bioihbjkbjnl/mcl2 huggingface dataset:
Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)
Condition: Migraines
MeSH terms: Migraine Disorders
Intervention: Telcagepant 140 mg; Talcagepant 280 mg; Placebo
Intervention description: Telcagepant 140 mg tablets; Telcagepant 280 mg tablets; Placebo tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1935.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple attacks of moderate to severe migraine headaches

Summary:

      The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in
      acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this
      study are that telcagepant is superior to placebo, as measured by the proportion of
      participants who have pain freedom, pain relief, pain freedom consistency, pain relief
      consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of migraines within the past year

          -  1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted
             between 4 to 72 hours if untreated

          -  Use acceptable contraception throughout the study

          -  Able to complete the study questionnaire(s) and paper diary

          -  Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

        Exclusion Criteria:

          -  Pregnant or breast-feeding or is expecting to become pregnant during the study

          -  Difficulty distinguishing his/her migraine attacks from tension or interval headaches

          -  A history of mostly mild migraine attacks or migraines that usually resolve
             spontaneously in less than 2 hours

          -  More than 15 headache-days per month or has taken medication for acute headache on
             more than 10 days a month in the past 3 months

          -  Greater than 50 years old at the age of migraine onset

          -  Previously taken telcagepant
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin degludec/insulin aspart; insulin aspart; insulin detemir; insulin aspart
Intervention description: Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.; Administered s.c. with the remaining meals. Dose individually adjusted.; Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing.; Administered s.c. at meal-times. Dose individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Detemir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 362.0
Sex: All
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North and South America. The aim of the trial is
      to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus
      insulin aspart for the remaining meals in children and adolescents with type 1 diabetes
      mellitus.
    

Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial
        related activities are any procedures that are carried out as part of the trial, including
        activities to determine suitability for the trial - Subjects diagnosed with type 1 diabetes
        mellitus - HbA1c below or equal to 11.0% Exclusion Criteria: - Known hypoglycaemic
        unawareness or recurrent severe hypoglycaemic events as judged by the investigator - More
        than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months
        prior to Visit 1 (Screening) - Any chronic disorder or significant concomitant disease,
        which in the investigator's opinion might jeopardise the subject's safety or compliance
        with the protocol
Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel; Vehicle Gel
Intervention description: Topical Gel to the face, once daily in the evening for 24 weeks.; Topical Gel to the face, once daily in the evening for 24 weeks.
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 243.0
Sex: All
Minimum age: 12 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Acne

Summary:

      The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide
      2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously
      treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline
      Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had
             obtained at least a good Improvement (Grade, 0, 1, 2 or 3)

        Exclusion Criteria:

          -  Female Subjects who are pregnant, nursing or planning a pregnancy during the study

          -  Subjects who foresee intensive UV exposure during the study (mountain sports, UV
             radiation, sunbathing, etc).
Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS; Placebo
Intervention description: topical product; topical product
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 373.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III
      Clinical Study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp,
             defined by an Investigator's Global Assessment (IGA) score of at least 2 at
             baseline/randomization

        Exclusion Criteria:

          -  Patients whose scalp psoriasis necessitates systemic or other concomitant topical
             therapies during the study (concomitant treatment of body psoriasis with over the
             counter topical products including emollients, is allowed).

          -  Patient has a scalp skin condition that would interfere with the diagnosis or
             assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema,
             cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse,
             pustular or erythrodermic psoriasis)

          -  Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the
             treatment areas that could interfere with the rating of efficacy parameters, including
             planned extensive exposure to sunlight during the study.

          -  History of psoriasis unresponsive to topical treatments.

          -  Current immunosuppression or history of organ transplant.

          -  Patients who have a history of or current diagnosis of glaucoma.

          -  Patients who have had surgery on the eyes or eyelids within 1 month before baseline or
             plan to have eye or eyelid surgery during the study.

          -  Patients with active infection (including but not limited to bacterial, fungal and
             viral infection) and/or open wounds on the entire head and neck area.
Phase 3 Study to Evaluate the Efficacy & Safety of Tralokinumab in Adults & Adolescents With OCS Dependent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Tralokinumab; Placebo
Intervention description: Tralokinumab dose; Placebo dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Reactive Airways; Repiratory Tract Disease; Obstructive Lung Disease; Lung Diseases

Summary:

      A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to
      Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent
      Asthma.
    

Eligibility criteria:

        Inclusion Criteria:

        1) Age 12-75 2) Documented physician-diagnosed asthma. 3) Documented treatment with ICS at
        a total daily dose corresponding to ≥500µg fluticasone propionate dry powder formulation
        and a LABA. 4) Subjects must have received OCS for the treatment of asthma for 6 months
        prior to Visit 1 and on a stable OCS dose between ≥7.5 to ≤30mg daily or daily equivalent
        for at least one month prior to enrolment (Visit 1) . 5) Pre-BD FEV1 value <80% (<90% for
        patients 12-17 yrs of age) of their PNV. 6) Post-BD reversibility of ≥12% in FEV1.

        Exclusion Criteria:

        1) Clinically important pulmonary disease other than asthma. 2) History of anaphylaxis
        following any biologic therapy. 3) Hepatitis B, C or HIV. 4) Pregnant or breastfeeding. 5)
        History of cancer. 6) Current tobacco smoking or a history of tobacco smoking for ≥10
        pack-years. 7) Previous receipt of tralokinumab.
An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Trabectedin; DOXIL; Dexamethasone
Intervention description: Type=exact number, unit=mg/m2, number=1.1, form=solution, route=IV. Trabectedin will be administered over 3 hours every 3 weeks.; Type=exact number, unit=mg/m2, number=30, 50, form=solution, route=IV. DOXIL will be administered over 90 minutes every 4 weeks when administered alone (monotherapy) and every 3 weeks when administered with trabectedin.; Type=exact number, unit=mg, number=20, form=solution, route=IV. Dexamethasone or its equivalent will be administered over 30 minutes prior to the DOXIL infusion.
Intervention MeSH terms: Dexamethasone; Trabectedin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 672.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian cancer; Trabectedin; Yondelis; Advanced Relapsed Ovarian Cancer; DOXIL; CAELYX

Summary:

      The purpose of the study is to compare the progression-free survival (PFS) of the combination
      of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or
             primary peritoneal cancer

          -  Prior treatment with only 1 platinum based chemotherapy regimen

          -  Eastern Cooperative Oncology Group status of not more than 2

          -  Progression more than 6 months after the start of initial chemotherapy treatment

        Exclusion Criteria:

          -  Treatment with more than 1 prior chemotherapy regimen

          -  Progression within 6 months after starting initial chemotherapy

          -  Prior exposure to anthracyclines

          -  Unwilling or unable to have central venous catheter

          -  Known clinically relevant central nervous system metastasis
Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
Condition: Transfusion; Age of Blood
Intervention: Blood transfusion
Intervention description: Blood transfusion in ICU patients aged 18 and over.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Two staff not involved in the direct care of each patient checked the red-cell units, and concealed the collection and expiry dates from clinical staff using a bag with opaque panels (Australia, Ireland and Saudi Arabia), or an obscuring sticker (NZ and Finland).
Enrollment: 4994.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In Australia, blood for transfusion has a "use by" date of 42 days after collection. The
      actual age of blood given to patients depends on what is available at the time and the rate
      of usage. During the last decade, it has been reported that blood transfusion in patients
      admitted to intensive care was associated with an independent increase of mortality. Some
      research suggests that transfusion of fresher blood might help patients in the intensive care
      unit to reach a better recovery. This project will test whether patients who receive
      'fresher' blood do better than patients who receive 'standard issue' blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in
             whom the decision has been made by medical staff to transfuse at least one RBC unit.

        Exclusion Criteria:

          -  Age younger than 18

          -  Previous RBC transfusion during the current hospital admission (including transfusion
             in another hospital for transferred patients)

          -  Diagnosis of transplantation or hematologic diseases

          -  Pregnancy

          -  Cardiac surgery during the present hospital admission

          -  Expected to die imminently (<24hrs)

          -  The treating physician believes it is not in the best interest of the patient to be
             randomised in this trial.

          -  Known objection to the administration of human blood products

          -  Participation in a competing study (see below)
Pramipexole Conversion to Ropinirole Controlled Release (CR)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Requip PR; Mirapex
Intervention description: Requip 24-Hour once a day for one month; All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5.
Intervention MeSH terms: Pramipexole; Ropinirole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PD; Parkinson's

Summary:

      A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in
      patients with Parkinson's disease to determine the appropriate conversion ratio and side
      effects related to the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Parkinson Disease

          -  Currently taking pramipexole

          -  Never have taken Requip CR

        Exclusion Criteria:

          -  Can not have significant adverse effects to standard Requip

          -  Can not have atypical PD due to drugs, metabolic disorders, encephalitis or
             degenerative diseases

          -  Can not have unstable medical conditions

          -  Can not be taking concurrent monoamine oxidase inhibitors except for selegiline (10mg
             per day or less)

          -  Female patients of childbearing potential must be using an effective method of
             contraception.

          -  Can not be pregnant or lactating.

        This may not be a complete list; there may be additional criteria which may apply.
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
Condition: Hepatitis C Virus (HCV)
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Glecaprevir/Pibrentasvir
Intervention description: Fixed-dose combination tablets taken orally once a day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glecaprevir; pibrentasvir; compensated cirrhosis; non-cirrhotic; interferon (IFN); pegylated interferon (pegIFN); ribavirin (RBV); sofosbuvir (SOF); Sustained Virologic Response 12 weeks post dosing (SVR12); Chronic; Genotype 5 or 6 Infection

Summary:

      A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of
      glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic
      hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis
      respectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.

          -  Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid
             (RNA) greater than or equal to 1000 IU/mL at Screening Visit.

          -  Participant must be HCV treatment-naïve (i.e., has never received a single dose of any
             approved or investigational anti-HCV medication) or treatment-experienced (i.e., has
             failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without
             ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior
             HCV treatment with any other approved or investigational medications is not allowed.
             Previous HCV treatment must have been completed greater than or equal to 2 months
             prior to screening.

          -  Participant must be documented as having no cirrhosis or compensated cirrhosis.

        Exclusion Criteria:

          -  Female participant who is pregnant, breastfeeding, or is considering becoming pregnant
             during the study or for approximately 30 days after the last dose of study drug.

          -  Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol in the opinion of the
             investigator.

          -  Positive test result at screening for hepatitis B surface antigen (HBsAg) or
             anti-human immunodeficiency virus antibody (HIV Ab).

          -  HCV genotype performed during screening indicating co-infection with more than one HCV
             genotype.

          -  History of severe, life-threatening or other significant sensitivity to any excipients
             of the study drug.
A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium Bromide; Placebo
Intervention description: Aclidinium Bromide, 200μg. Once daily oral inhalation.; Dose matched placebo, once daily oral inhalation.
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Bronchitis, Chronic; Emphysema

Summary:

      This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in
      reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It
      was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind
      treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria
      were randomized to one of two treatment groups: aclidinium bromide or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1
             >=30% and < 80% predicted and FEV1/FVC<70% predicted

          -  Current or former cigarette smoker

          -  Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of
             predicted value

          -  Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4

        Exclusion Criteria:

          -  History of presence of asthma, allergic rhinitis, or atopy

          -  Hospitalization for acute COPD exacerbation in the 3 months prior to study entry

          -  Respiratory tract infection (including the upper respiratory tract) or COPD
             exacerbation in the 6 weeks prior to study entry

          -  Clinically significant respiratory conditions other than COPD

          -  Chronic use of oxygen therapy >= 15 hours a day
A Study for Patients With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Teriparatide; Salmon Calcitonin
Intervention description: Subcutaneous, 20 micrograms/day, 24 weeks; Intranasal, 200 International Units (IU)/day, 24 weeks
Intervention MeSH terms: Teriparatide; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 364.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effect of injectable teriparatide to intranasal
      salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients
      with established osteoporosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of osteoporosis

          -  No other severe disabling conditions

          -  Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral
             density T-score should be less than -2.5

          -  Ambulatory

          -  Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years)

        Exclusion Criteria:

          -  History of a disease that affects bone metabolism

          -  History of treatment with any drug that may significantly affect bone metabolism

          -  History or presence of liver disease

          -  History or presence of kidney disease

          -  History of excessive alcohol drinking or drug abuse