bioihbjkbjnl/mcl2 huggingface dataset:
Enhancing Medication-based Analgesia in Humans- STUDY 2
Condition: Pain; Cannabis; Opioid Use
Intervention: Within-subject test of blinded study medications
Intervention description: Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Intervention model description: Within-subject study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Study drug administration will be concealed from all study staff and participants to prevent bias in outcomes.
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clinical Trial; Analgesia; Phase II; Abuse potential

Summary:

      This is a single-group, within-subject, double-blind, double-dummy, placebo and
      active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD;
      Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when
      compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of
      studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-75

          -  Urine sample tests negative for common illicit substances of abuse, including cannabis

          -  Medically cleared to take study medications

          -  Are not pregnant or breast feeding

          -  Willing to comply with the study protocol.

        Exclusion Criteria:

          -  Meet DSM-5 criteria for alcohol/substance use disorder

          -  Taking opioids for pain

          -  Previous adverse reaction to a cannabinoid product

          -  Prescribed and taking stimulants or benzodiazepines

          -  Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain

          -  Self-report any illicit drug or cannabinoid use in the past 7 days

          -  Presence of any clinically significant medical/psychiatric illness judged by the
             investigators to put subject at elevated risk for experiencing an adverse event

          -  History of seizure disorder

          -  Have a known allergy to the study medications or sesame seed oil

          -  ALT or AST levels >3x ULN and/or Bilirubin levels >2x ULN during Screening

          -  Current (past 60-day) suicidal thoughts or past year history of suicidal behavior

          -  Taking medications contraindicated with hydromorphone or cannabidiol

          -  Have a history of clinically significant cardiac arrhythmias or vasopastic disease

          -  Have an abnormal and clinically-significant ECG
Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)
Condition: Asthma
MeSH terms: Asthma
Intervention: Comparator: mometasone; Comparator: montelukast; Comparator: placebo (unspecified)
Intervention description: mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks); montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks); Placebo (Placebo once-daily, for approximately 2 weeks)
Intervention MeSH terms: Mometasone Furoate; Montelukast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 134.0
Sex: All
Minimum age: 15 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study assesses inhaled corticosteroid plus montelukast compared with inhaled
      corticosteroid therapy alone for treatment of patients with chronic asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has decreased breathing capacity (when not taking asthma medicine) that
             improves after taking a fast-acting asthma inhaler

          -  Within one month of the first study visit, patient has been treated with a fast-acting
             asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that
             combines a corticosteroid plus a bronchodilator

        Exclusion Criteria:

          -  Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene
             antagonists, or any of their components

          -  Has required an oral corticosteroid rescue for worsening asthma during the screening
             period
Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
Condition: Complicated Intra-abdominal Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Intervention: ceftazidime/NXL104 + metronidazole; meropenem
Intervention description: IV TID; IV TID
Intervention MeSH terms: Metronidazole; Meropenem; Ceftazidime; Avibactam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the
      treatment of complicated intra-abdominal infections as compared to a comparator group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  complicated intra-abdominal infections

        Exclusion Criteria:

          -  infections limited to hollow viscus

          -  ischemic bowel disease without perforation

          -  acute suppurative cholangitis

          -  acute necrotizing pancreatitis

          -  pts to undergo stated abdominal repair, open abdomen technique or marsupialization

          -  Apache II >25
Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
Condition: Refractory Leukemia; Acute Myelogenous Leukemia
MeSH terms: Leukemia; Neoplasm Metastasis; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Panobinostat/LBH589
Intervention MeSH terms: Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Acute myeloid leukemia; AML; relapsed acute myeloid leukemia; refractory AML; refractory de novo AML; refractory secondary AML; secondary AML; AML following myelodysplastic syndrome (MDS); AML following antecedent hematological disorder (AHD); AML resistant to therapy

Summary:

      This study was to evaluate the efficacy and safety of single agent oral panobinostat in
      patients who have refractory de novo or refractory secondary AML.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent prior to study-specific screening procedures

          -  Life expectancy of ≥ 60 days

          -  Eastern Cooperative Group (ECOG) performance status ≤ 2

          -  Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR-
             Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to
             AHD or MDS with either condition precedent to AML (MDS/AHD)

          -  Negative serum pregnancy test (within 7 days of first dose)

          -  Negative urine pregnancy test immediately prior to first dose

        Exclusion Criteria:

          -  Known HIV

          -  Psychiatric disorder that interfered with ability to understand the study and give
             informed consent, and/or would impact study participation or follow-up

          -  Concurrent use of medications that might prolong the QT interval or of inducing
             Torsade de Pointes

          -  Female patients who were pregnant or breast-feeding or patients of childbearing
             potential who were not willing to use a double barrier method of contraception during
             the study and for 3 months following the last dose of study drug.

          -  Male patients whose sexual partner(s) were women of childbearing potential who were
             not willing to use a double method of contraception, one of which included a condom,
             during the study and for 3 months after the end of treatment

          -  Patient unable to swallow capsules

          -  Patients with impaired gastrointestinal systems which might cause interference with
             digesting and absorbing panobinostat

        Other Protocol-defined inclusion/exclusion criteria may apply
Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population.
Condition: Obesity; Prediabetic State
MeSH terms: Prediabetic State
Intervention: Melatonin; Placebo
Intervention description: 2mg controlled release melatonin tablet; placebo tablet identical to circadin
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to
      extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly
      controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether
      sleep extension and nightly melatonin supplementation in the community is a feasible
      intervention with a beneficial effect on the following chronic kidney disease (CKD) risk
      factors: systemic and renal specific renin-aldosterone-angiotensin system (RAAS) activation
      (systemic plasma renin activity, plasma angiotensin II levels, 24-hour urine aldosterone
      excretion, and renal plasma flow response to captopril); nocturnal blood pressure measured by
      24-hour ambulatory blood pressure monitor; central blood pressure measured by pulse wave
      analysis; and glucose metabolism measured by Minimal Model assessment of insulin resistance
      and β-cell response to a mixed meal protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) ≥ 30 kg/m2

          -  Hemoglobin A1c (HbA1c) 6.7-6.4%

          -  Self reported sleep < 7 hours per night

        Exclusion Criteria:

          -  Inability to extend sleep by one hour each night

          -  Current or prior history of diabetes OR random serum glucose ≥200mg/dL

          -  Pregnancy

          -  Preexisting lung disease requiring oxygen

          -  Preexisting cardiovascular disease

          -  Active or uncontrolled psychotic disorder

          -  Active or uncontrolled bipolar illness

          -  Active malignancy with in the prior 5 years

          -  Use of hypoglycemic medication

          -  estimated glomerular filtration rate (eGFR) <60ml/min/1.73m2

          -  Use of antihypertensive medications

          -  Hepatic impairment

          -  Job requiring rotating overnight shifts

          -  Bariatric surgery within prior 12 months

          -  Use of hypnotic medications

          -  Hematocrit <34% (women), <36% (men)
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
Condition: Bone Cancer; Chondrosarcoma; Ewing's Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Bone Necrosis; Bone Sarcoma; Osteomyelitis
MeSH terms: Osteomyelitis; Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Chondrosarcoma; Bone Neoplasms; Osteonecrosis; Necrosis
Intervention: Feraheme; Magnetic Resonance Imaging (MRI) scan
Intervention description: 5 mg/kg by intravenous (IV) administration; Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 10 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with
      ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors
      to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help
      in diagnosing patients correctly and may result in more timely treatment.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Age 10 to 21 years

          -  Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis

          -  Informed consent with assent as appropriate.

        EXCLUSION CRITERIA

          -  Contraindication to MRI

          -  Presence of metal implants

          -  Need for sedation or anesthesia

          -  Claustrophobia

          -  Hemosiderosis or hemochromatosis

          -  History of allergic reactions to similar compounds will be obtained and patients with
             positive history of allergic reactions will be excluded from the study

          -  Females who are pregnancy or nursing
Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
Condition: Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Syndrome; Serotonin Syndrome
Intervention: BIM 23A760
Intervention description: BIM 23A760 is a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 dose of 1, 2, 4, 6 and 8 mg can be given to the patient according to a dose escalation and titration process. Patients will receive 24 weekly injections of BIM 23A760 during the treatment period. Patients eligible to continue the extension phase will be administered BIM 23A760 for further 52 weekly injections.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's
      overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with
      carcinoid syndrome after 24 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a carcinoid syndrome defined as ≥3 stools/day and/or ≥3 flushes/week.

          -  The patient has elevated 5-Hydroxyindoleacetic acid (above upper limit normal).

          -  The patient has a well-differentiated mid-gut carcinoid tumour or serotonin secreting
             tumour of unknown localisation with hepatic metastasis.

        Exclusion Criteria:

          -  The patient has undergone surgery related to a neuroendocrine tumour (NET) within 4
             weeks prior to study entry or has surgery planned during the study.

          -  The patient has received short acting somatostatin analogues (SSAs) within 2 weeks
             before study entry or has received short acting SSAs for more than 3 months.

          -  The patient has received a radiolabelled SSA at any time before study entry.

          -  The patient has received long acting SSAs under certain circumstances.

          -  The patient has previously received any specific anti tumour treatment such as
             chemotherapy, (chemo)embolisation, radiotherapy or interferon in the last 6 months.

          -  The patient has signs or symptoms of cardiac insufficiency.

          -  The patient has an ejection fraction <40% and/or clinically severe cardiac valvular
             regurgitation.
Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM197; Blood test
Intervention description: Blood test, 40-months and 60-months children; Blood test, 40-months and 60-months children
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 382.0
Sex: All
Minimum age: 40 Months
Maximum age: 63 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention of Meningococcal disease

Summary:

      The purpose of this study is to evaluate how well the immuno response against meningococcal
      serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study
             and are in good health

          -  Control subjects: healthy 60 months old who had received a complete MenC immunization
             course

        Exclusion Criteria:

          -  Subjects with any serious, acute or chronic progressive disease
A Phase II Safety and Tolerability Study of Bevacizumab When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Bevacizumab; Docetaxel; CPT-11; Paclitaxel; Vinorelbine Tartrate; Gemcitabine
Intervention description: Bevacizumab(Avastin) 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle. until progression or unacceptable toxicity develops; Docetaxel 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops; CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops; Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops; Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops; Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.until progression or unacceptable toxicity develops
Intervention MeSH terms: Paclitaxel; Vinorelbine; Docetaxel; Bevacizumab; Gemcitabine; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Metastatic; Brain; Anti-angiogenesis

Summary:

      Our hypothesis is that this study design, in which bevacizumab is added to one of six single
      agent chemotherapies with proven activity in metastatic breast cancer, will result in
      regression or stabilization of this disease in a safe and tolerable manner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female, 18+, with evaluable metastatic breast cancer and stable brain metastases

          -  Must have received definitive radiotherapy

          -  No evidence, or history of, central nervous system hemorrhage

          -  Adequate organ and hematological function

        Exclusion Criteria:

          -  Active infection, non-healing wound, or history of any bleeding diathesis or
             coagulopathy

          -  Uncontrolled hypertension, congestive heart failure, peripheral vascular disease
Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: AC-3933; AC-3933; Sugar Pill
Intervention description: 5mg twice daily; AC-3933, 20 mg twice daily; Sugar Pill twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 171.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Alzheimer; Dementia

Summary:

      The purpose of this study is to investigate efficacy and safety of different doses of AC-3933
      in patients with mild to moderate Alzheimer's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate Alzheimer's Disease

          -  Male or female 55 years or older

          -  Living with caregiver

          -  Read, understand and speak English

        Exclusion Criteria:

          -  Need to drive during the study

          -  Treatment with acetylcholinesterase inhibitors or NMDA antagonist, such as Aricept or
             Namenda, within 2 weeks of check-up and during the study

          -  Frequent Smoker

          -  Frequent Consumer of Caffeine
Effects of Pioglitazone on Platelet Function
Condition: Diabetes; Platelet Function; Healthy
Intervention: Aspirin; Pioglitazone
Intervention description: 81 mg; 30mg Pioglitazone x1
Intervention MeSH terms: Aspirin; Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pioglitazone; Thiazolidinediones; Platelet Function; Platelet aggregation; Diabetic; Aspirin.

Summary:

      The purpose of this study is to determine how pioglitazone and aspirin affect platelets in
      the blood of diabetic and non-diabetic subjects. Platelets are small cells in the blood that
      help with blood clotting. Pioglitazone is a drug that is used to lower blood sugar and fats
      by helping the body to use insulin correctly. Pioglitazone is presently used to treat
      diabetes but has not been approved for non-diabetics. This study will determine whether
      pioglitazone reduces the activity of platelets in people who are or are not also taking
      aspirin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be over 21 years of age and provide written informed consent.

          -  Normal subjects must have a BMI <30 and must not have known cardiovascular disease,
             Diabetes Mellitus (DM), hyperlipidemia, or hypertension. Diabetic subjects must have
             previously diagnosed DM.

        Exclusion Criteria:

          -  Subjects will be excluded if they have hypersensitivity to aspirin or pioglitazone, or
             if they are receiving warfarin or heparin therapy, are pregnant, or have congestive
             heart failure or hepatic function impairment.

          -  Subjects must not have taken aspirin or other drugs inhibiting platelet function such
             as Plavix or non-steroidal anti-inflammatory drugs for 7 days.

          -  Subjects will be excluded if they have a history of renal failure, severe liver
             disease, myeloproliferative disease or other conditions that impair platelet function.