bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Sertindole; Risperidone
Intervention description: Sertindole was supplied as 4, 12, 16, and 20 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national Summary of Product Characteristics (SPC) for sertindole; in countries where sertindole was not marketed, the European Union (EU) SPC applied (all national and EU SPCs were essentially identical). Recommended dose range: 12 to 20 mg/day. The investigators were instructed to contact H. Lundbeck A/S if they deemed it necessary to increase the dose of sertindole to 24 mg/day, which was allowed in exceptional cases; Risperidone was supplied as 1, 2, 3, and 4 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national SPC for risperidone. Recommended dose range: 2 to 8 mg/day
Intervention MeSH terms: Risperidone; Sertindole
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9809.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether there is an increased all-cause mortality in
      sertindole-treated patients in comparison to patients treated with a well-known antipsychotic
      (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has signed the Informed Consent Form or, if he/she is not able to sign it
             (according to the ICH GCP guidelines and the Declaration of Helsinki), the patient's
             legal representative has signed the Informed Consent Form

          -  The patient has been diagnosed with schizophrenia

          -  Based on the patient's clinical status, new or change of antipsychotic treatment is
             indicated

          -  The patient is at least 18 years of age

          -  The patient meets the criteria set out in the national SPCs for sertindole and
             risperidone. For those countries in which sertindole was not marketed, the EU SPC
             applied

        Exclusion Criteria:

          -  The last treatment taken by the patient was sertindole or risperidone

          -  The patient has never previously received any antipsychotic drug therapy

          -  The patient has contraindications to treatment with either sertindole or risperidone

          -  In addition to sertindole/risperidone, treatment with another antipsychotic is
             indicated

          -  The patient is homeless

          -  The patient has previously been included in one of the two H. Lundbeck A/S
             post-marketing studies, 99823 or 99824

          -  The patient is, in the opinion of the investigator, unlikely to comply with the study
             protocol or unsuitable for any other reason
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: losartan potassium
Intervention description: losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.
Intervention MeSH terms: Losartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 6 Months
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      This study will explore the dose-response of losartan as well as the safety and tolerability
      in children from 6 months to 6 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is determined to be hypertensive

        Exclusion Criteria:

          -  Participant has a history of severe or symptomatic hypertension

          -  Participant has history of heart failure, rhythm disturbance or cardiomyopathy, or
             obstructive valvular disease

          -  Participant has started taking hypertensive medications within the past 30 days

          -  Participant has a known sensitivity to losartan or history of angioneurotic edema
Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Condition: Hyperlipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Bococizumab (PF-04950615;RN316); Placebo
Intervention description: 150 mg every 2 weeks, subcutaneous injection, 12 months; subcutaneous injection, every 2 weeks for 12 months
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 711.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mixed dyslipidemia; high risk of cardiovascular events

Summary:

      This study is a multicenter, randomized study in subjects with high cholesterol receiving
      highly effective statins to assess the efficacy, safety and tolerability of Bococizumab
      (PF-04950615;RN316) to lower LDL-C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treated with a statin.

          -  Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.

          -  High or very high risk of incurring a cardiovascular event.

        Exclusion Criteria:

          -  Pregnant or breastfeeding females.

          -  Cardiovascular or cerebrovascular event of procedures during the past 30 days.

          -  Congestive heart failure NYHA class IV.

          -  Poorly controlled hypertension.
Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
Condition: Carcinoid Tumor; Malignant Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Serotonin Syndrome
Intervention: Octreotide; Placebo; Everolimus
Intervention description: Octreotide 30 mg intramuscularly (i.m.) every 28 days.; A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.; A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.
Intervention MeSH terms: Everolimus; Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 429.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Carcinoid; Tumor; Neuroendocrine; Carcinoma; Everolimus; Octreotide

Summary:

      The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment
      with depot octreotide prolongs progression free survival compared to treatment with
      octreotide alone in patients with advanced carcinoid tumor.
    

Eligibility criteria:

        Inclusion criteria:

          -  Advanced (unresectable or metastatic) carcinoid tumor

          -  Confirmed low-grade or intermediate-grade neuroendocrine carcinoma

          -  Documented progression of disease within 12 months prior to randomization.

          -  Measurable disease determined by triphasic computer tomography (CT) scan or magnetic
             resonance imaging (MRI).

        Exclusion criteria:

          -  Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
             adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.

          -  Hepatic artery embolization within the last 6 months or cryoablation of hepatic
             metastasis within 2 months of enrollment.

          -  Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus,
             temsirolimus, everolimus)

          -  Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.

          -  Severe or uncontrolled medical conditions

          -  Chronic treatment with corticosteroids or other immunosuppressive agent.

          -  Other primary cancer within 3 years.

        Other protocol-defined inclusion/exclusion criteria applied
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
Condition: Colorectal Neoplasms; Liver Neoplasms
MeSH terms: Neoplasms; Colorectal Neoplasms; Liver Neoplasms
Intervention: Irinotecan + 5 FU + folinic acid; Folinic Acid + 5 FU
Intervention description: irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks; folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
Intervention MeSH terms: Leucovorin; Folic Acid; Irinotecan; Fluorouracil; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 321.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver
      metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen,
      compared to 5-FU/FA alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven adenocarcinoma of the colon or rectum with complete resection of
             primary tumour.

          -  Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3
             weeks, and a maximum of 8 weeks prior to the first study treatment infusion.

          -  Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.

        Exclusion Criteria:

          -  Prior hepatic radiation or resection.

          -  Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver
             metastasis (es).

          -  Prior chemotherapy for metastatic disease.
Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness
Condition: Venous Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Intervention: Apixaban; Enoxaparin
Intervention description: Apixaban: Twice daily, 30 days
Placebo: Once daily, 6-14 days; Enoxaparin: Once daily, 6-14 days
Placebo: Twice daily, 30 days
Intervention MeSH terms: Enoxaparin; Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6758.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients

Summary:

      The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep
      vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within
      patients hospitalized for acute medical illness, and to learn how apixaban compares to
      enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be
      studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men and non-pregnant, non-breastfeeding women

          -  40 years or older

          -  hospitalized with congestive heart failure or acute respiratory failure

          -  infection (without septic shock)

          -  acute rheumatic disorder

          -  inflammatory bowel disease

        Exclusion Criteria:

          -  patients with venous thromboembolism (VTE)

          -  active bleeding or at high risk of bleeding

          -  unable to take oral medication

          -  with diseases requiring ongoing treatment with anticoagulants or antiplatelets other
             than aspirin at a dose ≤ 165 mg/day.
Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Insulin Lispro; Exubera
Intervention description: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.; Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
Intervention MeSH terms: Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: type two diabetes, insulin, HbA1c

Summary:

      The current trial will examine the efficacy and safety of Exubera administered as a mealtime
      insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or
      = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion
      of subjects to reach target glycosylated hemoglobin (A1C) levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with type 2 diabetes using Lantus® (insulin glargine) as their basal insulin,
             not at glycemic goal.

        Exclusion Criteria:

          -  lung disease

          -  current smoking or discontinued smoking within past 6 months
The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; placebo
Intervention description: Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.; Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 451.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 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 effect of liraglutide versus placebo when added to basal insulin analogues
      with or without metformin in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated
             with stable basal insulin analogue dose of minimum 20 U/day with or without stable
             metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening
             (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by
             the investigator)

          -  HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)

          -  Body mass index (BMI) 20-45 kg/m^2 (both inclusive)

        Exclusion Criteria:

          -  Female of child-bearing potential who is pregnant, breast-feeding or intending to
             become pregnant

          -  Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness

          -  Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria
             in a period of 12 weeks prior to screening

          -  Impaired liver or renal function

          -  Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to
             or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)

          -  Any clinically significant disorder, except for conditions associated with type 2
             diabetes history which in the investigator's opinion could interfere with results of
             the trial

          -  Known or suspected abuse of alcohol or narcotics
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery
Condition: Ocular Inflammation and Pain
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: APP13007, 0.05%; Matching Vehicle Placebo for APP13007, 0.05%
Intervention description: APP13007 eye drop, 0.05%; Matching vehicle placebo eye drop
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 378.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a
      randomized, parallel-group, double-masked fashion. The subjects will have undergone routine
      cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day
      1; POD1) after uncomplicated surgery for eligibility for randomization to study treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age or older expected to undergo unilateral uncomplicated
             cataract extraction via phacoemulsification and posterior chamber intraocular lens
             implantation in one eye.

          -  Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of
             the minimum angle of resolution (logMAR) in the study eye to be operated and
             contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study
             (ETDRS) chart at Visit 1.

          -  Willing and able to comply with study requirements and visit schedule.

          -  Provide signed and dated informed consent.

        Exclusion Criteria:

          -  Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any
             of the study medication's components including benzalkonium chloride and soybean
             lecithin or any routine medication required during cataract surgery or for the conduct
             of study procedures

          -  Have an ACC count > 0 or any evidence of intraocular inflammation (e.g., flare) in
             either eye at the Screening visit

          -  Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit

        Note: Other inclusion/exclusion criteria apply.
GlycoCholic Acid Treatment for Patients With Inborn Errors in Bile Acid Synthesis
Condition: Bile Acid Synthesis Defect; Inborn Error of Bile Acid Metabolism; Inborn Error of Bile Acid Conjugation
Intervention: Glycocholic Acid
Intervention description: 10-15mg/kg body weight/day taken orally. Supplied as either liquid or 50mg capsules.
Intervention MeSH terms: Cholic Acids; Glycocholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 1 Week
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to determine the way (mechanisms) by which your defect
      in bile acid handling (metabolism) causes your liver disease or abnormality in absorption of
      vitamins and the effect of an investigational bile acid therapy (glycocholic acid) on your
      vitamin absorption and your liver disease. An investigational therapy is one that not
      approved by the United States Food and Drug Administration (FDA) and is being provided to you
      under an Investigational New Drug application from the FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmation of a diagnosis of an inborn error of bile acid synthesis/conjugation
             based upon urine analysis by FAB-MS.

          2. Any age

          3. Participant must be willing and able to comply with study assessments and procedures.

          4. The participant and/or parent/legal guardian must have signed the written informed
             consent document prior to study start.

        Exclusion Criteria

        1. No confirmed diagnosis of inborn error of bile acid synthesis/conjugation based upon
        urine analysis by FAB-MS.
Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea
Condition: Antibiotic-associated Diarrhea; Clostridium Difficile; Diarrhea
MeSH terms: Diarrhea
Intervention: Saccharomyces boulardii; Placebo
Intervention description: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 477.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: antibiotic; associated; diarrhoea; saccharomyces boulardii; Antibiotic-associated diarrhoea (AAD); Clostridium difficile-associated-diarrhoea (CDAD)

Summary:

      When patients in hospitals receive antibiotics they often develop diarrhoea. The consequences
      may be grave for the patient. Thus far, no preventive measure is available. The investigators
      hypothesize that the apathogenic yeast Saccharomyces boulardii, administered in addition to
      the antibiotic, may prevent episodes of diarrhoea or may lead to less pronounced diarrhoea.
      To test this hypothesis, the investigators are carrying out a clinical trial in 1520 adult
      patients in several hospitals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patient (≥ 18 years)

          -  patient hospitalized

          -  patient receives systemic antibiotic treatment

          -  patient contractually capable

          -  patient able to follow study procedures

          -  informed consent of patient

        Exclusion Criteria:

          -  allergy against yeast and/or Perenterol® forte und/oder placebos containing
             Saccharomyces cerevisiae HANSEN CBS 5926, lactose-monohydrate, magnesium stearate,
             gelatine, sodium dodecyl sulfate, titan dioxide, microcrystalline cellulose.

          -  central venous catheter

          -  immunosuppression

          -  diarrhoea and/or chronic diarrhoea

          -  regular intake of Perenterol®, Perenterol® forte oder Yomogi® in the last seven days
             before the start of the study

          -  systemic antimycotic treatment

          -  systemic antibiotic treatment within the last 6 weeks

          -  no protection against conception, pregnancy, or lactation

          -  simultaneous participation in other clinical trials