bioihbjkbjnl/mcl2 huggingface dataset:
Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients
Condition: Induction of Labor Affected Fetus / Newborn
Intervention: Propranolol; Placebo
Intervention description: After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol.; After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Study drug and placebo will be randomized and mixed to appear identical by the Mount Sinai Investigational Drug Service (IDS). The randomization code will be kept by the lead pharmacist of the IDS until completion of the trial, at which point data will be unmasked.
Enrollment: 240.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Induction; Labor; Propranolol

Summary:

      A randomized, prospective trial will be offered to women admitted to the labor floors at
      Mount Sinai Medical Center for labor induction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nulliparous women undergoing induction of labor

          -  >37 weeks' gestational age

          -  Non-anomalous, singleton cephalic presenting fetus.

        Exclusion Criteria:

          -  Multiple gestations, known fetal anomalies

          -  Maternal cardiac or hypertensive disease

          -  Chronic beta blocker use

          -  Bronchial asthma

          -  Maternal or fetal indication for immediate delivery.
Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis
Condition: Chronic Liver Disease; HepatoCellular Carcinoma
MeSH terms: Liver Diseases
Intervention: P03277 at 0.1 mmol/kg; P03277 at 0.05 mmol/kg
Intervention description: P03277 will be administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.; P03277 will be administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is an exploratory study aiming to collect data about diagnosis efficacy
      (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with
      suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC
      confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology
      analysis. The standard of reference for diagnosis will be given by the site according to
      their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous
      contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site
      and/or the more recent AFP results available). 10 additional subjects will be included to
      explore the diagnostic efficacy for HCC at half dose of P03277.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject presenting with liver cirrhosis or chronic liver disease as shown by previous
             liver biopsy or by combination of clinical, endoscopic, biological, ultrasound
             parameters, and elastography

          -  Subject presenting with 1 to a maximum of 3 untreated hepatic nodule(s) of less than
             or equal to 3 cm (long axis) previously identified and/or characterized through
             enhanced CT and/or MRI within a maximum of 21 days before P03277 imaging, confirmed
             for HCC or not

        Exclusion Criteria:

          -  Subject presenting with hepatic nodule more than 3 cm in addition to nodule(s) less
             than or equal to 3 cm

          -  Subject already treated for HCC by surgery or thermal ablation for which the resection
             or coagulation area is less than 2 cm from the new nodule(s)

          -  Subject previously treated by transarterial chemoembolization

          -  Subject with moderate or severe renal impairment (eGFR < 60 mL/min/1.73 m2) based on
             measurement done or available within the 7 days before P03277 administration and
             assessed after any iodinated contrast agent administration, or with dialysis end stage
             renal disease (ESRD)
Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection
Condition: Large Polyps in the Gastrointestinal Tract
Intervention: Autologous blood injection; Normal saline; HPMC
Intervention description: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion; Normal saline will be injected under the lesion to create submucosal cushion; Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: submucosal cushion; polypectomy; endoscopic mucosal resection

Summary:

      For removal of large flat lesions of the gastro-intestinal tract injection of a solution
      under the lesion creates a "safety" cushion and protects from damage to the gastrointestinal
      tract wall. Various solutions are currently used, but some of them are easy to inject but
      quickly dissipate (normal saline),other solutions are more longer lasting (hydroxypropyl
      methylcellulose, hyaluronic acid, etc) but are very difficult to inject and can be expensive
      and not always available. The investigators performed previously animal experiments which
      demonstrated that blood is easy to inject and creates a protective cushion which lasts longer
      than other fluids which are currently used for protective cushion creation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Polyps equal or larger than 1 cm

        Exclusion Criteria:

          -  Coagulopathy

          -  Inability to sign informed consent
Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
Condition: Leukemia; Acute Myeloid Leukemia; AML
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Cytarabine; Idarubicin
Intervention description: 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).; 12 mg/m2 IV over 1 hour daily x 3 (days 1-3)
Intervention MeSH terms: Cytarabine; Idarubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 15 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cytarabine, Idarubicin; Leukemia; Acute Myeloid Leukemia; AML; Cytarabine; Idarubicin

Summary:

      The goal of this clinical research study is to find out if standard chemotherapy given with
      idarubicin and Cytarabine (ara-C) can help to control AML.

      Objectives:

      To determine the complete response (CR) rate, event-free survival (EFS) and overall survival
      (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard
      combination chemotherapy with Idarubicin and cytarabine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with
             M6 AML with less than 20% blasts are eligible.

          2. Patients aged 15 to 75 years are eligible. Patients must be chemo-naïve, i.e. not have
             received any prior chemotherapy (except hydrea) for AML. They could have received
             transfusions, hematopoietic growth factors or vitamins. Temporary measures such as
             pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .

          3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 at
             screening.

          4. Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl - total
             bilirubin </= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT)
             </= 3x upper limit of normal (ULN)

          5. Ability to understand and provide signed informed consent.

        Exclusion Criteria:

          1. Subjects with Acute Promyelocytic Leukemia (APL).

          2. Presence of active systemic infection.

          3. Any coexisting medical condition that in the judgment of the treating physician is
             likely to interfere with study procedures or results.

          4. Nursing women, women of childbearing potential with positive urine pregnancy test, or
             women of childbearing potential who are not willing to maintain adequate contraception
             (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or
             condoms by their partner) over the entire course of the study.
Efficacy and Safety of Itolizumab in COVID-19 Complications
Condition: Acute Respiratory Distress Syndrome; Cytokine Release Syndrome; Covid19
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Cytokine Release Syndrome
Intervention: Itolizumab IV infusion; Best supportive care (BSC)
Intervention description: First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.
BSC: similar to Arm B; Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      Randomized, Parallel Group, Active Controlled Trial
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female adults above 18 years (not tested in children yet)

          2. Informed consent for participation in the study

          3. Virological diagnosis of SARS-CoV2 infection (PCR)

          4. Hospitalized due to clinical/instrumental diagnosis of COVID-19 infection

          5. Oxygen saturation at rest in ambient air ≤94%

          6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of < 200

        Key Exclusion Criteria:

          1. Known severe allergic reactions to monoclonal antibodies

          2. Active tuberculosis (TB) infection

          3. History of inadequately treated tuberculosis or latent tuberculosis

          4. In the opinion of the investigator,progression to death is highly probable,
             irrespective of the provision of treatments

          5. Have received oral anti-rejection or immune-suppressive drugs within the past 6 months

          6. Participating in other drug clinical trials (participation in COVID-19 anti-viral
             trials may be permitted if approved by Medical Monitor)

          7. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination

          8. Patients with known history of Hepatitis B, Hepatitis C or HIV

          9. Absolute Neutrophils count (ANC) <1000 / mm3

         10. Platelets <50,000 / mm3

         11. Absolute Lymphocyte count (ALC): <500/mm3
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Condition: Postbariatric Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: exendin 9-39; Placebo
Intervention description: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.; Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This clinical study will evaluate whether taking an investigational drug called exendin 9-39
      is safe, well-tolerated, and helps to prevent low blood sugar in people who have had
      bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of up to 40 kg/m2

          -  Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior

          -  Diagnosis of PBH

          -  At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia

        Exclusion Criteria:

          -  Other cause of endogenous hyperinsulinism other than PBH

          -  Metabolic or bariatric surgical procedure other than RYGB

          -  History of non-RYGB upper GI surgery

          -  Use of agents that may interfere with glucose metabolism
Cytokine Induced Killer (CIK) Cells In Leukemia Patients
Condition: Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Intervention: in vitro expanded Cytokine Induced Killer (CIK) cells
Intervention description: Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hematologic malignancies (excluding Chronic Myeloid Leukemia)

Summary:

      The purpose of the Phase IIA study are to:

        1. define the safety profile

        2. evaluate the efficacy of a sequential infusion of unmanipulated Donor Lymphocyte
           Infusions (DLI) and Cytokine Induced Killer (CIK) cells for the treatment of molecular,
           cytogenetic or hematologic relapse after hematopoietic stem cell transplantation and The
           progression free survival and the overall survival after the sequential infusion of
           Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer(CIK) cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with haematologic malignancies (excluding chronic myeloid Leukemia- CML) with
             a molecular, cytogenetic or haematologic relapse after allogeneic transplantation.

          -  Patients with an available donor willing to donate peripheral blood lymphocytes

          -  Immunosuppression must be withdrawn at the beginning of the cell therapy program

          -  Written informed consent prior to any study procedures being performed

        Exclusion Criteria:

          -  Donors positive for HIV, HBV or HCV, or unfit to undergo leukapheresis

          -  Patients with active acute or chronic Graft versus host disease (GvHD)

          -  Patients with rapidly progressive disease or not controlled by palliative supportive
             treatments including chemotherapy and with a life expectancy less than 8 weeks

          -  Patients with severe psychiatric illness or any disorder that compromises ability to
             give truly informed consent for participation in this study
Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ublituximab; Placebo
Intervention description: Administered as an IV infusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: multiple sclerosis

Summary:

      This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in
      participants with relapsing forms of multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsing multiple sclerosis

          -  Active disease

          -  Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year
             prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion

        Exclusion Criteria:

          -  Treatment with anti-cluster of differentiation 20 (CD20) monoclonal antibody within
             the last 12 months

          -  Treatment with alemtuzumab within the last 12 months

          -  Pregnant or nursing mothers
A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Condition: Adenoid Hypertrophy
MeSH terms: Hypertrophy
Intervention: Dextromethorphan; Acetaminophen; Dexmedetomidine; Ketamine
Intervention description: Preoperative oral dextromethorphan 1 mg/kg; Preoperative oral acetaminophen 15 mg/kg; Intraoperative intravenous dexmedetomidine 0.5 μg/kg; Intraoperative intravenous ketamine 0.5 mg/kg
Intervention MeSH terms: Acetaminophen; Dexmedetomidine; Ketamine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 4 Years
Maximum age: 8 Years
Healthy volunteers: No

Summary:

      This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic
      regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and
      to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home
      following surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients undergoing adenoidectomy ± bilateral ear tube placement

          2. Have a parent/guardian who are compliant with routine medical care, capable of
             subjective evaluation and able to read, understand and sign the informed consent in
             accordance with IRB regulations

        Exclusion Criteria:

          1. An American Society of Anesthesiologists Physical Status ≥ 4 (severe disease that is
             life threatening);

          2. A known hypersensitivity or allergy to any of the study medications;

          3. A history of chronic opioid use prior to surgery;

          4. Coexisting renal or hepatic disease;

          5. Morbid obesity (BMI% ≥ 99).
A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections; Respiratory Sounds
Intervention: Lumicitabine; Placebo
Intervention description: Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.; Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 56 Days
Maximum age: 39 Months
Healthy volunteers: No

Summary:

      The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the
      clinical diagnosis of asthma and the frequency of wheezing in infants and children with
      respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo)
      and have completed their last planned study-related visit in a feeding Phase 2 study
      (64041575RSV2004).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infants and children who were previously randomized in study
             64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and
             who completed the planned course of the study drug and the last study-related visit of
             study 64041575RSV2004

          -  The participant's legally acceptable representative must sign an informed consent form
             (ICF) indicating that he or she understands the purpose of, and procedures required
             for, the study and is willing for the participant to participate in the study

        Exclusion Criteria:

          -  The participants legally acceptable representative, i.e, parent/legal
             guardian/caregiver, is not able to maintain reliable communication with the
             investigator

          -  Any condition for which, in the opinion of the investigator, participation would not
             be in the best interest of the participant (example, compromise the well-being) or
             that could prevent, limit, or confound the protocol-specified assessments