bioihbjkbjnl/mcl2 huggingface dataset:
Skin Toxicity Treatment in Metastatic Colorectal Cancer (mCRC) Patients Receiving Panitumumab + Irinotecan-based Therapy
Condition: Metastatic Colorectal Cancer; Skin Rash; Skin Toxicities; Colon Cancer; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Colonic Neoplasms; Exanthema
Intervention: Panitumumab; Irinotecan; FOLFIRI; Pre-emptive Skin Treatment; Reactive Skin Treatment
Intervention description: Administered by intravenous infusion; Recommended dosage regimen and administration of irinotecan was based on local standard of care, the package insert, and institutional guidelines.; Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.; Pre-emptive skin treatment included a skin moisturizer (eg, Lubriderm), sunscreen (free of paraaminobenzoic acid (PABA), skin protection factor (SPF) 15 or higher, ultraviolet-A (UV-A), and UV-B protection), topical steroid (1% hydrocortisone cream) and oral antibiotic (doxycycline, 100 mg twice daily).; Treatment was based on symptoms and severity and may have included an emollient (eg, Lubriderm, Vaseline), sunscreen (SPF ≥ 15), oral antibiotic (eg, doxycycline, ciprofloxacin, cefadroxil, amoxicillin/clavulanic acid), topical steroid (hydrocortisone cream), topical antibiotic (clindamycin), oral systemic steroid, topical medical treatment (eg, silver sulfadiazine, Silvadene), topical antihistamine or oral antihistamine (hydroxyzine)
Intervention MeSH terms: Irinotecan; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: STEPP; STEP; STEEP; mCRC; Skin Toxicities; Skin Rash; Metastatic Colorectal Cancer; Anti-EGFr Skin Rash; colon cancer; colorectal cancer; rectal cancer

Summary:

      A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in
      patients with metastatic colorectal cancer (mCRC) who are receiving second-line
      irinotecan-based chemotherapy concomitantly with panitumumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with unresectable metastatic adenocarcinoma of the colon or rectum that
             cannot, in the opinion of the investigator, be cured by surgical resection at the time
             of randomization;

          -  Patients who have failed first line treatment containing fluoropyrimidine and
             oxaliplatin based chemotherapy with or without bevacizumab for mCRC.

        Exclusion Criteria:

        • Prior irinotecan use for the treatment of mCRC.
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
Condition: Chemotherapy Induced Anemia
MeSH terms: Anemia
Intervention: Roxadustat
Intervention description: Roxadustat will be administered per schedule specified in the arm description.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anemia; Chemotherapy induced anemia; Myelosuppressive chemotherapy; Non-Myeloid malignances

Summary:

      The purpose of this study is to find out if roxadustat (also known as FG-4592) is safe and
      effective for the treatment of anemia in participants receiving chemotherapy treatment for
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of non-myeloid malignancy

          2. Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0
             grams (g)/deciliter (dL) at screening

          3. Planned concurrent treatment of cancer with chemotherapy for at least 8 additional
             weeks

          4. Estimated life expectancy ≥ 6 months at enrollment (Day 1)

        Exclusion Criteria:

          1. Participants with cancer receiving chemotherapy when the anticipated outcome is cure

          2. Participants who are only receiving hormonal products, biological products, cancer
             immunotherapy or radiation therapy to treat/manage their cancer

          3. History of leukemia

          4. Participants who have received an RBC transfusion or erythropoietic therapy within 4
             weeks of enrollment

          5. Use of any investigational drug within 8-weeks prior to treatment with roxadustat

          6. Clinically significant anemia due to other etiologies

          7. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or
             thromboembolic event (for example, deep vein thrombosis [DVT] or pulmonary embolism)
             within previous 6 months of screening

          8. Clinically significant or uncontrolled ongoing autoimmune disease (for example,
             rheumatoid arthritis, Crohn's disease, celiac disease, etc.)

          9. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
Condition: Healthy
Intervention: rLP2086; rLP2086; rLP2086; rLP2086
Intervention description: Vaccine administered at 0, 1, and 6 months; Vaccine administered at 0, 1, and 6 months; Vaccine administered at 0, 1, and 6 months; Vaccine administered at 0, 1, and 6 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 8 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: Adolescent; Meningococcal; Safety

Summary:

      Study to evaluate the safety of an investigational meningitis vaccine and the immune response
      to it in adolescents
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria

          -  Aged 8 to 14 years at the time of enrollment.

          -  Healthy male or female subjects

          -  Negative urine pregnancy test for female subjects

        Exclusion Criteria:

        Exclusion Criteria

          -  Prior vaccination with a meningococcal B vaccine

          -  Prior meningococcal disease
Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Placebo; High Dose Fish Oil; Low Dose Fish Oil
Intervention description: corn oil (n-6 fatty acids); n-3 fatty acids, 1060 mg EPA + DHA; n-3 fatty acids, 2160 mg EPA + DHA
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: epilepsy; cardiac risk factors; memory; cognition; n-3 fatty acids; fish oil; EPA; DHA; seizures

Summary:

      The purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify
      cardiac risk factors in people with epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 18 - 70

          -  History of intractable localization related/partial onset seizures and generalized
             tonic/clonic or tonic seizures defined according to International League Against
             Epilepsy (ILAE) classification as:

          -  A history compatible with localization related partial epilepsy

          -  A history of generalized tonic clonic or tonic seizures with loss of consciousness

          -  Three or more simple partial, complex partial or tonic-clonic seizures per month

          -  An EEG and/or an MRI consistent with a localization related epilepsy

          -  Evidence of at least three seizures per month for at least two months prior to the
             study

          -  Exposure to at least one antiepileptic drug at adequate dose

        Exclusion Criteria:

          -  Significant or progressive medical, cardiac, or other illness

          -  Allergy to fish products or fish oil

          -  History of a coagulation disorder

          -  History of non-epileptic seizures

          -  Consumption of Fish Oil at any time 30 days or less prior to enrollment

          -  Any change in antiepileptic drugs for 30 days or less prior to enrollment

          -  Treatment with Warfarin for 30 days or less prior to enrollment

          -  Previous poor compliance with therapy

          -  Drug or alcohol abuse

          -  Uncountable seizures as a result of seizure clustering, or inadequate supervision if
             the patient cannot count their own seizures.

          -  Pregnancy
Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery
Condition: Postoperative Ocular Pain After PRK Surgery
MeSH terms: Eye Pain
Intervention: SAF312; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ocular pain; photorefractive keratectomy (PRK); SAF312; corneal epithelial defect

Summary:

      The purpose of this study is to determine if SAF312 eye drops have an adequate safety and
      efficacy profile to justify further clinical development for the treatment of ocular pain
      associated with corneal epithelial defect such as after photorefractive keratectomy (PRK)
      surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal eye exam except for refractive error at baseline.

          -  Myopia should not exceed -4.00 Diopters (sphere) and 3.00 diopters of astigmatism,
             with spherical equivalent not higher than -4.50, confirmed by manifest refraction at
             baseline.

        Exclusion Criteria:

          -  Monocular patient (including amblyopia) or best corrected visual acuity score worse
             than 20/80 (Snellen) or 55 letters (EDTRS), at baseline.

          -  Any systemic or ocular disease that might affect wound healing (such as severe
             rheumatoid arthritis or diabetes or history of keloid formation) or a history of
             ocular trauma, uveitis, infection, or inflammation in the 6 months prior to baseline.

          -  Previous refractive or corneal surgery (such as LASIK, PRK, radial keratotomy,
             pterygium removal, corneal transplantation).

          -  Chronic pain of any etiology or any significant illness which has not resolved within
             two (2) weeks prior to initial dosing.

        Other inclusion and exclusion criteria apply.
Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: IVT aflibercept; Sham SC; SC CLS-TA
Intervention description: IVT aflibercept [2 mg/0.05 mL]; sham SC; CLS-TA [4 mg/100 μL] SC injection
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Aflibercept; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Diabetic Retinopathy; Microneedle; Mircoinjection; Triamcinolone; Choroid; Choroid Injection; Aflibercept; Suprachoroidal; Triamcinolone acetonide

Summary:

      The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA
      used with intravitreal aflibercept in subjects with DME.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of type 1 or type 2 DM

          -  DME with central involvement (> 300 µm in the central subfield on spectral-domain
             optical coherence tomography [SD-OCT], in the study eye

          -  ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye

          -  Naïve to local pharmacologic treatment for DME in the study eye

        Exclusion Criteria:

          -  IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded
             if IOP is <22 mmHg in the study eye with no more than 1 IOP lowering medication

          -  Any previous treatment in the study eye with an ocular corticosteroid implant

          -  Has significant media opacity precluding evaluation of retina and vitreous in the
             study eye.

          -  History of glaucoma or optic nerve head change consistent with glaucoma damage

          -  History of glaucoma surgery

          -  History of clinically significant IOP elevation in response to corticosteroid
             treatment ("steroid responder")
Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Tolvaptan
Intervention description: Participants were titrated to either the tolvaptan 45/15 or 60/30 mg split-dose over a 2-month Titration Period. They received the titrated dose for 34 months during the Fixed-dose Period. Following a planned off-treatment period, participants had the option to enter an Extension Period for an additional 12 months. Tolvaptan was supplied as tablets.
Intervention MeSH terms: Tolvaptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to
      determine the maximally-tolerated dose and acquire pilot efficacy data in patients with
      autosomal dominant polycystic kidney disease (ADPKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior participation in designated tolvaptan ADPKD studies (156-04-248, 156-04-249).

          -  Able to give Informed Consent.

        Exclusion Criteria:

          -  Women who are breast feeding and females of childbearing potential who are not using
             acceptable contraceptive methods.

          -  In the opinion of the study investigator or sponsor may present a safety risk.

          -  Patients who are unlikely to adequately comply with study procedures.

          -  Patients who at Day 1 have an estimated glomerular filtration rate (GFR) below 30
             mL/min or who anticipate renal-replacement therapy within one year of study entry.

          -  Patients having contraindications to magnetic resonance imaging (MRI) or gadolinium
             contrast will be eligible but will not be able to participate in MRI.

          -  Patients taking a diuretic within 1 week of enrollment or likely to need diuretic
             therapy prior to Month 2.
Augmentation Cystoplasty Using an Autologous Neo-Bladder
Condition: Neurogenic Bladder
MeSH terms: Urinary Bladder, Neurogenic
Intervention: Autologous neo bladder construct
Intervention description: augmentation cystoplasty with autologous neo-bladder construct
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      Subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment
      will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous
      neo-bladder construct will significantly increase bladder compliance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  subjects with neurogenic bladders secondary to myleodysplasia

        Exclusion Criteria:

          -  prior augment procedures

          -  recent urologic surgery

          -  requires concomitant urologic intervention
Naltrexone and Memantine Effects on Alcohol Drinking Behaviors
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking; Drinking Behavior
Intervention: Naltrexone and memantine first; Naltrexone and Placebo first
Intervention description: Naltrexone 50mg memantine 20mg; Naltrexone 50 mg Placebo
Intervention MeSH terms: Naltrexone; Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Alcohol; Drinking; Drinkers; Alcohol Drinking; Memantine; Naltrexone; Alcohol Dependence; Alcohol Abuse; Alcohol-Related Disorders; Ethanol; Alcoholism

Summary:

      The purpose of this study is to evaluate the combined effects of the study medications
      naltrexone and memantine on alcohol drinking behaviors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 21-55

          -  Able to read English at 6th grade level or higher and to complete study evaluations

          -  Regular alcohol drinker

        Exclusion Criteria:

          -  Individuals who are seeking alcohol treatment

          -  Medical conditions that would contraindicate the use of study medication

          -  Regular use of other substances
Effect of Miswak and Miswak Extract on Oral Malodor
Condition: Oral Malodor; Halitosis
MeSH terms: Halitosis
Intervention: Miswak extract mouth wash; Miswak stick; Chlorohexidine gluconate
Intervention description: 50% Miswak extract mouth wash (5ml) twice a day for 7 days; Miswak stick twice a day for 7 days; 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 212.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Halitosis; Oral Malodor; Miswak; Salvadora Persica

Summary:

      The aim of this experiment is to investigate the effect of Miswak on oral malodor and to
      determine whether this effect -if present- is the result of the mechanical action of Miswak
      or the chemical effect of its extract
    

Eligibility criteria:

        Inclusion Criteria:

          -  the participants should report that they suffered from bad oral malodor

          -  organoleptic score of 2 or above

        Exclusion Criteria:

          -  smoking

          -  current systemic diseases or medical treatment

          -  active caries or any faulty restorations

          -  acute sinusitis or oro-pharyngeal infection

          -  chronic periodontitis

          -  pregnancy

          -  breast feeding

          -  eating very spicy food

          -  use of antibiotic during the last two months before the start of the study
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: Calcipotriene plus betamethasone dipropionate ointment
Intervention description: Once daily application for 4 weeks
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX
      ointment in adolescent patients with psoriasis vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 12 to 17 years, inclusive.

          -  Psoriasis vulgaris on the trunk and/or limbs which is:

          -  amenable to topical treatment

          -  of an extent of 5-30% of BSA

          -  of at least a moderate severity

          -  A serum cortisol concentration above 5 mcg/dL before ACTH-challenge and above 18
             mcg/dL at 30 minutes after ACTH-challenge.

          -  Albumin-corrected serum calcium and urinary calcium:creatinine ratio within the
             reference range.

        Exclusion Criteria:

          -  Serious allergy, serious asthma, or serious allergic skin rash.

          -  A history of sensitivity to any medication.

          -  PUVA or Grenz ray therapy, UVB therapy, systemic treatment with biological therapies,
             corticosteroids, or other therapies with an effect on psoriasis, topical treatment
             with corticosteroids or vitamin D analogues, treatment with enzymatic inductors,
             cytochrome P450 inhibitors, hypoglycemic sulfonamides, antidepressive medications,
             estrogen therapy, calcium supplements or vitamin D supplements.

          -  Guttate, erythrodermic, exfoliative or pustular psoriasis.

          -  Viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds.

          -  Severe renal insufficiency, severe hepatic disorders, disorders of calcium metabolism
             associated with hypercalcemia, any cardiac condition or endocrine disorder.

          -  Diabetes mellitus

          -  Cushing's disease or Addison's disease.