

Summary:

      Aim of the study is to investigate whether Sildenafil treatment results in a reduction of
      pulmonary artery pressure without decrease of cardiac output (CO) and in improvement of
      exercise capacity in patients with heart failure with preserved ejection fraction (HFpEF)
      with pulmonary hypertension ( PH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 years

          -  Written inform consent

          -  PH secondary to diastolic left heart failure defined as

          -  PAP mean >25 mmHg

          -  Wedge mean >15 mmHg

          -  Normal systolic left ventricular (LV) function on echo/nuclear imaging (left
             ventricular ejection fraction (LVEF) > or =45%)

          -  New York Heart Association class (NYHA) II-IV despite heart failure therapy

        Exclusion Criteria:

          -  Severe noncardiac limitation to exercise (as severe chronic obstructive pulmonary
             disease)

          -  Other cause of PH besides diastolic heart failure

          -  Coronary ischemia or recent myocardial infarction (<6 months)

          -  Hypotension ( <90/50 mmHg)

          -  Ongoing nitrate therapy

          -  Ongoing therapy with citochrome P450 3A4 ( CYP3A4) inhibitors (ketoconazole,
             erythromycin, cimetidine, clarithromycin, itraconazole, voriconazole and protease
             inhibitors) or CYP3A4 inductors(carbamacepine, phenytoin, phenobarbital, rifampicin,
             Sint Janskruid ). Furthermore patients will be informed not to drink grapefruit juice
             while on study medication because of the known impact of grape fruit on
             pharmacokinetics of Sildenafil.

          -  Ongoing therapy with alpha -inhibitors

          -  Significant mitral or aortic valve dysfunction

          -  Severe liver dysfunction

          -  Pregnancy

          -  Unable to read and comprehend Dutch language
Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children
Condition: Agitation; Anesthesia; Pediatrics
MeSH terms: Delirium; Psychomotor Agitation; Emergence Delirium
Intervention: Dexmedetomidine; Saline
Intervention description: Dexmedetomidine will be dissolved in saline. An initial loading dose of 1.0 mg/kg given over 10 minutes followed by a continuous infusion at 0.4-0.7 mg/kg/hour. Beginning approximately one hour prior to end of surgery and continuing for one hour of recovery in the PACU and the PICU. This, the maximum dose for any one patient will be 2.4 mg/kg; Given by a continuous infusion
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Dexmedetomidine; Emergence Delirium; Agitation; Pediatric; Anesthesia

Summary:

      Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population
      undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine
      versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children age 6 months through 17 years of age undergoing interventional
             neuroradiologic procedures at our hospital under general anesthesia

          -  Patients classify as an ASA (American Society of Anesthesiologists) I-III

          -  Have not received anesthetic for over 30 days from previous procedures

        Exclusion Criteria:

          -  Receiving digoxin therapy from the study

          -  Severe congestive heart failure or pulmonary hypertension requiring vasodilators

          -  Disease processes other than that associated with their intracranial pathology, such
             as hepatic or renal dysfunction
Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: clomiphene citrate; raloxifene
Intervention description: 100mg PO on days 5-9 of the menstrual cycle; 100mg PO on days 5-9 of the menstrual cycle
Intervention MeSH terms: Raloxifene Hydrochloride; Clomiphene; Enclomiphene; Zuclomiphene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: Female
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Polycystic Ovary Syndrome; clomiphene citrate; Raloxifene

Summary:

      The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems.
      Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has
      a detrimental effect over uterine receptivity.

      Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental
      effect over the endometrium, and also increase the serum levels of FSH, thus, inducting
      ovulation.

      The objective of this study is to compare the ovulation rate in PCOS patients between
      clomiphene citrate and raloxifene in a double blind randomized trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients with polycystic ovarian syndrome will be invited to participate in the
             study. The PCOS criteria are according to modified Rotterdam criteria (7); i.e.,
             oligoovulation defined as < 6 menstrual periods per year, signs of clinical
             hyperandrogenism (Ferriman and Gallwey >8) or laboratorial (total Testosterone >=0.81
             ng/dL) or polycystic ovary > 10cm3.

        Furthermore, all patients with infertility diagnosis based solely on ovulation factor will
        included in the protocol

          -  Age >18 years old and <= 38 years old.

          -  No endometriosis on laparoscopy

        Exclusion Criteria:

          -  Not willing to participate in the study

          -  use of IUD or contraceptive pill within 2 months before the study.

          -  Hyperprolactinemia (>20ng/mL)

          -  Abnormal serum levels of TSH(normal range:0.4-40 mUI/mL).

          -  High 17-OH progesterone (>=4.9ng/mL)

          -  Endometriosis

          -  Known allergy to clomiphene or raloxifene
Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Cingal; Monovisc; Triamcinolone Hexacetonide
Intervention description: Hyaluronic Acid with Triamcinolone Hexacetonide; Hyaluronic Acid; Triamcinolone Hexacetonide
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the 16-02 study, subjects were randomized in a 4:4:1 ratio into the Cingal, Monovisc (hyaluronic acid) or TH (triamcinolone hexacetonide) arm. The 17-02 study is a 39-week follow-up to the 16-02 study.
Masking: Double (Participant, Outcomes Assessor)
Masking description: Study subjects and the Outcomes Assessor are blinded to the study treatment.
Enrollment: 526.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Intra-articular Injection; Hyaluronic Acid; Triamcinolone Hexacetonide

Summary:

      Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data
    

Eligibility criteria:

        Inclusion Criteria:

          1. Only subjects that were enrolled and met the inclusion criteria for the Cingal 16-02
             trial and signed the informed consent are eligible for Cingal 17-02 trial.

          2. Subject is able to understand and comply with the requirements of Cingal 17-02 and
             voluntarily provides consent.

        Exclusion Criteria:

        Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the
        inclusion / exclusion criteria for the Cingal 16-02 clinical trial.
A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)
Condition: Contraception
Intervention: ENG 120 µg + EE 15 µg intravaginal ring; DRSP 3 mg + EE 30 µg
Intervention description: 13 cycles of ENG-EE (NuvaRing) vaginal ring use. Each cycle 28 days, with a 21-day active treatment period followed by 7-day ring-free period. One ring per cycle, each ring containing 11.7 mg ENG and 2.7 mg EE, and releasing on average 120 mcg/day of ENG and 15 mcg/day of EE.; 13 cycles of DRSP-EE tablet use. Each cycle 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received total of 21 tablets per cycle, each tablet contained 3 mg DRSP and 30 μg EE.
Intervention MeSH terms: NuvaRing
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 983.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception; NuvaRing

Summary:

      This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of
      pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be
      assessed and compared with that of Yasmin.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Sexually active Chinese women, at risk for pregnancy and not planning to use condoms
             during trial medication use

          -  Women in need for contraception and willing to use a hormonal contraceptive method for
             13 cycles

          -  Body mass index ≥18 and ≤29 kg/m^2

        Key Exclusion Criteria:

          -  Contraindications for contraceptive steroids

          -  Abnormal cervical smear corresponding to indeterminate changes at screening

          -  Clinically relevant abnormal laboratory result at screening as judged by the
             investigator.