bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: Standard chemotherapy; bevacizumab [Avastin]
Intervention description: As prescribed; 7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label two-arm study will assess the safety and efficacy of a combination of
      bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in
      childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma
      soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard
      chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of
      induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1
      of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy
      with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time
      on study treatment is 1-2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  childhood and adolescent patients aged >/=6 months to 18 years of age

          -  metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma

          -  adequate bone marrow function

          -  adequate renal and liver function

          -  adequate blood clotting

        Exclusion Criteria:

          -  previous malignant tumors

          -  tumor invading major blood vessels

          -  prior systemic anti-tumor treatment
Titrating-Dose of Lonafarnib in Combination With Ritonavir
Condition: Chronic Delta Hepatitis
MeSH terms: Hepatitis D; Hepatitis D, Chronic; Hepatitis
Intervention: lonafarnib; Ritonavir
Intervention description: antiviral farnesyltransferase inhibitor; Cytochromes P450 3A4 inhibitor used to boost lonafarnib
Intervention MeSH terms: Ritonavir; Lonafarnib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamic activity of titrating-dose lonafarnib/ritonavir in patients chronically
      infected with hepatitis delta virus (HDV)
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female, 18 to 65 years of age, inclusive

          2. Chronic HDV infection documented by a positive HDV antibody (Ab) test of at least 6
             months duration and detectable HDV ribonucleic acid (RNA) by quantitative polymerase
             chain reaction (qPCR) at study entry

          3. Liver biopsy demonstrating evidence of chronic hepatitis

          4. Willingness to practice appropriate contraception

        Key Exclusion Criteria:

          1. Previous use of lonafarnib

          2. Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)

          3. Active jaundice defined by total bilirubin level >2.0 mg/dL and known not to have
             Gilbert's disease

          4. Decompensated liver disease or cirrhosis, history of bleeding esophageal varices,
             ascites, or hepatic encephalopathy

          5. Serum creatinine concentration ≥1.5 times upper limit of normal (ULN)

          6. Evidence of another form of viral hepatitis (not including hepatitis B virus or HCV)
             or another form of liver disease

          7. Evidence of hepatocellular carcinoma

          8. Use of alfa interferon, either interferon alfa-2a or interferon alfa-2b, or
             peginterferon alfa-2a within 2 months before the start of screening

          9. Concomitant use of any of the following:

               1. Medications or foods that are known moderate or strong inducers or inhibitors of
                  CYP3A4 or CYP2C19

               2. Drugs known to prolong the PR interval or QT interval of the electrocardiogram

               3. Receipt of systemic immunosuppressive therapy within the 3 months before start of
                  screening

               4. Statins, due to inhibition of mevalonate synthesis, which reduces protein
                  prenylation

               5. Medications contraindicated in the prescribing information for ritonavir
Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain
Condition: Crohn's Disease; Abdominal Pain
MeSH terms: Crohn Disease; Abdominal Pain
Intervention: Olorinab
Intervention description: Olorinab active treatment for 8 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this randomized, open-label, parallel, phase 2a study is to determine the
      tolerability, pharmacokinetics, and efficacy of olorinab in participants with Crohn's disease
      experiencing abdominal pain.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A clinical diagnosis of Crohn's disease for at least 3 months prior to screening
             corroborated by prior endoscopic and histopathologic documentation consistent with
             Crohn's disease.

          -  Quiescent to mildly active inflammatory Crohn's disease defined with a total of simple
             endoscopy score for Crohn's disease (SES-CD) score of < 10 or fecal calprotectin < 500
             mcg/g within 4 weeks before Screening.

          -  Moderate to severe abdominal pain as defined by average abdominal pain score (AAPS) of
             >/= 4points on 7 consecutive days of the screening period up to Day -2. AAPS will be
             based on the 11-point numeric rating scale where 0 (no abdominal pain) to 10 (worst
             possible abdominal pain).

        Key Exclusion Criteria:

          -  Female participants who are lactating or have a positive serum pregnancy test during
             the screening period or a positive urine pregnancy test on Day 1 prior to study drug
             administration.

          -  Recent history (within 6 months of screening visit) of cerebrovascular disease, Acute
             Coronary Syndrome, Cerebrovascular accident, Transient ischemic attack, Myocardial
             infarction, unstable angina.

          -  Other significant chronic pain conditions that in the opinion of the Investigator may
             influence the abdominal pain score.

          -  History of extensive colonic resection, subtotal or total colectomy.

          -  History of >3 small bowel resections or diagnosis of short bowel syndrome or who have
             undergone bowel resection within 6 months prior to randomization.

          -  Chronic active hepatitis B within the last year (unless shown at the time of study
             entry to be hepatitis B antigen negative) or any history of hepatitis C.

          -  Evidence of current gastro-intestinal infection (bacterial or parasitic) or
             significant infection within 45 days of screening.

        Note: other protocol defined Inclusion/Exclusion criteria may apply.
The Influence of Postoperative Analgesia on Systemic Inflammatory Response and POCD After Femoral Fractures Surgery
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Femoral Fractures; Cognitive Dysfunction
Intervention: morphine; levobupivacaine
Intervention MeSH terms: Morphine; Levobupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: postoperative analgesia; postoperative cognitive disfunction

Summary:

      The purpose of this study is to determine whether epidural levobupivacaine applied for the
      purpose of post-operative analgesia compared to systemic analgesia with morphine leads to
      better pain control, stronger suppression of the inflammatory response and the production of
      inflammatory mediators, faster recovery of patients and consequently less incidence of
      postoperative cognitive dysfunction (POCD) in elderly patients after surgical treatment of
      femoral fractures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients age 65 and over

          -  fracture of the proximal femur

          -  preoperative assessment American Society of Anesthesiologists(ASA) score I - ASA III

          -  a written consent of the patient to participate in research

        Exclusion Criteria:

          -  patient non-compliance

          -  ASA status IV and IV above

          -  patients younger than 65 years

          -  dementia, Parkinson's disease, cerebrovascular accident history; simultaneous head
             injuries,the use of opioids and benzodiazepines longer than a month before the
             surgery; alcoholism; serious liver disease (class C according to Child-Pugh's
             classification); severe kidney disease that require dialysis

          -  result of MMSE test (Mini-Mental State Examination) under 17

          -  the existence of any contraindications for the implementation of regional anesthesia
             and one or other form of post-operative analgesia.
Eltrombopag for Post Transplant Thrombocytopenia
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Intervention: Eltrombopag; Placebo
Intervention description: Starting daily dose 50 mg orally on empty stomach (1 hour before or 2 hours after a meal) for 8 weeks. East Asians start at 25 mg daily.; Once a day, orally for 8 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Transplant Thrombocytopenia; Hematopoietic cell transplantation; HCT; Low platelet count; Bleeding; Blood clot; Stem Cell Transplant; Blood And Marrow Transplantation; Eltrombopag; Promacta

Summary:

      The goal of this clinical research study is to learn if eltrombopag can help to improve
      platelet counts in patients with low platelets after they have had a stem cell transplant.
      The safety of this drug will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients >/= 35 days post HCT with Platelet count </= 20 x 10^9/l sustained for 7 days
             or patients are platelet transfusion dependent, and

          2. Neutrophil count >/= 1.5 x 10^9/l anytime within the last seven days before
             enrollment. Patients can be on myeloid or erythroid growth factors for example
             filgrastim), and

          3. Age >/= 18

        Exclusion Criteria:

          1. Recurrence or progression of primary malignancy after HCT

          2. ALT >/= 2.5 times the ULN

          3. Serum bilirubin >2mg/dl (unless due to Gilbert's syndrome)

          4. Documented deep vein thrombosis within 1 year before enrollment on the study, except
             if upper arm thrombosis related to central venous catheters, within 3 months before
             enrollment on the study.

          5. ECOG Performance status >2

          6. Pregnancy: Women of child-bearing potential and men must agree to use contraception
             prior to study entry and for the duration of study participation. A woman of
             child-bearing potential is defined as a woman who has not been naturally
             post-menopausal for at least 12 consecutive months or with no previous surgical
             sterilization. A negative pregnancy test result will be required before any study drug
             is given.
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
Condition: Candidemia
MeSH terms: Candidemia
Intervention: APX001
Intervention description: APX001
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy
      and safety of APX001 for the first-line treatment for candidemia including suspected or
      confirmed antifungal-resistant candidemia in non-neutropenic patients 18 yeas of age and
      older.

      Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not
      required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14
      days. After completion of 14 days study drug therapy, if further antifungal treatment is
      indicated to complete treatment of candidemia in accordance with standard practice
      guidelines, fluconazole (unless susceptibility results warrant alternative antifungal
      therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks
      (+4 days) after EOT. The total duration of participation in the study is up to approximately
      7.5 weeks.

      This study will be conducted at approximately 20 sites in the United States and globally.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Provision of written consent

          -  Adults ages 18 and above male or female

          -  New diagnosis of candidemia

          -  Able to have pre-existing intravascular catheters removed and replaced (as necessary)

        Key Exclusion Criteria:

          -  neutropenia

          -  deep-seated Candida-related infections

          -  hepatosplenic candidiasis

          -  received more than 2 days of prior systemic antifungal treatment for current
             candidemia episode

          -  severe hepatic impairment
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Cyclophosphamide; Etoposide; Melphalan; Carmustine; Filgrastim
Intervention description: Cyclophosphamide as a white powder in 100 mg, 200 mg and 500 mg vials, to be dissolved in ~250 mL of saline or D5W and infused IV over 2 hours; 100 mg etoposide as 5 mL solution in clear ampules for injection.; Melphalan as single-use glass vials of freeze-dried melphalan hydrochloride (equivalent to 50 mg of melphalan), to be reconstituted in 0.9% sodium chloride solution to not greater than 0.45 mg/mL, and administered within 1 hour of constitution.; Carmustine as a powder for reconstitution in 100 mg vials, to be reconstituted with 3 mL sterile dehydrated ethanol and D5W. Carmustine should be dissolved in 500 mL of 5% dextrose in water (D5W) and infused IV over 2 hours.; Filgrastim in vials of 300 µg or 480 µg at a concentration of 300 µg/mL, to be given as a daily subcutaneous injection.
Intervention MeSH terms: Cyclophosphamide; Melphalan; Carmustine; Etoposide; Etoposide phosphate; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to
      treat multiple myeloma. The study is being performed to evaluate the efficacy and side
      effects of treatment. Specifically, the study is designed to reduce the risk of interstitial
      pneumonitis.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Stage II to III multiple myeloma, or progression after initial treatment of Stage I
             disease; early or relapsed

          -  Age 18 to 75 years.

          -  Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.

          -  Patients with amyloidosis may be eligible for this trial, with approval by the
             Principle Investigator.

          -  Patients must have a Karnofsky performance status > 70%.

          -  Aspartate aminotransferase (AST) must be < 2 x upper limit of normal (ULN)

          -  Alanine aminotransferase (ALT) must be < 2 x ULN

          -  Total bilirubin < 2 mg/dL.

          -  Serum creatinine < 2.0 or 24-hour creatinine clearance ≥ 60 mL/min.

          -  Patients must be HIV-negative.

          -  Patients must provide signed, informed consent.

        EXCLUSION CRITERIA

          -  Severe psychological or medical illness

          -  Prior autologous hematopoietic cell transplantation

          -  Pregnant

          -  Lactating women

          -  Smoldering multiple myeloma,

          -  Monoclonal gammopathy of unknown significance or primary amyloidosis will be excluded
             from this study
Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
Condition: Acute Pain
MeSH terms: Emergencies; Acute Pain
Intervention: Placebos; Lorazepam
Intervention description: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients; The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.
Intervention MeSH terms: Lorazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      In this proposal, the investigators will determine if a single dose of oral lorazepam reduces
      distress, pain severity, and need for opiate analgesics both in the ED and in the acute
      recovery period after discharge. The investigators will compare the lorazepam arm to a
      placebo arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults between the ages of 18-65

          -  Sustained a physical injury with a pain score ≥ 5 on the numeric rating scale [NRS]
             from 0- 10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable"

          -  Expected to be in the ED for at least 2 hours, in a private treatment room

          -  Ownership of a cell phone with text messaging capabilities

          -  Emergency Department admission assessment confirmed subject is not suicidal.

        Exclusion Criteria:

          -  Non-English speaking

          -  Not medically suitable for lorazepam per treating MD (e.g. medical condition where
             benzodiazepines are contraindicated or may be unsafe)

          -  Not alert and oriented

          -  Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by
             treating team

          -  Seeking treatment due to a mental health or substance use disorder

          -  History of chronic opioid use

          -  Prescribed opioid or benzodiazepine use within the past 24 hours

          -  Alcohol use within the past 12 hours or medical history of alcoholism.

          -  Clinical indication for open-label benzodiazepine administration in the ED.

          -  Any use of recreational narcotics throughout lifetime

          -  Sensitivity or allergy or intolerance to opioids or benzodiazepines

          -  Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure
             disorder, etc.)

          -  Prisoner
Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer
Condition: Mucositis; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Mucositis
Intervention: Ketamine; Placebo
Intervention description: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mucositis; head and neck; cancer; radiation therapy; chemoradiation; oral; pain

Summary:

      -  The primary objective is to determine the reduction in pain score by ketamine mouthwash
           compared to placebo in head and neck cancer patients with refractory mucositis.

        -  The secondary objectives are to describe the duration of analgesia and adverse effects
           associated with ketamine and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed with head and neck tumors (any histology) receiving ongoing
             chemoradiation or radiation therapy

          -  Subjects with mucositis pain refractory to topical management, defined as any
             self-reported pain score of > 2 in the 24 hours prior to enrollment despite use of
             topical agents as prescribed

          -  Age ≥ 18 years

          -  Ability to understand and willingness to consent and to sign consent form

        Exclusion Criteria:

          -  Active substance abuse at time of registration (alcohol, drugs, non-prescription use
             of controlled substances)

          -  Subjects with history of allergic reactions to ketamine

          -  Persistent oral bleeding: > 15 mL (estimated) per day

          -  Pregnancy or breast feeding