bioihbjkbjnl/mcl2 huggingface dataset:
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
Condition: Hemorrhage
MeSH terms: Emergencies; Hemorrhage
Intervention: Idarucizumab
Intervention description: Intravenous
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in
      patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding
      requiring urgent intervention, and in patients treated with dabigatran etexilate who require
      emergency surgery or other invasive procedure.

      The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the
      clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of
      idarucizumab.
    

Eligibility criteria:

        Inclusion criteria:

          -  ≥ 18 years at screening.

          -  Male or female patients. Women of childbearing potential (WOCBP) and men able to
             father a child must be ready and able to use highly effective methods of birth control
             per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used
             consistently and correctly. A list of contraception methods meeting these criteria is
             provided in the patient information.

          -  Signed and dated written informed consent in accordance with ICH-GCP and local
             legislation prior to admission to the trial

          -  Currently taking dabigatran etexilate

          -  They meet the following criteria:

               -  Group A: Overt bleeding judged by the physician to require a reversal agent. OR

               -  Group B: A condition requiring emergency surgery or invasive procedure where
                  adequate hemostasis is required. Emergency is defined as within the following 8
                  hours.

        Exclusion criteria:

        Group A:

          -  Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with
             standard supportive care.

          -  Patients with no clinical signs of bleeding.

          -  Contraindications to study medication including known hypersensitivity to the drug or
             its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

        Group B:

          -  A surgery or procedure which is elective or where the risk of uncontrolled or
             unmanageable bleeding is low.

          -  Contraindications to study medication including known hypersensitivity to the drug or
             its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide
Condition: Epilepsy, Partial
MeSH terms: Epilepsies, Partial
Intervention: Lacosamide; Levetiracetam
Intervention description: 4-Week Titration Period: start dose Lacosamide (LCM) is 100 mg/day - up-titration of 100 mg/week LCM 8-Week Maintenance Period: dose can change first 4 weeks with 100 mg/week, must remain between 300 mg/day and 600 mg/day. Dose must remain stable last 4 weeks.; Levetiracetam (LEV) is taken at a stable dose 30 days before study entry and is ≥ 1000 mg/day at the first visit. The LEV dose may not be changed at any time.
Intervention MeSH terms: Lacosamide; Levetiracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Vimpat; Partial seizures; Carbamazepine; Hormone levels; Lipid levels; Lacosamide

Summary:

      The purpose of the trial is to investigate whether changes in lipids and hormonal parameters
      can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment,
      while Levetiracetam treatment remains unchanged.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subject with diagnosis of Epilepsy with Partial-Onset Seizures

          -  Subject only taking Levetiracetam in combination with Carbamazepine as adjunctive
             treatment for Epilepsy

        Exclusion Criteria:

          -  Subject is taking another Anti-Epileptic Drug (AED) than Carbamazepine (CBZ) and
             Levetiracetam (LEV)

          -  Subject is taking lipid lowering agents

          -  Subject is taking enzyme inducers
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: 13-valent Pneumococcal Conjugate Vaccine; 7 valent pneumococcal conjugate vaccine
Intervention description: 1 dose at 6, 10, 14 weeks and 12 months of age; 1 dose at 6, 10, 14 weeks and 12 months of age
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 708.0
Sex: All
Minimum age: 42 Days
Maximum age: 72 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccines, Pneumococcal

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given
      concomitantly with routine paediatric vaccinations in India.
    

Eligibility criteria:

        Inclusion Criteria

          1. Healthy infants aged 6 weeks (42-72 days) at time of enrolment

          2. Available for the entire study period

        Exclusion Criteria

          1. Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines

          2. A previous anaphylactic reaction to any vaccine or vaccine-related component

          3. Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus,
             pertussis, polio, hepatitis B or measles vaccines
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Intervention: pantoprazole sodium enteric-coated spheroid suspension
Intervention description: pediatric suspension taken daily x 7 days
Intervention MeSH terms: Pantoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 1 Month
Maximum age: 11 Months
Healthy volunteers: No
Keywords: GERD; Infant

Summary:

      The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic
      (PD) profiles to determine the safety and tolerability of single and multiple doses of
      pantoprazole in infants aged 1 through 11 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than 44 weeks beyond neonatal period but less than 12 months

          -  Presumptive diagnosis of GERD

          -  Weight greater than 2.5 kg but less than 15 kg

        Exclusion Criteria:

          -  History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal
             fistula, GI malabsorption

          -  Clinically significant medical or surgical abnormalities
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: EAS-AC (HeartLight); Control Arm Ablation
Intervention description: Pulmonary vien isolation; Treatment with standard ablation.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: atrial fibrillation; AF; PAF; PVI; ablation; paroxysmal atrial fibrillation; pulmonary vein isolation

Summary:

      The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus
      Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial
      fibrillation by creating electrical isolation of the pulmonary veins.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 75 years.

          -  paroxysmal atrial fibrillation

          -  failure of at least one AAD

          -  others

        Exclusion Criteria:

          -  overall good health as established by multiple criteria
BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis
Condition: Multiple Sclerosis, Secondary Progressive
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Intervention: dimethyl fumarate; Placebo
Intervention description: capsule; matched placebo capsule
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 58 Years
Healthy volunteers: No
Keywords: INSPIRE; SPMS; Tecfidera; BG00012

Summary:

      The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl
      fumarate) compared with placebo slows the accumulation of disability not related to relapses
      in participants with secondary progressive multiple sclerosis (SPMS). The secondary objective
      of the study is to assess the effect of BG00012 compared with placebo on patient-reported
      outcomes, brain atrophy, and cognitive function.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Onset of SPMS at least 1 to 2 years prior to randomization. SPMS is defined as
             relapsing-remitting disease followed by progression of disability independent of or
             not explained by relapses.

          -  Have documented confirmed evidence of disease progression independent of clinical
             relapses over the 1 year prior to randomization.

          -  Have an Expanded Disability Status Scale score of 3.0 to 6.5, inclusive.

          -  Have a Multiple Sclerosis (MS) Severity Score of 4 or higher.

        Key Exclusion Criteria:

          -  Have a diagnosis of relapsing remitting multiple sclerosis or primary progressive MS
             as defined by the revised McDonald criteria.

          -  Had a recent clinical relapse (within 3 months) prior to randomization.

          -  Uncontrolled intercurrent illness including, but not limited to: ongoing or active
             infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac
             arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled
             diabetes; serious or acute psychiatric illness that would limit compliance with study
             requirements.

        Note: Other protocol-defined Inclusion/Exclusion criteria may apply
A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Glargine; Insulin Lispro Protamine Suspension (ILPS); Insulin Lispro
Intervention description: patient glucose-level dependent, injection, once daily in the evening, 24 weeks; patient glucose-level dependent, injection, once daily in the evening, 24 weeks; subcutaneous injections prior to meals, 24 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Protamines
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 374.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to look at if a basal bolus regimen of insulin lispro protamine
      suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin
      glargine (when one basal bolus regimen is injected once daily together with insulin lispro
      injected 2-3 times daily).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diabetes Mellitus, Type 2

          -  Have been receiving metformin and at least one other oral antihyperglycemic medication
             (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit
             1 (Screening)

          -  Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%

          -  Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2

          -  Capable and willing to follow the protocol

          -  Give written consent

        Exclusion Criteria:

          -  Are taking any glucose-lowering agents (other than those listed in the inclusion
             criteria above)

          -  Have a history of severe hypoglycemia in the past 6 months

          -  Are pregnant or may become pregnant

          -  Women who are breastfeeding

          -  Have significant cardiac disease

          -  Have significant renal or liver disease

          -  Undergoing therapy for a malignancy

          -  Contraindications to the study medications

          -  Have an irregular sleep/wake cycle

          -  Have a serious disease or any condition considered by the investigator to be
             exclusionary
Pressure Ulcer Prevention in Ventilated Patients Using Two Repositioning Regimens
Condition: Pressure Ulcers
MeSH terms: Pressure Ulcer; Ulcer
Intervention: repositioning
Intervention description: Turning every 4 or 2 hours
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pressure ulcers; Repositioning; Prevention; Mechanical Ventilation; Critical care

Summary:

      The purpose of this study is to compare a 2-hour versus every 4-hour turning regimen on the
      incidence of grade > II pressure ulcers (PU) in patients in ICU on mechanical ventilation ≥
      24h that use alternating-pressure air mattresses (APAMs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients admitted to the medical-surgical ICU, requiring more than 24 hours of
             mechanical ventilation.

          -  Patients on alternating-pressure air mattresses.

          -  Patients or their legal representative able to provide written informed consent to
             participate in the study

          -  Patients whose weight are within the limits accepted by the mattresses (45-140 Kg)

          -  Over 18 years

        Exclusion Criteria:

          -  Patients with pressure ulcer at ICU admission.

          -  Pregnant patients

          -  Patients in which informed consent is not obtained in the first 48 hours of mechanical
             ventilation
A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: USL261
Intervention description: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
Intervention MeSH terms: Midazolam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsy; seizure cluster; acute repetitive seizures; open-label; intranasal Midazolam; USL261; Upsher-Smith

Summary:

      The purpose of this study is to examine the long-term safety and tolerability of USL261 in
      the treatment of seizure clusters.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has a competent, adult caregiver(s) who is able to recognize and observe the subject's
             seizure cluster episodes

          2. Has an established diagnosis of partial or generalized epilepsy that includes all the
             following:

               -  A documented history of seizure clusters lasting a minimum of 10 minutes, seizure
                  cluster pattern is observable, stereotyped, and recognizably different from the
                  subject's other non-cluster seizure activity (if any)

               -  A second seizure in the seizure cluster typically occurs within 6 hours from the
                  time of recognition

               -  A seizure cluster pattern composed of multiple (≥ 2) partial or generalized
                  seizures

               -  A seizure cluster pattern established >3 months before Visit 1

               -  A frequency of ≥ 3 stereotyped seizure clusters during the year before Visit 1

               -  At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1

          3. Currently on a stable regimen of AED(s) that includes a benzodiazepine

          4. Weight is 40 kg to 125 kg, inclusive

        Exclusion Criteria:

          1. Has a neurological disorder that is likely to progress in the next year

          2. Has a severe chronic cardio-respiratory disease

          3. Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1

          4. Has a history of their stereotypical seizure cluster progressing to status epilepticus
             within 2 years before Visit 1

          5. Has a history of acute narrow-angle glaucoma

          6. Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before
             Visit 1 or a suicide attempt in the past 5 years
Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
Intervention: Cervarix™
Intervention description: GSK Biologicals' vaccine against human papillomaviruses 16 and 18.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 798.0
Sex: Female
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.
      Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can
      lead over time to cervical cancer in women . This study will compare the immune response
      induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the
      manufacturing process.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A female subject between, and including, 18 and 25 years of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the subject prior to enrolment.

          -  Subject must have a negative urine pregnancy test.

          -  Healthy subject before entering the study entry as established by medical history and
             physical examination.

          -  Subject must be of non-childbearing potential.

        Exclusion Criteria:

          -  pregnant or breastfeeding subject.

          -  previous vaccination against human papillomavirus (HPV).

          -  Known acute or chronic, clinically significant neurologic, hepatic or renal functional
             abnormality.

          -  History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or
             kidney disease(s), diabetes or autoimmune disease.
Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Octreotide capsules
Intervention description: Octreotide was provided in hard gelatin capsules.
Intervention MeSH terms: Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: acromegaly; IGF-1; growth hormone; Octreolin; octreotide; somatostatin analog

Summary:

      MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical
      product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety
      of MYCAPSSA™ treatment in patients with acromegaly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects, aged 18 to 75 years old, inclusive.

          -  Subjects with acromegaly defined as documented evidence of growth hormone-secreting
             pituitary tumor that is abnormally responsive to glucose, or documented elevated
             insulin-like growth factor-1 (IGF-1), who are currently receiving a stable dose of a
             somatostatin analog for at least the previous 3 months.

          -  A serum IGF-1 level < 1.3 x the upper limit of normal (ULN) and a serum growth hormone
             (GH) level < 2.5 ng/mL.

          -  Subjects able and willing to comply with the requirements of the protocol.

          -  Subjects able to swallow capsules.

          -  Subjects able to understand and sign written informed consent to participate in the
             study.

        Exclusion Criteria:

          -  Receiving regular injections of a somatostatin analog less frequently than once a
             month, ie, longer than every 4 weeks.

          -  Symptomatic cholelithiasis.

          -  Received pituitary radiotherapy within ten years prior to screening.

          -  Undergone pituitary surgery within the prior 6 months.

          -  Any condition that may jeopardize study participation.

          -  Clinically significant gastrointestinal (GI), renal, or hepatic disease as determined
             by the Investigator.

          -  Conditions (eg, bariatric surgery) significantly affecting gastric acidity or
             emptying.

          -  Current use (within 1 month) of proton pump inhibitors (PPIs) and current chronic use
             of H2-antagonists.

          -  Female patients who are pregnant or lactating.

          -  Current or recent (< 3 months) therapy with pegvisomant.

          -  Current or recent (< 2 months) therapy with cabergoline.