bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Intervention: MEDI8897; Placebo
Intervention description: A single IM dose of 50 mg on Day 1 of the study.; A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1453.0
Sex: All
Maximum age: 365 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory Syncytial Virus, RSV; Preterm Infants; Lower Respiratory Tract Infection

Summary:

      The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and
      antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29
      and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV)
      season.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.

          2. Infants who are entering their first full RSV season at the time of screening.

        Key Exclusion Criteria:

          1. Meets American Academy of Pediatrics (AAP) or other local criteria to receive
             commercial palivizumab.

          2. Any fever (>= 100.4°F [>= 38.0°C], regardless of route) or lower respiratory illness
             within 7 days prior to randomization.

          3. Acute illness (defined as the presence of moderate or severe signs and symptoms) at
             the time of randomization.

          4. Active RSV infection (a child with signs/symptoms of respiratory infection must have
             negative RSV testing) or known prior history of RSV infection.

          5. Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including
             maternal RSV vaccination.
Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Condition: Infectious Skin Disease; Bacterial Skin Disease
MeSH terms: Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases
Intervention: PTK 0796; Linezolid
Intervention description: PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg; Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets
Intervention MeSH terms: Linezolid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: CSSSI

Summary:

      A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of
      complicated skin and skin structure infections (cSSSI).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients, ages 18 years to 80 years

          2. Has an acute complicated skin and skin structure infection

          3. Female patients must not be pregnant at the time of enrollment and must agree to a
             reliable method of birth control during the study and for 30 days following the last
             dose of study drug

        Exclusion Criteria:

          1. Has received an investigational drug within past 1 month

          2. Has been previously enrolled in this protocol

          3. Has received >48 hr of a potentially effective systemic antibiotic immediately prior
             to study drug

          4. Is nursing
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
Condition: Chronic Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: OBV/PTV/r; Sofosbuvir; Ribavirin (RBV)
Intervention description: Tablet; Tablet; Tablet
Intervention MeSH terms: Ritonavir; Ribavirin; Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus; Genotype 2; Chronic Hepatitis C; Genotype 3; Non-cirrhotic; Cirrhotic

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Ombitasvir
      (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV)
      in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV
      infection with or without Cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chronic HCV infection prior to study enrollment.

          2. Screening laboratory results from the central clinical laboratory indicating HCV
             genotype 2 or 3 infection only (no mixed genotype).

          3. Absence OR presence of cirrhosis.

          4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular
             carcinoma (HCC)

        Exclusion Criteria:

          1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus
             antibody

          2. Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse.

          3. Current enrollment in another clinical study, previous enrolment in this study, or
             previous use of any investigational or commercially available anti-HCV therapy (other
             than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir,
             boceprevir, ABT-450, or ombitasvir (ABT-267).

          4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.

          5. Abnormal lab tests.

          6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose
             partners are pregnant or planning to become pregnant
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Intervention: Serelaxin; Placebo
Intervention description: Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen; Matching placebo i.v infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Serelaxin,; Chronic heart failure,; Spiroergometry,; Troponin,; New York Heart Association (NYHA) functional Class II/III,; Left ventricular ejection fraction,

Summary:

      This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II
      clinical study that evaluated the effect of serelaxin versus placebo (both in addition to
      SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female ≥ 18 years of age, with body weight ≤ 160 Kg

          -  Diagnosis of stable CHF:

               -  New York Heart Association (NYHA) functional Class II/III.

               -  Receiving guideline-recommended treatment for CHF.

          -  Left ventricular ejection fraction < 45%, obtained within the last 3 months prior to
             screening.

          -  NT-proBNP > 300 ng/L in sinus rhythm or > 900 ng/L if not in sinus rhythm (determined
             locally).

          -  Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.

          -  Systolic BP ≥ 125 mmHg at randomization

          -  Renal function defined as an eGFR of ≥ 25 mL/min/1.73 m^2 at screening (sMDRD
             formula).

        Key Exclusion Criteria:

          -  Dyspnea primarily due to non-cardiac causes.

          -  Increased risk of developing hypotension during vasodilator therapy according to
             investigators judgement.

          -  Any contraindication for exercise testing and spirometry.

          -  Stopping of the spiroergometry at screening according to the stopping rules, unless
             the patient has reached maximum exercise capacity defined as carbon dioxide
             production/oxygen consumption (VCO2/VO2) > 1.05.

          -  Change in guideline-recommended CHF treatment within 1 month prior to screening.
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Patients With Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab; Placebo
Intervention description: Subjects will receive bimekizumab injections every four weeks (Q4W); Subjects will receive Placebo injections every four weeks (Q4W)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic plaque psoriasis; Psoriasis; Bimekizumab

Summary:

      This is a multicenter extension study to assess the long-term safety, tolerability and
      efficacy of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent

          -  Subject completes all dosing requirements in feeder study and completes PS0010 study
             without meeting any withdrawal criteria

          -  Female subjects of childbearing potential and male subjects with a partner of
             childbearing potential must continue to use an acceptable method of contraception (as
             detailed in PS0010) for up to 20 weeks after the last dose of study treatment in
             PS0011

        Exclusion Criteria:

          -  Subject has previously participated in this study.

          -  Female subjects who plan to become pregnant during the study or within 20 weeks
             following last dose of study medication. Male subjects who are planning a partner
             pregnancy during the study or within 20 weeks following the last dose

          -  Subject has any medical or psychiatric condition that, in the opinion of the
             Investigator, could jeopardize or would compromise the subject's ability to
             participate in this study.

          -  Subject must have a negative interferon gamma release assay (IGRA) as measured at Week
             8 of PS0010
Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: AVI-4658 (Eteplirsen)
Intervention description: Eteplirsen will be administered once weekly via an IV infusion. There are two treatment groups, 30 mg/kg and 50 mg/kg.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 7 Years
Maximum age: 13 Years
Healthy volunteers: No
Keywords: DMD, Duchenne, Eteplirsen, dystrophy, dystrophin, exon 51

Summary:

      The primary objective of this study is to assess the ongoing efficacy, safety, and
      tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne
      muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen
      study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers
      for DMD and the clinical status of participating DMD subjects.
    

Eligibility criteria:

        Inclusion Criteria:

        A subject must meet all of the following criteria to be eligible for this study.

          1. The subject and/or their parent/legal guardian are willing and able to provide signed
             informed consent.

          2. The subject has successfully completed 28 weeks of treatment in Study 4658-US-201.

          3. The subject has a parent(s) or legal guardian(s) who is able to understand and comply
             with all of the study procedure requirements.

        Exclusion Criteria:

        A subject who meets any of the following criteria will be excluded from this study.

        1. The subject has a prior or ongoing medical condition that, in the Investigator's
        opinion, could adversely affect the safety of the subject or make it unlikely that the
        course of treatment or follow-up would be completed or impair the assessment of study
        results.
Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer
Condition: Breast Cancer; Ductal Carcinoma in Situ
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Intervention: Intranasal Oxytocin
Intervention description: Intranasal spray, one spray or 4 IU of oxytocin will be administered into each nostril of each patient about 15-30 minutes before NAF collection
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Ductal carcinoma in situ (DCIS); Oxytocin

Summary:

      The purpose of this study is to examine the genetic material called microRNA of three types
      of specimens from women with breast cancer. The study also seeks to examine the effectiveness
      of using a new agent called oxytocin to increase the amount of nipple fluid that can be
      collected during surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Ductal carcinoma in situ (DCIS) or invasive breast cancer

          -  Candidate for breast conserving surgery or mastectomy

        Exclusion Criteria:

          -  Pregnant women

          -  Prior Breast Cancer diagnosis

          -  Adverse reaction to Oxytocin in the past
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Infections; Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: BMS-663068 400 mg; BMS-663068 800 mg; BMS-663068 600 mg; BMS-663068 1200 mg; Raltegravir 400 mg; Tenofovir 300 mg; Ritonavir 100 mg; Atazanavir 300 mg
Intervention description: Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose; Tablets, Oral, 100 mg, Once daily, 96 weeks; Capsules, Oral, 300 mg, Once daily, 96 weeks
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Raltegravir Potassium; Fostemsavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety, efficacy, tolerability and
      pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil
      Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well
      tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1
      infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plasma HIV-1 RNA ≥ 1000 copies/ml at Screening

          -  Treatment experience with antiretroviral therapies (excluding integrase inhibitors)

          -  Screening PHENOSENSE Entry indicating BMS-626529 inhibitory concentration (IC)50 < 0.1
             μM

          -  Cluster of differentiation (CD)4+ T-cell count > 50 cells/mm3

        Exclusion Criteria:

          -  History (or evidence at Screening) of genotypic resistance to any component of the
             study regimen [ Tenofovir Disoproxil Fumarate (TDF), Atazanavir (ATV), Raltegravir
             (RAL)]

          -  Certain laboratory and electrocardiogram (ECG) values
Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
Condition: Gastric Cancer; Chemotherapy Effect
MeSH terms: Stomach Neoplasms
Intervention: FLOT Chemotherapy; SOX Chemotherapy
Intervention description: 5-FU+Leucovorin+Docetaxel+Oxaliplatin; Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomly assigned(1:1) either to FLOT or SOX group.
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Neoadjuvant chemotherapy; perioperative chemotherapy; Systemic chemotherapy; FLOT; SOX; Gastric cancer

Summary:

      Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer
      patients in high volume center of China
    

Eligibility criteria:

        Inclusion criteria:

          -  Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric
             junction.

          -  Clinical stage: cTNM: stage III or above

          -  Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to
             symptomatic but in bed less than half the day)

          -  Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate
             renal, hepatic, hematologic, and pulmonary function.

          -  Written informed consent

        Exclusion criteria:

          -  Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e.
             uncontrolled cardiac disease, or other clinically significant uncontrolled
             comorbidities, unable to undergo general anesthesia

          -  Confirmed distant metastases

          -  Locally advanced inoperable disease (Clinical assessment)

          -  Relapse of gastric cancer

          -  Malignant secondary disease

          -  Prior chemo or radiotherapy

          -  Inclusion in another clinical trial

          -  Known contraindications or hypersensitivity for planned chemotherapy
Trial of IRE in Cholangiocarcinoma
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Intervention: IRE Device
Intervention description: For use in ablating soft tissue
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, single-center phase I study.
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: intraoperative use of IRE; 18-489

Summary:

      The purpose of this study is to test any good and bad side effects of surgery using IRE to
      treat cancer of the bile duct.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Capable of providing written and oral informed consent in English

          -  Locally advanced disease based on preoperative work-up demonstrating that the tumor is
             unresectable due to portal vein, hepatic artery, and/or bile duct involvement,
             insufficient hypertrophy response of the future liver remnant after portal vein
             embolization, or patients not able to tolerate major liver surgery

          -  Found to be unresectable intraoperatively based on vascular, biliary, or lymph node
             (N2) involvement upon exploratory laparotomy

          -  Patients will be assessed for chemotherapy prior to treatment with IRE, but given the
             common problem of recurrent cholangitis, some patients will not be candidates for
             chemotherapy until after IRE is performed.

        Exclusion Criteria:

          -  Locally advanced PHC eligible and accepted for liver transplantation evaluation

          -  PHC with > 5 cm extension along the common hepatic duct or common bile duct on
             preoperative imaging or intraoperative ultrasound

          -  Metastases to peritoneum, liver or other organs confirmed by percutaneous biopsy,
             staging laparoscopy or intraoperative frozen section

          -  Lymph node metastases beyond N2 stations, confirmed by intraoperative frozen sections
             or radiographic diagnosis

          -  History of cardiac disease:

               -  Congestive heart failure (NYHA class >2)

               -  Active Coronary Artery Disease (defined as myocardial infarction within 6 months
                  prior to screening)

               -  Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers
                  are permitted)

          -  Any implanted stimulation device (defined as implantable cardiac device and a
             pacemaker)

          -  Uncontrolled hypertension (blood pressure must be ≤160/95 mmHg at the time of
             screening on a stable antihypertensive regimen)

          -  Uncontrolled infections (> grade 2 NCI-CTC, version 3.0)

          -  Epilepsy

          -  Both narrowing (sclerosis) of the main portal vein and a reduced diameter of either
             the common hepatic artery, celiac trunk or superior mesenteric artery of >50%