bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Adult Caries Study (PACS)
Condition: Caries, Dental
MeSH terms: Dental Caries
Intervention: 10% w/v chlorhexidine acetate coating FDA IND #45466; Placebo
Intervention description: Dental coating topically applied by dental professional supragingivally to the full dentition
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 983.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Adult tooth decay is an infectious disease that afflicts the majority of Americans aged 55
      and older and is the most common chronic disease at midlife with an ever growing economic
      toll. Despite the fact that specific bacteria cause tooth decay, no FDA-approved
      anti-microbial treatment for decay is available to the American dental professional. The
      Prevention of Adult Caries Study (PACS) is a study designed to evaluate the efficacy of a
      topical, temporary, 10% w/v chlorhexidine dental coating in reducing new decay in adult
      dental patients at risk for decay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age and older

          -  at least 20 intact natural teeth, excluding third molars

          -  2 or more lesions, of which at least one must be a cavitated D2 or D3

          -  willing and able to provide informed consent

        Exclusion Criteria

          -  pregnant or planning to become pregnant or planning to become pregnant during the
             study (breastfeeding is permitted)

          -  use of fixed orthodontic appliances

          -  allergic to any of the ingredients of the study medication

          -  long-term antibiotic therapy

          -  a history of, or currently active, radiation therapy for cancers of the head or neck

          -  Sjögren's syndrome

          -  advanced periodontitis

          -  consumption of the equivalent of more than five servings of acidic or sugared drinks
             per day

          -  having 10 or more lesions requiring restorative care at the time of the screening
             visit

          -  remineralization therapy within one month of randomization

          -  investigator discretion
Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy
Condition: Recurrent or Progressive Glioblastoma
MeSH terms: Glioblastoma; Recurrence
Intervention: Bevacizumab; Chemotherapy; Fractionated radiosurgery
Intervention MeSH terms: Bevacizumab; Carboplatin; Irinotecan; Etoposide; Temozolomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: glioblastoma

Summary:

      This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to
      test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy ,
      and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and
      treatment response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven intracranial glioblastoma multiforme with pathologic or imaging
             confirmation of tumor progression or regrowth after failure of two previous treatment
             regimens

          -  Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma

          -  History and physical exam, including neurologic examination, within 4 weeks prior to
             registration

        Exclusion Criteria:

        • Warfarin or LMW heparin patients must have no active bleeding or pathological condition
        that carries a high risk of bleeding
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
Condition: Chronic Hepatitis c; Cirrhosis, Liver; Fibrosis, Liver; Hepatic Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Cirrhosis; Fibrosis
Intervention: Peginterferon alfa-2a + Ribavirin; Peginterferon alfa-2a
Intervention description: Peginterferon alfa-2a 180 mcg/week injection, for 24 weeks, plus 1000-1200 mg Ribavirin oral (prescribed according to weight <75 kg, >75 kg) daily in two divided doses for 24 weeks; 90 mcg/week injection, for 3.5 years
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1050.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: liver disease; hepatitis c virus; antiviral agent; cirrhosis

Summary:

      The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases
      sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated
      interferon) in patients who failed to respond to prior interferon treatment. All patients who
      enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin.
      Patients who respond to this 6 month treatment will continue to be treated for an additional
      6 months.

      Patients who do not respond to this treatment will be eligible for the long-term maintenance
      phase of this study where patients will be randomly selected to be treated with Peginterferon
      alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will
      be followed closely with quarterly study visits.

      The combination of peginterferon plus ribavirin has recently been approved by the FDA for
      treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated
      for at least 6 months with peginterferon and ribavirin outside of this study may be eligible
      to directly enter the randomized portion of the HALT-C Trial.

      The HALT-C study is designed to determine if continuing interferon long-term over several
      years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer
      and reduce the need for liver transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at entry at least 18 years.

          -  Positive for Hepatitis C.

          -  Previous treatment with any interferon or interferon and ribavirin for at least 3
             months.

          -  Documented non-response to treatment with interferon.

          -  A liver biopsy demonstrating significant liver scarring.

        Exclusion Criteria:

          -  No other liver disease.

          -  No unstable major medical diseases or conditions.

          -  No major complications of cirrhosis.

          -  No recent abuse of alcohol or illicit drugs.
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis
Condition: Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Intervention: Desmopressin; Placebo
Intervention description: Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.; Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.
Intervention MeSH terms: Deamino Arginine Vasopressin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      This is multi-center, randomized, placebo-controlled, parallel-group, double-blind,
      dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin
      orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary
      osmolality."
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality

          -  Age 6 or above but under 16 regardless of gender

          -  Out-patient

          -  Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights
             in each respective week

          -  Deemed healthy by the investigator

          -  Able to agree to and comply with fluid-intake restriction during the clinical trial
             and matters specified in the clinical trial protocol

          -  Consent from the pediatric patient's legally acceptable representative

          -  Demonstrate an understanding about this clinical trial after receiving an explanation
             corresponding to the prospective subject's intelligibility

          -  Show no possibility of being a nursing mother or pregnant, or becoming pregnant

          -  If under drug or medical therapy other than Desmopressin for treating nocturnal
             enuresis: able to discontinue such treatment

        Exclusion Criteria:

          -  Suffer from enuresis with an underlying disease

          -  Participated in another clinical trial within six months preceding consent

          -  Used an intranasal Desmopressin in the past

          -  Presently undergoing a systemic antibiotic treatment, a treatment with an antidiuretic
             or a drug that affects urinary concentration, or a drug or medical therapy for
             overactive bladder

          -  Have an anomaly or a disease that may affect the oral absorption of drug products

          -  Hard to get cooperation from subject by school refusal, punishment or bullying

          -  Deemed by the investigator to be inappropriate to participate in this trial

          -  Unable to be placed on water-intake restriction starting from two hours before bedtime

          -  Evidence of hepatic, renal, cardiac, or pulmonary dysfunction
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: AZLI 75 mg two times a day (BID)/ three times a day (TID)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 274.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: cystic fibrosis; Pseudomonas aeruginosa

Summary:

      The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI
      in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Compliance with Studies CP-AI-005 (NCT00104520) or CP-AI-007 (NCT00112359) by taking
             at least 50% of expected study medication.

          -  Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal
             antibiotics or for an AE unrelated to study medication tolerance.

          -  Ability to provide written informed consent/assent prior to initiation of
             study-related procedures.

          -  Ability to perform reproducible pulmonary function tests.

        Exclusion Criteria:

          -  Use of any investigational medication or device between the last visit of CP-AI-005 or
             CP-AI-007 and Visit 1 of this study.

          -  Concurrent participation in a study of another investigational drug or device.

          -  Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg
             prednisone/day or 20 mg prednisone every other day.

          -  History of sputum or throat swab culture yielding Burkholderia cepacia in the previous
             2 years.

          -  History of daily continuous oxygen supplementation or requirement for more than 2
             liters/minute at night.

          -  Inability to tolerate study medication in CP-AI-005 or CP-AI-007.

          -  Known local or systemic hypersensitivity to aztreonam.

          -  Inability to tolerate inhalation of a short acting beta-2 agonist.

          -  Abnormal renal or hepatic function based on results of most recent test.

          -  Female of child-bearing potential who was pregnant, lactating, or not (in the opinion
             of the investigator) practicing an acceptable method of birth control.

          -  Any serious or active medical or psychiatric illness which, in the opinion of the
             investigator, would have interfered with participant treatment, assessment, or
             compliance with the protocol.
Sublingual Fentanyl and Procedural Burn Pain
Condition: Burn Pain
MeSH terms: Burns
Intervention: Sublingual Fentanyl Spray
Intervention description: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Burn pain; Procedural pain; Sublingual fentanyl; Morphine

Summary:

      The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray
      (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn
      injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject capable of giving consent

          -  Age 18-65

          -  Total burn surface area greater than or equal to 5%

          -  Opioid tolerant

          -  BMI less than or equal to 35

        Exclusion Criteria:

          -  Subjects with cognitive or psychiatric impairment that would preclude study
             participation or compliance with protocol

          -  Allergy to fentanyl, morphine, naloxone

          -  Pregnancy, intent to become pregnant or lactating

          -  Evidence of burn injury to oral mucosa

          -  Active illicit drug use or illicit drug abuse history
Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: diclofenac diethylamine, DDEA 2.32% gel; Placebo
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Symptomatic knee OA Kellgren-Lawrence grade 1-3

Summary:

      This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient
      suffering from knee osteoarthritis (OA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Male or female ≥ 50 years old; 2. Symptomatic OA of one or both knees, according to
             ACR criteria, diagnosed at least 6 months previously; 3. Pain in either knee
             originates in the knee (not referred pain from other sites, such as hip or back) and
             no other cause of pain than knee OA; 4. Have used oral NSAIDs or COXIBs for the knee
             OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose
             per day, for not less than 10 days out of the 14 days preceding the screening visit
             and also within the 24 hours preceding the screening visit; 5. Be able to tolerate
             rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1-2 tablets up
             to a maximum of 6 tablets (3 grams) per day for the duration of the study

        Exclusion Criteria:

        - 1. Partial or total replacement of either knee joint, past or planned/expected during
        study duration.

        2. OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis,
        hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (however,
        common risk factors, such as obesity and past meniscectomy or ligament rupture and repair,
        are allowed); 3. History of systemic inflammatory (autoimmune) disease (rheumatoid
        arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis, etc.) or
        laboratory values indicative of such disease with subsequent diagnosis by a physician; 4.
        Fibromyalgia within the previous year; 5. Allergy or asthma to diclofenac, APAP, aspirin,
        other NSAIDs or any of the ingredients in the gel (i.e. isopropyl alcohol, propylene
        glycol, or butylhydroxytoluene), or any other contraindication for the study drug or the
        rescue medication
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis A; Hepatitis C; Coinfection; Hepatitis
Intervention: LDV/SOF
Intervention description: 90/400 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to determine the antiviral efficacy, safety, and
      tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with
      chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection

          -  Individuals must not be taking or requiring treatment with HBV antiviral therapy at
             screening. For participants that are HBV treatment experienced, the most recent
             treatment must have been completed at least 6 months prior to Day 1.

          -  Cirrhosis determination by Fibroscan

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female or male is of childbearing
             potential

        Key Exclusion Criteria:

          -  Current or prior history of clinically-significant illness or any other major medical
             disorder that may interfere with individual's treatment, assessment or compliance with
             the protocol

          -  Pregnant or nursing female

          -  Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)

          -  Hepatocellular carcinoma (HCC) or other malignancy

          -  Current or prior history of clinical hepatic decompensation

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels
Condition: Brain Fibrillarab Levels
MeSH terms: Amyloidosis
Intervention: [18F] Flutemetamol
Intervention description: Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.
Intervention MeSH terms: Flutemetamol
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 203.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Amyloid; PET-Positron Emission Tomography; SUVR-Standard uptake value ratios

Summary:

      To determine the level of association between quantitative regional estimates of brain uptake
      of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels
      of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject has a short life expectancy (approximately 1 year or less) as estimated by
             the Investigator.

          -  The subject is 70 years of age or older if cognitively normal, or 55 years of age or
             older if terminal because of dementia.

          -  The subject's general health is adequate to undergo the study procedures.

        Exclusion Criteria:

          -  The subject has a contraindication for PET.

          -  The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or
             to any of the excipients.

          -  The subject is unable to tolerate or cooperate with study procedures.
VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: VIR-7831; Placebo; Remdesivir
Intervention description: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1.; Commercially available 0.9% sodium chloride solution; Antiviral agent
Intervention MeSH terms: Remdesivir; Sotrovimab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 367.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; COVID 19; Coronaviridae Infections; Coronavirus Infections; RNA Virus Infections; Virus Diseases; Nidovirales Infections; SARS-CoV-2; SARS Coronavirus; ACTIV-3; ACTIV3; TICO

Summary:

      This study looks at the safety and effectiveness of VIR-7831 in treating COVID-19 in people
      who have been hospitalized with the infection. Participants in the study will be treated with
      either VIR-7831 plus current standard of care (SOC), or with placebo plus current SOC. This
      is ACTIV-3/TICO Treatment Trial H2.
    

Eligibility criteria:

        Inclusion Criteria: Refer to the master protocol (NCT04501978)

        Exclusion Criteria: Refer to the master protocol (NCT04501978)

        Additional Exclusion Criteria:

          1. Pregnant women

          2. Nursing mothers

        In addition, prior to the initial futility assessment which is performed when approximately
        150 participants have been enrolled on VIR-7831 and 150 on placebo, patients on highflow
        oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be
        excluded. These patients may be eligible for the trial if the initial futility assessment
        is passed by this agent.