bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: teduglutide
Intervention description: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
Intervention MeSH terms: Teduglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: short bowel syndrome; parenteral nutrition; PN; HPN; TPN; SBS

Summary:

      This study is a 2-year open label extension study to collect long term efficacy and safety
      data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.
    

Eligibility criteria:

        Inclusion Criteria:

          -  must have completed 24 weeks of dosing of the CL0600-020 study

        Exclusion Criteria:

          -  none
Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects
Condition: Rabies; Japanese Encephalitis
MeSH terms: Rabies; Encephalitis, Japanese; Encephalitis
Intervention: Rabies; Japanese Encephalitis; Placebo
Intervention description: Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).; Subjects received two doses of Japanese Encephalitis vaccine.; Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 661.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rabies; JE; accelerated schedule

Summary:

      Establish non-inferiority of the immune response and evaluate the safety and tolerability of
      Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to
      either of 2 schedules for preexposure prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females between 18 and 65 years of age (inclusive).

          2. Subjects who have given written consent.

          3. Individuals in good health as per investigator judgement.

        Exclusion Criteria:

          1. If female, pregnancy or unwillingness to practice acceptable contraception.

          2. If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test.

          3. Contraindication or precaution against Rabies and Japanese Encephalitis vaccination.

          4. Unable to comprehend and to follow all required study procedures for the whole period
             of the study.

          5. Participating in any other clinical trial 30 days prior to first study visit.

          6. History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis
             immunization.

          7. Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days
             prior to Day 1 vaccination through Day 43.

          8. Received any other vaccines within 2 weeks prior to enrollment in this study or plan
             to receive any vaccine within 4 weeks from the study vaccines.

          9. Ever received blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation in the past 12 weeks.

         10. Individuals who are part of study personnel or close family members conducting this
             study.

         11. Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study
             vaccination.

         12. Plans to travel within the next year to areas where Rabies and/or Japanese
             Encephalitis vaccine may be considered or offered. This includes but is not limited to
             India, Asia, Pacific-Rim, African countries.
A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease
Condition: Joint Diseases; Arthritis; Osteoarthritis
MeSH terms: Arthritis; Joint Diseases; Constipation
Intervention: oxycodone CR; oxycodone IR; Tapentadol ER (CG5503); Tapentadol IR (CG5503); Tapentadol IR (CG5503); placebo; placebo
Intervention description: flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day); 10mg for 14 days; flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day); 50mg for 14 days; 75mg for 14 days; 1 capsule for 14 days; Tablets and capsules 2 x a day for 28 days
Intervention MeSH terms: Oxycodone; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 597.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pain medication; Arthritis; Joint pain; Analgesia; Analgesics; tapentadol; CG5503; Nucynta

Summary:

      The purpose of this study is to compare bowel function/constipation that occurs during
      tapentadol treatment with that occuring during oxycodone treatment, as measured by the
      frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel
      movements will be determined from a Bowel Function Patient Diary completed by the enrolled
      sujbects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of osteoarthritis of the hip or knee

          -  End-stage degenerative joint disease

          -  Eligibility for primary unilateral total or partial joint replacement surgery

          -  Pain level moderate to severe and at such a level as to require daily doses of an
             opioid analgesic medication

        Exclusion Criteria:

          -  Has a life-long history of seizure disorder or epilepsy

          -  Had any of the following within the preceding 1 year: mild or moderate traumatic brain
             injury, stroke, transient ischemic attack, or brain neoplasm

          -  Had a severe traumatic brain injury within 15 years of screening (consisting of one or
             more of the following: brain contusion, intracranial hematoma, either unconsciousness
             or post traumatic amnesia lasting for more than 24 hours)

          -  Joint pain not associated with gout, fibromyalgia, rheumatoid arthritis, other
             autoimmune disease

          -  History of alcohol or drug abuse

          -  chronic hepatitis B and C or HIV, active hepatitis B and C within 3 months

          -  Severely impaired renal function or moderately to severely impaired hepatic function

          -  History of cancer within past 2 years
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: rhC1INH; Placebo (Saline)
Intervention description: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.; One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Hereditary Angioedema; HAE; Angioedema; Recombinant C1 Inhibitor; rhC1INH

Summary:

      This study is being conducted to confirm the efficacy, safety, and immunogenicity of
      recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of
      acute angioedema attacks in Hereditary Angioedema (HAE) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged at least 13 years

          -  Signed written informed consent

          -  Clear clinical and laboratory diagnosis of HAE with baseline plasma level of
             functional C1INH of less than 50% of normal

          -  Willingness and ability to comply with all protocol procedures

          -  Clinical symptoms of an eligible HAE attack with onset less than 5 hours before the
             time of initial evaluation

        Exclusion Criteria:

          -  Medical history of allergy to rabbits or rabbit-derived products (including rhC1INH),
             or positive anti-rabbit dander IgE test (cut off >0.35 kU/L; ImmunoCap® assay; Phadia
             or equivalent).

          -  A diagnosis of acquired C1INH deficiency (AAE)

          -  Pregnancy, or breastfeeding, or current intention to become pregnant

          -  Treatment with any investigational drug in the past 30 days

          -  Known or suspected addiction to drug and/or alcohol abuse

          -  Suspicion for an alternate explanation of the symptoms other than acute HAE attack
Endoscopic Biliary Co-axial Stent Placement Plus/Minus Use of Radiofrequency Ablation (RFA) for Clearance of Occluded Self Expandable Metal Stents (SEMS) in Patients With Distal Biliary Obstruction From Unresectable Biliary-pancreatic Malignancies
Condition: Pancreatic Cancer; Unresectable Biliary-pancreatic Malignancies
MeSH terms: Neoplasms
Intervention: ERCP with SEMS plus radiofrequency ablation; ERCP with SEMS alone (standard of care)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stent Placement; Biliary Obstruction; 14-260

Summary:

      The purpose of this study is to compare the effects good and/or bad of combining
      radiofrequency ablation with placement of a second stent, versus a second stent alone. The
      investigators will also look at the safety of the combination treatment, and see which
      treatment is better. In either case, the second stent will be placed inside the existing
      stent as is done in standard practice when treating a blocked stent for the first time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with any tumor obstructing the distal bile duct and causing an indwelling
             biliary SEMS

          -  Patients with jaundice or clinical cholangitis, with new elevation of alkaline
             phosphatase, total bilirubin, and imaging findings supportive of stent occlusion (loss
             of stent patency, debris within stent, loss of or excessive pneumobilia)

          -  Age ≥ 18 years

        Exclusion Criteria:

          -  Have altered gastro-duodenal or hepatobiliary anatomy such that ERCP is felt to be
             unacceptably technically difficult or unsafe

          -  Have additional sites of biliary strictures (intrahepatic/hilar) such that ERCP
             stenting is felt to be unlikely to provide adequate clinical benefit

          -  Have cardiac pacemakers

          -  Have Child B/C cirrhosis

          -  Are pregnant

          -  Are unsuitable for endoscopy (either because of hemodynamic instability, respiratory
             distress or unsafe hematological parameters such as refractory anemia <7g/dL,
             thrombocytopenia <50K/mcL, or coagulopathy with INR >2.0)

          -  Have biliary strictures not technically amenable to endoscopic therapy
Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Ezogabine: USAN Retigabine (International Nonproprietary Name)
Intervention description: Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.
Intervention MeSH terms: Ezogabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Epilepsy; Partial Seizures; Potassium Channels; Anticonvulsant; Complex Partial Seizures; Epilepsies, Partial; RTG115098

Summary:

      The purpose of this study is to evaluate the safety and tolerability of long-term therapy
      with retigabine administered as adjunctive therapy in adult epilepsy patients with
      partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of
      long-term treatment with retigabine and patient quality of life will also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has successfully completed the Maintenance and Transition phases of Study
             VRX-RET-E22-301 for the treatment of partial-onset seizures

          -  Patient is expected to benefit from participation in the study in the opinion of the
             Investigator.

        Exclusion Criteria:

          -  Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or
             is experiencing an ongoing serious adverse event.

          -  Patient is receiving any investigational drug or using any experimental device in
             addition to Retigabine for treatment of epilepsy or any other medical condition.

          -  Patient has any other condition that would prevent compliance with the study
             procedures or proper reporting of adverse events.
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone
Intervention description: 2% gel
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypogonadism

Summary:

      Low testosterone is a condition that occurs when the body is unable to produce sufficient
      quantities of testosterone. The medical name for low testosterone is hypogonadism.
      Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of
      energy and mood swings. The goal of testosterone replacement therapy is to return
      testosterone levels to the normal range and relieve symptoms.

      The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to
      maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18
      to 75 years. This will be determined by blood sampling at specified times during the study.
      The study is also intended to evaluate the tolerability of Fortigel, which will be applied to
      the skin each day throughout the study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:

               -  Single serum total testosterone concentration < 250 ng/dL, or

               -  Two consecutive serum total testosterone concentrations < 300 ng/dL (determined
                  at least one week apart during the screening period).

          -  Has a BMI ≥ 22 kg/m2 and < 35 kg/m2.
A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Intervention: 0.135mg MAP0010; 0.25mg MAP0010; Placebo
Intervention description: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks; 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks; Placebo delivered by nebulization twice daily for 12 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 360.0
Sex: All
Minimum age: 12 Months
Maximum age: 8 Years
Healthy volunteers: No
Keywords: asthmatic children

Summary:

      The purpose of this study is to examine the safety and efficacy of two doses of MAP0010
      versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week
      treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female asthmatic children with mild to moderate persistent asthma.

          -  12 months to 8 years of age.

          -  For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior
             to Visit 1, per NIH (EPR-3) criteria.

          -  For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months
             which lasted > 1 day and affected sleep.

          -  AND with at least one major or two minor risk factors.

        Exclusion Criteria:

          -  Any other significant childhood illness/abnormality or chronic lung disease

          -  Any history of upper or lower respiratory tract infection, within 2 weeks of
             screening.

          -  Any history of acute or severe asthma attack requiring ICU admission or ventilatory
             support.

          -  Use of any corticosteroid, including inhaled, parental, intranasal, or topical
             corticosteroid within 2 weeks of screening.

          -  Any use of oral corticosteroids within 30 days of screening or prolonged use (>10
             consecutive days) of oral corticosteroids, within 12 weeks of screening.
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: botulinum toxin Type A (200U); botulinum toxin Type A (300U); Normal saline (Placebo); botulinum toxin Type A (200U); Normal saline (Placebo); botulinum toxin Type A (300U)
Intervention description: botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection > Week 12; injections into detrusor; botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor; Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks; injections into detrusor; Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection > Week 12; injections into detrusor
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A
      in treating overactive bladder in spinal cord injury or multiple sclerosis patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord
             injury or multiple sclerosis

          -  Inadequate response to anticholinergic medication used to treat overactive bladder

        Exclusion Criteria:

          -  History or evidence of pelvic or urologic abnormality

          -  Previous or current diagnosis of bladder or prostate cancer

          -  Urinary tract infection at time of enrollment
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Condition: Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Imatinib; Nilotinib (AMN107)
Intervention description: Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days.; Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: leukemia; bone marrow; leukemia symptoms; cml; complete blood count; lymphocyte; blood cancer; leukocytes; chronic leukemia; bone marrow biopsy; leukemia research; leukemia cells; bone marrow disease; chronic myeloid leukemia; blood cancer symptoms; white blood cell diseases; chronic myelogenous leukemia; leukemia treatment; leukemia facts; leucemia; facts about leukemia; myelogenous leukemia; newly diagnosed CML; suboptimal response; Philadelphia chromosome positive (Ph+); chronic myelogenous leukemia in chronic phase (CML-CP)

Summary:

      In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with
      imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their
      Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase
      (CML-CP).
    

Eligibility criteria:

        Inclusion criteria:

        Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic
        phase.

        Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line
        therapy) defined as:

          -  6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or

          -  12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics,
             no FISH [fluorescence in situ hybridization] analysis was allowed).

        Exclusion criteria:

          -  Patient who have received more than 18 months of imatinib therapy

          -  Patients who have achieved partial or complete cytogenetic response and lost that
             response prior to entering the study.

          -  Prior treatment with greater than 400 mg/day imatinib.

          -  Uncontrolled or significant cardiovascular disease.

          -  Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or
             uncontrolled infection).

          -  Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)

          -  Currently taking certain medications that could affect the rhythm of your heart.

        Other protocol-defined inclusion/exclusion criteria may apply