bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: ACT-128800 Dose 1; Placebo; ACT-128800 Dose 2; ACT-128800 Dose 3
Intervention description: ACT-128800 (Dose 1) administered orally once daily; Matching placebo administered orally once daily; ACT-128800 (Dose 2) administered orally once daily; ACT-128800 (Dose 3) administered orally once daily
Intervention MeSH terms: Ponesimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 464.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with
      relapsing-remitting multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males and females

          -  Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for
             Multiple Sclerosis (MS).

          -  Signed inform consent prior to initiation of any study-mandated procedure.

        Exclusion Criteria:

          -  A diagnosis of MS categorized as primary progressive or secondary progressive or
             progressive relapsing.

          -  Patients currently treated for an autoimmune disorder other than MS.

          -  Contraindications for MRI.

          -  Ongoing bacterial, viral, or fungal infection.

          -  History or presence of malignancy.

        Additional inclusion and exclusion criteria apply with respect to medical conditions and
        concomitant treatments which could affect patients' risk from participating in the study.
Efficacy, Safety and Tolerability Study of AVP-923 (Dextromethorphan/Quinidine) for Treatment of Symptoms of Agitation in Participants With Alzheimer's Disease
Condition: Agitation; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Psychomotor Agitation
Intervention: AVP-923-20; Placebo; AVP-923-30
Intervention description: AVP-923-20: 20 mg of dextromethorphan and 10 mg of quinidine; Placebo capsule; AVP-923-30: 30 mg of dextromethorphan and 10 mg of quinidine
Intervention MeSH terms: Quinidine; Dextromethorphan
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: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: AVP-923-20; AVP-923-30; AVP-923; Dextromethorphan; Quinidine; Neuropsychiatric Inventory; Aggression; Efficacy; Safety

Summary:

      The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923
      compared to placebo, for the treatment of symptoms of agitation in participants with
      Alzheimer's Disease (AD).
    

Eligibility criteria:

        Key Inclusion Criteria:

        Diagnosis of probable Alzheimer's disease (AD).

        The participant has clinically significant symptoms of agitation secondary to AD, that
        interfere with daily routine and for which a prescription medication is deemed indicated,
        in the opinion of the investigator.

        Either out-patients or residents of an assisted-living facility or a skilled nursing home.

        CGI-S score is ≥ 4 (moderately ill) at screening and baseline.

        Mini Mental State Examination (MMSE) score at screening between 8 and 28 (inclusive).

        Caregiver who is able and willing to comply with all required study procedures, ensuring
        that the participant attends all study visits and takes the study medication as instructed.
        In order to qualify as a caregiver for this study, the individual should spend time with
        the participant for a minimum of 4 hours on 4 separate days per week.

        Key Exclusion Criteria:

        Participant has other type of dementia (e.g., vascular dementia, frontotemporal dementia,
        Parkinson's disease, substance-induced dementia).

        Participant with co-existent clinically significant or unstable systemic diseases that
        could confound the interpretation of the safety results of the study (e.g. malignancy,
        poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or
        hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac
        conduction abnormalities including QTc prolongation, or unstable valvular heart disease).

        Participant with myasthenia gravis.
The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Condition: Smoking
Intervention: naltrexone; varenicline; placebo
Intervention description: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).; 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).; placebo
Intervention MeSH terms: Naltrexone; Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: smoking lapse behavior; smoking cessation; varenicline; naltrexone; medication effect on smoking lapse behavior

Summary:

      The purpose of this study is to examine how medications thought to attenuate the effects of
      alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to
      resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming
      drink, in non-treatment seeking alcohol-drinking daily smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 21-55

          -  ability to read and write in English

          -  alcohol-drinking smokers

        Exclusion Criteria:

          -  any significant current medical conditions that would contraindicate smoking

          -  current DSM-IV abuse or dependence of other substances, other than nicotine dependence
             or alcohol abuse.

          -  positive test result at intake appointments on urine drug screens conducted for
             opiates, cocaine, or benzodiazepines

          -  women who are pregnant or nursing

          -  suicidal, homicidal or evidence of current severe mental illness

          -  participants prescribed any psychotropic drug in the 30 days prior to study enrollment

          -  blood donation within the past 6 weeks

          -  individuals seeking treatment for smoking cessation or drinking or have attempted to
             quit smoking or drinking within the past 3 months

          -  specific exclusion for administration of naltrexone not specified above including
             chronic pain conditions necessitating opioid treatment, and evidence of significant
             hepatocellular injury as evidenced by SGOT or SGPT > 3x normal or elevated bilirubin

          -  known allergy to varenicline or taking H2blockers (e.g., Cimetidine)

          -  participation within the past 8 weeks in other studies that involve additive blood
             sampling and/or interventional measures that would be considered excessive in
             combination with the current protocol
A Trial for Patients With Advanced/Recurrent Endometrial Cancer
Condition: Neoplasms; Neoplasms by Site; Urogenital Neoplasms; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms; Cancer of Endometrium; Endometrial Cancer; Cancer of the Endometrium; Endometrium Cancer; Neoplasms, Endometrial
MeSH terms: Neoplasms; Endometrial Neoplasms; Neoplasms by Site; Urogenital Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female
Intervention: pemetrexed
Intervention description: 900 mg/m2, intravenous (IV), every 21 days, until disease progression
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Healthy volunteers: No

Summary:

      The intent of this protocol is to screen a new agent for activity in patients with advanced
      or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed
      disodium works in treating patients with advanced or recurrent endometrial carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have recurrent or persistent endometrial adenocarcinoma, which is
             refractory to curative therapy or established treatments.

          -  Patients must have measurable disease.

          -  Patients must have had one prior chemotherapeutic regimen for management of
             endometrial carcinoma.

          -  Patients must have signed an approved informed consent.

          -  Patients of childbearing potential must have a negative serum pregnancy test prior to
             the study entry and be practicing an effective form of contraception during the study
             and for at least 3 months following the last dose of Pemetrexed.

          -  Patients must discontinue nonsteroidal anti-inflammatory (NSAIDs) medications 2-5 days
             prior to and for 1-2 days after receiving Pemetrexed, depending on the half-life of
             the NSAIDs treatment.

          -  Patients must agree to this schedule in conjunction with every dose of Pemetrexed.

          -  Patients must receive 350-1000 mcg of folic acid (e.g. one prenatal vitamin) starting
             7 days prior to the first treatment with Pemetrexed.

          -  Patients must be able to ingest 350-1000 mcg of folic acid daily until 3 weeks after
             the last dose of Pemetrexed.

          -  Patients must receive 4 mg Dexamethasone by mouth twice daily, 1 day prior to the
             dose, the day of and the day after every dose of Pemetrexed.

          -  Patients must receive a 1000 mcg vitamin B12 injection 7 days prior to receiving the
             first treatment with Pemetrexed.

          -  Patients must agree to receive 1000 mcg vitamin B12 injection every 9 weeks until 3
             weeks after the last dose of Pemetrexed.

        Exclusion Criteria:

          -  Patients who have had prior therapy with Pemetrexed

          -  Patients who have received radiation to more than 25% of marrow bearing areas
Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
Condition: Left Ventricle Function
MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Left
Intervention: AZD1305; Placebo
Intervention description: iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes; iv single infusion: initial iv loading dose which will be followed by a maintenance dose given for a maximum of 90 minutes
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: AZD1305; anti-arrhythmics; safety

Summary:

      To explore if AZD1305 compromises left ventricular performance in patients with left
      ventricular dysfunction
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients and postmenopausal women

          -  Mildly/moderately decreased heart function

          -  Regular heart rhythm

        Exclusion Criteria:

          -  Potassium outside normal reference values

          -  Child bearing potential

          -  Severely decreased heart function
A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: SYM-1219; Placebo
Intervention description: Oral; Oral
Intervention MeSH terms: Secnidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 215.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety and effectiveness of the oral
      investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are females at least 18 years of age in good general health who are not menopausal.

          -  Have a clinical diagnosis of bacterial vaginosis, defined as having all of the
             following criteria:

          -  Off-white (milky or gray), thin, homogeneous vaginal discharge

          -  Vaginal pH ≥ 4.7

          -  Presence of clue cells of ≥ 20% of the total epithelial cells on microscopic
             examination of the vaginal saline wet mount

          -  A positive 10% KOH Whiff test.

          -  Have a Gram stain slide Nugent score ≥ 4 at the Baseline visit (Day 1)

        Exclusion Criteria:

          -  Are pregnant, lactating, or planning to become pregnant during the study.

          -  Are suspected clinically (or confirmed diagnostically) of having alternative causes of
             vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis,
             Neisseria gonorrhoeae or Herpes simplex.

          -  Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14
             days prior to the Baseline visit (Day 1).
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
Condition: Relapsed or Plateau-Phase Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: DENOSUMAB
Intervention description: 120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each.
Intervention MeSH terms: Denosumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma, Relapsed, Plateau-Phase

Summary:

      The purpose of this study is to determine if denosumab is effective in the treatment of
      relapsed or plateau-phase multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age ≥ 18 years

          -  clinical diagnosis of relapsed or plateau-phase multiple myeloma

          -  measurable disease (>0.5 g/dL) as determined by special blood tests

          -  ECOG 0 or 1

        Exclusion Criteria:

          -  newly diagnosed myeloma

          -  non-secretory myeloma

          -  plasma cell leukemia or plasma cell dyscrasia with POEMS syndrome

          -  prior allogeneic stem cell transplant

          -  administration of oral or IV bisphosphonates within 2 weeks of enrollment to study

        Other criteria also apply.
A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Multivalent; Tdap; polysaccharide
Intervention description: Pneumococcal conjugate vaccine; Tetanus, diphtheria, acellular pertussis vaccine; 23-valent pneumococcal polysaccharide vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Observer-blinded
Enrollment: 511.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a
      2-arm parallel design in each stage.

      In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination
      will be randomized equally to receive either a single intramuscular dose of multivalent
      pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis
      combination vaccine (Tdap) (control group).

      In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2
      months prior to investigational product administration will be randomized equally to receive
      either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the
      licensed 23-valent pneumococcal polysaccharide vaccine (control group).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage 1: Healthy male or female adults 50 to 64 years of age with no history of
             pneumococcal vaccination

          -  Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated
             with Prevnar 13 >= 2 months prior to investigational product administration

        Exclusion Criteria:

          -  Stage 1: Vaccination within 12 months before investigational product administration
             with diphtheria-, pertussis-, or tetanus-containing vaccine

          -  Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior
             dose of Prevnar 13
Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
Condition: Acute Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Intervention: Tacrolimus (TAC); Methotrexate (MTX); Rapamycin (RAPA)
Intervention description: Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.; Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance.; Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.
Intervention MeSH terms: Sirolimus; Methotrexate; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Acute Graft Versus Host Disease (aGVHD); GVHD; graft-versus-host disease; tacrolimus; sirolimus; methotrexate; combination therapy; GVHD prophylaxis

Summary:

      The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to
      Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease.
      Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell
      transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone
      marrow and blood cells that come from someone other than the patient (a donor).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 16 and ≤ 70

          -  Signed informed consent

          -  Adequate vital organ function

          -  No active infection, or asymptomatic infection well controlled by antibiotic HIV
             negative by ELISA or RT-PCR [if ELISA is positive and RT-PCR is negative, the ELISA is
             considered false positive]

          -  Hepatitis B and C negative by serology or RT-PCR

          -  Performance status: Karnofsky Performance Status Score ≥ 60%.

        Exclusion Criteria:

          -  Those with any Sorror's co-morbidity factors with score > 3

          -  2 or more Sorror's factors with composite score of ≥ 3
A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell
Intervention: Regorafenib (Stivarga, BAY73-4506)
Intervention description: Patients will be treated with BAY73-4506 160 mg po qd for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Patients will continue treatment with BAY73-4506 until disease progression, intolerable toxicity, or patient refusal to continue with the study or investigator decision to remove the patient from study.
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
Healthy volunteers: No
Keywords: Renal Cell Carcinoma

Summary:

      This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to
      evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or
      unresectable renal cell cancer (RCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients >/= 18 years of age.

          -  Patients, who suffer from unresectable and/or metastatic, measurable predominantly
             clear cell RCC (renal cell carcinoma histologically) or cytologically documented.

          -  Patients must be previously untreated for advanced disease. Prior palliative radiation
             therapy is allowed if the target lesion(s) are not included within the radiation field
             and no more than 30% of the bone marrow is irradiated.

          -  Patients who have at least one uni-dimensional measurable lesion by computed
             tomography (CT-scan) or magnetic resonance imaging (MRI) according to Response
             Evaluation Criteria in Solid Tumors (RECIST).

          -  Patients with "Intermediate" or "Low" risk per the Motzer score.

          -  Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of
             0 or 1.

          -  Adequate bone marrow, renal and hepatic function as assessed by the following
             laboratory requirements to be conducted within 7 days prior to study drug treatment

        Exclusion Criteria:

          -  Patients who have received prior systemic treatment regimens for RCC.

          -  Uncontrolled/unstable cardiac disease

          -  Uncontrolled hypertension

          -  Active clinically serious infections (> Common Terminology Criteria for Adverse Events
             [CTCAE] grade 2 )

          -  History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.

          -  Known history or symptomatic metastatic brain or meningeal tumours

          -  Patients with seizure disorder requiring medication

          -  Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding
             event >/= CTCAE Grade 3 within 4 weeks of first dose of study.

          -  Pregnant or breast-feeding patients