bioihbjkbjnl/mcl2 huggingface dataset:
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
Condition: Lower Limb Spasticity Due to Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Intervention: IncobotulinumtoxinA (16 Units per kg body weight); IncobotulinumtoxinA (12 Units per kg body weight); IncobotulinumtoxinA (4 Units per kg body weight)
Intervention description: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 400 units; Mode of administration: intramuscular injection into spastic muscles.; Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 300 units; Mode of administration: intramuscular injection into spastic muscles.; Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 100 units; Mode of administration: intramuscular injection into spastic muscles.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 311.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether injections of Botulinum toxin type A into
      muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with
      increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male subject of 2 to 17 years of age (inclusive).

          -  Uni- or bilateral cerebral palsy with clinical need for uni- or bilateral LL
             injections with BoNT for the treatment of spasticity.

          -  Ashworth Scale [AS] score ≥2 in plantar flexors (at least unilaterally).

          -  Clinical need for a total dose of 16 U/kg BW NT 201 (maximum of 400 U) for the
             treatment of LL spasticity according to the clinical judgment of the investigator.

        Exclusion Criteria:

          -  Fixed contracture defined as severe restriction of the range of joint movement on
             passive stretch or predominant forms of muscle hypertonia other than spasticity (e.g.,
             dystonia) in the target limb(s).

          -  Surgery on pes equinus on side(s) intended to be treated with BoNT injections in this
             study within 12 months prior to Screening Visit (V1), in the screening period or
             planned for the time of participation in this study.

          -  Hip flexion requiring BoNT injection.
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
Condition: Renal Transplantation
Intervention: Cyclosporin A; Belatacept Less Intensive Regimen (LI); Belatacept More Intensive Regimen (MI)
Intervention description: tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months; solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months; solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
Intervention MeSH terms: Cyclosporine; Abatacept; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 595.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to learn if Belatacept is effective and safe as a first line of
      immunosuppression treatment in patients undergoing a renal transplant where the donor kidney
      is obtained in patients with extended criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a first-time recipient of a kidney transplant from a deceased donor.

          -  Specific donor criteria

        Exclusion Criteria:

          -  Donor age <10 years

          -  Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)

          -  Subjects with a positive T-cell lymphocytotoxic crossmatch.

          -  Subjects who are positive for Hepatitis B or C, or HIV

          -  Active tuberculosis

          -  History of cancer in the last 5 years

          -  History of substance abuse

          -  Specific laboratory results are exclusionary

          -  Mammography suspicious for cancer

          -  Allergy to iodine

          -  For Long-term extension study-Subjects who have completed three years of study
             treatment (through Week 156)
Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Placebo; Pregabalin
Intervention description: Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose); Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose)
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 498.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the
      efficacy and safety of pregabalin in patients with fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ACR criteria for fibromyalgia

          -  A score of more or equal to 40 mm on the Pain VAS

          -  An average score more or equal to 4 on 4 daily pain diaries

        Exclusion Criteria:

          -  Patients with other severe pain conditions

          -  Patients with severe depression

          -  Patients taking excluded medications

          -  Patients with suicidality
Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
Condition: Purulent Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: T1225; Tobramycin
Intervention description: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2; 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
Intervention MeSH terms: Tobramycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 286.0
Sex: All
Minimum age: 1 Day
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent
      bacterial conjunctivitis of children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ one day of life and ≤ 18 years

          -  Purulent bacterial conjunctivitis
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: risankizumab; secukinumab
Intervention description: Subcutaneous (SC) injection; Subcutaneous (SC) injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque Psoriasis

Summary:

      The main objective of this study is to evaluate the efficacy and safety of risankizumab
      compared with secukinumab for the treatment of adult subjects with moderate to severe plaque
      psoriasis who are candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least
             6 months before the Baseline Visit

          -  Subject has stable moderate to severe chronic plaque psoriasis with or without
             psoriatic arthritis

          -  Subject must be a candidate for systemic therapy as assessed by the investigator;

          -  Subject must be an acceptable candidate to receive secukinumab according to the local
             label for this compound.

        Exclusion Criteria:

          -  History of erythrodermic psoriasis, generalized or localized pustular psoriasis,
             medication-induced or medication-exacerbated psoriasis, or new onset guttate
             psoriasis; or active skin disease other than psoriasis that could interfere with the
             assessment of psoriasis;

          -  Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or
             active tuberculosis. Subjects with a positive QuantiFERON®-TB/purified protein
             derivative (PPD) test result may participate in the study if further work up
             (according to local practice/guidelines) establishes conclusively that the subject has
             no evidence of active tuberculosis. If presence of latent tuberculosis is established,
             then treatment must have been initiated and maintained according to local country
             guidelines.

          -  Active systemic infection during the last 2 weeks prior to Baseline Visit (exception:
             common cold)

          -  History of any documented active or suspected malignancy or history of any malignancy
             within the last 5 years except for successfully treated non-melanoma skin cancer
             (NMSC) or localized carcinoma in situ of the cervix

          -  Previous exposure to risankizumab

          -  Previous exposure to secukinumab
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Condition: Oral Mucositis
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Intervention: GC4419 90mg; Placebo
Intervention description: 60 minute IV infusion; 60 minute IV infusion
Intervention MeSH terms: Manganese; Avasopasem manganese
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 455.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oral Mucositis; Superoxide Dismutase Mimetic; Cisplatin; Intensity-Modulated Radiation Therapy; Chemoradiation; OM; IMRT; Head and Neck Cancer; Squamous Cell Carcinoma; SCC; Oral Cavity; Oropharnyx; Mouth Sores; avasopasem mangenese

Summary:

      The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese)
      administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of
      radiation induced oral mucositis in patients who have been diagnosed with locally advanced,
      non-metastatic squamous cell carcinoma of the head and neck.
    

Eligibility criteria:

        Inclusion Criteria:

          -  squamous cell carcinoma of the head and neck

          -  treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy
             with a cumulative radiation dose of 60-72 Gy

          -  Treatment plan to receive standard cisplatin monotherapy

          -  Age 18 years or older

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Adequate hematologic, renal and liver function

          -  Negative serum pregnancy test

          -  Use of effective contraception

        Exclusion Criteria:

          -  Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands

          -  Metastatic disease

          -  Prior radiotherapy to the region of the study cancer or adjacent anatomical

          -  Prior induction chemotherapy

          -  Receiving any approved or investigational anti-cancer agent other than those provided
             for in this study

          -  Concurrent participation in another interventional clinical study

          -  Inability to eat soft solid food at baseline

          -  Malignant tumors other than HNC within the last 5 years

          -  Active infectious disease excluding oral candidiasis

          -  Presence of oral mucositis at baseline

          -  Known history of HIV or active hepatitis B/C

          -  Female patients who are pregnant or breastfeeding

          -  Known allergies or intolerance to cisplatin and similar platinum-containing compounds

          -  Requirement for concurrent treatment with nitrates or other drugs that may create a
             risk for a precipitous decrease in blood pressure
An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Condition: Hyperoxaluria, Primary
MeSH terms: Hyperoxaluria, Primary
Intervention: Oxabact OC5 - Oxalobacter formigenes Strain HC-1
Intervention description: Live, commensal bacteria
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label study in which all patients will receive Oxabact OC5
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No

Summary:

      Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent (as applicable for the age of the subject).

          2. Participation in and completion of study OC5-DB-02.

          3. Subjects who had received vitamin B6 during OC5-DB-02 study should maintain a stable
             dose. Subjects not receiving vitamin B6 during OC5-DB-02 must be willing to refrain
             from initiating pyridoxine during study participation.

        Exclusion Criteria:

          1. Inability to swallow size 4 capsules.

          2. Use of antibiotics to which O. formigenes is sensitive.

          3. Current treatment with a separate ascorbic acid preparation.

          4. Pregnant or lactating women (or women who are planning to become pregnant).

          5. Women of childbearing potential who are not using adequate contraceptive precautions.

          6. Presence of a medical condition that the Investigator considers likely to make the
             subject susceptible to adverse effect of study treatment or unable to follow study
             procedures or any condition that is likely to interfere with the study drug mechanism
             of action (such as abnormal GI function).

          7. Participation in any interventional study of another investigational product,
             biologic, device, or other agent or not willing to forego other forms of
             investigational treatment during this study.
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Condition: Prostate Cancer; Prostate Adenocarcinoma
MeSH terms: Prostatic Neoplasms
Intervention: Ga-PSMA-11
Intervention description: The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment.
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: Male
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Newly Diagnosed

Summary:

      Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically proven prostate adenocarcinoma

          -  Age ≥ 18 years

          -  Patients already diagnosed with prostate cancer: Primary Staging: intermediate and
             high-risk patients per NCCN guidelines

          -  Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or
             radiation therapy (external beam or brachytherapy):

             a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal
             to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second
             determination of a PSA level of >0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix
             consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA

          -  Ability to understand a written informed consent document, and the willingness to sign
             it.

        Exclusion Criteria:

          -  Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would
             preclude PET/CT imaging.

          -  Patients with any medical condition or circumstance that the investigator believes may
             compromise the data collection or lead to a failure to fulfil the study requirements.

          -  Patients with known hypersensitivity to the active substance or to any of the
             excipients of the investigational product.
Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
Condition: Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae Infections
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Hepatitis; Tetany
Intervention: Quinvaxem
Intervention description: A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at 2, 3 and 4 months of age
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 60 Days
Maximum age: 120 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccination; Immunisation; Virus; Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae; Immunity

Summary:

      The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine
      (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H.
      influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4
      months of age according to the local Expanded Programme on Immunisation (EPI) schedule
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and
             free from any obvious health problems

          -  Have a normal gestational age (≥ 37 weeks); birth weight > 2.5 kg

          -  There is no congenital disease detected through interview and clinical examination

          -  Already had or not yet received Hepatitis B vaccination at birth

          -  Do not have dermatological diseases such as eczema, allergies

          -  Parent or legal guardian voluntarily provides consent for their child for
             participation in the study by signing the informed consent and agrees to comply with
             all study procedures

        Exclusion Criteria:

          -  Already vaccinated with DTP vaccine

          -  Have an acute infection at the time of study vaccination

          -  Contraindications to Quinvaxem

          -  Receiving treatment with systemic corticosteroids

          -  Currently participating in another clinical trial

          -  In receipt of a parenteral immunoglobulin preparation and/or blood/blood products
             since birth

          -  Parents intend to move to another location during the study (the next 12 months)
Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Pangramin SLIT HDM mix.; Placebo
Intervention description: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.; Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 617.0
Sex: All
Minimum age: 5 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: House dust mite induced allergic rhinitis.

Summary:

      Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix
      compared to placebo in the treatment of House Dust Mite (HDM) induced rhinitis with or
      without asthma.

      Sublingual immunotherapy has been used during several years and has been shown to provide
      benefits compare to traditional subcutaneous treatment. This study will investigate if
      improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a
      consequence of being treated under specific immunotherapy.

      This study aim also to contribute to the documentation of tolerability and safety profile of
      Pangramin HDM Mix.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 5 to ≤ 55 years of age.

          -  A history HDM induced allergic rhinitis.

          -  Use of medication for the control of rhinoconjunctivitis symptoms.

          -  Positive Skin Prick Test (SPT).

          -  Positive specific IgE.

        Exclusion Criteria:

          -  PEF ≤ 70% of predicted value.

          -  History of significant symptomatic seasonal or perennial allergic rhinitis and/or
             asthma caused by an allergen to which the patient is regularly exposed, and sensitized
             (e.g. pollens, cat, dog, cockroach…except house dust mites).

          -  Severe asthma.

          -  Current symptoms of upper respiratory tract infection or other relevant infectious
             process.

          -  Current food allergies with oral allergy syndrome.

          -  A clinical history of chronic sinusitis.

          -  Current severe atopic dermatitis.

          -  Concomitant or previous treatment by immunotherapy.