bioihbjkbjnl/mcl2 huggingface dataset:
AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Intervention: AZD7325; AZD7325; AZD7325; Placebo
Intervention description: 2 tablets taken twice a day for 28 days; 2 tablets taken twice a day for 28 days; 2 tablets taken twice a day for 28 days; 2 tablets taken twice a day for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 725.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; GAD; Anxiety

Summary:

      The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe
      and effective in the treatment of generalized anxiety disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent before any study-related procedures start.

          -  The patient is previously diagnosed with Generalized Anxiety Disorder.

          -  The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.

        Exclusion Criteria:

          -  Patient has a lifetime history of schizophrenia or other psychotic disorders

          -  Patient has a history of seizures or seizure disorder.

          -  Patient is pregnant or breast feeding.

          -  Patient has received electroconvulsive treatment (ECT) in the past.
A Study of the Antiplatelet Effects Comparing Ticagrelor (Ticag. - AZD6140) With Clopidogrel (Clop.) Responder and Non-responders
Condition: Stable Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Ticagrelor; Clopidogrel; Aspirin
Intervention description: Tablets, Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily for 2 weeks; (over encapsulated) capsule, Oral, 75 mg; 600 mg loading dose followed by 75 mg once daily for 2 weeks; Tablets, Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study
Intervention MeSH terms: Aspirin; Clopidogrel; Ticagrelor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coronary artery disease (CAD); heart attack; stable angina

Summary:

      The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet
      medication, affects platelets. Anti-platelet agents are medications that block the formation
      of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding,
      but when they form inside the arteries their formation is linked to a risk of medical
      problems such as heart attack and stroke. This study investigated the effect of Ticagrelor on
      inhibition of platelet aggregation compared with clopidogrel in patients previously
      identified as non-responsive to clopidogrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with documented stable Coronary Artery Disease (CAD) (stable angina, previous
             MI history, previous history of revascularization)

          -  Females of child bearing potential must have a negative pregnancy test prior to
             receiving study drug and be willing to use a hormonal contraceptive in addition to
             double barrier contraception

        Exclusion Criteria:

          -  History of Acute Coronary Syndromes within 12 months of screening or need for
             revascularization (angioplasty or coronary artery bypass graft (CABG))

          -  Any acute or chronic unstable condition in the past 30 days

          -  Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high
             blood pressure, low platelet count, recent major trauma

          -  History of intolerance or allergy to aspirin or clopidogrel
A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms; Neoplasm Metastasis
Intervention: Erlotinib; Gemcitabine
Intervention description: 100 mg, PO, once per day; 1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the relationship between the skin toxicity of Tarceva in
      combination with gemcitabine, and survival, in patients with advanced and/or metastatic
      pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will
      be administered 100mg po per day. The anticipated time on study treatment is until disease
      progression, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  locally advanced and/or metastatic pancreatic cancer (stage III or IV);

          -  Karnofsky performance Status of >=60%.

        Exclusion Criteria:

          -  local(stage IA to IIB) pancreatic cancer;

          -  <=6 months since last adjuvant chemotherapy;

          -  previous systemic therapy for metastatic pancreatic cancer;

          -  other primary tumor within last 5 years (except for adequately treated cancer in situ
             of cervix, or basal cell skin cancer);

          -  clinically significant cardiovascular disease.
Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: AGN-199201; AGN-190584; AGN-199201 Vehicle
Intervention description: 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.; 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.; 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 40 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and
      concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus
      for near vision).
    

Eligibility criteria:

        Inclusion Criteria:

        -Presbyopia in each eye that impacts daily activities.

        Exclusion Criteria:

          -  Use of any topical ophthalmic medications, including artificial tears

          -  Contact lens use in either eye within 14 days or planned use during the study

          -  History of eye surgery

          -  Diagnosis of any type of glaucoma or ocular hypertension
Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; Anastrozole
Intervention description: intramuscular injection; 1 mg oral tablet
Intervention MeSH terms: Fulvestrant; Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Healthy volunteers: No
Keywords: Breast neoplasms; breast cancer; early breast cancer; oncology; cancer; breast cancer micrometastasis; fulvestrant

Summary:

      Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells,
      clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole
      and fulvestrant or anastrozole alone in patients with early breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with hormone receptor-positive early breast cancer and a positive
             Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior
             to randomisation

        Exclusion Criteria:

          -  Inflammatory and/or metastatic breast cancer.

          -  Current or previous malignancy within previous 5 years (other than Breast cancer or
             adequately treated non-melanoma skin cancer or in-situ cervical cancer).

          -  History of bleeding diathesis.
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
Condition: Premature Birth; Brain Injury
MeSH terms: Brain Injuries; Premature Birth
Intervention: Melatonin injection
Intervention description: A single intravenous infusion of melatonin will be given to each infant over 6 hours so that successive groups will receive increasing doses until the correct dose for age is found.
Based on the pharmacokinetics and clearance of melatonin in adults an approximate dose has been calculated. The starting dose of melatonin will be 0.1 microgram/kg/hr to be given over 6 hours intravenously. The range of expected dose is 0.1-0.5 microgram/kg/hr.
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 23 Weeks
Maximum age: 31 Weeks
Healthy volunteers: No
Keywords: Premature Birth; Brain injury; Neuroprotection; Melatonin; Pharmacokinetics

Summary:

      Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may
      reduce this risk. The unborn baby receives melatonin from the mother but following premature
      delivery there maybe a period of prolonged melatonin deficiency. This deficiency may be
      harmful because studies suggest that melatonin is important in protecting the brain and
      reducing the risk of brain injury after preterm birth. The purpose of this study is to find
      the ideal dose of melatonin to give to preterm babies. We intend to study a total of 24
      babies less than 31 weeks gestation and who are less than 7 days old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants born less than 31 weeks gestation who are less than 7 days old, after parental
             consent for participation will be included in the study.

        Exclusion Criteria:

          -  Those with major congenital malformation, or cystic periventricular leucomalacia
             (cPVL) or haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography prior to
             enrolment will be excluded from the study.
LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Vinorelbine 25 mg/m2 weekly; Afatinib 40mg once daily (OD); Paclitaxel 80 mg/m2 weekly
Intervention description: Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy; Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease; Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
Intervention MeSH terms: Paclitaxel; Vinorelbine; Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW
      2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who
      progress on afatinib monotherapy within this trial) as treatment in patients with
      HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the
      neoadjuvant or adjuvant setting
    

Eligibility criteria:

        Inclusion criteria:

          1. Female patients >=18 years with proven diagnosis of HER2-overexpressing,
             histologically confirmed breast cancer

          2. Stage IV metastatic disease

          3. At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria
             for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target
             lesions

          4. Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and
             lapatinib treatment in the neoadjuvant and/or adjuvant setting

        Exclusion criteria:

          1. Prior first line therapy for metastatic breast cancer

          2. Known pre-existing interstitial lung disease

          3. Active brain metastases

          4. History or presence of clinically relevant cardiovascular abnormalities such as
             uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable
             angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to
             trial treatment.

          5. Cardiac left ventricular function with resting ejection fraction of less than 50%.

          6. Prior treatment with Epidermal Growth Factor Receptor (EGFR)/HER2-targeted small
             molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or
             adjuvant setting

          7. Prior treatment with paclitaxel in the past 12 months

          8. Must not have received prior vinorelbine treatment - Further exclusion criteria apply
Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
Condition: Hormone Deficiency; Aging
Intervention: Growth Hormone Releasing Hormone (GHRH )
Intervention description: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks
Intervention MeSH terms: Hormones; Growth Hormone-Releasing Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Growth Hormone Releasing Hormone; Growth Hormone Insufficiency; Aging; Growth Hormone; Physiologic Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones

Summary:

      The purpose of the study is to evaluate the effect of a naturally occurring hormone, called
      Growth Hormone Releasing Hormone (GHRH) on the muscle, bone, and fat tissues of the body.
      GHRH stimulates the production of growth hormone (GH), which regulates the build up of many
      tissues in the body, including muscles and bones. Many elderly people have low levels of GH.
      The overall goal of this research is to determine the efficacy of GHRH to raise levels of GH
      and improve these body tissues. Healthy men and women age 65 and older will receive GHRH in
      four doses nightly for 12 weeks and assessed for changes in muscle strength, body mass,
      physical performance, and how the body uses sugar.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age of 65 years or older

          -  Fasting IGF-1 level <135ng/ml

          -  BMI 23-40 kg/m2

          -  Capable of giving informed consent

        Exclusion Criteria:

          -  Diabetes mellitus or use of hypoglycemic agents

          -  Known coronary artery disease

          -  Liver disease, abnormal liver function tests (LRTs>2x upper limit of normal) or
             inflammatory bowel disease

          -  Renal insufficiency (serum creatinine > or = to 1.4 mg/dL)

          -  Hematocrit < 33% or > 50%

          -  History of malignancy < 5 years other than basal cell of the skin

          -  Chronic pulmonary disease or other systemic disorders which affect glucose hemostasis

          -  Use of growth hormone, corticosteroids, thiazide diuretics, estrogen supplements or
             androgen supplements

          -  Inability to perform strength or performance testing

          -  Uncontrolled hypertension (blood pressure >160/95

          -  NYHA Class III or IV heart failure

          -  Current smoking

          -  Alcohol use > or = to 30g/day

          -  Serious or unstable medical or psychological conditions that, in the opinion of the
             investigator, would compromise the subject's safety or successful participation in the
             study

          -  Participation in an investigational drug study within 6 weeks prior to screening visit

          -  Plan to change diet or exercise regimen during the study period
Clinical Trial of Glatiramer Acetate in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: 40 mg glatiramer acetate; Placebo
Intervention description: parenteral drug
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 366.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under
      the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone®
      (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting
      multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and
      neuroprotective properties, which are believed to be of therapeutic value in ALS. The study
      treatment duration is 1 year (52 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.

          2. Subject has experienced his/her first ALS symptoms within 3 years prior to the
             screening visit.

          3. Slow VC test equal or greater than 70% of the predicted value.

          4. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.

          5. Stable dose of riluzole for at least 8 weeks prior to screening.

          6. Age - 18-70 (inclusive).

        Exclusion Criteria:

          1. The use of invasive or non-invasive ventilation.

          2. Subject having undergone gastrostomy.

          3. Subject with any clinically significant or unstable medical condition.

          4. Subjects participating in any other clinical trial (within 12 weeks prior to screening
             and thereafter).

          5. Additional criteria per protocol.
A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
Condition: Osteogenesis Imperfecta, Type I; Osteogenesis Imperfecta Type III; Osteogenesis Imperfecta Type IV
MeSH terms: Osteogenesis Imperfecta
Intervention: setrusumab; Calcium; Vitamin D; zoledronic acid (optional)
Intervention description: Intravenous infusion; tablets; capsules; Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, Dose-finding Study, incorporating an open-label substudy
Masking: Double (Participant, Investigator)
Masking description: Sponsor will be masked until the primary analysis of the study except for open-label substudy treatment arm. The study site pharmacist will be unmasked to treatment allocation throughout. Study treatment will be monitored by a separate unmasked monitoring team.
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Osteogenesis Imperfecta; Brittle Bone Disease

Summary:

      The purpose of this study is to select a suitable dose of BPS804 by measuring the
      strength/quality of bone using a special type of CT scanner. Participants will be treated for
      12 months and followed up for a further 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a clinical diagnosis of OI Type I, III or IV with a confirmed defect in
             the COL1A1/COL1A2 genes, as confirmed by genetic testing

          -  One or more fractures in the past 5 years

          -  Capable of giving signed consent

        Exclusion Criteria:

          -  History of skeletal malignancies or other bone diseases (other than OI)

          -  History of neural foraminal stenosis (except if due to scoliosis)

          -  History of myocardial infarction, angina pectoris, ischaemic stroke or transient
             ischaemic attack

          -  History of endocrine or thyroid/parathyroid conditions that could affect bone
             metabolism

          -  Treatment with bisphosphonates within 3 months of randomisation

          -  Treatment with teraparatide, denosumab or other anabolic/anti-reabsorptive medications
             within 6 months of randomisation
Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: MTX
Intervention description: Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group)
Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)
Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Relative Bioavailability Comparison study
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥18 years of age, diagnosed with Rheumatoid Arthritis

        Exclusion Criteria:

          -  Pregnant females

          -  Any other clinically significant disease or disorder which, in the opinion of the
             investigator might put the subject at risk