bioihbjkbjnl/mcl2 huggingface dataset:
Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Melphalan; Bortezomib
Intervention description: Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
Dosing will be based on body surface area calculated using actual body weight
Stem cell infusion:
Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of melphalan. The infusion of peripheral blood stem cells will be done in accordance with the Blood and Marrow Transplant program standard operating procedures.
Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day starting on day+3 then daily starting on day 9 until engraftment (at least).; Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
Intervention MeSH terms: Bortezomib; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: multiple myeloma; transplant

Summary:

      In this study the investigators are comparing this standard regimen to the newly established
      regimen of melphalan and bortezomib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of multiple myeloma less than 12 months since initiation of
             systemic therapy

          -  Age ≥60 years at time of transplantation

          -  KPS 70-100%

          -  Recovery from complications of prior therapy

        Exclusion Criteria:

          -  Diagnosis other than multiple myeloma

          -  Chemotherapy or radiotherapy within 8 days of initiating treatment in this study

          -  Prior dose-intense therapy within 56 days of initiating treatment in this study

          -  Uncontrolled bacterial, viral, fungal or parasitic infections

          -  Uncontrolled CNS metastases

          -  Known amyloid deposition in heart

          -  Organ dysfunction

          -  LVEF <40% or cardiac failure not responsive to therapy

          -  FVC, FEV1 or DLCO < 40% of predicted and/or receiving supplementary continuous oxygen

          -  Evidence of hepatic synthetic dysfunction or total bilirubin > 2x or AST > 3x ULN

          -  Measured creatinine < 20ml/min

          -  Sensory peripheral neuropathy grade 4 within 14 days of enrollment

          -  Karnofsky score < 70%

          -  Life expectancy limited by other co-morbid illnesses
HDR Brachytherapy 68-Ga-RM2 PET, 68-Ga-PSMA-11 PET &Multi Parametric MRI in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68-Ga RM2.; 68-Ga PSMA11; PET/MRI
Intervention description: PET radiopharmaceutical; PET radiopharmaceutical; PET/MR scanner by GE healthcare
Intervention MeSH terms: Gallium 68 PSMA-11; Bombesin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being conducted to determine whether the combination of imaging agents 68-Ga
      RM2 and 68-Ga PMSA11 is better at assessing response to high dose rate (HDR) local therapy
      than standard imaging or biopsy in patients with known prostate cancer (PC)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be at least 18 years of age;

          -  Patients must be able to provide informed consent;

          -  Histologically proven low-grade or intermediate-grade prostate cancer (PC)

          -  Scheduled to undergo targeted local therapy (HDR brachytherapy).

        Exclusion Criteria:

          -  Inability to lie still for the entire imaging time;

          -  Inability to complete the needed investigational and standard-of-care imaging
             examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);

          -  Any additional medical condition, serious intercurrent illness, or other extenuating
             circumstance that, in the opinion of the Investigator, may significantly interfere
             with study compliance;

          -  Metallic implants (contraindicated for MRI).
A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
Condition: Bacterial Enteritis
MeSH terms: Enteritis
Intervention: OPS-2071 tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 19 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial
      Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient provides written, informed consent before the clinical trial is initiated

          -  The patient has distinctive symptoms and findings of bacterial enteritis

          -  The patient has bacterial enteritis with one or more of the following causative
             pathogens either proven or presumed: C. difficile, Salmonella, Campylobacter,
             pathogenic E. coli, and other bacteria estimated to cause bacterial enteritis

          -  The patient and his/her partner are willing to take contraceptive measures from
             initiation of investigational medicinal products (IMPs) to 4 weeks after
             administration of IMPs

        Exclusion Criteria:

          -  The patient has severe or progressive underlying disease or complication, making it
             difficult to ensure safety in the study or proper efficacy assessment

          -  The patient has a current diagnosis or history of convulsive disorders, such as
             convulsion and epilepsy

          -  The patient has a severe hepatic dysfunction

          -  The patient has a severe cardiac dysfunction

          -  The patient has cardiac arrhythmia or congenital or sporadic long QTc syndrome. Or the
             patient is treated with a drug reported to prolong QTc interval

          -  The patient has a moderate or severe renal dysfunction

          -  Women with confirmed or suspected pregnancy or breast-feeding women

          -  Patients judged to be ineligible by the investigator for any other reasons
PRO 140 by IV Administration in Adults With HIV-1 Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases
Intervention: PRO 140; PRO 140; Placebo
Intervention description: 10 mg/kg PRO 140, one IV dose (N=10); 5 mg/kg PRO 140, one IV dose (N=10); PBO, one IV dose (N=10)
Intervention MeSH terms: Leronlimab; HIV Antibodies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; treatment naïve

Summary:

      The purpose of this study is:

        1. To assess and characterize the PK and PD of PRO 140 administered IV

        2. To assess the antiviral activity of PRO 140

        3. To assess the safety and tolerability of PRO 140
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males & females, age ≥ 18 years (or minimum adult age as determined by local
             regulatory authorities)

          2. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL

          3. CD4+ T-lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250
             cells/mm3

          4. Has not taken any anti-retroviral therapy (ART) w/in 12 wks of Early Screening Visit

          5. Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit

          6. Clinically normal or "not clinically significant (NCS)" resting electrocardiogram

          7. Women of reproductive potential must have a negative serum pregnancy test at Late
             Screening Visit & a negative urine pregnancy test w/in 72 hrs prior to first dose of
             study medication, & be non-lactating. Male & female subjects must agree not to
             participate in a conception process from Early Screening Visit through Day 59.

        Exclusion Criteria:

          1. CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.

          2. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant
             during the study.

          3. History of active hepatitis within the previous 24 wks

          4. Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, experimental
             or approved.
Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Placebo; DP001
Intervention description: oral, once daily; oral, once daily
Intervention MeSH terms: Dihydroxycholecalciferols
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 157.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoporosis; 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3; Vitamin D; Bone Density Conservation Agents; Bone Regeneration

Summary:

      This study will evaluate the effect of a 1-year administration of the vitamin D analog
      2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density
      (BMD), safety, and tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal female subjects, defined as amenorrheic for at least 5 years

          -  Body Mass Index of 18 to 35

          -  Osteopenic

          -  Generally healthy

          -  Informed consent

        Exclusion Criteria

          -  History or evidence of acute or unstable chronic hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, psychiatric, or neurologic diseases

          -  Current or recent treatment with any medications or products affecting vitamin D
             metabolism, calcium balance, bone turnover, or an investigational drug therapy

          -  12-lead electrocardiogram demonstrating QTc (QT interval corrected for heart rate)
             >450 milliseconds at screening

          -  Abnormal creatinine clearance

          -  Elevated urinary calcium levels

          -  Vitamin D deficiency

          -  Excessive dietary calcium or vitamin D intake

          -  Current use of any illicit drug and/or history of alcohol abuse
Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy
Condition: Cancer; Influenza Viral Infections
MeSH terms: Influenza, Human; Virus Diseases
Intervention: Standard Trivalent Influenza Vaccine; High-Dose Influenza Vaccine
Intervention description: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.; Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Influenza vaccine; Oncology; Chemotherapy

Summary:

      The safety and immunogenicity of high dose influenza vaccine has not been studied in young
      patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and
      safety of high dose influenza to standard dose influenza vaccine in adult oncology patients
      who are younger than 65 years old receiving chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years old to less than 65 years old

          2. Subjects with malignancy must be receiving chemotherapy

          3. Medically stable

          4. Able to understand and willingness to sign a written informed consent

          5. Able to comply with study procedures

          6. Life expectancy of more than 3 months

          7. Adequate organ function:

               -  ANC >1000/mm3

               -  Platelet >100,000/uL

               -  Creatinine <2 mg/dL

               -  AST and ALT <3 times the ULN

        Exclusion Criteria:

          1. Allergy to eggs

          2. Prior allergy to Influenza Vaccine

          3. History of Guillain-Barre Syndrome

          4. Current febrile illness

          5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled
             HIV)

          6. Autologous or Allogenic Stem Cell Transplant with in a year

          7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or
             ofatumumab)
Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension
Condition: Primary Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Bimatoprost; Timolol 0.5%; Placebo Eye Drops; Placebo Ocular Insert
Intervention description: Bimatoprost ocular insert; Timolol 0.5% solution; Placebo topical eye drops; Ocular insert without any active drug
Intervention MeSH terms: Timolol; Bimatoprost; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Primary Open-Angle Glaucoma; Ocular Hypertension

Summary:

      The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is
      non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Written informed consent

          -  Primary open-angle glaucoma or ocular hypertension in both eyes

          -  Best-corrected distance vision of 20/80 or better

          -  Stable visual field

          -  corneal thickness between 490-620 micrometers

        Key Exclusion Criteria:

          -  Cup-to-disc ratio greater than 0.8

          -  significant risk of angle closure due to pupil dilation, defined as a Shaffer
             classification of less than grade 2 based on gonioscopy

          -  laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12
             months

          -  past history of corneal refractive surgery

          -  past history of any incisional surgery for glaucoma at any time

          -  corneal abnormalities that would interfere with tonometry readings

          -  current participation in an investigational drug or device study or participation in
             such a study within 30 days of screening

          -  Inability to accurately evaluate the retina
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
Condition: Schizophrenia; Major Depressive Disorder; Bipolar I Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Aripiprazole + IEM (Ingestible Event Marker)
Intervention description: Oral aripiprazole (2, 5, 10, 15, 20, or 30 mg) with an ingestible event marker in a single daily dose for duration of the trial.
Intervention MeSH terms: Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will assess the helpfulness of the integrated call center in optimizing use of the
      Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or
      Bipolar Disorder taking oral aripiprazole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary diagnosis of Schizophrenia (SCH), Major Depressive Disorder (MDD), or Bipolar
             1 Disorder (BP1), per the Diagnostic and Statistical Manual of Mental Disorders, Fifth
             Edition (DSM-5)

          -  Must be able to swallow tablets

          -  Currently taking a stable daily dose of oral aripiprazole

          -  Must have capacity to utilize the technology

          -  Skin in area of patch application must be free of any skin disorders or dermatological
             problems

        Exclusion Criteria:

          -  Subjects using long acting injectable antipsychotic medications

          -  Subjects likely to be incapable of using the Digital Medicine System even with
             assistance

          -  Subjects who present serious risk of suicide

          -  History of epilepsy or seizures

          -  History of hypersensitivity to antipsychotic agents, adhesive tape or any component of
             the sensor skin patch or ingestible event marker

          -  Current history of substance use disorder meeting DSM-5 criteria

          -  Subject with unstable mood, acute psychosis or exhibiting symptoms requiring
             hospitalization
Aprepitant and Granisetron for the Prophylaxis of Radiation Induced Nausea and Vomiting - A Pilot Study
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Aprepitant; Palliative radiation therapy; Granisetron
Intervention description: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.; Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.; Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT).
Intervention MeSH terms: Aprepitant; Granisetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Healthy volunteers: No
Keywords: nausea; vomiting; antiemetics; radiotherapy; Radiation-induced nausea and vomiting

Summary:

      The primary objective of this pilot study is to examine the efficacy of Aprepitant given in
      combination with Granisetron for the prevention of delayed-phase RINV in 84 patients
      receiving a single 8Gy of moderately emetogenic palliative RT in the RRRP at Sunnybrook
      Odette Cancer Centre for painful bony metastases from any primary solid tumor. Patients will
      be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least
      one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings
      on Days 1 and 2 following the radiation treatment.. Secondary objectives include determining
      the complete RINV prophylaxis rate (acute and delayed phases), the partial emesis control
      rate, the safety of the combined regime, QOL issues, the time to the first emetic event and
      the time to the first use of rescue medication .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with bone metastases from any primary solid tumor site scheduled to receive a
             single 8 Gy fraction of palliative radiotherapy considered to be moderately emetogenic
             (an area of at least 80 cm2 in the anterior/posterior direction and located between
             the level of upper border of T11 and the lower border of L3) in the RRRP at Sunnybrook
             Odette Cancer Centre will be considered eligible.

        Exclusion Criteria:

          -  Exclusion criteria include having nausea or vomiting 24hrs prior to radiation

          -  Having received or being scheduled to receive cranial radiation, moderately or highly
             emetogenic cytotoxic therapy 7 days prior to, during, or after radiation, receiving
             corticosteroids (except inhaled or topical), 5HT3 receptor antagonists or NK-1
             antagonists or other antiemetic medication, being allergic to study medications,
             having a KPS<40, being pregnant or of childbearing potential and not using
             contraceptive measures.
Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: Emtricitabine
Intervention description: 6 mg/kg capsule once daily, up to a maximum dose of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
Intervention MeSH terms: Emtricitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 1 Month
Maximum age: 17 Years
Healthy volunteers: No
Keywords: HIV-1 infection; emtricitabine; pediatrics; pediatric patients

Summary:

      The primary objectives of this trial are to provide FTC-203 study participants in South
      Africa with continued access to the study drug, emtricitabine (FTC), following completion of
      the FTC-203 study and to collect long-term safety information in participants receiving
      emtricitabine in combination with other antiretroviral agents.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Complete or have previously completed at least through the Week 96 Visit (i.e., 96
             weeks on study) for the FTC-203 study.

          -  Complete all End-of-Study Visit procedures for the FTC-203 study.

          -  Either (a) have a plasma HIV-1 RNA viral load of ≤ 400 copies/mL at the End-of-Study
             Visit for the FTC-203 study, or (b) if the subject's plasma HIV-1 RNA viral load at
             the End-of-Study Visit for FTC-203 study is > 400 copies/mL, their viral load is < 1.0
             log10 above the nadir recorded after Week 8 of the FTC-203 study and there is reliable
             genotypic evidence showing a lack of resistance to emtricitabine.

          -  A parent or other legal guardian has provided written informed consent to the subject
             participating in the rollover protocol. As applicable, based on the subject's age and
             normal institution practice, the subject should additionally provide their written
             informed consent or assent to participate in the rollover protocol.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.