bioihbjkbjnl/mcl2 huggingface dataset:
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
Condition: Heart Failure; Heart Failure, Systolic; Erectile Dysfunction
MeSH terms: Erectile Dysfunction; Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Intervention: LCZ696; Enalapril matching placebo; Enalapril; LCZ696 matching placebo
Intervention description: sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets; Placebo to Enalapril 10 mg film-coated tablets; Enalapril 10 mg film-coated tablets; Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Intervention MeSH terms: Enalapril; Enalaprilat; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: heart failure; systolic heart failure; heart failure with reduced ejection fraction; erectile dysfunction; Enalapril; Enalaprilat; LCZ696; Sacubitril/valsartan

Summary:

      The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs.
      Enalapril on improvement in erectile function and ability in male patients with chronic heart
      failure with reduced ejection fraction and erectile dysfunction.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients with a diagnosis of chronic heart failure (NYHA class II) and reduced
             ejection fraction (LVEF < 40%)

          -  Patients must be living in a stable and sexually active heterosexual partnership for
             at least 6 months prior study start

          -  Patients must have a mild to moderate erectile dysfunction (determined by using the
             IIEF-5 questionnaire)

          -  Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior
             study start

          -  Patients must be literate in German

        Key Exclusion Criteria:

          -  History of hypersensitivity to any of the study drugs or its excipients or to drugs of
             similar chemical classes, ACEIs, ARBs or NEP inhibitors, as well as known or suspected
             contraindications to the study drugs

          -  Previous history of intolerance to recommended target doses of ACEIs or ARBs

          -  Known history of angioedema

          -  Current acute decompensated HF (exacerbation of chronic HF manifested by signs and
             symptoms that may require intravenous therapy)

          -  Symptomatic hypotension

          -  Impaired renal function

          -  Penile anatomical defects and Peyronie's disease

          -  Diabetes mellitus Type I or insulin-dependent Type II

          -  Known prostate cancer
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Intervention: Triclosan, Fluoride; Fluoride
Intervention description: subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.; subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To test effectiveness of dentifrice in maintaining periodontal health.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Poor glycaemic control as evidenced by an HbA1c of >6.0% for the past 12 months

          -  Aged 18 to 75 years

          -  Able to give informed consent

          -  Minimum of 12 teeth

          -  Chronic periodontitis as indicated by periodontal probing depths >5mm on at least 6
             teeth

        Exclusion Criteria:

          -  Pregnancy

          -  Gross dental caries

          -  Prosthetic heart valves, a history of infective endocarditis or any other condition
             requiring antibiotic cover for dental treatment (rheumatic fever, mitral valve
             prolapse with regurgitation)

          -  Anticoagulant therapy (excluding asprin)
Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Vitamin C; L-Carnitine; Placebo
Intervention description: VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days; L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days; 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: 33.0
Sex: All
Minimum age: 15 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Atrial fibrillation; Cardiac valve repair; Aneurysm repair; CABG; On-pump; Cardiac surgery; Vitamin C

Summary:

      The purpose of this study is to determine whether vitamin C is effective in the prophylaxis
      of post-operative atrial fibrillation in on-pump cardiac surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing on-pump cardiac surgery

        Exclusion Criteria:

          -  Off-pump cardiac surgery procedure

          -  AF before the procedure

          -  Recent infection and/or infectious endocarditis

          -  Presence of neoplasia

          -  Chronic renal failure with creatinine>2.3 mg/dl

          -  Hepatic failure

          -  Autoimmune disease and/or disease that brings about a systematic inflammatory response

          -  Thyroid disease

          -  Systematic use of supplements that contain vitC or carnitine

          -  The use of NSAIDs other than aspirin for a time period up to one month before the
             procedure
Efficacy and Safety of Pasireotide Long Acting Release vs. Octreotide Long Acting Release in Patients With Metastatic Carcinoid Disease
Condition: Symptomatic Refractory Resistant Carcinoid Disease
MeSH terms: Carcinoid Tumor
Intervention: Pasireotide; Octreotide
Intervention description: Pasireotide LAR 60mg i.m. injection - patients may also receive pasireotide 600 µg s.c 3 times a day for symptom control as needed; Octreotide LAR 40mg i.m. depot injection - Patients may also receive octreotide 100 µg s.c. 3 times a day for symptom control as needed
Intervention MeSH terms: Octreotide; Pasireotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carcinoid; neuroendocrine; gastroenteropancreatic; somatostatin analogue; Symptomatic Refractory Resistant Carcinoid Disease

Summary:

      The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of
      paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are
      inadequately controlled by currently available somatostatin analogues.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patients aged 18 or greater

          -  Patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not
             adequately controlled by somatostatin analogues.

          -  Female patients of child bearing potential must have a negative pregnancy test at
             baseline.

          -  Patients for whom written informed consent to participate in the study has been
             obtained.

        Exclusion criteria:

          -  Patients receiving radiolabeled somatostatin analogue therapy within the 3 months or
             any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to
             randomization

          -  Diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly
             controlled as indicated by HBA1C > 8%

          -  Patients with symptomatic cholelithiasis

          -  Patient with malabsorption syndrome, short bowel or cholegenic diarrhea not controlled
             by specific therapeutic means.

        Other protocol-defined inclusion/exclusion criteria may apply
Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens
Condition: Complications of Bone Marrow Transplant; Hematologic Neoplasms
MeSH terms: Hematologic Neoplasms
Intervention: Olanzapine; Placebo
Intervention description: Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy; Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to compare the effectiveness of olanzapine added to standard
      triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone
      in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients
      receiving highly or moderately emetogenic chemotherapy regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inpatient or outpatient hematology patient receiving one of the following regimens:

          -  Chemotherapy for hematologic malignancy:

          -  ABVD

          -  ICE ± R

          -  7+3

          -  Conditioning therapy for stem cell transplantation:

          -  BEAM

          -  Bu/Cy ± ATG

          -  Bu/Flu ± ATG

          -  FluCy ± ATG

          -  FluCy + TBI

          -  BuMel

          -  FluBuCy

          -  Melphalan

          -  Etoposide + TBI

          -  Cyclophosphamide + TBI

        Exclusion Criteria:

          -  Allergy to olanzapine

          -  Documented nausea or vomiting ≤24 hours prior to enrollment

          -  Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine,
             phenothiazine or butyrophenone ≤30 days prior to enrollment or planned during protocol
             therapy

          -  Chronic alcoholism

          -  Pregnant

          -  Declined or unable to provide an informed consent
A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Oseltamivir IV; Oseltamivir Oral
Intervention description: Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment. Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol.; Oseltamivir (TAMIFLU®) capsules taken orally for 5 days. Twice daily (every 12 hours) for patients with moderate renal impairment, once daily for patients with severe renal impairment and dose frequency according to protocol for patients on renal replacement therapy.
Intervention MeSH terms: Oseltamivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 118.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      This partially randomized, multi-center parallel-group study will evaluate the safety,
      pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in
      patients with influenza. Adult and adolescent patients will be randomized to receive either
      100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are
      blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral
      Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days,
      with an optional treatment extension of a further 5 days, if necessary. There will be a
      non-randomized, open-label treatment group for patients with moderate/severe renal impairment
      or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to
      their renal situation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult and adolescent patients, 13 years of age and older

          -  Diagnosis of influenza

          -  ≤ 144 hours between the onset of influenza-like illness and first dose of study drug

        Non-randomized, open-label treatment group:

          -  Patients with moderate/severe renal impairment or renal failure with creatinine
             clearance 10-60 mL/min

        Exclusion Criteria:

          -  Clinical evidence of severe hepatic decompensation at the time of randomization

          -  Acute ischemia or significant arrhythmia
A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
Condition: Episodic Cluster Headache; Chronic Cluster Headache
MeSH terms: Cluster Headache; Headache
Intervention: Galcanezumab
Intervention description: Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cluster headache; headache; brain diseases; central nervous system diseases; headache disorders; headache disorders, primary; nervous system diseases; neurologic manifestations; pain; trigeminal autonomic cephalalgias

Summary:

      The main purpose of this study is to assess the long-term safety and tolerability of
      galcanezumab administered up to once monthly in participants with episodic or chronic cluster
      headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM
      (NCT02438826).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who participated in and completed either study CGAL or study CGAM.

          -  Investigator judges the participant as reliable to follow all study procedures, keep
             all study visits, and be compliant with study requirements.

        Exclusion Criteria:

          -  Current enrollment in or discontinuation within the last 30 days from, a clinical
             trial involving any investigational drug or device (with the exception of Study CGAL
             or Study CGAM).

          -  Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP)
             antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF)
             (with the exception of Study CGAL or Study CGAM).

          -  A history of migraine variants that could implicate or could be confused with
             ischemia.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins.

          -  A history or presence of other medical illness that indicates a medical problem that
             would preclude study participation.

          -  Evidence of significant active or unstable psychiatric disease, in the opinion of the
             investigator.

          -  Women who are pregnant or nursing.
Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
Condition: Pelvic Inflammatory Disease
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection
Intervention: Azithromycin
Intervention description: The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.
Intervention MeSH terms: Azithromycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Female
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical
      bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and
      eradication rate in the western clinical trials. Development of azithromycin intravenous
      formulation would bring the clinical benefit to patients with pelvic inflammatory disease
      (PID) in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

        Both of following symptoms should be observed.

          -  Lower abdominal pain and/or lower abdominal tenderness.

          -  Hypochondrial pain and/or hypochondrial tenderness (tenderness of uterus or adnexa of
             uterus).

        Exclusion Criteria:

        Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or
        ketolides.

        Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).
A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate
Condition: Metastatic Castration-resistant Prostate Cancer; Metastatic Breast Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Prednisone
Intervention description: Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily; Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily
Intervention MeSH terms: Prednisone; Abiraterone Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Healthy volunteers: No
Keywords: Metastatic castration-resistant prostate cancer; Metastatic breast cancer; Abiraterone acetate; Low-dose corticosteroid treatment; Long-term access

Summary:

      The purpose of this study is to collect follow-up safety data from participants in completed
      abiraterone acetate studies for a maximum duration of 9 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently participating in an abiraterone acetate clinical study considered complete
             and had received at least 3 months of treatment with abiraterone acetate tablets.

        Exclusion Criteria:

          -  Medical conditions that require hospitalization.

          -  Any condition or situation which, in the opinion of the investigator, may put the
             patient at significant risk, may confound the study results, or may interfere
             significantly with the patient's participation in the study.
Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants
Condition: Pantothenate Kinase-Associated Neurodegeneration
MeSH terms: Pantothenate Kinase-Associated Neurodegeneration; Nerve Degeneration
Intervention: Fosmetpantotenate; Placebo
Intervention description: Daily dosing; Daily dosing
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 6 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: PKAN

Summary:

      This study investigated whether fosmetpantotenate (RE-024), a phosphopantothenate replacement
      therapy, was safe and effective in treating participants with PKAN.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant had a diagnosis of PKAN as indicated by confirmed mutations in the
             pantothenate kinase 2 gene.

          2. The participant was male or female aged 6 to 65 years, inclusive.

          3. The participant had a score of ≥ 6 on the PKAN-specific activities of daily living
             measure.

        Exclusion Criteria:

          1. The participant had required regular or intermittent invasive ventilatory support to
             maintain vital signs within 24 weeks prior to randomization.

          2. The participant had a deep brain stimulation device implanted within 6 months prior to
             screening.

          3. The participant had taken deferiprone within 30 days prior to screening.

          4. The participant was unable to maintain stable doses of allowed concomitant medications
             for the first 24 weeks of the study.
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; metformin; glimepiride; placebo; placebo; liraglutide; liraglutide
Intervention description: 0.6 mg for s.c. (under the skin) injection.; 1.5-2.0 g tablets; 4 mg tablets; Glimepiride placebo 1 mg and 2 mg tablets; Liraglutide placebo 1-3 mL for s.c. (under the skin) injection; 1.2 mg for s.c. (under the skin) injection; 1.8 mg for s.c. (under the skin) injection
Intervention MeSH terms: Metformin; Liraglutide; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1091.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is
      designed to show the effect of treatment with liraglutide when adding to existing metformin
      therapy and to compare it with the effects of metformin monotherapy and combination therapy
      of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised,
      double-blinded period followed by an 18 months open-label extension, in total 2 years (104
      weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs
             (OADs) for at least 3 months

          -  HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.)
             in subjects on OAD combination therapy

          -  Body Mass Index (BMI) less than or equal 40 kg/m2

        Exclusion Criteria:

          -  Subjects treated with insulin within the last three months

          -  Subjects with any serious medical condition

          -  Females of child bearing potential who are pregnant, breast-feeding or have the
             intention of becoming pregnant or not using adequate contraceptive methods

          -  Subjects using any drug (except for OADs), which in the Investigator's opinion could
             interfere with the glucose level (e.g. systemic corticosteroids)