bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Placebo; 2400mg SPN-804; 1200mg SPN-804
Intervention description: Non-active tablet identical to study drug tablets; tablets containing 600mg OXC XR, identical to non-active tablets; two active tablets and two non-active tablets, all identical
Intervention MeSH terms: Oxcarbazepine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 366.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Partial onset epilepsy; Partial onset seizures

Summary:

      Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults
      with partial onset seizures
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capable of complying with the study procedures.

          -  Able to provide written informed consent

          -  Male or female aged 18 to 65 years, inclusive.

          -  Diagnosis of partial onset seizures

          -  Minimum of three seizures per 28 days

          -  Receiving treatment with 1-3 AEDs

          -  Refractory to at least one AED

          -  No progressive neurological conditions by recent MRI/CT

          -  Adequate birth control in women of child-bearing potential

        Exclusion Criteria:

          -  Refractory to OXC for reasons of efficacy

          -  Recent status epilepticus

          -  Recent non-epileptic seizures

          -  Current diagnosis of major depression

          -  Recent suicidal plan or intent or more than one attempt

          -  Current use of oxcarbazepine, felbamate for < 18 months, phenytoin with levels
             >15mcg/mL or frequent need for rescue benzodiazepines

          -  Current use of sodium-lowering non-seizure medications.

          -  Clinically significant hepatic, renal, or cardiovascular function

          -  History of recent substance abuse

          -  Females who are pregnant or lactating.

          -  Hypersensitivity to OXC or related drugs

          -  Difficulty swallowing study medication
Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery
Condition: Cataracts; Inflammation
MeSH terms: Cataract; Inflammation
Intervention: Difluprednate ophthalmic emulsion, 0.05%; Prednisolone acetate ophthalmic suspension, 1.0%
Intervention description: Topical ocular administration; Topical ocular administration
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Difluprednate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Maximum age: 3 Years
Healthy volunteers: No
Keywords: Pediatric; Cataracts; Inflammation; Durezol; Pred Forte; Difluprednate; Prednisolone

Summary:

      The primary objective of this study was to compare the safety and efficacy of Durezol™
      compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a
      pediatric population 0 to 3 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  0 to 3 years of age.

          -  Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular
             lens.

          -  Informed consent signed by a parent or legal guardian.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Presence of any active or suspected viral, bacterial, or fungal disease in the study
             eye.

          -  Use of any topical medication in the study within 7 days prior to surgery, except for
             drops that are needed to examine the eye or to prepare for surgery.

          -  Patients with posttraumatic cataract.

          -  Active uveitis in the study eye.

          -  Ocular neoplasm in the study eye.

          -  Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS).

          -  Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye
             must not be the patient's only good eye.

          -  Patients on systemic steroids or nonsteroidal anti-inflammatory drugs.

          -  History of steroid-induced intraocular pressure (IOP) rise.

          -  Currently on medication for ocular hypertension or glaucoma in the study eye.

          -  Diabetes.

          -  Other protocol-defined exclusion criteria may apply.
A Study of Vemurafenib in Participants With Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Vemurafenib
Intervention description: Participants will receive continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.
Intervention MeSH terms: Vemurafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3219.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This multi-center study evaluates the safety and efficacy of vemurafenib in participants with
      BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV
      (American Joint Committee on Cancer [AJCC]) metastatic melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with Histologically confirmed metastatic melanoma (surgically incurable
             and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by
             Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had
             confirmation from a surgical oncologist

          -  Participants with either measurable or non-measurable disease according to Response
             Evaluation Criteria in Solid Tumours (RECIST) Version 1.1

          -  Participants may or may not have received prior systemic therapy for metastatic
             melanoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2

          -  Adequate hematologic, renal and liver function

        Exclusion Criteria:

          -  Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or
             anti-seizure medications for treatment of brain metastases prior to the first
             administration of vemurafenib

          -  Previous malignancy (other than melanoma) within the past 2 years, except for treated
             and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of
             the cervix

          -  Concurrent administration of any anti-cancer therapies other than those administered
             in the study

          -  Clinically significant cardiovascular disease or event within the 6 months prior to
             first administration of study drug

          -  Refractory nausea or vomiting, external biliary shunt, or significant bowel resection
             that would preclude adequate absorption
Efficacy of TAP Block in Cesarean Section Patients
Condition: Pain Control
Intervention: TAP block using Bupivacaine 0.5%; TAP block using Bupivacaine 0.25%; TAP block using Normal Saline
Intervention description: Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.; Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.; Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1: Bupivacaine 05%, arm 2: Bupivacaine 0.25%, and arm 3: placebo (Normal saline)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The randomization sheet was given to someone who is not involved in the study, also the person who prepare the medicine is not involved in the study.
Enrollment: 60.0
Sex: Female
Healthy volunteers: No

Summary:

      TAP Block done with 2 different concentrations of bupivacaine and placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy pregnant women

        Exclusion Criteria:

          -  Allergy to local anesthetics
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
Condition: Pediculosis
MeSH terms: Lice Infestations
Intervention: Malathion gel 0.5%; Permethrin 1% rinse (Nix Crème)
Intervention description: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.; Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.
Intervention MeSH terms: Permethrin; Malathion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 403.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Head Lice

Summary:

      In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for
      head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an
      established head lice treatment. The new formulation has been evaluated in 2 previous studies
      of patients 2 years of age and older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed active head lice infestation

        Exclusion Criteria:

          -  Allergy to pediculicides or hair care products

          -  Scalp conditions other than head lice

          -  Previous head lice treatment within the past 4 weeks

          -  Current antibiotic treatment
Drug Exposure and Depot Medroxyprogesterone Acetate (DMPA) in Adolescent Subjects
Condition: Weight Gain; Disorder of Bone Density and Structure, Unspecified; Uterine Bleeding
MeSH terms: Bone Diseases; Uterine Hemorrhage; Weight Gain
Intervention: Depot medroxyprogesterone acetate (DMPA)
Intervention description: 75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 34.0
Sex: Female
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Birth Control; Contraceptive Methods; Female Contraception; Weight Gain; Bone Density

Summary:

      The investigators are doing this study to look at how different doses of the Depot
      medroxyprogesterone acetate (DMPA) shot effect weight gain and bone mineral density in teens.
      The investigators hope that what the investigators learn from this study will be used to
      develop ways to keep girls from gaining weight or losing bone density when receiving DMPA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 12-21 years

          2. Healthy, post-menarcheal female

          3. Self-selected to initiate depot medroxyprogesterone acetate (DMPA)

          4. Willingness to use a barrier method of contraception in addition to DMPA

        Exclusion Criteria:

          1. Chronic disease known to affect weight or bone mineral density (BMD) (e.g. diabetes,
             kidney)

          2. Use of medication known to affect weight or BMD (e.g. corticosteroids)

          3. DMPA use within the past 12 months

          4. Pregnancy within the past 6 months

          5. Etonogestrel implant, levonorgestrel-releasing intrauterine system or combined
             estrogen/progesterone contraceptive use within the past 30 days (OC, patch, vaginal
             ring)

          6. Weight exceeding 450 lbs

          7. Need for confidential contraceptive care for individuals < 18 years of age.
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Condition: Cataract; Inflammation; Surgery
MeSH terms: Cataract; Inflammation
Intervention: Mapracorat; Placebo
Intervention description: 1 drop of study medication into the study eye QID for 14 days; 1 drop of vehicle into the study eye QID for 14 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 369.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this clinical study is to compare the safety and efficacy of mapracorat
      ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation
      and pain following cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are candidates for routine, uncomplicated cataract surgery.

          -  Subjects who, in the Investigator's opinion, have potential postoperative pinhole
             Snellen visual acuity (VA) of at least 20/200 in the study eye.

          -  Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following
             cataract surgery (postoperative day 1).

        Exclusion Criteria:

          -  Subjects who have a severe/serious ocular condition or history/presence of chronic
             generalized systemic disease that the Investigator feels might increase the risk to
             the subject or confound the result(s) of the study.

          -  Any intraocular inflammation in either eye (cells or flare score greater than Grade 0
             at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the
             Screening Visit.

          -  Presence of active external ocular disease: infection or inflammation of the study
             eye.

          -  Subjects who have known hypersensitivity or contraindication to the study drug(s) or
             their components.

          -  Subjects who currently require or are expected to require treatment with any
             medication listed as a disallowed medication per the Disallowed Therapy section of the
             protocol.
A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Intervention: turoctocog alfa pegol
Intervention description: Fixed dose of turoctocog alfa pegol for intravenous injections (i.v.) twice weekly for prophylaxis. In addition, turoctocog alfa pegol will be administered to treat bleeding episodes during the trial period. Bleeding episodes will be treated with doses of 20-75 U/kg body weight.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: Male
Minimum age: 0 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and
      pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP)
      in children with severe haemophilia A who have undergone treatment with previous factor VIII
      (FVIII) products.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients with severe congenital haemophilia A (FVIII activity level below 1%)

          -  Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII
             products for patients aged 6-11 years and above 50 ED to FVIII products for patients
             aged 0-5 years

        Exclusion Criteria:

        - Any history of FVIII inhibitors
Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Placebo; Idalopirdine
Intervention description: Once daily, matching placebo capsules, orally; Once daily, encapsulated tablets, orally
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 858.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic
      treatment of patients with mild-to-moderate Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a knowledgeable and reliable caregiver.

          -  The patient is an outpatient.

          -  The patient has probable AD.

          -  The patient has mild to moderate AD.

          -  Stable treatment with donepezil.

          -  The patient, if a woman, must have had her last natural menstruation ≥24 months prior
             to baseline, OR be surgically sterile.

          -  The patient, if a man, agrees to protocol-defined use of effective contraception if
             his female partner is of childbearing potential, OR must have been surgically
             sterilised prior to the screening visit.

        Exclusion Criteria:

          -  The patient has evidence of any clinically significant neurodegenerative disease, or
             other serious neurological disorders other than AD.

          -  The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition,
             Text Revision (DSM-IV-TR) Axis I disorder other than AD.

          -  The patient has evidence of clinically significant disease.

          -  The patient's donepezil therapy is likely to be interrupted or discontinued during the
             study.

          -  The patient is currently receiving memantine or has taken memantine within 2 months
             prior to screening.

        Other inclusion and exclusion criteria may apply.
Crisaborole for Chinese and Japanese Subjects (≥2 Years of Age) With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole Ointment; Crisaborole Placebo Vehicle
Intervention description: Crisaborole ointment 2%; Placebo for crisaborole ointment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 391.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This study is a phase 3, randomized, double blind and vehicle study to evaluate the efficacy
      and safety of Crisaborole ointment, 2% in Chinese and Japanese subjects with mild to moderate
      atopic dermatitis involving at least 5% treatable BSA. Eligible subjects will be randomized
      in a 2:1 ratio to one of 2 treatment groups (Crisaborole BID, Vehicle BID, respectively).
    

Eligibility criteria:

        Inclusion Criteria:

        - Is male or female 2 years and older at the Screening visit/time of informed
        consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and
        Rajka), of at least 5% BSA.

        Exclusion Criteria:

          -  Has any clinically significant medical disorder, condition, or disease (including
             active or potentially recurrent non AD dermatological conditions and known genetic
             dermatological conditions that overlap with AD, such as Netherton syndrome) or
             clinically significant physical examination finding at Screening that in the PI's or
             designee's opinion may interfere with study objectives.

          -  Has participated in a previous crisaborole clinical study.