bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
Condition: Ileus
MeSH terms: Ileus
Intervention: Alvimopan; Placebo
Intervention description: alvimopan pill; placebo pill
Intervention MeSH terms: Alvimopan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIPEC; peritoneal carcinomatosis

Summary:

      The purpose of this study is to investigate the ability of alvimopan to reduce the time to
      return of bowel function in patients undergoing cytoreductive surgery and hyperthermic
      intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half
      will receive placebo immediately before and for up to seven days after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand and the willingness to sign a written informed consent.

          -  Scheduled to undergo open (non-minimally invasive) CRS/HIPEC.

          -  Scheduled to receive postoperative pain management with intravenous opioids.

          -  Age > 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

          -  Women of child-bearing potential with negative pregnancy test prior to initiating
             study drug dosing.

        Exclusion Criteria:

          -  Greater than 7 days of consecutive opioid use immediately prior to scheduled surgery.

          -  Child-Pugh Class C hepatic impairment.

          -  End-stage renal disease (GFR < 15 mL/min/1.73 m2 and/or on peritoneal dialysis or
             hemodialysis).

          -  Complete mechanical bowel obstruction.

          -  Contraindication or inability to tolerate oral medication postoperatively.

          -  Presence of gastrointestinal ostomy after CRS/HIPEC.

          -  Pancreatic or gastric anastomosis performed during CRS/HIPEC.

          -  History of allergic reactions or hypersensitivity attributed to compounds of similar
             chemical or biologic composition as alvimopan at the treating investigators
             discretion.

          -  Severe or uncontrolled medical disorder that would, in the investigator's opinion,
             impair ability to receive study treatment (i.e. uncontrolled diabetes, chronic renal
             disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric
             illness/social situations that would limit compliance with study requirements).

          -  History of myocardial infarction in the 12 months prior to scheduled surgery.

          -  Pregnant or nursing.
Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS Topical product
Intervention description: once daily for 28 days
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: Accepts Healthy Volunteers

Summary:

      An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal
      Use Treatment with DSXS .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating females 18 years of age or older.

          -  IRE-approved, signed informed consent form that meets all criteria of current FDA
             regulations.

        Exclusion Criteria:

          -  Females who are pregnant, nursing, planning to become pregnant during the duration of
             the study, or if of child-bearing potential and sexually active and not prepared to
             use appropriate contraceptive methods to avoid pregnancy.
Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
Condition: Post-Dural Puncture Headache; Sphenopalatine Ganglion Block
MeSH terms: Ganglion Cysts; Synovial Cyst; Post-Dural Puncture Headache; Headache
Intervention: Lidocaine
Intervention description: Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes.
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single arm, pilot study
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion
      block to alleviate the pain of post-dural puncture headache (PDPH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Complains of symptoms suggestive of post-dural puncture headache

          2. Has a history of dural puncture (lumbar puncture or accidental dural puncture during
             epidural placement) within the previous 7 days

          3. Fluent in written and spoken English

        Exclusion Criteria:

          1. Those with a known history of hypersensitivity to local anesthetics of the amide type
             or to other components of GLYDO

          2. Those with any congenital or acquired, anatomical deformity of the nostril, which
             preclude performing the block

          3. Those who refuse to consent to participate in the study

          4. Patients who have had a failed epidural blood patch

          5. Cognitive Impairment

          6. Prisoner
Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Medication management; Non-pharmacological pain management; Buprenorphine-Naloxone
Intervention description: Individualized management of medications for pain; Individualized management of non-medication pain treatment approaches; Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 820.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Opioid analgesics; Opioid partial agonists; Health care delivery; Back pain; Osteoarthritis; Veterans health

Summary:

      Background and significance: Treatment with opioid pain medications (like hydrocodone and
      morphine) is common for severe pain, but studies show these medications may not always help
      and can cause serious problems. High daily doses of opioids can be especially unsafe. To help
      patients with chronic pain have better quality of life and avoid medication toxicity, health
      care teams need to manage pain while helping patients reduce opioid medication doses to safer
      levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate or high-dose long-term opioid therapy (≥ 20 ME mg daily for at least 3
             months) for chronic pain

          -  Chronic pain of at least moderate severity (defined as pain that is present every or
             nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥
             5)

        Exclusion Criteria:

          -  Dementia diagnosis

          -  Unstable or severe untreated psychiatric disorder, including severe untreated
             substance use disorder or active suicidal ideation

          -  Unstable or end-stage medical disease that would interfere with participation,
             including cancer requiring active treatment and life expectancy < 12 months

          -  Documentation of suspected controlled substance diversion

          -  Inability to communicate by telephone
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
Condition: Premature Birth; Brain Injury
MeSH terms: Brain Injuries; Premature Birth
Intervention: Melatonin injection
Intervention description: A single intravenous infusion of melatonin will be given to each infant over 6 hours so that successive groups will receive increasing doses until the correct dose for age is found.
Based on the pharmacokinetics and clearance of melatonin in adults an approximate dose has been calculated. The starting dose of melatonin will be 0.1 microgram/kg/hr to be given over 6 hours intravenously. The range of expected dose is 0.1-0.5 microgram/kg/hr.
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 23 Weeks
Maximum age: 31 Weeks
Healthy volunteers: No
Keywords: Premature Birth; Brain injury; Neuroprotection; Melatonin; Pharmacokinetics

Summary:

      Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may
      reduce this risk. The unborn baby receives melatonin from the mother but following premature
      delivery there maybe a period of prolonged melatonin deficiency. This deficiency may be
      harmful because studies suggest that melatonin is important in protecting the brain and
      reducing the risk of brain injury after preterm birth. The purpose of this study is to find
      the ideal dose of melatonin to give to preterm babies. We intend to study a total of 24
      babies less than 31 weeks gestation and who are less than 7 days old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants born less than 31 weeks gestation who are less than 7 days old, after parental
             consent for participation will be included in the study.

        Exclusion Criteria:

          -  Those with major congenital malformation, or cystic periventricular leucomalacia
             (cPVL) or haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography prior to
             enrolment will be excluded from the study.
The SCCS Polypill Pilot Trial
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide; Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: combination pill; polypill; primary prevention

Summary:

      In this study the investigators will examine the effect of the polypill on medication
      adherence, systolic blood pressure, and LDL cholesterol over a 12 month span.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Enrolled at the SCCS site in Mobile, Alabama, obtain care at Franklin Primary Health
             Center, or live in the surrounding area.

          -  Aged 45-75 years

          -  Baseline systolic blood pressure ≥120 mm Hg. In this open-label trial, the study
             physicians are permitted to prescribe any additional medication deemed appropriate to
             achieve blood pressure control.

        Exclusion Criteria:

          -  History of coronary heart disease or stroke

          -  History of cancer, except for basal cell skin cancer

          -  History of liver disease, not including chronic, clinically-stable hepatitis

          -  Laboratory evidence of hepatic dysfunction (an alanine aminotransferase level more
             than two times the upper limit of the normal range)

          -  Known renal disease, estimated creatinine clearance < 60

          -  Current use of more than 2 anti-hypertensive medications

          -  LDL cholesterol ≥190 mg/dl

          -  Insulin-dependent diabetes

          -  Known intolerance to any of the components of the polypill

          -  Potassium <3.4 or >5.5 mEq/L

          -  Use of medications that interact with statins, including those affecting the
             cytochrome P450 system

          -  Current use of diuretics for indications other than hypertension

          -  Comorbidities that might be expected to limit lifespan during the 12-month follow-up
             period

          -  Inability to provide consent.
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Condition: Obstetric Labour, Premature
MeSH terms: Premature Birth; Obstetric Labor, Premature
Intervention: GSK221149A; Placebo
Intervention description: 6mg/h and 12 mg/h; Matched Placebo to Drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Premature Labor; Pre Term Labor; intravenous; fetal fibronectin

Summary:

      Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity
      and mortality and is frequently associated with long-term disability. Oxytocin is a hormone
      produced by the body during labor. GSK221149A is an experimental drug that will be used to
      block the effects of oxytocin, and therefore pause or prevent contractions. In this study,
      patients with preterm labor will be given an intravenous infusion of GSK221149A over
      approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study,
      patients with preterm labor will be give an intravenous infusion of GSK221149A over
      approximately 48 hours. The use of a rescue tocolytic is allowed in the study.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy pregnant females, 30 -36 weeks pregnant, without ruptured membranes

          -  18-45 inclusive

          -  Symptoms of pre-term labor, (greater than or equal to 6 uterine contractions per hour,
             each of which at least 30 sec in duration, with cervical dilatation of less than or
             equal to 4 cm, (measured by tocodynamometry).

        Exclusion criteria:

          -  Any clinically relevant abnormality identified on the screening examination or any
             other medical condition or circumstance making the patient (mother and/or fetus)
             unsuitable for participation in the study

          -  Any clinically relevant pre-existing or pregnancy-related co-morbid condition that may
             affect maternal pregnancy outcome or neonatal outcome (eg. hypertension, diabetes
             mellitus, bleeding/clotting diathesis)
Metronomic Therapy in Patients With Metastatic Melanoma
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Intervention: vinblastine; Cyclophosphamide; dacarbazine
Intervention description: 1 mg/m2 vinblastine given three times per week administered intravenously.; 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest; 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest
Intervention MeSH terms: Cyclophosphamide; Dacarbazine; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metronomic Therapy; Metastatic Melanoma; Vinblastine; Cyclophosphamide; Dacarbazine

Summary:

      SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low
      Dose Vinblastine, Cyclophosphamide, and Dacarbazine.

      Patients with measurable metastatic melanoma are eligible. All patients will be treated as
      outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will be
      treated continuously, until evidence of progression of disease, or for up to two cycles
      following disappearance of all disease. A cycle will be defined as three weeks of continuous
      therapy with a one week rest.
    

Eligibility criteria:

        -  Metastatic melanoma with measurable disease

          -  Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or
             chemotherapy (6 weeks for nitrosoureas) and recovered from all ill

          -  Karnofsky Performance Status ≥60%

          -  Life expectancy ≥ twelve weeks

          -  Adequate end organ function

          -  Women should not be lactating and, if of childbearing age, have a negative pregnancy
             test within two weeks of entry to the study.

          -  Appropriate Contraception in both sexes

          -  The patient must be competent and signed informed consent.

        EXCLUSION CRITERIA

          -  Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive
             cancer such as cervical CIS, superficial bladder cancer without local recurrence,
             breast CIS.

          -  In patients with a prior history of invasive malignancy, less than five years in
             complete remission.

          -  Have evidence of significant co-morbid illness such as uncontrolled diabetes -
             Uncontrolled brain metastasis: Patients with brain metastasis most have been treated
             with brain radiation therapy or surgery and remain clinically stable for a minimum of
             4 weeks.
Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: radiotherapy
Intervention description: prostate radiation to 70Gy; nodal radiation to 56Gy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to
      escalate the biologically effective dose to the pelvic lymph nodes in a short course of
      radiation therapy. An increased total and biologically effective dose will be delivered to
      the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short
      course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prostate cancer stage T-T3

          -  Predicted risk of lymph node involvement > 15%

          -  Gleason > 7

        Exclusion Criteria:

          -  Distance metastases

          -  Use of anti-coagulant therapy
A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Intervention: Revusiran (ALN-TTRSC)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Cardiomyopathy; Heart Failure; FAC; Amyloid; Transthyretin; TTR; RNAi therapeutic

Summary:

      The purpose of this study was to evaluate the safety and clinical activity of long-term
      dosing with revusiran (ALN-TTRSC). Dosing has been discontinued; patients are being
      followed-up for safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who previously received and tolerated revusiran (ALN-TTRSC) in the
             ALN-TTRSC-002 study

          -  Adequate liver function

          -  Not Pregnant or nursing

        Exclusion Criteria:

          -  Inadequate renal function

          -  Uncontrolled hypertension, ischemic heart disease or clinically significant cardiac
             arrhythmia

          -  Untreated hypo- or hyperthyroidism

          -  Prior major organ transplant
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Placebo; ABT-494
Intervention description: Oral Dosing; Oral Dosing
Intervention MeSH terms: Upadacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease

Summary:

      To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately
      to severely active Crohn's Disease with a history of inadequate response to or intolerance to
      Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of Crohn's disease (CD) for at least 90 days.

          2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or
             equal to 450.

          3. Subject inadequately responded to or experienced intolerance to previous treatment
             with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or
             anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

        Exclusion Criteria:

          1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.

          2. Subject who has had surgical bowel resections in the past 6 months or is planning
             resection.

          3. Subjects with an ostomy or ileoanal pouch.

          4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

          5. Subject who has short bowel syndrome.

          6. Subject with recurring infections or active Tuberculosis (TB).