bioihbjkbjnl/mcl2 huggingface dataset:
Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
Condition: Squamous Cell Carcinoma of Nasopharynx; Squamous Cell Carcinoma of Oropharynx; Squamous Cell Carcinoma of Hypopharynx
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Nasopharyngeal Carcinoma; Mucositis; Stomatitis
Intervention: Low Level Laser Therapy- (DMC, São Paulo, Brazil); Placebo (DMC, São Paulo, Brazil)
Intervention description: Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.; The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Oral mucositis; Low Level Laser Therapy; Head and neck cancer

Summary:

      Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas
      patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level
      laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This
      study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the
      incidence and/or severity of oral mucositis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Histological diagnosis of squamous cell carcinoma (nasopharynx, oropharynx and
             hypopharynx)

          -  Candidates for surgery or treatment for organ preservation

          -  Performance status (PS) of 0 or 1 according to the Eastern Cooperative Oncology Group
             (ECOG)

          -  Indication for radiotherapy and concurrent platinum-based chemotherapy

          -  Oral mucosa intact

          -  Agree to follow the protocol of oral hygiene

          -  Informed consent.

        Exclusion Criteria:

          -  Patients using medication for treatment and or prevention of mucositis

          -  Patients incapable of treatment compliance or of performing the protocol of oral
             hygiene
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
Condition: Hepatitis; Hepatitis B, Chronic; Cirrhosis
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Liver Cirrhosis; Fibrosis
Intervention: Telbivudine; Lamivudine; Placebo
Intervention description: 600mg/day oral tablet for 104 weeks; 100mg/day oral tablet for 104 weeks; Telbivudine matching placebo or lamivudine matching placebo tablet.
Intervention MeSH terms: Lamivudine; Telbivudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 232.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This research study was conducted to compare the safety and effectiveness of the
      investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by
      the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The
      results for patients taking LdT will be compared to results for patients taking lamivudine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented decompensated chronic hepatitis B defined by all of the following: 1.
             Clinical history compatible with decompensated chronic hepatitis B related cirrhosis;
             2. Child-Turcotte-Pugh score > 7 points.

          -  Evidence of hepatic cirrhosis or portal hypertension.

        Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Patient is pregnant or breastfeeding.

          -  Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human
             immunodeficiency virus (HIV).

          -  Patient previously received lamivudine, adefovir, or an investigational anti-hepatitis
             B virus (HBV) nucleoside or nucleotide analog at any time

          -  Patient has received interferon or other immunomodulatory treatment for HBV infection
             in the 12 months before Screening for this study.

        Other protocol-defined exclusion criteria may apply.
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
Condition: Aneurysm, Dissecting; Aortic Aneurysm, Thoracic
MeSH terms: Aortic Dissection; Aneurysm; Aortic Aneurysm; Aortic Diseases; Aortic Aneurysm, Thoracic
Intervention: Endovascular Stent-graft repair of descending thoracic aorta
Intervention description: A TAG device will be used to repair the pathology in the thoracic aorta
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      PURPOSE OF RESEARCH:

      Endovascular stent-graft repair of aortic pathologies is a minimally-invasive alternative to
      open surgery that may decrease morbidity and mortality, particularly in high risk patients.
      Optimal patient selection, based on pathology and anatomy, is being defined. Technically
      successful implantation requires adequate assessment of pathology and anatomy, and
      development and execution of novel and delicate procedures that resolve the pathology while
      minimizing morbidity and mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients should be poor or high risk open surgical candidates.

          2. Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or
             extension including dissection and transection.

          3. Anatomy meets TAG Endoprosthesis specification criteria.

          4. Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm

               -  <60 angle in the aortic arch may require additional length of non-aneurysmal
                  segment is the arch is included in the treatment segment.

          5. Ability to comply with protocol requirements including follow-up.

          6. Signed Informed Consent

        Exclusion Criteria:

          1. >4mm aortic taper and inability to use devices of different diameters, to compensate
             for the taper, in the treatment area of the aorta.

          2. Significant thrombus at the proximal or distal implantation sites.

          3. Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit
             or alternate perfusion routes for end organ(s) provided.

          4. Degenerative connective tissue disease, e.g. Marfan's or Ehler's Danlos Syndrome,
             unless the proximal and distal implantation sites of the TAG Endoprosthesis are
             located with in previous surgical grafts.

        6. Female of child bearing age with positive pregnancy test.
Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia
Condition: Acute Schizophrenia
MeSH terms: Schizophrenia
Intervention: OPC-34712; OPC-34712; OPC-34712; Placebo
Intervention description: Higher dose tablet, once daily, for six weeks,; Middle dose tablet, once daily, for six weeks; Lower dose tablet, once daily, for six weeks; Placebo, once daily, for six weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 674.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses
      of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects between 18 and 65 years of age, with a diagnosis of
             schizophrenia, as defined by DSM-IV-TR criteria

          2. Subjects who have been recently hospitalized or who would benefit from hospitalization
             for an acute relapse of schizophrenia

          3. Subjects experiencing an acute exacerbation of psychotic symptoms

          4. Other protocol specific inclusion criteria may apply

        Exclusion Criteria:

          1. Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving study drug

          2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

               -  Schizoaffective disorder

               -  MDD

               -  Bipolar disorder

               -  Delirium, dementia, amnestic or other cognitive disorder

               -  Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality
                  disorder

          3. Subjects presenting with a first episode of schizophrenia

          4. Other protocol specific exclusion criteria may apply
Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain
Condition: Post-operative Dental Pain
MeSH terms: Toothache
Intervention: Test acetaminophen; Commercial acetaminophen; Commercial ibuprofen; Placebo
Intervention description: single dose of 2 Test acetaminophen 500 mg tablets; single dose of 2 acetaminophen 500 mg caplets; Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules; 2 placebo caplets
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Post-operative dental pain following third molar extraction.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 664.0
Sex: All
Minimum age: 17 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as
      two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen
      administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen
      administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental
      pain model following third-molar extractions.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 17 to 50 years old

          2. Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)

          3. Dental extraction of three or four third molars

          4. Meets post-surgical pain criteria

          5. Females of childbearing age must be willing to use acceptable method of birth control

        Exclusion Criteria:

          1. Currently pregnant or planning to be pregnant or nursing a baby

          2. Known allergy to acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs)
             including aspirin, as well as hydrocodone or other opioids

          3. Inability to swallow whole large tablets or capsules

          4. Have other conditions that the investigator feels may impact subject's safety and/or
             the integrity of the study

          5. Use of pain medications 5 or more times per week

          6. Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the
             last 5 years

          7. History of endoscopically documented peptic ulcer disease or bleeding disorder in the
             last 2 years

          8. Have a positive urine drug screen
Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
Condition: Schizophrenia; Schizophrenic Disorders; Psychotic Disorders; Dementia Praecox
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Paliperidone ER
Intervention description: 1.5 to 12 mg tablet once daily for 6 months
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 400.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Schizophrenia; Adolescent; Paliperidone; Antipsychotic agents; Antipsychotic drugs; Psychosis.

Summary:

      The purpose of this open-label study is to evaluate the long-term (6-month) safety and
      tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible
      dosages to adolescents with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets the DSM-IV criteria for schizophrenia, otherwise physically healthy

          -  Weight >=63.9 pounds (29 kg)

          -  Must not be a danger to self or others and must have family support available to be
             maintained as outpatients

          -  Responsible adult must be available to accompany the patient to the investigational
             site at each visit.

        Exclusion Criteria:

          -  Meets the DSM-IV criteria for dissociative disorder, bipolar disorder, major
             depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic
             disorder, or primary substance-induced psychotic disorder

          -  mild, moderate, or severe mental retardation

          -  History of substance dependence (including alcohol, but excluding nicotine and
             caffeine) according to the DSM-IV criteria in the 3 months before screening

          -  pregnancy (for females)

          -  History or presence of circumstances that may increase the risk of the occurrence of
             torsade de pointes or sudden death in association with the use of drugs that prolong
             the QTc interval.
A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: Pilocarpine HCl; Vehicle
Intervention description: Pilocarpine HCl ophthalmic solution 1.25% ocular drops.; Oxymetazoline HCl and pilocarpine HCl placebo ocular drops.
Intervention MeSH terms: Pilocarpine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 230.0
Sex: All
Minimum age: 40 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Presbyopia; AGN-190584; Pilocarpine HCl 1.25%; Old Eye; Aged Eye

Summary:

      Currently available treatments for presbyopia (old eye) include nonsurgical options
      (spectacles or contact lenses) and surgical options, however, each has its own risks and
      limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating
      presbyopia compared to vehicle (placebo).

      AGN-190584 is an investigational drug being developed for the treatment of presbyopia.
      Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a
      different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle.
      Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in
      the study in approximately 20 sites in the United States.

      Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days.

      There may be additional procedures for participants in this trial compared to their standard
      of care. Participants will attend regular visits during the study at a doctor's office. The
      effect of the treatment will be checked by medical assessments, vision/eye tests, checking
      for side effects and completing questionnaires.
    

Eligibility criteria:

        Inclusion Criteria:

        - Objective and subjective evidence of presbyopia.

        Exclusion Criteria:

          -  Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial
             dystrophy, guttata, or edema) in either eye that are likely to interfere with visual
             acuity.

          -  Narrow iridocorneal angles (Shaffer grade <=2 or lower on gonioscopy examination),
             history of angle-closure glaucoma, or previous iridotomy.

          -  Diagnosis of any type of glaucoma or ocular hypertension.

          -  History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery,
             radial keratotomy, or any intraocular surgery.

          -  Use of temporary or permanent punctal plugs or history of punctal cautery in one or
             both eyes.
Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: clobetasol propionate spray 0.05%; calcitriol ointment
Intervention description: clobetasol propionate spray, 0.05%, applied topically twice daily; calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
Intervention MeSH terms: Calcitriol; Clobetasol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 305.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the safety & efficacy of consecutive
      treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body
             surface area

          -  Overall Disease Severity of at least 3 (moderate)

        Exclusion Criteria:

          -  Surface area involvement too large (>20% BSA)

          -  Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas
Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Ritalin LA (methylphenidate hydrochloride extended release)
Intervention description: Ritalin LA 20 mg or 30 mg (a racemic mixture of d- and l-thre-Methylphenidate Hydrocloride (MPH), Extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg. For 40mg dose patients took (2) Ritalin LA 20mg daily, for 60mg patients took (2) Ritalin LA 30mg daily and for 80mg patients took (2) Ritalin LA 30mg daily + (1) Ritalin LA 20mg daily for their optimal dose.
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 299.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Attention Deficit /Hyperactivity Disorder,; hyperactivity

Summary:

      This study will evaluate the long-term safety of methylphenidate hydrochloride extended
      release in adults with attention deficit/hyperactivity disorder
    

Eligibility criteria:

        Inclusion Criteria:

        1. Completion of the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments
        or Patients who meet predefined criteria for treatment failure, were withdrawn from the
        core study, and have completed core-study week 40 assessments (Premature Discontinuation
        Visit)

        Exclusion Criteria:

          1. Patients who, during the core study, developed any psychiatric condition that requires
             treatment with medication or that may interfere with study participation and /or study
             assessments.

          2. Patients who during the core study developed cardiovascular disorders.

          3. Pregnant women.

          4. Patients who developed seizures during the core study.

          5. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.

          6. Diagnosis or family history of Tourette's syndrome.

          7. Patients who during the core study developed cerebrovascular disorders such as
             cerebral aneurysm, vascular abnormalities including vasculitis and stroke

        Other protocol-defined inclusion/exclusion criteria may apply
JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; PF-04965842; PF04965842
Intervention description: Placebo; 100 mg QD; 200 mg QD
Intervention MeSH terms: Abrocitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 287.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis, JAK1 inhibitor

Summary:

      This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to
      evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of
      age with moderate to severe AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged between 12 and to 17 with a minimum body weight of 40 kg

          -  Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate
             to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS
             severity 4)

        Exclusion Criteria:

          -  Acute or chronic medical or laboratory abnormality that may increase the risk
             associated with study participation

          -  Unwilling to discontinue current AD medications prior to the study or require
             treatment with prohibited medications during the study

          -  Prior treatment with JAK inhibitors

          -  Other active non-AD inflammatory skin diseases or conditions affecting skin

          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,
             malignancies, current or history of certain infections, lymphoproliferative disorders
             and other medical conditions at the discretion of the investigator

          -  Pregnant or breastfeeding women, or women of childbearing potential who are unwilling
             to use contraception