bioihbjkbjnl/mcl2 huggingface dataset:
A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: PS433540; placebo; PS433540
Intervention description: 200mg capsule, once daily for 28 days; placebo capsule, once daily for 28 days; 500mg capsule, once daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 280.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hypertension; high blood pressure

Summary:

      The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and
      to see how safe PS433540 is compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females 30 - 80 years

          -  Mean seated Systolic Blood Pressure (SBP) ≥ 150 - ≤ 179 mmHg and mean seated DBP < 110
             mmHg at two consecutive qualifying visits. The mean difference in SBP between the two
             consecutive qualifying visits must be ≤ 10 mmHg.

          -  Mean daytime (8AM - 4PM) ambulatory SBP must be between ≥ 140 - ≤ 179 mmHg and mean
             daytime (8AM - 4PM) Diastolic Blood Pressure (DBP) ≤ 110 mmHg

          -  Subjects must have a usual daytime schedule. Night shift workers are excluded from
             participation.

          -  Women of child-bearing potential (WOCBP) and male subjects must use two reliable forms
             of contraception if sexually active. Alternatively, female subjects must be
             postmenopausal (for at least 1 year)

        Exclusion Criteria:

          -  Subjects with serious disorders which may limit the ability to evaluate the efficacy
             or safety of PS433540, including cardiovascular, renal (including the absence of one
             kidney), pulmonary, hepatic, gastrointestinal (including clinically significant
             malabsorption), endocrine/metabolic, hematologic/oncologic (including an active
             malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.

          -  Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass
             surgery or New York Heart Association (NYHA) class II-IV heart failure within the last
             6 months.

          -  Subjects with a history of cerebrovascular accident or transient ischemic attack
             within the last 1 year.

          -  Subjects with diabetes mellitus (type I and type II).
Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children
Condition: Respiratory Syncytial Virus
MeSH terms: Respiratory Insufficiency
Intervention: Azithromycin 10 mg; Azithromycin 20mg; Placebo
Intervention MeSH terms: Azithromycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Participant, clinical providers and study staff are masked to the intervention. The random assignment of treatment was determined by random permutation. A statistician generated the randomization schedule and provided the randomization schedule (with randomization IDs) in an excel file to the study pharmacist in charge of dispensing the appropriate treatment.
Enrollment: 48.0
Sex: All
Maximum age: 16 Years
Healthy volunteers: No
Keywords: RSV; respiratory support; ICU; Azithromycin

Summary:

      This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single
      tertiary pediatric intensive care unit (PICU). The study will include children with RSV
      infection who were admitted to the pediatric intensive care unit and require respiratory
      support via positive pressure ventilation (invasive and noninvasive).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission to the PICU with RSV infection

          -  Need for positive pressure ventilation (invasive and non-invasive)

          -  Randomization and drug/placebo initiation within 48 hours of admission to Pediatric
             Intensive Care Unit

        Exclusion Criteria:

          -  Azithromycin use within 7 days of PICU admission

          -  Contraindication to azithromycin use including:

               -  Patients with electrocardiogram QT interval corrected for heart rate (Qtc) ≥ 450
                  ms

               -  Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)

               -  Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide
                  drug

               -  Cardiac arrhythmia

          -  History of pyloric stenosis

          -  Immunocompromised children (any cause)

          -  Current use of any medication known to cause QT prolongation
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Teriflunomide; Placebo (for teriflunomide); Interferon-β [IFN-β]; Glatiramer Acetate [GA]
Intervention description: Film-coated tablet
Oral administration; Film-coated tablet
Oral administration; Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection; Solution in prefilled syringe for subcutaneous injection
Intervention MeSH terms: Interferons; Interferon-beta; Teriflunomide; Glatiramer Acetate; Interferon beta-1b; (T,G)-A-L
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The primary objective was to evaluate the long-term safety and tolerability of teriflunomide
      when added to treatment with interferon-β [IFN-β] or glatiramer Acetate [GA] in patients with
      multiple sclerosis [MS] with relapses.

      Secondary objectives were to evaluate the long-term effect on relapse rate, disability
      progression and Magnetic Resonance Imaging [MRI] parameters.

      This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865)
      studies. Participants who successfully completed the initial study were offered to continue
      their treatment (same compound, same dose) for 24 additional weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PDY6045 or PDY6046 participant who:

               -  completed the week 24 visit of either study PDY6045 or PDY6046,

               -  was still meeting eligibility criteria for receiving treatment,

               -  had agreed to continue stable dose of Interferon-β [IFN-β] or Glatiramer Acetate
                  [GA] and consented to continue on treatment.

        Exclusion Criteria:

          -  Any known condition or circumstance that would have prevented in the investigator's
             opinion, compliance or completion of the study

        The above information is not intended to contain all considerations relevant to patient's
        potential participation in a clinical trial.
Simvastatin For Intracerebral Hemorrhage Study
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Intervention: Simvastatin 80 mg; Placebo
Intervention description: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.; Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Intracerebral; Hemorrhage; Edema; Statins

Summary:

      Study Objective: To analyze if statins are effective in ameliorating perihematomal edema
      evolution thereby reducing mortality and improving functional outcomes following spontaneous
      intracerebral hemorrhage (ICH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with CT evidence of ICH admitted within 24 hours of onset of symptoms.

        Exclusion Criteria:

          -  Age < 18 or > 85

          -  Admission Glasgow Coma Score (GCS) < 6

          -  ICH volume < 10 cc

          -  ICH secondary to trauma, aneurysm, Arterio-Venous Malformation (AVM), tumor or post
             surgical

          -  Multiple ICH

          -  Associated Subdural hematoma or significant Subarachnoid hemorrhage

          -  History of prior neurologic disease with modified Rankin Scale (mRS) > 1

          -  Hematoma evacuation, hemicraniectomy, clot lysis

          -  Myopathy

          -  Active Liver disease

          -  Pregnancy

          -  Statin allergy

          -  Patients on statins prior to admission

          -  Patients with an acute indication for statin therapy (Unstable angina)
Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
Condition: Acute Pain
MeSH terms: Emergencies; Acute Pain
Intervention: Placebos; Lorazepam
Intervention description: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients; The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.
Intervention MeSH terms: Lorazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Adults between the ages of 18-65

          -  Sustained a physical injury with a pain score ≥ 5 on the numeric rating scale [NRS]
             from 0- 10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable"

          -  Expected to be in the ED for at least 2 hours, in a private treatment room

          -  Ownership of a cell phone with text messaging capabilities

          -  Emergency Department admission assessment confirmed subject is not suicidal.

        Exclusion Criteria:

          -  Non-English speaking

          -  Not medically suitable for lorazepam per treating MD (e.g. medical condition where
             benzodiazepines are contraindicated or may be unsafe)

          -  Not alert and oriented

          -  Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by
             treating team

          -  Seeking treatment due to a mental health or substance use disorder

          -  History of chronic opioid use

          -  Prescribed opioid or benzodiazepine use within the past 24 hours

          -  Alcohol use within the past 12 hours or medical history of alcoholism.

          -  Clinical indication for open-label benzodiazepine administration in the ED.

          -  Any use of recreational narcotics throughout lifetime

          -  Sensitivity or allergy or intolerance to opioids or benzodiazepines

          -  Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure
             disorder, etc.)

          -  Prisoner
Study of BGB-A317 in Participants With Previously Treated Unresectable HCC
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma
Intervention: Tislelizumab
Intervention description: Administered intravenously
Intervention MeSH terms: Tislelizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced liver cancer; RATIONALE-208

Summary:

      This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1
      monoclonal antibody BGB-A317 in participants with previously treated hepatocellular
      unresectable carcinoma.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Histologically confirmed HCC

          2. Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not
             amenable to locoregional therapy or relapsed after locoregional therapy, and not
             amenable to a curative treatment approach

          3. Has received at least 1 line of systemic therapy for unresectable HCC

          4. Has at least 1 measurable lesion as defined per RECIST v1.1

          5. Child-Pugh score A

          6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1

          7. Adequate organ function

        Key Exclusion Criteria:

          1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
             histology

          2. Prior therapies targeting PD-1 or PD-L1

          3. Has known brain or leptomeningeal metastasis

          4. Tumor thrombus involving main trunk of portal vein or inferior vena cava

          5. Loco-regional therapy to the liver within 4 weeks before enrollment

          6. Medical history of interstitial lung disease, non-infectious pneumonitis or
             uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis,
             or acute lung diseases

          7. Has received:

               1. Within 28 days or 5 half-lives (whichever is shorter) of the first study drug
                  administration: any chemotherapy, immunotherapy (eg, interleukin, interferon,
                  thymoxin) or any investigational therapies

               2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or
                  any Chinese herbal medicine or Chinese patent medicines used to control cancer

          8. Active autoimmune diseases or history of autoimmune diseases that may relapse

          9. Participant with any condition requiring systemic treatment with either
             corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive
             medication within 14 days before study drug administration

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Cetuximab; 5-FU; Hydroxyurea; Twice-daily radiation; Cisplatin; Accelerated fraction radiotherapy with concomitant boost
Intervention description: 250mg/m2(day 1, weekly x 10);; 600 mg/m2/day; days 0-5 (120 h total) every other week x 5; 500 mg PO BID, days 0-5 every other week x 5; 150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks); 100 mg/m2, week 1 and 4 on day 1 (or 2); 72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.
Intervention MeSH terms: Cetuximab; Hydroxyurea
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cetuximab; Erbitux; locally; advanced; head; neck; cancer; neoplasms; squamous; carcinoma; lymphoepithelioma

Summary:

      The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®)
      added to two concurrent chemoradiotherapy platforms of different intensity in locally
      advanced head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Stage III and IV head and neck cancer

          -  Patients with squamous cell carcinoma of unknown primary and suspected origin in the
             head and neck area

          -  No prior chemotherapy or radiotherapy

          -  Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures
             only

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

          -  Normal organ and marrow function

        Exclusion Criteria:

          -  Unequivocal demonstration of metastatic disease

          -  Known severe hypersensitivity to drugs used in the study

          -  Treatment with a non-approved or investigational drug within 30 days before Day 1

          -  Incomplete healing from previous surgery

          -  Pregnancy or breast feeding

          -  Uncontrolled intercurrent illness including

          -  Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any
             history of clinically significant CHF

          -  Acute hepatitis or known HIV

          -  Severe baseline neurologic deficits

          -  Prior therapy which specifically and directly targets the EGFR pathway

          -  Prior severe infusion reaction to a monoclonal antibody
Ataluren for Nonsense Mutation Methylmalonic Acidemia
Condition: Amino Acid Metabolism, Inborn Errors
MeSH terms: Metabolism, Inborn Errors; Amino Acid Metabolism, Inborn Errors
Intervention: Ataluren
Intervention description: Ataluren will be provided as a vanilla-flavored powder to be mixed with water.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      Methylmalonic acidemia (MMA) is a rare genetic disorder caused by mutations in the gene for
      mitochondrial enzyme methylmalonyl-CoA mutase (MCM) or in one of the genes for
      adenosylcobalamin (AdoCbl). Lack of these proteins causes toxic elevations of methylmalonic
      acid (MMacid) in blood, urine, and other tissues. A specific type of mutation, called a
      nonsense (premature stop codon) mutation, is the cause of the disease in approximately 5% to
      20% of participants with mutations in the MCM gene, and approximately 20% to >50% of
      participants with mutations in one of the AdoCbl genes. Ataluren is an orally delivered,
      investigational drug that acts to overcome the effects of the premature stop codon,
      potentially enabling the production of functional MCM/AdoCbl. This study is a Phase 2a trial
      evaluating the safety and activity of ataluren in participants with MMA due to a nonsense
      mutation. The main purpose of this study is to understand whether ataluren can safely
      decrease MMacid levels.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Ability to provide written informed consent (parental/guardian consent if
             applicable)/assent (if applicable)

          -  Age ≥2 years

          -  Phenotypic evidence of methylmalonic acidemia (MMA) based on the presence of
             characteristic clinical symptoms or signs and an elevated plasma MMacid level (>0.27
             micromole/liter (umol/L)

          -  Presence of a nonsense mutation in at least 1 allele of the mutase (mut), Cobalamin A
             (cblA), or Cobalamin B (cblB) gene

          -  Glomerular filtration rate ≥30 milliliters (mL)/minutes/1.73 meters squared (m^2),
             serum aminotransferase values ≤2.5*the upper limit of normal, serum bilirubin ≤1.5*the
             upper limit of normal, plasma adrenocorticotropic (ACTH) within normal limits

          -  Willingness and ability to comply with scheduled visits, drug administration plan,
             study restrictions, and study procedures

        Major Exclusion Criteria:

          -  Known hypersensitivity to any of the ingredients or excipients of the study drug

          -  Any change in chronic treatment for MMA within 2 months prior to start of screening
             laboratory assessments

          -  Episode of metabolic decompensation within 1 month prior to start of Screening
             laboratory assessments

          -  History of organ transplantation

          -  Ongoing dialysis for renal dysfunction
Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: Alanyl-glutamine
Intervention description: Alanyl-glutamine, 44g, taken by mouth daily for 10 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile; glutamine; diarrhea; alanyl-glutamine

Summary:

      The aim of this study is to test the efficacy of alanyl-glutamine supplementation in the
      treatment of C. difficile infection. We hypothesize that alanyl-glutamine when given with
      standard antibiotic treatment for C. difficile infection will decrease diarrhea, mortality
      and recurrent disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult of either gender, 18 years or older, with C. difficile infection (CDI)

          -  Diarrhea associated with C. difficile positive stool assay

          -  Within 48 hours of receiving either metronidazole for mild-moderate disease or
             vancomycin for severe uncomplicated disease

          -  Admitted in the hospital at the time of enrollment

          -  Ability to provide informed consent

          -  Have an understanding of study procedures

          -  Ability to comply with study procedures for the entire length of the study

        Exclusion Criteria:

          -  Hypotension or shock

          -  Megacolon or moderate to severe ileus

          -  Acute abdomen

          -  Severe leukocytosis (WBC > 20,000 cells /µL)

          -  Admission to intensive care unit on enrollment

          -  Inability to tolerate oral medication

          -  Other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal
             disease)

          -  Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)

          -  Enrollment in another investigational drug trial

          -  Currently receiving other alternative treatment for CDI (e.g. antibiotics other than
             metronidazole or vancomycin; probiotics; immunoglobulin therapy; fecal transplant)

          -  Pregnancy

          -  Unavailable for follow-up visits

          -  Life expectancy of < 6 months

          -  Chronic liver disease or in subjects without known liver disease, ALT > 3x normal

          -  Chronic kidney disease or in subjects without known kidney disease, estimated
             Creatinine clearance of < 30 ml/min, even after rehydration