bioihbjkbjnl/mcl2 huggingface dataset:
AM-101 in the Treatment of Post-Acute Tinnitus 1
Condition: Tinnitus
MeSH terms: Tinnitus
Intervention: AM-101
Intervention description: AM-101 gel for intratympanic injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 76 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety and local tolerance of repeated
      treatment cycles of AM-101.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of TACTT2 study;

          -  Negative pregnancy test (woman of childbearing potential);

          -  Willing and able to attend the study visits during at least one treatment cycle.

        Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Adverse event leading to treatment discontinuation in TACTT2;

          -  Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating
             hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;

          -  Ongoing drug-based therapy for otitis media or otitis externa;

          -  Drug-based therapy known as potentially tinnitus-inducing;

          -  Other treatment of tinnitus;

          -  Drug abuse or alcoholism;

          -  Subjects with psychiatric diseases requiring drug treatment;

          -  Use of antidepressant or anti-anxiety medication;

          -  Any clinically relevant disorder or abnormality in physical examination;

          -  Women who are breast-feeding, pregnant or who are planning to become pregnant during
             the study;

          -  Women of childbearing potential who are unwilling or unable to practice contraception.

        Other protocol-defined exclusion criteria may apply.
A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: TMC435; Pegylated interferon (pegIFN alpha-2a); Ribavirin (RBV)
Intervention description: 100-mg capsule once daily for 12 weeks; 180 mcg injected subcutaneously (by a syringe under the skin) once weekly for 12 to 36 weeks (or until Week 48).; 200-mg tablets (daily dose: 600-1000 mg) taken orally (by mouth) two times a day for 12 to 36 weeks (or until Week 48).
Intervention MeSH terms: Interferons; Ribavirin; Peginterferon alfa-2a; Simeprevir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C, Chronic; Hepatitis C virus; Interferon Alfa-2a; Ribavirin; Viral RNA

Summary:

      The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination
      with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus
      (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in
      Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have chronic genotype 1 HCV with HCV RNA level >= 5.0 log10 IU/mL

          -  Participant relapsed after previous IFN-based therapy

          -  Participant must be willing to use contraceptive measures from the time of informed
             consent to 6 months after last dose of study medication.

        Exclusion Criteria:

          -  Co-infection with any other HCV genotype or co-infection with the human
             immunodeficiency virus (HIV)

          -  Diagnosed with hepatic cirrhosis or hepatic failure

          -  A medical condition which is a contraindication to pegIFN or ribavirin therapy

          -  History of, or any current medical condition, which could impact the safety of the
             patient in the study
Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever
Condition: Allergy
Intervention: Sublingual immunotherapy; Placebo
Intervention description: once daily intake of sublingual drops; once daily intake of sublingual drops
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of
      birch pollen induced allergy
    

Eligibility criteria:

        Inclusion Criteria:

          -  A history of birch pollen allergy

          -  Positive skin prick test to birch

          -  Positive conjunctival test to birch

          -  Positive specific Immunoglobulin E (IgE) to birch

        Exclusion Criteria:

          -  Forced expiratory volume in 1 second (FEV1)<70% of predicted value

          -  History of seasonal allergy interfering with study

          -  History of symptomatic perennial allergy

          -  History of emergency visit or admission for asthma in the previous 12 month
Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia
Condition: Acute Schizophrenia
MeSH terms: Schizophrenia
Intervention: OPC-34712 [Brexpiprazole] High Dose; Experimental: OPC-34712 [Brexpiprazole] Middle Dose; Experimental: OPC-34712 [Brexpiprazole] Low Dose; 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
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 636.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effectiveness, safety and tolerability of three
      different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects between 18 and 65 years of age, with a diagnosis of
             schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders
             (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

               -  Major depressive 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
Monoamine Transporters Genotypes: Risk of PTSD and Related Comorbidities
Condition: PTSD
Intervention: Paroxetine
Intervention description: SSRI
Intervention MeSH terms: Paroxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clinical; Genetics; Monoamine transporter; Pharmacogenetics; Post Traumatic Stress Disorder

Summary:

      Dr. Wang's merit review is aimed at providing a better understanding of the relationship
      between SLC6A3/SLC6A4 and the mental health of veterans exposed to high levels of combat
      stress, specifically focusing on PTSD symptoms, related co-morbidities, treatment outcomes
      and seeks new approaches to therapy for our Veteran population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female combat veterans ages 18 years and older who meet DSM-III-R criteria
             for principle diagnosis of PTSD as determined by the CAP-S;

          2. A minimum 6-month duration of PTSD illness; 3)CGI-S score of 4 or higher and a total
             CAPS-2 severity score of 50 or higher at the baseline visit;

          3. Homozygous for either the S/S or L/L 5-HTT;

          4. Females must not be pregnant or lactating and must agree to an acceptable form of
             contraception while receiving study medication and for 1 month after.

        Exclusion Criteria:

          1. Presence of any other primary axis I disorder (concurrent depression will be permitted
             if it is judged to be secondary to development for PTSD);

          2. Suicide ideation or attempts within the past 3 months;

          3. Alcohol or substance abuse or dependence in the past six months;

          4. Evidence of clinically significant hepatic or renal disease;

          5. Previous seizure disorder or condition predisposing to seizures, or on medications
             that might lower the seizure threshold

          6. Any acute or unstable medical condition that might interfere with the safe conduct of
             the study;

          7. Intolerance or hypersensitivity to citalopram or any other SSRI;

          8. Treatment with a monoamine oxidase inhibitor within 14 days of initiating the study;

          9. Concomitant treatment with serotonin agonists, other SSRIs, meperidine, tramadol or
             other medication as determined by the study clinician.

         10. PTSD symptoms in need of immediate treatment as determined by clinical assessment from
             a psychiatrist not affiliated with the study.
Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
Condition: Tonsillectomy
MeSH terms: Psychomotor Agitation; Emergence Delirium
Intervention: Dexmedetomidine; Placebo
Intervention description: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 4 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: tonsillectomy; emergence agitation

Summary:

      To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of
      Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus
      Injection of Dexmedetomidine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children undergoing tonsillectomy with and without adenoidectomy and myringotomy and
             tube insertion

          -  ASA 1,2,3

          -  females who have started menses but have a negative urine pregnancy test

        Exclusion Criteria:

          -  patients with known dysrhythmias,

          -  not recovering in the ICU

          -  developmental delay,

          -  autism communication disorder

          -  bleeding disorder

          -  PI discretion
Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation
Condition: Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
Intervention: MOVIPREP
Intervention description: MOVIPREP solution
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Bowel preparation, MOVIPREP®

Summary:

      To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5
      colon segments prior to colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female ≥18 years and ≤ 85 years

          -  colonoscopy procedure indicated

          -  willing to stay in the outpatient clinical site for colonoscopy and questionnaire
             completion

          -  willing and able to undergo study-related procedures

          -  informed consent signed by a patient for participation in the study

          -  negative pregnancy test in women with childbearing potential and consent for double
             barrier method birth control for subjects, men and women, during the study

        Exclusion Criteria:

          -  ileus

          -  suspected colonic tumor with manifestations of intestinal obstruction

          -  delayed gastric emptying (gastroparesis), weak vomiting reflex, tendency to aspiration
             and regurgitation

          -  toxic megacolon which is a result of severe inflammatory conditions of the colon
             including Crohn's disease and ulcerative colitis

          -  suspected intestinal perforation or risk of gastrointestinal perforation

          -  signs of severe intestinal bleeding

          -  acute inflammatory anal or perianal pathology

          -  severe concomitant diseases of internal organs

          -  psychiatric diseases in aggravation stage

          -  hypersensitivity to polyethylene glycol and/or any component of MOVIPREP® preparation

          -  phenylketonuria or diagnosed glucose-6-phosphate dehydrogenate deficiency

          -  unconsciousness

          -  dehydration

          -  severe inflammatory diseases

          -  acute abdominal pain of unknown etiology

          -  pregnancy and lactation period

          -  participation in any other clinical study (including studies of experimental devices)
             in 30 days prior participation in the present trial

          -  patients who test positive for human immunodeficiency virus (HIV)/autoimmune disease
             (AID), Wasserman reaction (RW) or hepatitis B virus (HBC)

          -  any condition or circumstance that, in the opinion of the Investigator, would
             compromise the safety of the participant or the quality of study data
A Trial of Tadalafil and Glycemic Traits
Condition: Cardiovascular Disease; Insulin Resistance; Glucose Intolerance; Obesity
MeSH terms: Cardiovascular Diseases; Insulin Resistance; Glucose Intolerance
Intervention: Tadalafil; Placebo
Intervention description: 20 mg Tadalafil taken once a day for 3 months; Placebo tablet taken by mouth once a day for 3 months
Intervention MeSH terms: Tadalafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tadalafil; Phosphodiesterase 5 Inhibitors; Cyclic Guanylyl Monophosphate Pathway; Pharmacologic Actions; Vasodilator Agents; Cardiovascular Agents; Obesity; Glycemic Traits; Insulin Resistance; Glucose Metabolism

Summary:

      The purpose of this study is to find out if tadalafil can help overweight and obese people
      metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day
      of tadalafil for 3 months is safe to take without causing too many side effects. The
      investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years and < 50 years

          -  BMI > 30 kg/m2

          -  Fasting insulin > 10 uU/mL

        Exclusion Criteria:

          -  Systolic blood pressure (SBP) < 100, > 150 mmHg

          -  Current anti-hypertensive medication use, including diuretics

          -  Current use of organic nitrates

          -  Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)

          -  History of reaction to PDE-5 inhibitors

          -  Known HIV infection

          -  Use of medications that strongly alter CYP3A4 activity

          -  History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke,
             transient ischemic attack, or seizure

          -  Known non-arteritic ischemic optic retinopathy (NAIOR)

          -  History of hearing loss

          -  Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 by the modified diet
             in renal disease (MDRD) equation

          -  Hepatic transaminase (AST and ALT) levels greater than three times the upper limit of
             normal

          -  Known pregnancy or those unwilling to avoid pregnancy during the course of the study

          -  History of priapism

          -  Use in excess of four alcoholic drinks daily

          -  History of diabetes mellitus or use of anti-diabetic medications

          -  Known anemia (men, Hct < 38% and women, Hct < 36%)
A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; Upadacitinib; Placebo Upadacitinib; Placebo Methotrexate
Intervention description: Capsule; Oral; Tablet; Oral; Tablet; Oral; Capsule; Oral
Intervention MeSH terms: Methotrexate; Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 648.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Musculoskeletal Disease; Arthritis; Joint Disease; Anti-inflammatory agents; Antirheumatic agents; Upadacitinib; ABT-494

Summary:

      The study objective of Period 1 of this study is to compare the safety and efficacy (signs
      and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone
      versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis
      (RA) with an inadequate response to MTX.

      The study objective of Period 2 is to evaluate the long term safety, tolerability, and
      efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA for >= 3 months.

          -  Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable
             dose for >= 4 weeks prior to first dose of study drug.

          -  Must have discontinued all conventional synthetic disease-modifying anti-rheumatic
             drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.

          -  Meets the following minimum disease activity criteria: >= 6 swollen joints (based on
             66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and
             Baseline Visits.

        Exclusion Criteria:

          -  Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
             tofacitinib, baricitinib, and filgotinib).

          -  Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).

          -  Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of
             secondary Sjogren's Syndrome is permitted.
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Inspire Upper Airway Stimulation System
Intervention description: Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 929.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No
Keywords: tongue; surgery; neurostimulation; hypoglossal nerve; upper airway stimulation

Summary:

      The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the
      Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat
      moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of
      the hypoglossal nerve. Study objectives include demonstrating that the Inspire system
      improves key indices of sleep apnea in a pre-specified percentage of patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Likely suffer moderate-to-severe OSA based on history and physical

          -  Have failed or have not tolerated CPAP treatment

          -  Willing and capable of providing informed consent

          -  Willing and capable to have stimulation hardware permanently implanted, and to use the
             patient programmer to activate the stimulation

          -  Willing and capable to return for all follow-up visits and sleep studies, including
             the evaluation procedures and filling out the questionnaires

        Exclusion Criteria:

          -  Body Mass Index limits

          -  Surgical resection or radiation therapy for cancer or congenital malformations in the
             larynx, tongue, or throat

          -  Significant co-morbidities making the patient unable or inappropriate to participate
             in the trial