bioihbjkbjnl/mcl2 huggingface dataset:
Dose Finding Study to Treat High Phosphate Levels in the Blood.
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: AZD1722; Placebo
Intervention description: AZD1722, oral tablet; Placebo bid, double dummy technique
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: S-phosphate, hyperphosphatemia, hemodialysis, ESRD

Summary:

      Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks
      treatment period
    

Eligibility criteria:

        Inclusion Criteria:

          1. Females and males aged ≥18 years

          2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months

          3. Prescribed and taking at least 3 doses of phosphate binder per day

          4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58
             mmol/L (inclusive) at screening

          5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening

          6. For randomization in the study, after up to 3 weeks wash out of phosphate binders,
             patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but
             below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48
             mmol/L) vs pre wash out

        Exclusion Criteria:

          1. Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points
             during clinical routine monitoring for the 3 preceding months before screening visit.

          2. Serum parathyroid hormone >1200 pg/mL

          3. Significant metabolic acidosis

          4. Clinical signs of hypovolemia at randomization

             -
Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Rapamycin; Mycophenolate Mofetil; Tacrolimus; Steroids
Intervention description: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.; MMF 1 gm BID beginning 1st day postoperative day; Part of standard maintenance.; Part of standard maintenance
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Rapamycin; Mycophenolate Mofetil (MMF); Kidney-Pancreas Transplant

Summary:

      This study was designed to determine which maintenance immunosuppressive agent, rapamycin or
      mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal
      failure, who presented for a kidney-pancreas transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with Type 1 diabetes and end stage renal disease.

          -  Women of childbearing potential must have had a negative pregnancy test (serum or
             urine).

          -  Patient agrees to participate in the study and sign an informed consent.

          -  Patient has no known contraindication to the administration of rapamycin or
             mycophenolate mofetil.

          -  Patient has no history of hypersensitivity to rapamycin or mycophenolate mofetil.

        Exclusion Criteria:

          -  Patient has history of a malignancy within two years, with the exception of adequately
             treated localized squamous or basal cell carcinoma of the skin without evidence of
             recurrence.

          -  Patient is currently abusing drugs or alcohol.

          -  Patient is known or suspected to have an active infection or be seropositive for
             hepatitis B surface antigen (HBsAg), hepatitis C (HCV) or human immunodeficiency virus
             (HIV).
Use of Pancreatic Enzymes in Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: Pancreatic Enzyme
Intervention description: All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 4 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: pancreatic enzymes

Summary:

      Patients with short bowel syndrome have a high mortality rate that is mainly attributed to
      complications from central lines and long-term intravenous (IV) nutrition. There are few
      medical therapies to date that improve gut absorption in patients with short bowel syndrome.
      The primary objective of this study is to evaluate if absorption from the GI tract improves
      in subjects with short bowel syndrome following therapy with pancreatic enzymes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of a small bowel resection with subsequent dependence on parenteral nutrition
             for at least three months

          -  age 4 years to 65 years

          -  usual state of health for the past two weeks with no medication changes

          -  able to participate in a study for about four weeks with four study visits

          -  able to take pancreatic enzyme medication orally

        Exclusion Criteria:

          -  significant disease other than short bowel syndrome affecting the gastrointestinal
             tract that impacts absorption or digestions

          -  motility disorder

          -  medications that directly alter fat absorption

          -  cholestatic liver disease defined as a serum conjugated bilirubin greater than 1.0
             mg/dL, chronic renal failure, gout, or hyperuricemia

          -  history of a pork allergy

          -  women who are pregnant or lactating

          -  history of fibrosing colonopathy

        Those subjects who are eligible for the malabsorption blood test (MBT) test will be
        excluded if they have a history of a soy or safflower oil allergy.
A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Calcinosis; Constriction, Pathologic
Intervention: Ataciguat (HMR1766); Placebo Comparator: Matching Placebo
Intervention MeSH terms: 5-chloro-2-(5-chlorothiophene-2-sulfonylamino)-N-(4-(morpholine-4-sulfonyl)phenyl)benzamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Stenosis; Aortic Valve; Aorta; Calcified; Calcific; Calcification

Summary:

      The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows
      progression of valve calcification in patients with moderate calcific aortic valve stenosis.
      Secondary and tertiary objectives are to determine whether Ataciguat slows progression of
      aortic valve function, reduces systemic inflammation, and prevents left ventricular
      dysfunction in patients with moderate calcific aortic valve stenosis.
    

Eligibility criteria:

        Inclusion Criteria

          1. Age > 50 years

          2. Male or female sex

          3. Aortic valve area greater than 1.0 cm2 but less than 2.0 cm2

          4. Aortic valve calcium levels greater than 300 AU from chest CT

          5. Ejection fraction >50%

        Exclusion Criteria

          1. Orthostatic intolerance or symptomatic hypotension prior to study or during study
             visits

          2. Positive pregnancy test during screening visit

          3. Nitrate use or α-antagonist medication use within 24 hours

          4. Systolic blood pressure <110 mm Hg

          5. Mean systemic arterial pressure <75 mm Hg

          6. Severe mitral or aortic regurgitation

          7. Retinal or optic nerve problems

          8. Recent (≤30 days) acute coronary syndrome

          9. Oxygen saturation <90% on room air

         10. Congenital valve disease

         11. Hepatic dysfunction/elevated liver enzymes

         12. Prescription of drugs known to alter NO-sGC-cGMP signaling (sildenafil, nitrates,
             etc.)

         13. Prescription of Warfarin (Coumadin) for chronic anticoagulation

         14. Concomitant participation in other trials at Mayo Clinic or elsewhere

         15. Use of phenytoin or related compounds for any indication

         16. Chronic midazolam treatment for any indication

         17. Use of monoamine oxidase inhibitors for any indication

         18. Use of anti-diabetic drugs in the sulfonylurea family
Proton Therapy in Reducing Toxicity in Anal Cancer
Condition: Anus Neoplasms
MeSH terms: Anus Neoplasms
Intervention: Proton therapy; Chemotherapy
Intervention description: Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions; 5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anal Cancer

Summary:

      The purpose of this research study is to determine whether the amount of radiation given to
      the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing
      the side effects that are seen with standard therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Karnofsky Performance Status >70%

          -  Histologically documented squamous or basaloid carcinoma of the anal canal

          -  Stage T2-4 disease with any N category

        Exclusion Criteria:

        • Patients with a life expectancy of < 3 months.
Long Term Study of Canakinumab (ACZ885) in Patients With Gout
Condition: Gouty Arthritis
MeSH terms: Arthritis; Arthritis, Gouty
Intervention: Canakinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Gouty; Gouty arthritis; Gout flares; Anti-interleukin-1β monoclonal antibody

Summary:

      This 24-week open-label extension study is designed to provide additional long-term safety
      data up to a total of 1-year for patients rolling over from the core study, and to collect
      further efficacy and tolerability data for all the patients, irrespective whether they have
      an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885)
      in this extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed the core study CACZ885H2251. A patient is defined as completing
             the core study if he/she completed the study up to and including the last visit (Visit
             9).

          -  Patients who have signed a written informed consent before any trial procedure is
             performed.

        Exclusion Criteria:

          -  Patients for whom continuation in the extension 1 is not considered appropriate by the
             treating physician.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive pregnancy test (serum or urine).

          -  Female patients who were physiologically capable of becoming pregnant, unless they
             were:

               -  Female patients whose career, lifestyle, or sexual orientation precluded
                  intercourse with a male partner.

               -  Female patients whose partners had been sterilized by vasectomy or other means.

               -  Using an acceptable method of contraception with a failure rate (Pearl Index
                  (PI)) < 1.

               -  Reliable contraception had to be maintained throughout the study and for 2 months
                  after study drug discontinuation.

        Other protocol defined inclusion/exclusion criteria may apply
Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial)
Condition: Arterial Stiffness; Vitamin K2 Deficiency
Intervention: Vitamin K2 (MK7)
Intervention MeSH terms: Vitamin K; Vitamin K 2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a single arm, single center clinical trial that aims to evaluate the effect of
      8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in
      stable renal transplant patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Functional renal graft

          -  Stable renal function for at least 3 months prior to enrollment

        Exclusion Criteria:

          -  History of thrombotic events

          -  Diagnosed coagulopathy

          -  Cardiovascular event in the past month prior to enrollment

          -  Current or planned pregnancy

          -  Lactation

          -  Soy allergy

          -  Concomitant or recent (past 6 months) use of supplements that contain vitamin K

          -  Warfarin treatment

          -  Known intestinal malabsorption or hypomotility syndromes
Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension
Condition: Tourette Syndrome in Children; Tourette Syndrome in Adolescence
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Ecopipam
Intervention description: Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings.
Intervention MeSH terms: Ecopipam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Tourette Syndrome

Summary:

      This study was an international, multicenter, open-label, long term extension study
      evaluating the safety of ecopipam tablets for the treatment of children and adolescent
      subjects with Tourette Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up
             Visit within the last 30 days (or longer with permission of the medical monitor)
             without a major reportable protocol deviation and must be someone the Investigator
             feels would benefit from continued participation.

        Exclusion Criteria:

          -  Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder,
             schizophrenia, major depressive disorder).

          -  Unstable medical illness or clinically significant lab abnormalities.

          -  Risk of suicide.

          -  Pregnant or lactating women.

          -  Moderate to severe renal insufficiency.

          -  Positive urine drug screen.

          -  Certain medications that would lead to drug interactions.
Daratumumab in Treating Patients With Multiple Myeloma
Condition: Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Daratumumab
Intervention description: Given IV
Intervention MeSH terms: Daratumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well daratumumab works in treating
      patients with multiple myeloma when the infusion is accelerated. Monoclonal antibodies, such
      as daratumumab, may interfere with the ability of tumor cells to grow and spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have received >= 2 daratumumab infusions and be scheduled to receive
             another dose

          -  All races and ethnic groups are eligible for this study

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Any other medical condition, including mental illness or substance abuse, deemed by
             the principal investigator to likely interfere with a patient's ability to sign
             informed consent, cooperate and participate in the study, or interfere with the
             interpretation of the results

          -  Concurrent use of complementary or alternative medicines that in the opinion of the
             principal investigator would confound the interpretation of toxicities and/or
             antitumor activity of the study drug

          -  Prisoner
Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
Condition: Lupus Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Intervention: Filgotinib; Lanraplenib; Filgotinib placebo; Lanraplenib placebo
Intervention description: 200 mg tablet administered orally once daily; 30 mg tablet administered orally once daily; Tablet administered orally once daily; Tablet administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib
      (previously GS-9876) in adults with lupus membranous nephropathy (LMN).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Kidney biopsy within the 36 months prior to screening with a histologic diagnosis of
             LMN (International Society of Nephrology [ISN] and the Renal Pathology Society [RPS]
             2003 classification of lupus nephritis), either Class V alone, or Class V in
             combination with Class II.

          -  Urine protein excretion ≥ 1.5 grams per day

          -  Estimated glomerular filtration rate (eGFR) ≥ 40 mg/min/1.73m^2 based on the
             modification of diet in renal disease (MDRD) formulation at screening

          -  No evidence of active or latent tuberculosis (TB) as assessed during screening

        Key Exclusion Criteria:

          -  Prior treatments as follows:

               -  Previous treatment with a janus kinase (JAK) inhibitor within 3 months of Day 1

               -  Use of rituximab or other selective B lymphocyte depleting agents (including
                  experimental agents) within 6 months of Day 1. Enrollment is permitted if the
                  last dose was given > 6 months and CD19-positive B cells are detectable at
                  Screening.

          -  Use of any concomitant prohibited medications as described in the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: ALXN1840
Intervention description: Individualized oral doses of ALXN1840.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of the study was to evaluate the efficacy of ALXN1840 (formerly WTX101) for
      24 weeks on non-ceruloplasmin-bound copper (NCC) concentrations adjusted for molybdenum
      plasma concentration in participants newly diagnosed with Wilson Disease (WD) who were aged
      18 and older and who had NCC concentrations within or above the reference range at the time
      of enrollment in the study. The study consisted of a 24-week Treatment Period, followed by a
      planned 36-month Extension Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to understand and willing to comply with study procedures, restrictions, and
             requirements, as judged by the Investigator.

          -  Newly established diagnosis of WD by Leipzig-Score ≥ 4 documented by testing as
             outlined in 2012 European Association for the Study of the Liver Wilson Disease
             Clinical Practice Guidelines.

          -  NCC levels within or above the normal reference range (0.8 to 2.3 micromole).

          -  Willing to undergo 48 hour washout from current WD treatment

        Exclusion Criteria:

          -  Treatment for greater than 24 months for WD with chelation therapy (for example,
             penicillamine, trientine hydrochloride) or zinc therapy.

          -  Decompensated hepatic cirrhosis.

          -  Model for End-Stage Liver Disease score > 11.

          -  Modified Nazer score > 6.

          -  Gastrointestinal bleed within past 6 months.

          -  Alanine aminotransferase > 5 x upper limit of normal.

          -  Marked neurological disease requiring either nasogastric feeding or intensive
             in-patient medical care.

          -  Severe anemia with a hemoglobin < 9 grams/deciliter.