bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin C & Thiamine to Treat Sepsis and Septic Shock
Condition: Sepsis; Septic Shock
MeSH terms: Sepsis; Toxemia; Shock, Septic; Shock
Intervention: Vitamin C; Vitamin B1
Intervention description: Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum).; Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).
Intervention MeSH terms: Vitamins; Ascorbic Acid; Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All parties involved, except for pharmacy personnel will be blinded.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Sepsis; Septic Shock; Vitamin C; Thiamine

Summary:

      Investigators propose to investigate the use of IV vitamins B1 and C in a randomized,
      double-blinded, prospective trial to determine if these medications decrease mortality rates
      in patients with severe sepsis or septic shock.
    

Eligibility criteria:

        Patients must meet all inclusion criteria:

          1. Between the ages of 18 and 90 years old

          2. Have severe sepsis or septic shock. Severe sepsis and septic shock will be defined by
             the Surviving Sepsis 2012 guidelines.

          3. Weight more than 30 kg

          4. Full code

        Exclusion Criteria:

          1. Not diagnosed with severe sepsis or septic shock

          2. Younger than 18 or older than 90 years old

          3. With a history of nephrolithiasis

          4. Who are pregnant

          5. Weigh less than 30 kg

          6. Not located in the ICU

          7. Do not resuscitate (DNR) or do not intubate (DNI), no escalation of care, or comfort
             measures only (CMO)

          8. Currently on dialysis
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
Condition: Excessive Daytime Sleepiness; Parkinson Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Intervention: BEN-2001; Placebo
Intervention description: Bavisant dihydrochloride monohydrate for oral use; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 244.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This phase 2b study is designed as multicentre, multinational, randomized, double blind,
      parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in
      subjects with excessive daytime sleepiness with Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either sex aged 50 to 80 years *Subjects with previous diagnosis of
             Parkinson's disease (following the UK Parkinson's disease society brain bank clinical
             diagnostic criteria)*

          -  Subjects capable of understanding and complying with protocol requirements

          -  Subjects with medical history of excessive daytime sleepiness

        Exclusion Criteria:

          -  Subjects with excessive daytime sleepiness due to conditions other than Parkinson's
             disease (including narcolepsy)

          -  Subjects with clinical evidence of depression with significant psychiatric
             comorbidities (Hamilton Rating Scale for Depression - HAM-D score greater than or
             equal to 17; with or without treatment)

          -  Subjects with evidence of significant fatigue (Fatigue Severity Scale - FSS greater
             than or equal to 36

          -  Subjects with known history of abuse of alcohol or other addictive substances in the 6
             months prior to inclusion.

          -  Subjects with known allergies or hypersensitivity to Bavisant or any of its
             excipients.

          -  Subjects who are pregnant or lactating.
Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Condition: Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Bendamustine hydrochloride; Bortezomib; Dexamethasone
Intervention description: Given IV; Given SC; Given PO
Intervention MeSH terms: Dexamethasone; Bortezomib; Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies side effects and how well bendamustine hydrochloride, bortezomib,
      and dexamethasone work in treating patients with newly diagnosed multiple myeloma. Drugs used
      in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways
      to stop the growth of cancer cells, either by killing the cells, by stopping them from
      dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells
      by blocking some of the enzymes needed for cell growth. Giving bendamustine hydrochloride
      with bortezomib and dexamethasone may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          1. New diagnosis of multiple myeloma with no prior history of systemic treatment
             (Exceptions include corticosteroids, bisphosphonates, single agent cyclophosphamide,
             <= 21 days of the first cycle of a planned regimen

          2. >= 18 years of age

          3. ECOG <= 3

          4. Signed informed consent

          5. Measurable serum paraprotein on SPEP or serum free light chains and ratio, or
             quantifiable Bence-Jones proteinuria on 24 hour urine specimen. If the monoclonal
             protein has merged with the beta region we will follow the serum immunoglobulin of the
             involved heavy chain and comment on either partial remission (PR, as judged by two
             protocol investigators) or complete remission (CR, as defined by the achievement of PR
             as above and the resolution of the monoclonal protein by immunofixation in the serum
             and urine.)

        Exclusion Criteria:

          1. Failure to sign informed consent

          2. Smoldering myeloma, monoclonal gammopathy of undetermined significance (MGUS), or
             plasma cell leukemia

          3. History of previously treated smoldering myeloma

          4. Grade 3 or above peripheral neuropathy

          5. Uncontrolled human immunodeficiency virus (HIV)

          6. Active hepatitis A, B or C

          7. Pregnant or lactating females

          8. Total bilirubin >3 times the upper limit of normal

          9. ASLT/ALT > 2.5 times the upper limit of normal
Exparel Interscalene vs Indwelling Catheter
Condition: Pain
Intervention: Exparel; Indwelling Interscalene Catheter
Intervention description: A shot of long acting local anesthetic for post operative pain management; ropivacaine, given through a catheter inserted between the shoulders
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 40 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: shoulder surgery, post operative pain

Summary:

      The investigators are comparing an indwelling catheter with intermediate duration local
      anesthetic to a single shot peripheral nerve block with long acting a local anesthetic
      (Exparel).
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesia (ASA) 1, 2, and 3

          -  Ages 40-74

          -  Patients scheduled for total shoulder replacement

        Exclusion Criteria:

          -  ASA 4 and 5

          -  Pre-existing pain disorder

          -  Regular consumption of chronic pain medication

          -  pregnant women

          -  any medical condition such as a clotting disorder

          -  anatomic abnormality that precludes use of an indwelling scalene catheter

          -  Body Mass Index (BMI) >40

          -  Patient refusal

          -  Pre-existing diabetic neuropathy or Hemoglobin A1c >9

          -  Failed block
Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia
Condition: Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
MeSH terms: Anemia; Thalassemia; Anemia, Sickle Cell
Intervention: Montelukast added to Hydroxyurea; Placebo added to Hydroxyurea
Intervention MeSH terms: Hydroxyurea; Montelukast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      In this feasibility trial, the investigators will compare participants treated with
      montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1)Diagnosis of HbSS, or HbSβ-thalassemia0, confirmed by hemoglobin analysis

          -  2)Males and females age 16 years to 70 years old

          -  3)Greater than 2 episodes of pain in the last 12 months

          -  4)On a stable dose of hydroxyurea for at least 2 months and a stable hemoglobin

        Exclusion Criteria:

          1. Judged not likely to be study compliant by his/her hematologist

          2. History of adverse reaction to montelukast or any of the components of montelukast

          3. Have used medications known to interact with montelukast such as rifampin,
             phenobarbital, and gemfibrozil within 4 weeks of enrollment

          4. Currently being treated with a leukotriene antagonist (montelukast or zileuton) or
             have used montelukast/zileuton within the last 60 days

          5. Chronic blood transfusion therapy defined as regularly scheduled transfusions.

          6. Hemoglobin A greater than15% on hemoglobin analysis

          7. Individuals with a current physician diagnosis of asthma (within last 12 months) or
             requires continuous supplemental oxygen, or predicted or current use of asthma
             medications (inhaled corticosteroids, but participants taking bronchodilators will be
             allowed to participate).

          8. Current participation in another therapeutic trial for SCD

          9. Known current pregnancy

         10. Known history of HIV

         11. Serum creatinine greater than 3 times the site's upper limit of normal
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum
Condition: Hyperemesis Gravidarum
MeSH terms: Hyperemesis Gravidarum
Intervention: Gabapentin; Metoclopramide
Intervention MeSH terms: Gabapentin; Metoclopramide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pregnancy; nausea; vomiting; hyperemesis; treatment; gabapentin; metoclopramide; safety

Summary:

      The investigators will compare the effectiveness of gabapentin to metoclopramide for 1 week
      among 60 women with hyperemesis gravidarum (HG) in this randomized, double-blinded trial.
      After completion of the 1-week double-blind phase, subjects will be offered open-label
      gabapentin with rescue metoclopramide until their symptoms no longer require treatment.
      Enrollment will occur at the University's at Buffalo, of Rochester and of Wisconsin.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have received at least 2 administrations of intravenous (iv) hydration separated by at
             least 1 week or daily emesis for at least the last 14 days and 1 administration of iv
             hydration.

          2. Have at least one of the following: 2-4+ ketonuria, serum potassium < 3.4mmol, or >5%
             weight loss from weight upon entry to prenatal care.

          3. Have failed therapy with at least one antiemetic.

          4. Have fetal ultrasound within 6 weeks prior to enrollment confirming a
             normal-appearing, intrauterine, singleton pregnancy of gestational age < 16 weeks at
             time of enrollment.

          5. Felt by the patient's obstetrician or emergency room attending physician not to have
             other medical problems such as bowel obstruction, pancreatitis, biliary colic, or
             peptic ulcer disease that could be contributing to the patient's symptoms.

          6. Be >18 years old and not decided to terminate the pregnancy.

          7. Have not received or planning to receive a peripherally inserted central catheter (PIC
             line).

          8. Have a Motherisk-PUQE score of ≥12 for the 24-hour Baseline period.

          9. Felt not to have any other significant medical, psychiatric or substance abuse problem
             that would preclude participation in the study.

         10. Denies drinking any alcohol after learning about current pregnancy.

         11. Agrees to discontinue any current anti-emetic treatments (including antihistamines,
             ginger, > 10mg/day vitamin B6, serotonin or dopamine antagonists, anticholinergics,
             acupuncture, hypnosis, or wrist bands) for the next 4 weeks.

         12. Pregnancy not conceived through in-vitro fertilization.

         13. Able to understand and comply with the study procedures and give informed consent.

        Exclusion Criteria:

        None not mentioned under Inclusion Criteria.
Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: QCC374
Intervention description: 0.015mg and 0.06mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary hypertension (PH),; Increase blood pressure in the pulmonary artery; Increased blood pressure in the pulmonary vein; Increased blood pressure in the lung vasculature; Shortness of breath; Dizziness; Fainting; Leg swelling; Cough; Angina pector

Summary:

      This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in
      adult patients with PAH. This study provides the patients who completed the QCC374X2201 study
      with the option to continue receiving QCC374. The study will monitor the long-term safety,
      tolerability and efficacy of QCC374 in patients with PAH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed.

          -  Subject was enrolled in the QCC374X2201 study and completed per protocol

        Exclusion Criteria:

          -  Subjects who have started receiving prostacyclin (epoprostenol), prostacyclin analogs
             (i.e. trepostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e.
             selexipag) since the last study drug intake in the QCC374X2201 study.

          -  Females who are pregnant, or who plan to become pregnant during the study, or who are
             breastfeeding

          -  Any known factor or disease that may interfere with treatment compliance or study
             conduct (i.e. drug or alcohol dependence)

          -  Subjects who withdrew consent from the study QCC374X2201
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: TERN-101; Placebo
Intervention description: Investigational drug; Matching placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Farnesoid X receptor; NASH; Nonalcoholic Steatohepatitis; NAFLD; Nonalcoholic Fatty Liver Disease; FXR

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate
      the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic
      NASH patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 75 years of age

          -  Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2

          -  Presumed NASH based on clinical characteristics or prior liver biopsy

          -  ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women

          -  MRI PDFF liver fat content ≥ 10 %

          -  Written informed consent

        Exclusion Criteria:

          -  History or clinical evidence of chronic liver diseases other than NAFLD

          -  History or clinical evidence of cirrhosis, hepatic decompensation or other severe
             liver impairment

          -  History of liver transplant, or current placement on a liver transplant list

          -  Total bilirubin > 1.2 mg/dL

          -  Albumin < 3.5 g/dL

          -  INR > 1.1

          -  AST or ALT > 5 x ULN

          -  ALP > 156 IU/L

          -  Platelet count < 150,000 /mm3

          -  eGFR < 60 mL/min/1.73m2

          -  Weight loss > 5% within past 3 months prior to Screening

          -  Uncontrolled diabetes

          -  Uncontrolled hyperlipidemia

          -  Active COVID-19 infection

          -  Other protocol-defined inclusion/exclusion criteria could apply
Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease
Condition: Hyperuricemia; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperuricemia
Intervention: Allopurinol
Intervention description: Allopurinol dosed to target uric acid levels of 3-5 mg/dL.
Intervention MeSH terms: Allopurinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 2 Years
Maximum age: 20 Years
Healthy volunteers: No

Summary:

      Aim 1. To determine the effect of Allopurinol treatment on renal function (glomerular
      filtration rate, GFR) in pediatric chronic kidney disease (CKD) patients with high uric acid
      levels (hyperuricemia).

      Aim 2. Establish whether Allopurinol treatment reduces Nlrp3 inflammasome and renal injury
      biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic Kidney Disease stage 1-5

          -  Hyperuricemic (UA >= 5.5 mg/dL)

        Exclusion Criteria:

          -  Contraindication to Allopurinol

          -  Elevated baseline liver function tests

          -  Receiving acute or chronic dialysis

          -  Primary metabolic disorder

          -  Sickle cell disease

          -  Autosomal Dominant Polycystic Kidney Disease

          -  Cystinosis

          -  Bartter or Gitelman Disease

          -  Pregnant or nursing
Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris
Condition: Pemphigus Vulgaris
MeSH terms: Pemphigus
Intervention: VAY736; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Pemphigus vulgaris; pemphigus; blistering disease

Summary:

      The study evaluated the efficacy, safety and pharmacokinetics of VAY736 in the treatment of
      patients with pemphigus vulagaris (PV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients 20 to 70 years of age

          -  Confirmed diagnosis of pemphigus vulgaris

          -  Presence of mild to moderate pemphigus vulgaris

          -  Patients must weight between 40 kg and 150 kg inclusive

          -  on a stable dose of oral corticosteriod therapy (with or without azathioprine or
             mycophenolate)

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential unless they are using a highly effective method of
             birth control during dosing and for 4 months following study treatment

          -  Recent previous treatment with photo therapy, biological therapy, steroids,
             immunosuppresive agents (unless washout period applied)

          -  Active or recent history of clinically significant infection

          -  use of rituximab within 1 year Other protocol-defined inclusion/exclusion criteria may
             apply.