bioihbjkbjnl/mcl2 huggingface dataset:
Bronchial Hyper-responsiveness in Reflux Cough
Condition: Cough
MeSH terms: Cough; Bronchial Hyperreactivity
Intervention: Omeprazole; Ranitidine
Intervention description: 20 mg BD tablet 8 weeks duration; 300 mg od nocte tablet 8weeks duration
Intervention MeSH terms: Omeprazole; Ranitidine; Ranitidine bismuth citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hyper-responsiveness, reflux cough

Summary:

      The study aim is to determine the effect of 8 weeks of anti-reflux treatment (full acid
      suppression) on bronchial hyper-responsiveness and whether there is a symptomatic
      improvement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive methacholine challenge test PC20 less than 4mg/ml (Can be previously
             documented in patients notes within last 4weeks)

          -  Written informed consent

          -  Patients with a history of chronic cough (at least 3 months duration), and associated
             symptoms of gastro-oesophageal reflux

          -  Male and female subjects of at least 18 yrs of age

          -  Subjects able to perform satisfactory FEV1 manoeuvres

          -  Subjects able to understand the study and co-operate with the study procedures

          -  Subjects who consent to their general practitioner (GP) being informed of their study
             participation

        Exclusion Criteria:

          -  has had a heart attack in the last three months

          -  suffers from angina, hypertension or ischaemic heart disease

          -  has epilepsy for which he/she is taking medication

          -  FEV1< 60% predicted

          -  FEV1<1.6L

          -  Female subjects who are pregnant, or lactating, or who are of child bearing potential
             but are not using contraceptive measures

          -  Suffering from any concomitant disease which may interfere with study procedures or
             evaluation.

          -  A lower respiratory tract infection 4 weeks prior to entry on to study

          -  Participation in another study (use of investigational product) within 30 days
             preceding entry on to study.

          -  Alcohol or drug abuse

          -  Use of opiates to treat cough 1 week prior to enrollment

          -  Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors.

          -  Subjects who have significant pathology on most recent chest X-Ray.

          -  Inability to understand the procedures and the implications of a challenge test

          -  Patients already taking or have taken in last 4 weeks PPI and H2 receptor antagonist
             (full acid suppression treatment
Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT)
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: BF-200 ALA gel; Placebo to BF-200 ALA gel; Photodynamic therapy with BF-RhodoLED
Intervention description: BF-200 ALA was applied over 1-2 fields of approximately 20 cm² in total, allowed to dry for approximately 10 minutes, and covered with occlusive tape material for 3 h.; The reference product was a placebo (a nanoemulsion gel formulation similar to the Investigational Medicinal Product (IMP), but without the active ingredient). The placebo was packaged, assigned to each patient, and administered in the same way as the IMP.; After cleaning the lesions, the entire treatment field(s) were illuminated using the novel narrow spectrum BF-RhodoLED lamp, a red light illumination source (approximately 635 nm) developed by Biofrontera, until a total light dose of 37 J/cm² (per treated field) was achieved.
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Photodynamic Therapy; Field-directed Treatment

Summary:

      The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz)
      versus placebo in the field-directed treatment of mild to moderate actinic keratosis with
      photodynamic therapy (PDT) when using the BF-RhodoLED lamp.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females between 18 and 85 years of age (inclusive)

          -  Presence of 4 to 8 clinically confirmed actinic keratosis (AK) target lesions of mild
             to moderate intensity within 1-2 fields

        Exclusion Criteria:

          -  History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA

          -  Current treatment with immunosuppressive therapy

          -  Presence of other malignant or benign tumors of the skin within the treatment area (eg
             malignant melanoma, basal cell carcinoma (BCC) or squamous cell carcinoma (SCC))
             within the last 4 weeks

          -  Confirmed diagnosis of SCC for the representative lesion by screening biopsy
An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.
Condition: Healthy Subjects; Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: GSK1755165; placebo; zopiclone
Intervention description: Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone
Intervention MeSH terms: Zopiclone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 25 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Zopiclone; Hypnotic; Residual effects; Eszopiclone

Summary:

      This study will explore potential next-day residual effects of a single evening dose of 3mg
      of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Healthy male and female subjects providing written informed consent.

        EXCLUSION CRITERIA:

          -  Significant medical disorders;

          -  Sleeping difficulties; alcohol and/or substance abuse;

          -  Recent use of psychotropic medications, or need to use them during study;

          -  Very high BMI or very low BMI or bodyweight;

          -  Known hypersensitivity to the study medications or their excipients;

          -  Unwilling or unable to meet certain lifestyle or dietary restrictions during the
             study.
Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)
Condition: Gastroenteritis; Rotavirus
MeSH terms: Gastroenteritis
Intervention: Rotavirus Vaccine, Live, Oral, Pentavalent
Intervention description: Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To observe the safety, tolerability and immunogenicity of the administration of 3 doses of
      rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 6 weeks through exactly 12 weeks

          -  Healthy infants

        Exclusion Criteria:

          -  Clinical evidence of active gastrointestinal illness

          -  Fever, with a rectal temperature of greater than and equal to thirty eight degree
             celsius at the time of immunization

          -  History of congenital abdominal disorders, intussusception, or abdominal surgery

          -  History of known prior rotavirus disease

          -  Known or suspected impairment of immunological function

          -  Prior administration of any rotavirus vaccine

          -  Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis
Condition: Chronic Hepatitis C Infection; Compensated Cirrhosis
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Intervention: ABT-450/r/ABT-267, ABT-333; Ribavirin (RBV)
Intervention description: Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet; Capsule
Intervention MeSH terms: Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 381.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Cirrhosis; Hepatitis C; Child Pugh A; Compensated Cirrhosis; Hepatitis C Genotype 1; Cirrhotic; Chronic Hepatitis C; Hepatitis C Virus; ombitasvir; paritaprevir; dasabuvir; Interferon-Free; Viekira Pak

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267
      (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and
      ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus
      (HCV) genotype 1-infected adults with compensated cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be practicing specific forms of birth control on study treatment, or be
             post-menopausal for more than 2 years or surgically sterile

          -  Male or female between 18 and 70 years, inclusive, at time of Screening.

          -  Chronic HCV-infection prior to study enrollment.

          -  Screening laboratory result indicating HCV genotype 1-infection.

          -  Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at
             Screening

          -  Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

        Exclusion Criteria:

          -  Significant liver disease with any cause other than HCV as the primary cause

          -  Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human
             Immunodeficiency virus antibody (HIV Ab) at screening.

          -  Prior therapy with direct acting antiviral agents for the treatment of HCV, including
             telaprevir and boceprevir.

          -  Any current or past clinical evidence of Child-Pugh B or C Classification or clinical
             history of liver decompensation including ascites (noted on physical exam), variceal
             bleeding or hepatic encephalopathy.

          -  A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a
             subsequent CT Scan or MRI during the screening period.
Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
Condition: Post-Operative Ileus (POI)
MeSH terms: Ileus
Intervention: Methylnaltrexone; Placebo
Intervention description: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.; Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm.
Intervention MeSH terms: Methylnaltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 524.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of MNTX in participants who have undergone segmental
      colectomy and to assess if the time between the end of surgery and the first bowel movement
      is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo
      regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants at least 18 years of age.

          -  All participants must meet American Society of Anesthesiologists (ASA) physical status
             I, II, or III.

          -  Participants must sign an informed consent form (ICF).

          -  Participants must be scheduled for a segmental colectomy via open laparotomy with
             general anesthesia.

          -  Females of childbearing potential must have a negative serum pregnancy test at the
             screening visit.

          -  Negative for history of chronic active hepatitis B, hepatitis C or Human
             Immunodeficiency Virus (HIV) infection.

        Exclusion Criteria:

          -  Participants who received any investigational new drug in the 30 days prior to
             screening visit.

          -  Females who are pregnant or lactating.
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Faster-acting insulin aspart; insulin aspart
Intervention description: Injected s.c. /subcutaneously (under the skin); Injected s.c. /subcutaneously (under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 472.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and the United States of America (USA). The aim of this
      trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of
      Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age at least 18 years at the time of signing the informed consent

          -  Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or
             supported by laboratory analysis as per local guidelines) equal or above 1 year prior
             to the day of screening

          -  Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754),
             Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a
             rapid acting insulin analogue for at least six months prior to screening and willing
             to stay on the same pump model throughout the trial (if the model is changed the
             change should not exceed 7 consecutive days.)

          -  HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central
             laboratory at screening

          -  Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening

          -  Ability and willingness to take at least 3 daily meal-time insulin bolus infusions
             every day throughout the trial

        Exclusion Criteria:

          -  Any of the following: myocardial infarction, stroke, hospitalization for unstable
             angina or transient ischaemic attack within the past 180 days prior to the day of
             screening

          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of
             screening

          -  History of hospitalization for ketoacidosis below or equal to 180 days prior to the
             day of screening

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria in a period of 90 days before screening

          -  Any condition which, in the opinion of the Investigator, might jeopardise a Subject's
             safety or compliance with the protocol
Phase 3 Study of Dexpramipexole in ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: Dexpramipexole; Placebo
Intervention description: Oral tablet 150mg twice daily for up to 18 months.; Oral tablet twice daily for up to 18 months.
Intervention MeSH terms: Pramipexole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 942.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Amyotrophic Lateral Sclerosis; ALS; Motor Neurone Disease; Motor Neuron Disease; Lou Gehrig's disease

Summary:

      The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe
      and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 to 80 years old, inclusive, on Day 1.

          -  Diagnosis of sporadic or familial ALS.

          -  Onset of first ALS symptoms within 24 months prior to Day 1.

          -  World Federation of Neurology El Escorial criteria are met for a possible,
             laboratory-supported probable, probable, or definite ALS diagnosis.

          -  Upright slow vital capacity (SVC) of 65% or more at screening.

          -  Patients taking or not taking Riluzole are eligible for this study: if a patient has
             never taken Riluzole, he or she is eligible; if a patient is currently taking
             Riluzole, he or she must have been on a stable dose for at least 60 days; if a patient
             has discontinued Riluzole, he or she must have stopped taking it for at least 30 days.

          -  Must be able to swallow tablets at the time of study entry.

        Exclusion Criteria:

          -  Other medically significant illness.

          -  Clinically significant abnormal laboratory values.

          -  Pregnant women or women breastfeeding.

          -  Prior exposure to dexpramipexole.

          -  Currently taking pramipexole or other dopamine agonists.

        Other protocol-defined inclusion/exclusion criteria may apply.
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: OTO-201 (ciprofloxacin)
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 501.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Otitis media; Ear infection; Tympanostomy tubes

Summary:

      This is an 8-week, multicenter, open-label study in which eligible subjects with a history of
      otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is
      designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement
      with common concurrent surgeries and any middle ear effusion status.
    

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 history of otitis media requiring bilateral tympanostomy tube placement

          -  Subject's caregiver is willing to comply with the protocol and attend all study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has a history of prior ear or mastoid surgery, not including myringotomy or
             myringotomy with TT placement

          -  Subject has been designated for any other surgical procedure that would occur
             concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal
             endoscopy, and nasal cautery for epistaxis

          -  Subject has a history of sensorineural hearing loss
Rapid HIV Testing and Counseling in Drug Abuse Treatment
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Intervention: On-site HIV rapid test and brief, prevention counseling; On- site HIV rapid test & information; Referral for off-site HIV testing
Intervention description: Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.; Participants will be offered an on-site oral fluid HIV rapid test with basic info.; Participants will be offered a referral list of HIV testing agencies in the community.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1281.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized controlled clinical trial in which adults receiving drug abuse treatment
      will be recruited to participate in a multi-center HIV testing and counseling study. The
      purpose of this study is to assess the relative effectiveness of three HIV testing strategies
      on increasing receipt of test results: (1) on-site HIV rapid testing with brief,
      participant-tailored prevention counseling, (2) on-site HIV rapid testing with information
      only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness
      of the three testing strategies in reducing HIV risk behaviors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  HIV-negative or HIV status unknown

          -  No receipt of results from HIV test initiated within last 12 months

          -  Be able to communicate in English