bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Study of KAD-1229 in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: KAD-1229
Intervention MeSH terms: Mitiglinide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Type 2 diabetes; HbA1c; Long-term study

Summary:

      The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as
      combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show
      inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide
             or DPP-4 inhibitor monotherapy

          -  Age in the 20 years or over inclusive

          -  HbA1c in the range of ≥ 6.5 to < 9%

        Exclusion Criteria:

          -  Type 1 diabetes mellitus

          -  Patients with serious diabetic complications and other serious complications
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
Condition: Syndrome of Inappropriate Antidiuretic Hormone Secretion
MeSH terms: Inappropriate ADH Syndrome; Diabetes Insipidus; Hyponatremia; Syndrome
Intervention: Tolvaptan Oral Tablet
Intervention description: Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The objective of this study is to investigate the efficacy and safety of tolvaptan based on
      the change in serum sodium concentration following administration of tolvaptan oral tablets
      at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment
             Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2011"

          -  Subjects who have been on fluid restriction for at least 7 consecutive days at the
             time of informed consent and who are showing no improvement of hyponatremia at the
             time of the screening examination

        Exclusion Criteria:

          -  Subjects who have transient hyponatremia induced by drug administration

          -  Subjects who are unable to sense thirst or who have difficulty with fluid intake

          -  Subjects with urinary tract obstruction

          -  Subjects who have participated in any other clinical trial within 30 days prior to
             informed consent

          -  Subjects with serum sodium concentration of <120 mEq/L associated with neurologic
             impairment, including apathy, confusion, or seizures
ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: CyclASol topical ocular, eye drops; Vehicle topical ocular, eye drops
Intervention description: Cyclosporine A solution in vehicle; Vehicle
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 834.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this pivotal trial is to assess the efficacy, safety and tolerability of
      CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye
      Disease (DED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed ICF (Informed Consent Form)

          -  Patient-reported history of DED in both eyes

          -  Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms

          -  Ability and willingness to follow instructions, including participation in all study
             assessments and visits

        Exclusion Criteria:

          -  Women who are pregnant, nursing or planning a pregnancy

          -  Unwillingness to submit a urine pregnancy test at screening and the last visit (or
             early termination visit) if of childbearing potential, or unwillingness to use
             acceptable means of birth control

          -  Clinically significant slit-lamp findings or abnormal lid anatomy at screening

          -  Ocular/periocular malignancy

          -  History of herpetic keratitis

          -  Active ocular allergies or ocular allergies that may become active during the study
             period

          -  Ongoing ocular or systemic infection at screening or baseline

          -  Wear of contact lenses within 3 months prior to screening or anticipated use of
             contact lenses during the study

          -  Use of topical Cyclosporine A or Liftigrast within 2 months prior to screening

          -  Intraocular surgery or ocular laser surgery within the previous 6 months, or have any
             planned ocular and/or lid surgeries over the study period

          -  Presence of uncontrolled systemic diseases

          -  Presence of known allergy and/or sensitivity to the study drug or its components

          -  Randomized in a previous CyclASol trial
CONNECT for Better Falls Prevention in VA Community Living Centers
Condition: Accidental Falls
Intervention: CONNECT educational intervention; FALLS educational intervention
Intervention description: The CONNECT educational intervention is a training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving. Includes in class sessions, group and individual mapping exercises, self-monitoring of interactions, and individual staff coaching.; FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 689.0
Sex: All
Healthy volunteers: No
Keywords: staff education; complexity science; social constructivist theory

Summary:

      This is a randomized trial of 2 nursing home staff educational approaches to reduce falls in
      VA nursing home (CLC) residents. One is a traditional falls education program using web-based
      modules, feedback of quality indicators, and meetings with influential peers. The other is a
      12 week program that trains staff to form better connections and use effective communication
      strategies with a diverse network of co-workers, so that problem solving about resident
      problems is enhanced. The study will test whether the second intervention increases the
      effectiveness of the traditional falls education program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All clinical and support staff in participating VA Community Living Centers

        Exclusion Criteria:

          -  Inability to speak and understand English
A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19
Condition: COVID-19; Coronavirus; Coronavirus Infection
MeSH terms: COVID-19; Coronavirus Infections
Intervention: INOpulse; Placebo
Intervention description: Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.; Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID; Sars-CoV-2; iNO; INOpulse; Severe Acute Respiratory Syndrome (SARS) Pneumonia; Severe Acute Respiratory Syndrome Coronavirus 2; SARS-CoV 2; COViNOX; pulsed inhaled nitric oxide; inhaled nitric oxide; portable pulsed inhaled nitric oxide; nitric oxide

Summary:

      A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of
      pulsed inhaled iNO compared to placebo in subjects with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  At least 18 years old

          -  Subjects must be hospitalized and have the following:

               -  proven or high suspicion of SARS-CoV-2 infection and,

               -  requiring oxygen supplementation defined as:

               -  SpO2 ≤ 92% regardless of supplemental oxygen (ie on room air or on oxygen), or

               -  SpO2 ≥ 92% on supplemental O2 and in the opinion of the Investigator it is not
                  safe to decrease or remove the supplemental oxygen

               -  require supplemental oxygen of no more than 10 L/minute, and

               -  radiologic suspected or proven COVID-19 pneumonitis (chest x-ray or CT scan)

          -  Female subjects must have a negative pregnancy test

          -  Willing and able to comply with the treatment schedule and study procedures

        Exclusion Criteria:

          -  Participating in another clinical trial of an investigational treatment for COVID-19

          -  Methemoglobin > 3%

          -  Evidence of severe multi organ failure

          -  Use of assisted ventilation prior to initiation of iNO

          -  Pregnancy or positive pregnancy test pre-dose

          -  Open tracheostomy

          -  Chronic use of a nitric oxide donor agent such as nitroglycerin or drugs known to
             increase methemoglobin such as lidocaine, prilocaine, benzocaine, nitroprusside,
             isosorbide, or dapsone at screening

          -  History or clinical evidence of systolic heart failure, left ventricular dysfunction
             (LVEF <40%)

          -  Subjects reporting massive hemoptysis associated with the current illness or with
             radiologically proven pulmonary embolus
Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Pneumonia, Pneumococcal; Streptococcal Infections
Intervention: Synflorix™( GSK1024850A); Infanrix hexa™
Intervention description: Intramuscular, 3 doses; Intramuscular, 3 doses
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal vaccine

Summary:

      The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK
      1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix
      hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between, and including 6-12 weeks of age at the time of the
             first vaccination.

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  Written and signed or thumb-printed informed consent obtained from the parent(s)/LAR
             of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be
             countersigned by a witness.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product.

          -  Acute disease and/or fever at the time of enrolment.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine(s).

          -  History of chronic condition(s) requiring treatment such as cancer or autoimmune
             disease.

          -  Hypersensitivity to latex.

          -  Previous vaccination against diphtheria, tetanus, pertussis, Hemophilus influenzae
             type b and/or Streptococcus pneumoniae. Locally recommended EPI vaccines to be given
             at birth are allowed, but should be administered at least one month before the first
             dose of the study vaccine is administered. Other locally recommended vaccines are
             allowed, even if concomitantly administered with the study vaccines, but should be
             documented in the eCRF.
Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Methacholine Chloride (SK-1211)
Intervention MeSH terms: Methacholine Chloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation
      challenge in children with bronchial asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of bronchial asthma

          -  FEV1/FVC must be 70% or more

          -  <10% decrease in FEV1 in response to inhalation of normal saline

        Exclusion Criteria:

          -  Moderate or severe airflow limitation（FEV1<60% predicted）

          -  Heart attack or stroke in last 3 months

          -  Uncontrolled hypertension, systolic BP>200, or diastolic BP>100

          -  known aortic aneurysm
Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)
Condition: Anesthesia, General; Neuromuscular Blockade
Intervention: Sugammadex
Intervention description: After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was to be administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could have been administered if necessary. At 1-2 PTC after the last administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was to be administered.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in
      Chinese and Caucasian subjects for registration purposes in China.
    

Eligibility criteria:

        Inclusion Criteria:

        -Subjects who are willing to provide informed consent; be between 18 and 64 years old; are
        American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for
        elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which
        requires neuromuscular blockade using

        rocuronium; be compliant with the dose/visit schedules, and use an accepted method of
        contraception (if applicable).

        For China only: Subjects of Chinese descent born in China, never emigrated out of China and
        have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe,
        never emigrated out of Europe and have a European home address.

        Exclusion Criteria:

        -Subjects with expected difficult intubation, neuromuscular disorders affecting
        neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet,
        (family) history of malignant hyperthermia, allergy to general anesthesia medications,
        contraindication to study drugs, breast feeding, pregnant, participation in previous or new
        trials, a clinically significant condition that may interfere with the trial, or membership
        in the

        (family of) study/sponsor staff.
A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment
Condition: Human Immunodeficiency Virus (HIV) Infections; Acquired Immunodeficiency Syndrome (AIDS) Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Darunavir; Ritonavir
Intervention description: Darunavir (DRV): type = exact number, unit = mg, number = 800, form = tablet, route = oral use; ritonavir (rtv): type = exact number, unit = mg, number = 100, form = tablet, route = oral use
Intervention MeSH terms: Ritonavir; Darunavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Darunavir (DRV); TMC114; Prezista; HIV; virologic response; neurocognitive function

Summary:

      The purpose of this study is to compare the efficacy, safety and tolerability of
      darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing
      darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors
      (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who
      have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral
      Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function
      will be compared throughout the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infection

          -  receiving HAART for at least 48 weeks

          -  Have at least 2 documented plasma HIV-1 RNA <50 copies/mL, and no HIV-1 RNA >=50
             copies/mL in the 48 weeks prior to the screening

          -  Be taking the same antiretroviral (ARV) combination for at least 8 weeks before
             screening

          -  Have the preference, together with the physician, to change the current HAART regimen
             for reasons of simplification and/or toxicity

        Exclusion Criteria:

          -  Has a history of virologic failure defined as 2 consecutive plasma HIV-1 RNA >500
             copies/mL while on previous or current antiretroviral therapy

          -  Has a history of any primary PI mutations

          -  Has clinical or laboratory evidence of significantly decreased hepatic function or
             decompensation, irrespective of liver enzyme levels (liver insufficiency)

          -  Is diagnosed with acute viral hepatitis at screening or before Baseline 1

          -  Is co-infected with hepatitis B
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2
Condition: Skin Structures and Soft Tissue Infections
MeSH terms: Soft Tissue Infections
Intervention: Iclaprim; Vancomycin
Intervention description: Experimental treatment; Active comparator
Intervention MeSH terms: Vancomycin; Iclaprim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 613.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim
      compared to vancomycin for the treatment of skin and skin structure infections.
    

Eligibility criteria:

        Inclusion Criteria:

          1. written informed consent;

          2. ≥18 years of age;

          3. a bacterial infection of the skin with a lesion size area of at least 75 cm2;

          4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;

          5. the presence of purulent or seropurulent drainage or at least three signs and symptoms
             of infection (discharge, erythema, swelling, warmth, or pain).

        Exclusion Criteria:

          1. severely impaired arterial blood supply such that amputation of the infected
             anatomical site is likely;

          2. infected diabetic foot ulcers;

          3. infected decubitus ulcers;

          4. necrotizing fasciitis or gangrene;

          5. uncomplicated skin or skin structure infection;

          6. infections associated with a prosthetic device;

          7. suspected or confirmed osteomyelitis;

          8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression
             therapy.
Efficacy and Safety of IQP-VV-102 in Weight Management
Condition: Obesity; Overweight
MeSH terms: Overweight
Intervention: IQP-VV-102; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Subjects are randomized to either IQP-VV-102 or a matching placebo. Over 12 weeks, the
      subjects' body weight, body fat and safety parameters are monitored
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 60 years

          -  25 kg/m2 ≤ BMI ≤ 35 kg/m2

          -  Written informed consent

        Exclusion Criteria:

          -  Known sensitivity to sources of the active ingredients and excipients

          -  Pregnancy or nursing

          -  Inability to comply with study requirements, e.g. due to language difficulties

          -  Participation in another study during the last 30 days of the screening visit