bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
Condition: Anemia; Chronic Kidney Disease; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: Darbepoetin Alfa; Placebo
Intervention description: Administered by subcutaneous or intravenous injection; Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 116.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Dialysis; Anemia; Nephrology; Pediatric; Hemodialysis; Peritoneal Dialysis; Chronic Renal Insufficiency

Summary:

      The primary objectives of this study are the following:

        1. To test if the proportion of participants achieving a hemoglobin value greater than or
           equal to 10.0 g/dL at any time point after the first dose during the study is greater
           than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of
           anemia in pediatric patients with chronic kidney disease receiving and not receiving
           dialysis, and

        2. To test if the proportion of participants achieving a hemoglobin value greater than or
           equal to 10.0 g/dL at any time point after the first dose during the study is greater
           than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of
           anemia in pediatric patients with chronic kidney disease receiving and not receiving
           dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current diagnosis of Chronic Kidney Disease, either receiving or not receiving
             dialysis

          -  Anemic, with two consecutive screening hemoglobin values drawn at least 7 days apart <
             11.0 g/dL

          -  Transferrin saturation (Tsat) greater than or equal to 20%

        Exclusion Criteria:

          -  Any erythropoiesis stimulating agent (ESA) use within 12 weeks prior to randomization

          -  other hematologic disorders

          -  upper or lower gastrointenstinal bleeding within 6 months prior to randomization

          -  uncontrolled hypertension

          -  prior history (within 12 weeks prior to randomization) of acute myocardial ischemia,
             hospitalization for congestive heart failure, myocardial infarction, stroke or
             transient ischemic attack

          -  prior history (within 6 months prior to randomization) of thromboembolism
Effect of High Dose Ciclesonide on Asthma Control
Condition: Bronchial Asthma
MeSH terms: Asthma
Intervention: Ciclesonide
Intervention description: During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)
Intervention MeSH terms: Ciclesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 520.0
Sex: All
Minimum age: 12 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: ciclesonide; asthma

Summary:

      The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day.
      Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent was provided

          -  History of persistent bronchial asthma for at least 6 months

          -  Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose
             range of 200-1000 μg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12
             weeks

          -  Good inhalation technique

          -  Under the current ICS pre-treatment the ACQ score ranges between ≥ 0.75 and ≥ 2

        Exclusion Criteria:

          -  Clinically relevant abnormal laboratory values suggesting an unknown disease and
             requiring further clinical evaluation

          -  Concomitant severe diseases (e.g. malignant diseases during the past 5 years [other
             than basal or squamous cell carcinoma], hepatitis C, acquired immune deficiency
             syndrome [AIDS])

          -  Diseases which are contraindications for the use of ICS (e.g. active or inactive
             pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower
             respiratory tract demanding specific treatment)

          -  Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6
             weeks) before entry into the baseline period, or more than 3 times during the last 6
             months
OTC Mouthpiece for Snoring
Condition: Snoring
MeSH terms: Snoring
Intervention: Zyppah Anti-snoring Appliance
Intervention description: Use of an OTC mouth guard at night to prevent snoring
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Patient serves as their own control
Masking: Double (Care Provider, Investigator)
Masking description: The data is compiled and analyzed by an outside, independent organization
Enrollment: 604.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Online patient registration to participate in clinical trial to test OTC mouthpiece that
      controls position of the tongue to reduce snoring.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over 18 years of age

          -  Living in the United States

          -  Signing the Informed Consent Form

        Exclusion Criteria:

          -  Missing teeth (as the device won't be properly fitted)

          -  Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD,
             or a similar condition

          -  Poor dental health, such as severe gum disease, loose teeth, an abscess, mouth sores,
             or bleeding gums

          -  A dental implant placed within the last three months

          -  Diagnosed with a Temporomandibular joint condition (TMJ)

          -  Actively experiencing any mouth or jaw pain, including clenching of the teeth,
             grinding, or any other physical injury to the jaw or teeth

          -  Full dentures

          -  Braces

          -  Diagnosis of sleep apnea

          -  Less than 18 years of age
Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
Condition: Post Herpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: Pregabalin; placebo
Intervention description: Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks; Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 806.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Control Release Pregabalin in Post Herpetic Neuralgia

Summary:

      The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin
      formulation versus placebo for patients with post herpetic neuralgia (Shingles)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have pain present for more than 3 months after the healing of the herpes
             zoster skin rash.

          -  At screening (V1) and enrollment (V2), patients must have a score of greater than or
             equal to 4 on the Pain Numeric Rating Scale (1 week recall period).

          -  At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within
             the last 7 days and the average pain score must be greater than or equal to 4.

          -  Male or female of any race, at least 18 years of age, and using appropriate methods of
             contraception

        Exclusion Criteria:

          -  Creatinine clearance <30 mL/min (estimated from serum creatinine).

          -  Skin conditions in the affected dermatome that could alter sensation

          -  Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days
             should be washed out of pregabalin for at least 30 days prior to screening visit.
             Patients who had not responded to pregabalin
Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
Condition: Healthy
Intervention: Heatwrap 1
Intervention description: 8 hours continuous topically-applied heat
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 169.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; tolerability; heatwrap; lower back; healthy subjects

Summary:

      The objectives of this study are to evaluate the dermal safety and on-body temperature of a
      disposable heatwrap product when worn while in a supine position for five consecutive days.
      The product will be worn on the back for approximately 8 hours per 24 hour period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject is a male or female in generally good health greater or equal to 35 years
             of age;

          -  Female subjects of child-bearing potential and those who are post-menopausal for less
             than 2 years must be using a medically-approved method of contraception (i.e., oral,
             transdermal, or implanted contraceptive hormones, cervical cap, intrauterine device,
             diaphragm, condom, abstinence, or surgical sterility including partner's vasectomy);

          -  The subject has a waist-hip circumference of between 27-47 inches inclusive.

        Exclusion Criteria:

          -  The subject is a pregnant or lactating woman;

          -  The subject is diabetic;

          -  The subject has a history of melanoma, squamous or basal cell carcinoma in the area of
             application of the lower back and hip;

          -  The subject has any active skin disease which may contraindicate participation,
             including eczema, rash, broken or irritated skin, contact dermatitis and atopic
             dermatitis, or any skin condition that may be aggravated by heat;

          -  The subject has used (within the previous week) or is using any topical drug or
             heatwrap or electrical heat pads at the application site; or

          -  The subject has damaged skin in, or around the test sites which includes sunburn,
             uneven skin tones, tattoos, scars or other disfiguration at the application site,
             including an erythema grading of greater than 0 at the application site.
Study Evaluating Rapamune® Maintenance Regimen
Condition: Renal Transplant
Intervention: Sirolimus (Rapamune®)
Intervention description: (1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.
Intervention MeSH terms: Sirolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed
      acute rejection episode at 6 months after transplantation in Korean renal transplantation
      recipients.

      Secondary :

        1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal
           transplantation recipients.

        2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after
           transplantation, and to investigate the incidence of biopsy-confirmed acute rejection
           episode at 12 months after transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than or equal to 13 years of age.

          2. End-stage renal disease in patients scheduled to receive a primary renal allograft
             from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding
             0 antigen mismatch) donor. A mismatch donor is defined as a donor human leukocyte
             antigen (HLA) antigen not shared by the patient.

          3. Patients with a panel of reactive antibody (%PRA) less than or equal to 50%

        Exclusion Criteria:

          1. Evidence of active systemic or localized major infection at the time of initial
             sirolimus administration.

          2. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during
             pre-study screening.

          3. Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac
             abnormality contraindicating general anesthesia or surgery.

          4. History of malignancy within 5 years before enrollment into the study (with the
             exception of adequately treated basal cell or squamous cell carcinoma of the skin).

          5. Current treatment with partial opioid agonists (eg, buprenorphine) or combination
             agonists/antagonists.
Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Idalopirdine 60 mg
Intervention description: once daily, encapsulated tablets, orally
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1463.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive
      therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind,
             placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641

        For patients in the OLEX-MEM:

          -  The patient has completed Visit 6 (Week 28) of the OLEX.

          -  The patient, according to the judgement of the investigator, requires initiation of
             treatment with memantine as per local label/SmPC/treatment guidelines.

        Exclusion Criteria:

          -  The patient has a moderate or severe ongoing adverse event from the lead-in study
             considered a potential safety risk by the investigator.

          -  The patient has experienced seizures before Completion Visit in the lead-in study.

          -  The patient has evidence of clinically significant disease.

          -  The patient's donepezil treatment is likely to be interrupted or discontinued during
             the study.

          -  The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).

        Other protocol-defined inclusion and exclusion criteria may apply.
Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Condition: Grade B Acute Graft Versus Host Disease; Grade C Acute Graft Versus Host Disease; Grade D Acute Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Intervention: Remestemcel-L
Intervention description: No intervention was given in Study MSB-GVHD002 (NCT02652130). It was a safety follow-up trial of remestemcel-L-treated participants from Study MSB-GVHD001.
Intervention MeSH terms: Remestemcel-l
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 2 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: GVHD

Summary:

      Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L
      treatment in pediatric participants with acute graft versus host disease (aGVHD), following
      allogeneic hematopoietic stem cell transplant (HSCT), that have failed to respond to
      treatment with systemic corticosteroid therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have participated in MSB-GVHD001 and have received at least one
             infusion of remestemcel-L.

          -  Participant or participant's authorized representative must be capable of providing
             written informed consent. Assent, if applicable, must also be collected when required
             by the Institutional Review Board (IRB)/Ethics Committee (EC).

          -  Female participants of childbearing potential (≥ 10 years of age) must use a medically
             accepted method of contraception and must agree to continue use of this method for the
             duration of the study and for the follow-up time period. Acceptable methods of
             contraception include abstinence, barrier method with spermicide, intrauterine device
             (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in
             conjunction with a barrier method.

          -  The participant must be willing and able to comply with study procedures, remain at
             the clinic as required during the study period, and return to the clinic for the
             follow-up evaluation as specified in this protocol.

        Exclusion Criteria:

          -  The investigator believes it to be in the best interest of the participant not to
             participate in the safety follow-up study.

          -  Participant has participated or is currently participating in any autologous or
             allogeneic stem cell or gene therapy study for the treatment of aGVHD. Participants
             participating in investigative protocols aimed at modification of the transplant graft
             (such as T cell depletion) or aimed at modification of the conditioning regimen will
             be allowed in the study.
Monotherapy Study of MP-513 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Teneligliptin 20 mg; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: insulin resistance

Summary:

      The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in
      patients with type 2 Diabetes for 12 weeks administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are 20 - 75 years old

          -  Patients who are under dietary management and taking therapeutic exercise for diabetes
             over 12 weeks before administration of investigational drug

          -  Patients whose HbA1c is between 6.5% - 10.0%

          -  Patients who were not administered diabetes therapeutic drugs within 12 weeks before
             administration of investigational drug.

        Exclusion Criteria:

          -  Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or
             secondary diabetes (Cushing disease, acromegaly, etc)

          -  Patients with Class III/IV heart failure symptoms according to New York Heart
             Association (NYHA) functional classification

          -  Patients with serious diabetic complications.

          -  Patients who are habitual excessive alcohol consumption.

          -  Patients with severe hepatic disorder or severe renal disorder.

          -  Patients who are pregnant, lactating, and probably pregnant patients, and patients who
             can not agree to contraception
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: DF289; DF277; DF289 plus DF277
Intervention description: Ear drops; Ear drops; Ear drops
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 331.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Years
Healthy volunteers: No
Keywords: with tubes

Summary:

      The purpose of this study is to determine if a combination of an antibiotic plus a
      corticosteroid is safe and effective in treating middle ear infections in children with ear
      tubes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6 months to 12 years

          -  ear tube in the ear which will be treated

          -  otorrhea for 3 weeks or less

          -  moderate or severe otorrhea

        Exclusion Criteria:

          -  other ear diseases
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
Condition: HIV Enteropathy; Diarrhea With HIV
MeSH terms: HIV Enteropathy; Diarrhea
Intervention: Crofelemer
Intervention description: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV +; HIV positive; HIV associated diarrhea; AIDS; Diarrhea

Summary:

      This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg
      twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive
      (HIV+) subjects with diarrhea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 years old

          -  History of HIV-1 infection

          -  On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated
             conditions (including prophylactic antibiotics for Pneumocystis jirovecii or
             infection) for at least 4 weeks prior to screening

          -  Self-reported presence of diarrhea necessitating ADM use for at least 4 weeks

        Exclusion Criteria:

          -  CD4 counts < 100 cells/mm3

          -  Oral temperature greater than 38.0° C, or unintentional weight loss of 5.0 kg or
             greater during the prior 2 months

          -  Bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure)
             origin

          -  Immediate need for GI surgery or intervention for active GI bleeding, pancreatitis,
             peritonitis, intestinal obstruction, or intra-abdominal abscess