bioihbjkbjnl/mcl2 huggingface dataset:
BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
Condition: HIV; Salivary Gland Disease; Benign Lymphoepithelial Lesion
MeSH terms: Salivary Gland Diseases
Intervention: Ciprofloxacin; Placebo
Intervention description: Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.; Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Salivary Gland Disease; Benign Lymphoepithelial Lesion; BK Polyomavirus

Summary:

      The purpose of this study is to analyze BK viral infection in salivary gland diseases;
      specifically, to determine a definitive relationship between BK Virus and HIV associated
      salivary gland disease (HIVSGD). Participants are adults HIV+SGD+ who will be randomized 1:1
      to receive BK Virus antiviral (ciprofloxacin) or placebo for 28 days. Salivary
      function/protein secretion will be correlated with BK polyomavirus titers. It is expected
      that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will
      benefit from Ciprofloxacin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV positive with Salivary Gland Disease

          -  Ability to read and understand English

        Exclusion Criteria:

          -  Allergy to the family of fluoroquinolones (including ciprofloxacin)

          -  Currently taking tizanidine

          -  Concurrently taking antiacids containing magnesium hydroxide or aluminum hydroxide

          -  Current use of Theophylline

          -  Previous tendon disorder such as Rheumatoid arthritis

          -  History of seizures

          -  Current use of phenytoin

          -  Current use of glyburide

          -  Current use of methotrexate

          -  Severe renal impairment (known creatinine clearance < 30 or on dialysis)
Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin degludec; insulin glargine; insulin aspart
Intervention description: Injected subcutaneously once daily. Dose was individually adjusted.; Injected subcutaneously once daily. Dose individually adjusted.; Injected subcutaneously as mealtime insulin. Dose was individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 629.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Europe and the United States of America (USA).

      The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue
      (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients
      with type 1 diabetes.

      The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension
      period is registered as NN1250-3644.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes mellitus for at least 12 months

          -  Current treatment with any basal bolus insulin for at least 12 months

          -  HbA1c below or equal to 10.0%

          -  BMI (Body Mass Index) below or equal to 35.0 kg/m^2

          -  For the extension trial only: Completion of the 52 week treatment period in trial
             NN1250-3583 (NCT00982228)

        Exclusion Criteria:

          -  Use of any other antidiabetic drug than insulin within the last 3 months

          -  Cardiovascular disease within the last 6 months

          -  Uncontrolled treated/untreated severe hypertension

          -  Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for
             diabetic ketoacidosis during the previous 6 months

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements

          -  Cancer and medical history of cancer
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Intervention: Sufentanil NanoTab PCA System/15 mcg; Placebo Sufentanil NanoTab PCA System
Intervention description: 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.; Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.
Intervention MeSH terms: Sufentanil; Dsuvia
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: In patient, post operative pain; Adult post-operative inpatients who are expected to require parenteral opioid analgesia for at least 48 hours after open abdominal surgery

Summary:

      The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA
      System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute
      moderate to severe post-operative pain after open abdominal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients who are 18 years or older

          -  Patients who are scheduled to undergo an open abdominal surgery (including
             laparoscopic-assisted) under general anesthesia or spinal anesthesia that does not
             include intrathecal opioids during the operation.

          -  Post-surgical patients who have been admitted to the PACU and are expected to remain
             hospitalized and to have acute post-operative pain requiring parenteral opioids for at
             least 48 hours after surgery.

        Exclusion Criteria:

          -  Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
             of more than 15 mg of morphine (or equivalent), within the past 3 months prior to
             surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg
             hydrocodone per tablet).

          -  Patients with an allergy or hypersensitivity to opioids.

          -  Female patients who are pregnant or breast-feeding
PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)
Condition: Newly Diagnosed, Previously Untreated Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Dexamethasone; Elotuzumab
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Elotuzumab; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and
      Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma
      cells at the time of progression than those who receive Lenalidomide and Dexamethasone
      without Elotuzumab
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

        Subjects who are newly diagnosed with symptomatic MM and who:

          -  Have not received any prior systemic anti-myeloma therapy

          -  Have measurable disease

          -  And are not candidates for high-dose therapy plus stem-cell transplantation (SCT)
             because of age (≥65 years) or coexisting conditions. Refusal to undergo high dose
             therapy with SCT is NOT sufficient for entry onto CA204-006 for a subject <65 years
             old. There must be a comorbidity that prevents SCT for a subject <65 years old

        Exclusion Criteria:

          -  Subjects with non-secretory or oligo-secretory or free light-chain only myeloma

          -  Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

          -  Monoclonal Gammopathy of Undetermined Significance (MGUS)

          -  Active plasma cell leukemia

          -  Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Uterine Cervical Dysplasia
Intervention: SWETZ; LLETZ cone
Intervention description: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.; LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 164.0
Sex: Female
Healthy volunteers: No
Keywords: Conization; Cervical Intraepithelial Neoplasia; Cervix Dysplasia; Therapy; Electrosurgery

Summary:

      The purpose of this trial is to evaluate if Straight Wire Excision of the Transformation Zone
      (SWETZ) is superior to (Large Loop Excision of the Transformation Zone) LLETZ cone in
      reducing the incomplete excision of disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients were eligible if the colposcopist decided that a cone biopsy was indicated.

          -  Common indications for a cone biopsy included:

               -  High-grade Squamous Intraepithelial Lesion in a type 3 transformation zone,

               -  suspicion of micro-invasive or invasive carcinoma and

               -  suspicion of glandular disease.

        Exclusion Criteria:

          -  Patients were excluded if pregnancy, coagulation disorders and cervicitis were present
             or if they refused to participate in the study.
The Efficacy of Symbiotic on Cytokines
Condition: Necrotising Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Intervention: distilled water; symbiotic
Intervention description: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days; Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 1 Hour
Maximum age: 2 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Symbiotic,cytokines, necrotising enterocolitis

Summary:

      The aim of this prospective double blinded randomised study is to investigate the efficacy of
      symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum,
      Bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama
      acting on Th1 pathway, interleukin -5 acting on Th2, interleukin -10 acting on T regulatory
      pathway, and interleukin -17 acting on Th-17 pathway that were related with necrotizing
      enterocolitis pathogenesis in very low birth weight neonates.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Neonates born 26- 32 gestational weeks and 750-1500 gram birth weights

          2. Neonates who tolerated minimal enteral feeding during first week of life

        Exclusion Criteria:

          1. PROM> 24 hour and/or chorioamnionitis

          2. Mechanical ventilation supply more than 7 days

          3. Culture proven sepsis

          4. Major congenital anomaly

          5. Neonates undergoing surgery
Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Condition: Schizoaffective Disorder; Psychotic Disorder
MeSH terms: Psychotic Disorders
Intervention: Placebo; Paliperidone ER; Paliperidone ER
Intervention description: for 6 weeks; (3-12mg/day in 3 mg/day increments for 6 weeks); (3-12mg/day in 3 mg/day increments for 6 weeks)
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizoaffective Disorder; antipsychotic; paliperidone; placebo

Summary:

      The purpose of this study is to measure the effectiveness and assess the safety of different
      dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER)
      in patients who are experiencing an acute episode of schizoaffective disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of
             schizoaffective disorder

          -  A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of >= 60

          -  A score of >= 16 on Young Mania Rating Scale (YMRS) or a score of >= 16 on the
             Hamilton Depression Rating Scale (HAM-D 21)

        Exclusion Criteria:

          -  A primary active mental illness diagnosis other than schizoaffective disorder

          -  Patients with first episode psychosis

          -  Active substance dependence within previous 6 months

          -  Treatment with clozapine within 6 months of randomization

          -  A history of treatment resistance, defined by failure to respond to 2 adequate trials
             of antipsychotic medication

          -  Pregnancy, breast-feeding, or planning to become pregnant
Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Metformin; Metformin; Placebo
Intervention description: Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose); Metformin, orally, 500 mg daily (single dose; two 250 mg tablets) for 24 weeks; Metformin, orally, 500 mg daily (divided dose; 250 mg tablet b.i.d.) for 24 weeks; Placebo to match metformin 250 mg tablets, orally, for 24 weeks
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 337.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice
      daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes
      mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and
      sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg
      b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from
      baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d.
      is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in
      HbA1c at 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes Mellitus (T2DM)

          -  Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 4
             weeks, on any additional oral hypoglycemic agent (AHA) in the prior 8 weeks, and HbA1c
             ≥ 6.0% and ≤ 9.0%; or

          -  Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 10
             weeks, not on any additional oral AHA in the prior 8 weeks, and HbA1c ≥ 6.5% and <
             10.0%

        Exclusion Criteria:

          -  Type 1 diabetes mellitus,

          -  Secondary diabetes mellitus, or

          -  Gestational diabetes mellitus
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Levodopa-Carbidopa Intestinal Gel (LCIG); CADD-Legacy® 1400 ambulatory infusion pump; Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)
Intervention description: LCIG for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa (5 mg/mL) in an aqueous gel that is dispensed in a medication cassette reservoir containing 100 mL of LCIG.; Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.; All participants previously had a PEG-J placed in one of the prior LCIG studies.
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 262.0
Sex: All
Minimum age: 30 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: levodopa/carbidopa intestinal gel; Severe Motor Fluctuations; Levodopa; Carbidopa; Parkinson's Disease; Dyskinesia

Summary:

      The primary objective of this study is to provide continued access to levodopa-carbidopa
      intestinal gel (LCIG), to participants who have already participated in an open-label
      efficacy and safety study with the same treatment (Study S187.3.003 [NCT00360568] or Study
      S187.3.004 [NCT00335153]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant should have completed participation in Study S187.3.003 or S187.3.004;
             and, in the opinion of the Principal Investigator, would benefit from long-term
             treatment with LCIG.

          -  For Canada, participants will be allowed to participate in the S187.3.005 study with a
             minimum of 6 months of exposure to LCIG in the S187.3.004 study.

          -  The participant must be able to understand the nature of the study and must provide
             written informed consent prior to the conduct of any study related procedures. If the
             participant does not have the capacity to provide informed consent, full informed
             consent must be obtained from the participant's legally authorized representative.
             Consenting will be performed according to local regulations.

        Exclusion Criteria:

          -  Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be
             clinically significant and which could interfere with the participant's participation
             in the study.
A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
Condition: Chronic Pancreatitis; Pancreatectomy; Pancreatic Exocrine Insufficiency
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency
Intervention: Pancrelipase delayed release capsule; Placebo Comparator
Intervention description: 24,000 unit capsule; Placebo
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Pancreatitis; Pancreatectomy; Pancreatic Exocrine Insufficiency

Summary:

      This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen
      absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a
      run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind
      period and a 6-month Open-Label Follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

        Pancreatic exocrine insufficiency has to be proven (in medical history) by the following
        criteria:

          -  Direct or indirect pancreatic function test (except stool fat excretion) or Clinical
             signs of severe steatorrhoea that resolved upon administration of pancreatic
             supplementation.

          -  Total stool fat > 40 g over 4 days (using Van De Kamer method)

          -  Proven chronic pancreatitis

          -  Females of child-bearing potential must agree to continue using a medically acceptable
             method of birth control

        Exclusion Criteria:

          -  Ileus or acute abdomen

          -  Any type of malignancy involving the digestive tract in the last 5 years

          -  Presence of pseudo-pancreatic cyst ≥ 4

          -  Continued excessive intake of alcohol or drug abuse

          -  Known infection with HIV