bioihbjkbjnl/mcl2 huggingface dataset:
Rainbow Extension Study
Condition: Retinopathy of Prematurity (ROP)
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: Ranibizumab
Intervention description: 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No
Keywords: open-label,; long-term,; extension study,; intravitreal ranibizumab,; laser ablation therapy,; retinopathy of prematurity,; preterm infants,; RAINBOW

Summary:

      The purpose of this study was to evaluate the long term efficacy and safety of intravitreal
      ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy
      of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent from parent(s) or legal guardian(s), in compliance with local
             requirements

          -  The patient successfully completed the core study H2301, as defined by providing
             assessments at the Visit 112 (the last scheduled visit in the core study) or, if
             appropriate, at the last of the additional assessment visits as per protocol in H2301,
             whichever was latest

          -  The patient received study treatment in both eyes at baseline of study H2301

        Exclusion Criteria:

          -  Patient had a medical condition or personal circumstance which precluded study
             participation or compliance with study procedures, as assessed by the Investigator

          -  Patient had been discontinued from the core study H2301 at any time
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: Ravulizumab; Placebo
Intervention description: Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.; Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
Intervention MeSH terms: Ravulizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: All investigative site personnel, sponsor staff, sponsor designees, staff directly associated with the conduct of the study, and all participants will be blinded to treatment assignments.
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for
      the treatment of participants with generalized myasthenia gravis (gMG).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the
             Screening Visit as confirmed by specific criteria.

          2. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at
             screening.

          3. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).

          4. Vaccinated against meningococcal infections within 3 years prior to, or at the time
             of, initiating study drug to reduce the risk of meningococcal infection (N
             meningitidis).

        Exclusion Criteria:

        Medical Conditions

          1. Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy
             unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years
             before screening.

          2. History of thymectomy within the 12 months prior to screening.

          3. History of N meningitidis infection.

          4. Use of the following within the time period specified below:

               -  IV immunoglobulin within 4 weeks of randomization

               -  Use of plasma exchange within 4 weeks of randomization

               -  Use of rituximab within 6 months of screening

          5. Participants who have received previous treatment with complement inhibitors (for
             example, eculizumab).
Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
Condition: Acellular Pertussis; Diphtheria; Tetanus
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Boostrix™; ADACEL®
Intervention description: Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine; Sanofi Pasteur
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2337.0
Sex: All
Minimum age: 19 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prophylaxis for diphtheria, tetanus, pertussis; Immunogenicity, booster, dTpa

Summary:

      GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug
      Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has
      recently issued provisional recommendations for universal adult Tdap vaccination. The current
      study will provide pivotal data in support of extending the age range for Boostrix vaccine to
      include adults 19-64 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A healthy male or female, 19 to 64 years of age (not having reached the 65th birthday)
             at the time of study vaccination.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding administration of study vaccine, or planned
             use during the active phase of the study.

          -  Chronic administration of immunosuppressants or within six months prior to
             administration of study vaccine.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days of administration of study vaccine (with the exception of an influenza
             vaccine).

          -  Administration of a diphtheria-tetanus (Td) booster within previous five years.

          -  Administration of Tdap vaccine at any time prior to study entry. History of serious
             allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria
             toxoid or pertussis-containing vaccine or any component of the study vaccines.
Ultrasound Guided Supraclavicular Nerve Block
Condition: Local Anesthetic
Intervention: Ropivacaine; Mepivacaine
Intervention description: ropivacaine (15 ml).; One syringe will contain mepivacaine (15 ml)
Intervention MeSH terms: Ropivacaine; Mepivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: surgery for arm hand or elbow; mepivacaine; ropivacaine; hand surgery; elbow surgery; forearm surgery

Summary:

      This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90
      seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a
      quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local
      anesthetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing upper extremity procedures suitable for supraclavicular
             anesthesia, including but not limited to oHand surgery oForearm surgery oElbow surgery

          -  Age between 18 and 70 years

        Exclusion Criteria:

          -  Contraindications to supraclavicular block

               -  Coagulopathy

               -  Infection at the needle insertion site

               -  Severe chronic obstructive pulmonary disease (COPD)

               -  Contralateral pneumothorax or diaphragmatic paralysis

          -  Pregnancy

          -  Preexisting neuropathy involving the surgical limb

          -  Routine opioid use

          -  Inability to attain adequate ultrasound images in the supraclavicular area
ACT-293987 in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: ACT-293987
Intervention description: Tablets, twice daily
Intervention MeSH terms: Selexipag
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 709.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-label; PAH; Pulmonary Arterial Hypertension

Summary:

      Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the
      safety and tolerability of ACT-293987 in patients with PAH who participated in the
      double-blind study AC-065A302 (GRIPHON)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participated to the double-blind study AC-065A302 and either had a
             morbidity event or had completed the study as scheduled per protocol.

          -  Signed informed consent.

        Exclusion Criteria:

          -  Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin
             analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in
             AC-065A302/GRIPHON.

          -  Severe hepatic impairment (Child-Pugh C).

          -  Females who are pregnant or who plan to become pregnant during the study, or are
             breastfeeding.

          -  Any known factor or disease that might interfere with treatment compliance, study
             conduct or interpretation of the results, such as drug or alcohol dependence, or
             psychiatric disease.
Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B
Condition: Severe Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: rFIXFc
Intervention description: Administered as specified in the treatment arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Male
Healthy volunteers: No
Keywords: B-LONG; B-YOND; B-LONG Extension; rFIXFc; Severe Hemophilia B

Summary:

      The primary objective of the study is to evaluate the long-term safety of rFIXFc in
      participants with hemophilia B.

      The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention
      and treatment of bleeding episodes.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects who have completed studies 998HB102 (NCT01027364) or 9HB02PED (NCT01440946)
             or other studies with rFIXFc

          -  Ability to understand the purposes & risks of the study and provide signed and dated
             informed consent.

        Key Exclusion Criteria:

          -  High-titer inhibitor (>/=5.00 BU/mL)

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Secondary Adjuvant Long Term Study With Arimidex
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Anastrozole
Intervention description: 1mg tablet daily
Intervention MeSH terms: Anastrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3484.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hormone receptor positive breast cancer

Summary:

      The study assesses the effect of further 2 years vs further 5 years of adjuvant treatment
      with anastrozole after initial 5 years of adjuvant endocrine therapy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Postmenopausal patients with histologically confirmed, local radically treated
             invasive or minimal-invasiv Mammacarcinom with or without previous chemotherapie
             and/or radiotherapie.

          2. No distant metastasis at randomization

          3. No relapse at randomization

          4. TNM- classification at time of diagnosis: T1-3, N0 and N+, M0

          5. Estrogen- and or progesterone positive before the beginningof primary endocrine
             therapy

          6. Endocrine therapy for 5 years (maximum deviation ±12 months)

          7. Therapy break (from the preliminary therapie) maximum 12 months.

          8. Informed Consent before the randomisation

        Exclusion criteria:

          1. Premenopausal patients or patients with non definable menopausal statusat time of
             randomisation

          2. Apparent secondary malignant tumor or status after secondary malignant tumor
             (Exceptions: simultaniously appearing bilateral breast carcinoma, estrogen- and or
             progesteronereceptor positive on both sides at the time of diagnosis; in situ
             carcinomaof the cervix and basal cell carcinoma of the skin)

          3. General contraindication respectively hypersensitivity to Anastrozol.

          4. In-situ carcinoma of any size with or without Mb. Paget of the Mamilla respectively T4
             tumor at the time of first diagnosis.

          5. Receptor unknown or negative at time of diagnosis respectively at beginning of primary
             endocrine therapy

          6. Known liver- and/or kidneyinsufficiency

          7. Performance Index >2 according to WHO

          8. Regular intake of hormon supplement as well as Hormone Replacement Therapy (HRT) more
             than 6 months since primary surgery of the mamma carcinoma

          9. Serious accessory disease, that prevents the adjuvant therapy according to protocol
             and/or the regular follow-up care.

         10. Lacking compliance of the patient

         11. Legal incompetence and/or other circumstances, that prevent the patient from
             understanding the nature, meaning and consequences of the clinical trial

         12. Existing psychiatrical diseaseaccording to ICD (especially alcohol addiction) et the
             time of admission into the study
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
Condition: Chemotherapy-induced Thrombocytopenia
MeSH terms: Thrombocytopenia
Intervention: Avatrombopag; Placebo Oral Tablet
Intervention description: Oral avatrombopag tablet; Placebo comparator tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CIT; Thrombocytopenia

Summary:

      Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and
      safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving
      chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women greater than or equal to 18 years of age;

          -  A diagnosis of ovarian, lung (small cell or non-small cell) or bladder cancer
             requiring systemic chemotherapy

          -  Participant receiving a chemotherapy regimen given in a 21 or 28-day cycle, including
             1 or more of the following agents or class of agents:

               -  Nucleoside analog, including gemcitabine and fluorouracil;

               -  Carboplatin or cisplatin;

               -  Anthracycline; or

               -  Alkylating agent;

          -  Participant experienced severe thrombocytopenia, defined as 2 platelet counts <50 x
             109/L measured at least 24 hours apart, during the qualifying chemotherapy cycle, of
             their current chemotherapy regimen

          -  ECOG performance status <=2

        Exclusion Criteria:

          -  Participant has experienced >=Grade 2 CIT other than during the current chemotherapy
             treatment regimen within 6 months of Screening;

          -  Participant has any history of hematologic malignancies, including leukemia, myeloma,
             myeloproliferative disease, lymphoma, or myelodysplastic diseases;

          -  Participant has received >2 previous lines of chemotherapy or is receiving whole brain
             radiation during the study treatment period;

          -  Participant has a known medical history of genetic prothrombotic syndromes

          -  Participant has a history of arterial or venous thrombosis within 3 months of
             screening;

          -  Use of vitamin K antagonists;

          -  Participant has previously received a thrombopoietin receptor agonist or recombinant
             human thrombopoietin for the treatment of CIT within 3 months of screening
Multi-Center Study of New Medications to Treat Vaginal Infections
Condition: Vaginal Infection
MeSH terms: Infections
Intervention: Metronidazole; Gel vehicle
Intervention MeSH terms: Metronidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the
      treatment of vaginal infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:

          -  Capable of providing written informed consent or assent

          -  Currently not menstruating and not anticipating menses during treatment

          -  If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically
             sterile, or practicing an acceptable form of birth control

          -  Negative pregnancy test

          -  Other criteria as identified in the protocol

        Exclusion Criteria:

          -  Other infectious causes of vulvovaginitis

          -  Subject has recently used, or is expected to require the concomitant use of prohibited
             medications/products

          -  Nursing mother

          -  Use of any investigational drug within 30 days of enrollment

          -  History of hypersensitivity to any ingredient/component of the formulations

          -  Other criteria as identified in the protocol
Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Ga-68 labeled PSMA-11; Positron emission tomography-computed tomography (PET/CT); Positron emission tomography-magnetic resonance imaging (PET/MRI)
Intervention description: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.; Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session; A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session
Intervention MeSH terms: Edetic Acid; Gallium 68 PSMA-11
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 485.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are imaging patients with prostate cancer using a new Positron Emission
      Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect
      prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male, age >= 18.

          2. Histopathologically proven prostate adenocarcinoma.

          3. Concern for metastatic disease in one of the following settings:

               1. Initial staging with intermediate to high risk prostate cancer.

               2. Biochemical recurrence after initial therapy.

          4. Ability to understand a written informed consent document, and the willingness to sign
             it.

        Exclusion Criteria:

        1. Patient unlikely to comply with study procedures, restrictions and requirements and
        judged by the Investigator to be unsuitable for study participation.
Proton/Photon Rt - Benign Meningiomas(P92-13)
Condition: Benign Meningioma
MeSH terms: Meningioma
Intervention: Standard Treatment; Higher Dose
Intervention description: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.; 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sphenoid region; parasellar area; photon radiation therapy; proton radiation therapy

Summary:

      The purpose of this study is to determine the best radiation dose for participants with
      meningioma that has grown back after previous surgery, or which the surgeon has been unable
      to remove completely. This research study is designed to determine whether a higher dose of
      radiation will decrease the likelihood that the tumor will grow back, compared to the
      probability of re-growth that occurs after standard radiation doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or over

          -  Histological documentation of benign meningioma

          -  Documentation by imaging studies (CT and/ or MRI) or residual or recurrent
             intracranial tumor

          -  Karnofsky performance status of ≥ 70

          -  Study specific informed consent

        Exclusion Criteria:

          -  Malignant meningiomas

          -  Prior cranial irradiation, except treatment of localized skin cancer of the face or
             scalp

          -  Patients having a concurrent primary cancer (except skin)

          -  Patients having another cancer controlled < 3 years

          -  Pregnant patients