bioihbjkbjnl/mcl2 huggingface dataset:
Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Daclatasvir; Asunaprevir; Pegylated interferon alfa-2a; Ribavirin
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Asunaprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received
      placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and
      determine whether addition of these drugs results in higher cure rates in patients who
      previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS
      study NCT01428063 (AI447-028) will receive active drugs in this study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to
             control arm (pegIFNα-2a/ribavirin + placebo) during the trial

          -  Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)

          -  HCV RNA viral load detectable

        Key Exclusion Criteria:

          -  Discontinuation from a prior BMS HCV clinical trial due to a
             pegIFNα-2a/ribavirin-related event

          -  Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or
             BMS-791325

          -  Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2
             antibody at screening

          -  Evidence of medical condition associated with chronic liver disease other than HCV
             infection

          -  Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: Metformin; Placebo; Lifestyle Intervention
Intervention description: Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).; Placebo; A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 114.0
Sex: Female
Minimum age: 12 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Polycystic Ovary Syndrome (PCOS); Anovulation; Elevated Testosterone

Summary:

      The purpose of this study is to determine if the combination therapy of lifestyle
      intervention and use of Metformin together will improve ovulation induction and
      hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and
      adolescent females.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Spontaneous intermenstrual periods of greater than or equal to 45 days or a total of 8
             or less periods per year

          -  Elevated testosterone levels

          -  General good health

          -  Off of current medications which may confound response to study medications

        Exclusion Criteria:

          -  Pregnancy

          -  Lactose Intolerance

          -  Medical Contraindications

          -  Elevated Prolactin, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests

          -  Diabetes, liver, heart, kidney or uncorrected thyroid disease
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Sofosbuvir/Velpatasvir/Voxilaprevir
Intervention MeSH terms: Sofosbuvir; Velpatasvir; Sofosbuvir-velpatasvir drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C relapse

Summary:

      This study will evaluate the safety, tolerability, and efficacy of
      sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C
      infection who have failed to eradicate hepatitis C despite previous combination directly
      acting antiviral therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Available for clinical follow-up through Week 44 after enrollment.

          -  Recurrent HCV GT-1

          -  Exposure to combination DAA therapy

          -  Able and willing to complete the informed consent process.

          -  Use of protocol specified methods of contraception

          -  Hepatitis B coinfected participants must have evidence of chronic infection and
             controlled on treatment

          -  HIV coinfected participants must have HIV status of one of the following:

               1. HIV untreated for >8 weeks prior to screening, CD4 >500, no intention of
                  initiating ARV therapy for the duration of the trial.

               2. HIV suppressed on a stable, protocol-approved ARV regimen for >4 weeks prior to
                  screening.

        Exclusion Criteria:

          -  Combination DAA therapy was completed or discontinued less than 8 weeks prior to
             enrollment.

          -  Current or prior history of any clinically significant illness, organ transplantation,
             and/or concomitant medication that may interfere with the subject treatment,
             assessment of compliance with the protocol.

          -  Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease,
             alfa-1 antitrypsin deficiency, cholangitis)

          -  Laboratory results outside acceptable ranges at screening.

          -  Female who is pregnant, breast-feeding or planning to become pregnant during study.
Lidocaine as an Endotracheal Tube (ETT) Cuff Media
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Intervention: 1.8% lidocaine plus 0.76% sodium bicarbonate; Air
Intervention description: At the time of intubation, the endotracheal tube cuff will be inflated with a solution containing 1.8% lidocaine plus 0.76% sodium bicarbonate until loss of air leak at a positive pressure of 20 cm of water. This solution will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.; At the time of intubation, the endotracheal tube cuff will be inflated with air until loss of air leak at a positive pressure of 20 cm of water. The air will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac Surgery

Summary:

      Researchers will compare the effects of lidocaine versus air, as a way to fill the breathing
      tube cuff which is gently inflated to hold in place the trachea (airway) during surgery. Air
      is the traditional method used to inflate the breathing tube cuff. Researchers wish to find
      if lidocaine works better than air to facilitate tolerance to the breathing tube (decreased
      coughing, sore throat, hoarseness). They also want to learn more about its effectiveness for
      this particular surgical intervention.
    

Eligibility criteria:

        Patients who meet the inclusion criteria below and are expected to require ventilatory
        support for a period of less than 5 hours post-operatively in the cardiac ICU will be
        enrolled.

        Inclusion Criteria:

          -  All patients > 18 years of age (male and female) who will receive general anesthesia
             for cardiac surgery at St. Mary's Hospital (SMH) in Rochester, Minnesota

          -  Cardiac surgery includes: single valve repair, myectomy, cabbage, pericardectomy.

          -  American Society of Anesthesiologists (ASA) physical status I-III

        Exclusion Criteria:

          -  Age < 18 years old at time of surgery

          -  Patients who are not sent to the cardiac ICU post-operatively

          -  Patients who are anticipated to have a difficult tracheal intubation

          -  Patients having risk factors of postoperative aspiration of gastric contents

          -  Patients who have respiratory disease or recent respiratory tract infection

          -  > 1 attempt to secure an airway

          -  Patients undergoing transcatheter aortic valve replacement (TAVR) procedures or any
             form of "robotic" procedures
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
Condition: GCT; Giant Cell Tumor of Bone
MeSH terms: Giant Cell Tumors; Bone Neoplasms; Giant Cell Tumor of Bone
Intervention: Denosumab; Calcium/Vitamin D
Intervention description: Administered by subcutaneous injection
Intervention MeSH terms: Vitamin D; Denosumab; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Giant Cell Tumor of Bone

Summary:

      To determine how safe and effective denosumab is in treating patients with giant cell tumor
      of bone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults, 18 years and older

          -  Histologically confirmed and measurable giant cell tumor (GCT)

          -  Recurrent GCT confirmed by radiology or unresectable GCT

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

        Exclusion Criteria:

          -  Pateints for whom surgery to the affected limb/area is planned within 27 days after
             receiving 1st dose of denosumab

          -  Radiation to affected region within 28 days before enrollment to study

          -  Known diagnosis of osteosarcoma or brown tumor of bone

          -  Known history of second malignancy within the past 5 years, except for basal cell
             carcinoma or cervical carcinoma in situ

          -  Concurrent treatment with bisphosphonates, calcitonin, or interferon.

        Other criteria also apply.
Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
Condition: Pain
MeSH terms: Acute Pain
Intervention: Celecoxib; Celecoxib; Placebo
Intervention description: Initial dose: Celecoxib 200mg tablet x 2 will be administrated during a period from 1 to 2 hours post lateral mandibular impacted third molar tooth extraction in subjects with "moderate pain" or "severe pain"rated as 45.0 mm or more on the VAS; Additional dose: Celecoxib 200mg tablet x 1 will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain; Additional dose: Placebo (tablet) will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 255.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction

Summary:

      To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in
      patients with post lateral mandibular impacted third molar tooth extraction pain.
    

Eligibility criteria:

        Inclusion Criteria:

        Initial dose:

          -  20 to 64 years

          -  Patients with undergoing mandibular impacted third molar tooth extraction accompanied
             by lateral bone removal and crown cutting

          -  Patients with pain that meets both of the following criteria

          -  Pain intensity (4-categorical): "moderate pain" or "severe pain"

          -  Pain intensity (VAS): 45.0 mm or more

        Additional dose:

          -  Patients with pain that corresponds to "4. Agree" or "5. Strongly agree" as the answer
             to the "question about the pain intensity" during the period from 5 hours to 12 hours
             post-initial dose of the study drug

        Exclusion Criteria:

          -  Patients with acute inflammatory findings in the oral cavity necessitating treatment

          -  Patients who are scheduled to receive general anesthesia and analgesics in the process
             of the eligible tooth extraction
Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: SB-742457; Donepezil; Placebo
Intervention description: investigational drug; comparator; comparator
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 576.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; Cognition; SB-742457

Summary:

      The study is designed to investigate the efficacy, safety and tolerability of SB-742457
      versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an
      experimental treatment which increases the levels of certain chemicals in the brain that are
      often decreased in patients with Alzheimer's disease.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects and their caregivers must provide informed consent prior to study entry.

          -  Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's
             disease with a documented 6-month history of AD symptoms

          -  Subjects must have a regular caregiver who is willing to attend visits, oversee the
             subject's compliance with the study and report on the subject's status.

          -  Female subjects of child-bearing potential must agree to pregnancy testing and
             approved form of birth control.

        Exclusion criteria:

          -  Diagnosis of possible, probable or definite vascular dementia.

          -  History/evidence of any other CNS disorder that could be interpreted as a cause of
             dementia

          -  History of known or suspected seizures, loss of consciousness or significant head
             trauma

          -  Subjects with ECG, blood pressure and laboratory values outside of protocol criteria
             are excluded.

          -  Subjects with known photosensitivity

          -  Subjects with a history of previous exposure to SB-742457, taking agents for which
             there is a theoretical risk of interaction with SB-742457, or taking medication for
             Alzheimer's disease or centrally acting agents which might impact study outcomes may
             not participate.
A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Adenocarcinoma; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung
Intervention: afatinib (BIBW 2992)
Intervention description: afatinib (BIBW 2992) po QD
Intervention MeSH terms: Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete
      Response, Partial Response) as determined by Response Evaluation Criteria in Solid
      Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the
      lung harbouring wild-type EGFR.
    

Eligibility criteria:

        Inclusion criteria:

          1. Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung
             cancer[NSCLC]

          2. Progressive disease following a second-line cytotoxic chemotherapy including at least
             one platinum-containing regimen

          3. A known wild-type EGFR status

          4. Patients 18 years of age or older

        Exclusion criteria:

          1. More than two prior cytotoxic chemotherapy treatment regimens for relapsed or
             metastatic disease

          2. Prior treatment with EGFR targeting small molecules or antibodies

          3. Radiotherapy or surgery within 4 weeks prior to study entry

          4. Active brain metastasis

          5. Known pre-existing interstitial lung disease

          6. History or presence of clinically relevant cardiovascular abnormalities

          7. Cardiac left ventricular function with resting ejection fraction of less than 50%

          8. Absolute neutrophil count[ANC] < 1,500/mm3

          9. Platelet count <100,000/mm3

         10. Creatinine clearance<60ml/min or serum creatinine >1.5 times upper limit of normal

         11. Women of childbearing potential, or men who are able to father a child, unwilling to
             use a medically acceptable method of contraception during the trial

         12. Pregnancy or breast-feeding
Open-Label Study of OTO-201 for Treatment of AOMT
Condition: Acute Otitis Media; AOMT
MeSH terms: Otitis; Otitis Media
Intervention: OTO-201
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Acute otitis media with tympanostomy tubes

Summary:

      This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with
      either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible
      subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is
      designed to characterize safety, procedural factors and clinical effect of OTO-201
      administered in subjects with AOMT.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female aged 6 months to 17 years, inclusive

          -  Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)

          -  Subject's caregiver is willing to comply with the protocol an attend all study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has a history of sensorineural hearing loss

          -  Subject has tympanic membrane perforation other than the surgical tympanostomy tube
             perforation

          -  Subject has a history of known immunodeficiency disease
Use of Donepezil for Treatment of Cocaine Dependence
Condition: Cocaine Abuse and Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Donepezil, 5 mg daily; Oral Placebo
Intervention description: This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.; Inactive Comparator with Similar Appearance to Active Medication
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Acetylcholine; Acetylcholinesterase; Butyrylcholinesterase; Cholinesterase Inhibitor

Summary:

      The purpose of this study is to determine the safety of intravenous cocaine in subjects
      receiving oral donepezil.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-treatment seeking, experienced cocaine users, who have used cocaine by smoking or
             intravenous injection within the four weeks prior to screening, and must supply a
             cocaine-positive urine obtained within four weeks of entry into the study.

        Exclusion Criteria:

          -  Shows signs of psychostimulant toxicity, or has a history of a medical adverse
             reaction to cocaine or other psychostimulants, including loss of consciousness, chest
             pain, cardiac ischemia, or seizure.

          -  Has a current psychiatric disorder other than drug abuse or dependence or dementia.

          -  Meets the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for
             dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics.

          -  Has received opiate-substitution therapy (methadone or buprenorphine) within two
             months prior to enrollment.

          -  Has current or past history of seizure disorder, including alcohol- or
             psychostimulant- related seizures, or family history of seizure disorder.

          -  Has a diagnosis of adult asthma, or chronic obstructive pulmonary disease, including a
             history of acute asthma within the past two years, and those with current or recent
             (with the past two years) treatment with an inhaled or oral beta-adrenergic agonist.

          -  Has had head trauma that resulted in neurological sequelae.

          -  Has an unstable medical condition, which, in the judgement of investigators, would
             make participation hazardous.