bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Disease Progression
Intervention: Erlotinib
Intervention description: Erlotinib was supplied as tablets.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single-arm study will evaluate the safety and efficacy of Tarceva
      (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who
      have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients
      will receive Tarceva at a dose of 150 mg orally daily until disease progression or
      unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients ≥ 18 years of age.

          -  Histologically documented non-small cell lung cancer (NSCLC).

          -  Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.

          -  Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet
             without progression.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

          -  Patients of reproductive potential must agree to use effective contraception.

        Exclusion Criteria:

          -  Prior exposure to agents directed at the human epidermal growth factor receptor (HER)
             axis (eg, gefitinib, cetuximab, trastuzumab).

          -  Prior treatment with any monoclonal antibody therapy.

          -  Any other malignancies within the previous 5 years, except for adequately treated
             carcinoma in situ of the cervix or squamous cell skin cancer.

          -  Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active
             infection

          -  Pre-existing interstitial lung disease.

          -  Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus
             (HCV) infection.

          -  Pregnant or lactating women.
Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Azacitidine
Intervention description: Subjects will receive azacitidine 75 mg/m2/day SC for 7 days every 28 days for up to 6 cycles, unless they are discontinued from the treatment. In addition, subjects may receive best supportive care as needed, including antibiotics and transfusions, per Investigator discretion.
Intervention MeSH terms: Azacitidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndromes; Taiwan; Azacitidine; Vidaza; Celgene; Pathologic Processes; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Therapeutic Uses; Enzyme inhibitors

Summary:

      The primary purpose of this study is to determine the effectiveness and safety of azacitidine
      in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of RAEB or RAEB-T according to FAB classification for MDS and with an IPSS
             score of intermediate-2 or high risk or a diagnosis of myelodysplastic CMML per
             modified FAB criteria.

          -  Taiwanese males and females ≥ 18 years of age

          -  ECOG 0, 1, or 2;

          -  Adequate hepatic and renal organ function

        Exclusion Criteria:

          -  Previous treatment with azacitidine or decitabine

          -  Malignant disease diagnosed within prior 12 months

          -  Uncorrected red cell folate deficiency or vitamin B12 deficiency

          -  Diagnosis of metastatic disease

          -  Malignant hepatic tumors

          -  Known or suspected hypersensitivity to azacitidine or mannitol

          -  Prior transplantation or cytotoxic therapy, including azacitidine and chemotherapy,
             administered to treat MDS

          -  Treatment with erythropoietin or myeloid growth factors during the 21 days prior to
             Day 1 of Cycle 1 or androgenic hormones during the 14 days prior to Day 1 of Cycle 1;

          -  Active HIV or viral hepatitis type B or C

          -  Treatment with other investigational drugs within the previous 30 days prior to Day 1
             of Cycle 1, or ongoing adverse events from previous treatment with investigational
             drugs, regardless of the time period;

          -  Pregnant or lactating females
Enhancing the Effectiveness of Electroconvulsive Therapy in Severe Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: ECT Mecta 5000M; Methohexitone; Suxamethonium
Intervention description: ECT is administered twice weekly with hand-held electrodes using the Mecta 5000M device following a standard stimulus dosing protocol. Seizure duration is measured by EEG monitoring. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0 mg/kg) as muscle relaxant. Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.; Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia along with suxamethonium (0.5-1.0 mg/kg)for muscle relaxation. Anesthesia is the same for both arms of the trial.; Suxamethonium (0.5-1.0 mg/kg)is used for muscle relaxation along with Methohexitone (0.75-1.0 mg/kg) for anaesthesia. Anesthesia is the same for both arms of the trial.
Intervention MeSH terms: Methohexital; Succinylcholine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Electroconvulsive therapy; ECT; electrode placement; effectiveness; cognition; autobiographical memory

Summary:

      Electroconvulsive therapy (ECT) is the most powerful antidepressant treatment available and
      is often life-saving. There are concerns, however, that standard bitemporal ECT (the most
      commonly used form of ECT worldwide) causes persisting retrograde amnesia. However, clinical
      trials have indicated that high-dose unilateral ECT may be as effective as bitemporal ECT but
      have much less cognitive side-effects.

      The trial aims to test the primary experimental hypothesis: High-dose (6 x ST) right
      unilateral ECT is as effective as (i.e. not inferior to) standard (1.5 x ST) bitemporal ECT
      for severe depression in terms of Hamilton Depression Rating Score (HDRS) at the end of the
      treatment course.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥18 years diagnosed with major depressive episode (DSM-IV) and referred for
             ECT

        Exclusion Criteria:

          -  Any condition rendering patients medically unfit for general anaesthesia or ECT;
             treatment with ECT in previous six months; dementia or other Axis 1 diagnosis;
             alcohol/other substance abuse in previous six months; inability/refusal to consent.
Preterm Infant Inhaled Albuterol Dosing
Condition: Bronchopulmonary Dysplasia; Very Low Birth Weight
MeSH terms: Bronchopulmonary Dysplasia; Birth Weight
Intervention: Varied albuterol dose response
Intervention description: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to 33w6d. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a sinlge dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 14 Days
Healthy volunteers: No
Keywords: Bronchopulmonary dysplasia; very low birth weight; albuterol; pulmonary function test

Summary:

      The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in
      premature babies at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic
      lung disease of prematurity and is associated with increased morbidity and mortality, longer
      hospital stays, and increased healthcare utilization. Albuterol is an inhaled medication
      frequently used in premature infants with chronic lung disease and in people with asthma. It
      is believed to be safe, but the optimal dose for infants is not clear. The investigators
      hypothesize that albuterol may help a subset of premature infants with lung disease, but they
      need to determine the best dose prior to doing research about how effective it is for chronic
      lung disease/BPD. Response to each of three doses of albuterol will be measure using
      pulmonary function tests.
    

Eligibility criteria:

        Inclusion Criteria:

          -  very low birthweight infant (<1500g)

          -  gestational age at birth <32 weeks

          -  age 14 or more days and corrected to 28w0d to 33w6d gestational age

          -  continuing to require respiratory support and/or supplemental oxygen

        Exclusion Criteria:

          -  chromosomal abnormalities

          -  major congenital anomalies

          -  congenital heart disease, except atrial septal defect and patent ductus arteriosus

          -  clinical providers determine subject too unstable to undergo pulmonary function
             testing
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
Condition: Hyperparathyroidism, Secondary; Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: doxercalciferol
Intervention MeSH terms: 1 alpha-hydroxyergocalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Patients with chronic kidney disease and end stage renal disease have greater cardiovascular
      risk than the general population. Vitamin D analogues have been shown in observational
      studies to have mortality benefit for these patients. This study is designed to investigate
      doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible
      mechanism to explain the mortality benefit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage 5 Chronic Kidney Disease

          -  Hyperparathyroidism (PTH>300) requiring vitamin D therapy

          -  Age 18-80 years old

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  Subjects with neovascularization present, such as neoplasm, active wounds or
             significant retinopathy

          -  Subjects with contraindications or allergy to vitamin D

          -  Subjects currently on vitamin D therapy or a history of vitamin D therapy in the
             previous 60 days

          -  Serum phosphorus > 6

          -  Serum calcium > 10.5

          -  contraindications to nitroglycerin (such as being on sildenafil)
Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia
Condition: Trichiasis
MeSH terms: Trichiasis
Intervention: azithromycin; topical tetracycline
Intervention description: oral antibiotic
Intervention MeSH terms: Azithromycin; Tetracycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1452.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: trichiasis; azithromycin; trichiasis surgery; topical tetracycline

Summary:

      Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of
      blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar
      and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and
      abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a
      multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis.
      Despite this encouraging news, under the best of circumstances the recurrence rate of
      trichiasis following surgery is disappointingly high. The objective of our project is to
      conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment,
      comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in
      Ethiopia with the goal of determining the impact of treatment on rates of trichiasis
      recurrence at one and two years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of trichiasis:

          -  no previous report of trichiasis surgery in at least one eye with trichiasis:

          -  Agreement by at least one other family member accompanying the patient that, if the
             patient is randomized to the family-treatment arm, s/he also would be willing to
             receive antibiotic treatment

          -  Age 18 or older

        Exclusion Criteria:

          -  other household members concurrently participating in the trial

          -  Self-reported pregnancy

          -  Documented allergy to tetracycline

          -  Plans to move out of the region within 1 year.
Minocycline for Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Minocycline
Intervention description: Minocycline 100 to 300mg per day for 8 weeks
Intervention MeSH terms: Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: Bipolar disorder; depression; minocycline; mood disorders; bipolar depression

Summary:

      The purpose of this study is to evaluate minocycline as a potential treatment for bipolar
      depression when added to a mood-stabilizing medication. Minocycline is an antibiotic that is
      approved for the treatment of infections and acne. Participation in this research study is
      expected to last 8 weeks, and includes five outpatient visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for Bipolar I Disorder or Bipolar II disorder, depressed phase

          -  A baseline score of at least 18 on the Montgomery-Asberg Depression Rating Scale
             (MADRS)

          -  Participants on mood stabilizer medication for at least two weeks prior to starting
             the study, and must remain on the treatment during the study

          -  Able to understand English

        Exclusion Criteria:

          -  DSM-IV diagnosis of Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type

          -  Pregnant women or women of child bearing potential who are not using a medically
             accepted means of contraception (defined as oral contraceptive pill or implant,
             condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy)

          -  Serious suicide or homicide risk

          -  Unstable medical illness including cardiovascular, hepatic, renal, respiratory,
             endocrine, neurological, or hematological disease

          -  Clinical or laboratory evidence of hypothyroidism; if maintained on thyroid medication
             must be euthyroid for at least 1 month before visit 1

          -  Drug/alcohol dependence within past 30 days, or current substance use disorder that
             requires detoxification

          -  Current use of minocycline or history of anaphylactic reaction or intolerance to
             minocycline

          -  Primary clinical diagnosis of antisocial or borderline personality disorder

          -  Patients with metallic foreign bodies or claustrophobia will be excluded from the MRS
             component
Effects of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Hormonal Responses to Macronutrient Ingestion
Condition: Healthy; Type 2 Diabetes
Intervention: Sitagliptin; placebo
Intervention description: 100 mg sitagliptin before ingestion of macronutrient; A placebo tablet is given before ingestion of macronutrients
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: Male
Minimum age: 20 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GLP-1; Insulin secretion; Macronutrients

Summary:

      The regulation by DPP-4 inhibition after ingested of different individual macronutrients is
      not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose
      or mixed meal on the concentrations of incretin hormones and insulin secretion with or
      without concomitant administration of a DPP-4 inhibitor (sitagliptin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men

          -  Age 20-30 years

          -  BMI 20-30 kg/m2

        Exclusion Criteria:

          -  Any disease

          -  Any medication
Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium Carbonate; Sertraline; Nortriptyline; Risperidone
Intervention MeSH terms: Risperidone; Lithium Carbonate; Sertraline; Nortriptyline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Intervention model description: This is a pragmatical clinical trial. The patients follow a pre-established algorithm About the participant flow the results the table to indicate the number of participants who received treatment in the whole algoritm, not in each step.
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cost effectiveness; Bipolar disorder; Depressive episodes; Quality of Life

Summary:

      To evaluate the effectiveness of an algorithm for Bipolar Disorder depressive episodes (BDD)
      using medications available in the Brazilian Public Healthcare System (SUS). Quality of life
      assessment of these patients was also employed.

      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of
      episodes of bipolar disorder depression episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ages between 18 and 65;

          2. BD current acute mixed episode;

          3. total capacity to understand and respond to self-applied instruments;

          4. the presence of symptoms in the last 30 days;

          5. abstinence for at least 30 days for drug addicts.

        Exclusion Criteria:

          1. presence of Organic Brain Syndrome (OBS);

          2. pregnancy or lactation;

          3. criteria for psychiatric hospitalization. -
Effect of Gabapentin on Orthopedic Pain
Condition: Degenerative Arthritis and Postoperative Pain
MeSH terms: Osteoarthritis; Pain, Postoperative
Intervention: Placebo; Gapabentin
Intervention description: Normal Saline; 400mg orally at 9pm day of surgery and the first evening post operatively.
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: orthopedic pain

Summary:

      This study is being done to determine if a drug called gabapentin helps in the postoperative
      management of patients undergoing hip and knee operations. The investigators wish to
      determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a
      patient's pain and improve sleep, the patient will be better able to participate in their
      physical therapy. Gabapentin has already been shown to lessen postoperative pain when given
      before surgery. In healthy patients, it has also been shown to improve certain aspects of
      sleep. We hope to identify the effect of the drug, when given after surgery, on patients'
      pain and sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing a hip arthroplasty, total knee arthroplasty, hip fracture repair American
             Society of Anesthesiologist rating I-III as determined by your anesthesiologist

        Exclusion Criteria:

          -  Pregnancy and breast feeding

               -  An allergy to any of the drugs to be used in the study (midazolam, Celecoxib,
                  gabapentin, hydromorphone, bupivacaine)

               -  History of a sleep disorder (Obstructive sleep apnea or daytime somnolence)

               -  History of taking chronic narcotic pain medications or gabapentin

               -  History of rheumatoid arthritis, a psychiatric disorder, or diabetes with
                  impaired renal function

               -  History of alcohol or illicit drug abuse.

               -  History of a kidney or liver problem.

               -  Inability or unwilling to use patient-controlled analgesia.

               -  Unable to meet the criteria for removal of the endotracheal tube in the Operating
                  Room

               -  History of asthma, hives or an allergic type reaction following an aspirin or
                  other NSAIDS drug such as Ibuprofen.

               -  History of stroke or heart attack or thrombotic event within the past 3 months

               -  Lactose intolerance

               -  History of cardiac surgery