bioihbjkbjnl/mcl2 huggingface dataset:
Sandostatin for Patients With Androgen Independent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Sandostatin
Intervention description: Sandostatin 30mg intramuscular every 28 days
Intervention MeSH terms: Octreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Male
Healthy volunteers: No

Summary:

      This is an open label, single center Phase II trial of Sandostatin LAR in patients with
      hormone refractory prostate cancer. Patients will receive Sandostatin LAR 30 mg
      intramuscularly every 28 days. Patients will be treated until the time of disease
      progression, unacceptable toxicity or withdrawal of consent. The study will require 27
      evaluable patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate.

          -  Biochemical disease progression following androgen deprivation and therapy with at
             least one antiandrogen defined as three rises in PSA with PSA determinations at least
             4 weeks apart and each PSA value > 0.2 ng/ml.

          -  Four weeks since prior therapy with Flutamide.

          -  Six weeks since prior therapy with Bicalutamide or Nilutamide.

          -  Current PSA > 5 ng/ml.

          -  Testosterone <50 ng/dL.

          -  SGPT (ALT) < 1.5 times upper limit of normal.

          -  Fasting blood glucose > 60 mg/dL.

          -  ECOG performance status 0, 1 or 2.

          -  No visceral or bony metastatic disease (Lymph node only metastases are allowed).

          -  No prior chemotherapy for prostate cancer.

          -  No current treatment with insulin or an oral hypoglycemic.

          -  No history of treatment with octreotide analogs for prostate cancer.

          -  No NYHA Class 3 or 4 cardiac status.

        Exclusion Criteria:

          -  Diabetes Mellitus requiring medical therapy and/or that which is not controlled by
             dietary means (HbA1C<6.0).

          -  A history of gallstones that has been clinically significant. Patients who have
             undergone cholecystectomy are eligible.

          -  Other concomitant medical or psychiatric condition which would make it undesirable, in
             the physician's opinion, for the patient to participate in the protocol or would
             jeopardize compliance with the protocol requirements.

          -  Prior treatment with chemotherapy for prostate cancer.

          -  No current treatment with Saw Palmetto, or Proscar. Patients must be off these
             medicines for more than 4 weeks.
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
Condition: Skin and Subcutaneous Tissue Bacterial Infections; Gram-Positive Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Gram-Positive Bacterial Infections
Intervention: TNP-2092; Vancomycin
Intervention description: TNP-2092 100mg/vial; Vancomycin 1g/vial
Intervention MeSH terms: Vancomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TNP-2092; ABSSSI; Safety; Efficacy

Summary:

      The purpose of this study is to evaluate safety, tolerability, pharmacokinetic
      characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be
      caused by gram-positive pathogens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects may be included in the study if they meet all of the following inclusion
             criteria:

               -  Males or females, 18 years of age or older;

               -  ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including:

               -  Cellulitis/erysipelas;

               -  Wound infection;

               -  Major cutaneous abscess;

               -  Lesion with a minimum surface area of 75 cm2;

               -  Capable of giving signed informed consent.

        Exclusion Criteria:

          -  Subjects will be excluded from the study if any of the following exclusion criteria
             apply prior to randomization:

               -  History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin
                  or glycopeptide classes;

               -  ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the
                  glycopeptide class;

               -  Prior administration of systemic antibacterial therapy within 96 hours before
                  randomization;

               -  ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic
                  organisms;

               -  ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial,
                  parasitic, or viral pathogens;

               -  Evidence of significant hepatic, hematologic, or immunologic disease;

               -  History or evidence of severe renal disease.
Efficacy of Caffeine Injection as an Adjuvant to Opioid Therapy in Cancer Pain
Condition: Cancer; Pain
MeSH terms: Cancer Pain
Intervention: Caffeine; Normal saline
Intervention description: Intravenous injection of caffeine 200mg with 100ml of normal saline over 1 hour, once a day, for two days.; Intravenous injections of 100ml of normal saline over 1 hour, once a day, for two days
Intervention MeSH terms: Sodium Benzoate; Caffeine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Cancer patients; Caffeine; Adjuvant analgesics; Sedation; Confusion; Quality of life; Fatigue

Summary:

      Pain is a most common symptom and it has a high impact on quality of life in cancer patients.
      Many cancer patients have received opioid therapy, but also many of them have suffered from
      side effects of opioids. Drowsiness and confusion are common side effects of opioids.
      Caffeine is a well known psychostimulant,and it is widely used as an analgesics. Thus, the
      investigators aimed to prove the efficacy of intravenous caffeine administration as an
      adjuvant analgesics to opioids. At the same time, the investigators tried to find that the
      side effects of opioids could be ameliorated by caffeine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced (Stage IV) cancer inpatients

          -  Adults aged over 18 years

          -  Patients who have received opioid therapy and whose pain scales are under 6 (by
             numeric rating scale)

          -  Patients who do not take caffeine beverage 48 hours before study period

          -  Volunteers who provided written informed consent

        Exclusion Criteria:

          -  Sensitivity (palpitation,headache,irritability,insomnia) to caffeine

          -  Uncontrolled hypertension and/or heart disease

          -  Liver failure (alanine aminotransferase >= 100 IU/L)

          -  Kidney failure (serum creatinine >= 2.0 mg/dL)

          -  Patients taken theophylline

          -  Gastroesophageal reflux disease

          -  Chronic glaucoma

          -  Cognitive impairment

          -  Progressive pain over 7 (by numeric rating scale)
Liposomal Bupivacaine in Bariatric Surgery
Condition: Bariatric Surgery Analgesia
Intervention: Liposomal Bupivacaine TAP block; Bupivacaine TAP block
Intervention description: Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.; Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bariatric surgery; liposomal bupivacaine

Summary:

      The aim of this study is to perform a randomized controlled trial for patients undergoing
      bariatric surgery, comparing the need for opiates with and without administration of a
      transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal
      bupivacaine (Exparel®). From this study, the investigators will assess whether use of long
      acting local anesthetic can reduce the need for opiates in the bariatric population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese patients undergoing bariatric surgery (LSG or LRYGB)

          -  Patients 18 years of age and older

          -  Surgical treatment between 01/01/2018 and 12/31/2018 over a 1 year period

        Exclusion Criteria:

          -  Patients under the age of 18 years old

          -  Patients taking any opiates within 30 days of enrollment in the trial

          -  Patients with a history of chronic pain.

          -  Patients taking pregabalin or gabapentin.

          -  ASA IV

          -  Prior laparotomy

          -  Body Mass Index ≥ 60 kg/m2

          -  History of cardiac arrhythmia

          -  History of Seizure

          -  Psychiatric Diagnosis currently on antipsychotic medication
A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome
Condition: Sjögren Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: Remibrutinib; Placebo
Intervention description: Remibrutinib 100 mg was administered orally as two 50 mg hard gelatin capsules. Patients in the remibrutinib 100 mg bid dose group took 2 capsules of active medication in the morning and 2 capsules of active medication in the evening. Patients in the remibrutinib 100 mg qd dose group took 2 capsules of active medication in the morning and 2 capsules of the placebo in the evening.; Placebo was administered orally as two hard gelatin capsules. Patients in the placebo dose group took 2 capsules of placebo in the morning and 2 capsules of placebo in the evening.
Intervention MeSH terms: Remibrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: LOU064; remibrutinib; Sjogren Syndrome; Dry Eye Syndromes; Pathological Processes; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Summary:

      This was an adaptive design phase 2 study to establish safety and efficacy; and to
      characterize the dose-response of LOU064 in subjects with moderate to severe Sjögren's
      syndrome. LOU064 is an oral Bruton's tyrosine kinase (BTK) inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of SjS according to the 2016 ACR/EULAR criteria

          -  Screening ESSDAI (based on weighted score) ≥ 5 derived from 8 domains

          -  Screening ESSPRI ≥ 5

          -  Seropositive for anti-Ro/SSA antibodies at or within 3 months prior to screening

          -  Unstimulated salivary flow > 0 mL/min.

        Exclusion Criteria:

          -  Sjögren's Syndrome overlap syndromes with another autoimmune disease as primary
             illness

          -  DMARDs or kinase inhibitors within 3 months prior to baseline above certain doses OR
             maintained during study

          -  Rituximab or other B cell depleting drug within 12 months of Screening .

          -  Current use of prednisone or equivalent > 15mg/d or dose change within 2 weeks prior
             to Screening

          -  Use of medication known to cause, as a major side effect, dry mouth / eyes

          -  HIV, Hepatitis C, Hepatitis B, known or suspected history of an ongoing, chronic or
             recurrent infectious disease such as tuberculosis
Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer
Condition: Lung Neoplasms; Carcinoma; Cancer of the Lung; Non-Small-Cell Lung Carcinoma
MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Intervention: Cetuximab; Cisplatin; Vinorelbine
Intervention description: Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision; Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles; Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles
Intervention MeSH terms: Cetuximab; Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used
      for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and
      Vinorelbine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on
             Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery
             and/or radiation therapy

          -  Evaluable or measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

        Exclusion Criteria:

          -  Uncontrolled Central Nervous System (CNS) metastasis.

          -  Previous exposure to monoclonal antibodies, signal transduction inhibitors or
             Epidermal growth factor receptor (EGFR) targeting therapy

          -  Concurrent malignancy

          -  Prior chemotherapy for NSCLC

          -  Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2

          -  Superior vena cava syndrome contra-indicating hydration

          -  White Blood Cells (WBC) < 3,000/mm³

          -  Absolute neutrophile count (ANC) < 1,500/mm³

          -  Platelet < 100,000/mm³

          -  Hemoglobin (Hgb) < 9.0 g/dL

          -  Total bilirubin > 1.5 x Upper limit of normal (ULN).

          -  Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) > 5.0 x ULN.

          -  Serum creatinine >1.25 x ULN and calculated creatinine clearance <60mL/min
Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-118 Lotion; IDP-118 Monad HP Lotion; IDP-118 Monad Taz Lotion; IDP-118 Vehicle Lotion
Intervention description: Lotion; Active Comparator; Active Comparator; Vehicle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate the safety and efficacy of a topical lotion
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of
             at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and
             intertriginous areas are to be excluded in this calculation.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or
             4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded
             in this assessment, if psoriasis is present).

        Key Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently
             participating in another clinical study with an investigational drug or device.
Inhaled Nitrous Oxide and Labor Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Inhaled nitrous oxide
Intervention description: Administration of nitrous oxide for labor analgesia
Intervention MeSH terms: Nitrous Oxide; Entonox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 14 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nitrous oxide; labor and delivery; analgesia

Summary:

      Hypothesis: The administration of nitrous oxide for labor analgesia will decrease the labor
      epidural anesthesia rate by 15%.

      Specific Aim: To determine if nitrous oxide can be an effective alternative technique for the
      provision of labor analgesia at Magee-Womens Hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all women of childbearing age (including children aged 14 years and above)who are
             pregnant

          -  parturients who request labor analgesia of family medicine investigators certified in
             the use of nitrous oxide for labor analgesia at Magee-Women's Hospital

          -  informed verbal and written consent

        Exclusion Criteria:

          -  coexisting medical conditions that are contraindications to the use of nitrous oxide
             (i.e. recent eye or ear surgery, history of Meniere's disease, history of vitamin B-12
             deficiency)

          -  history of severe nausea and vomiting

          -  history of chronic pain

          -  inability to hold a facemask

          -  impairment of consciousness or intoxication at time of delivery

          -  received intravenous opioids within two hours prior to initiation of nitrous oxide

          -  impaired oxygenation (ex: lung cysts, pneumothorax, pulmonary hypertension, or
             pulmonary edema) with a room-air pulse oximetry reading less than 95%

          -  hemodynamic instability

          -  non-reassuring fetal heart rate tracing

          -  inability to read, write and understand the English language enough to complete all
             survey questionnaires and pain assessment scales.
Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: cholecalciferol; placebo
Intervention description: softgels 4000 IU daily for approximately two months prior to surgery (prostatectomy).; softgel containing no active ingredient daily for approximately two months prior to surgery (prostatectomy).
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: Male
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: prostate cancer; vitamin D

Summary:

      The study population will be 80 adult men who have been diagnosed with prostate cancer who
      are scheduled to have their prostate surgically removed at either the Medical University of
      South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men
      will be randomized into two groups: one group will take vitamin D3 supplementation and the
      other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of
      the study and again after two months, just prior to the surgical procedure (prostatectomy).
      Prostate tissue will be obtained from the surgical procedure and studied for the effect of
      vitamin D on the prostate cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of prostate cancer (by prostate biopsy)

          -  Scheduled to undergo a prostatectomy

          -  Ability to give his own consent to participate in the study

        Exclusion Criteria:

          -  Serum 25(OH)D level less than 8ng/ml or greater than 50 ng/ml

          -  Vitamin D3 supplementation greater than or equal to 1000 IU daily