bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: 13-valent Pneumococcal Conjugate Vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 355.0
Sex: All
Minimum age: 7 Months
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal Vaccines

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not
      previously been immunized with Pneumococcal vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged from 7 months to <72 months at time of enrollment.

          2. Available for entire study period and whose parent/legal guardian could be reached by
             telephone.

          3. Healthy as determined by medical history, physical examination, and judgment of the
             investigator.

          4. Parent/legal guardian had to be able to complete all relevant study procedures during
             subject participation.

        Exclusion Criteria:

          1. Previous vaccination with licensed or investigational pneumococcal vaccine.

          2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

          3. Contraindication to vaccination with pneumococcal vaccine.

          4. Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          5. Known or suspected immune deficiency or suppression.

          6. History of culture-proven invasive disease caused by S pneumoniae.

          7. Major known congenital malformation or serious chronic disorders.

          8. Significant neurological disorder or history of seizure including febrile seizure, or
             significant stable or evolving disorders such as cerebral palsy, encephalopathy,
             hydrocephalus, or other significant disorders. Does not include resolving syndromes
             due to birth trauma such as Erb palsy.

          9. Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the
             last 3 months.

         10. Participation in another investigational or interventional trial. Participation in
             purely observational studies is acceptable.

         11. Child is a direct descendant (child or grandchild) of a member of the study site
             personnel.
A Long Term Study of GK530G in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: GK530G
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 436.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne Vulgaris

Summary:

      This open label study is to determine the safety profile of GK530G in a long-term treatment
      (up to 12 months) in subjects with acne vulgaris and to evaluate the efficacy of GK530G in a
      long-term treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women at the age of 12 or older at the Screening visit.

          -  Those with clinical diagnosis of acne vulgaris with more than 20 non-inflammatory
             lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions
             (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

        Exclusion Criteria:

          -  Those with more than two nodular acne lesions or any cyst.

          -  Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or
             any drug induced acne.

          -  Those who have clinically significant abnormal findings or conditions on skin other
             than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially
             interfere with study assessments according to Investigator's judgment
NAC for Head Trauma-induced Anosmia
Condition: Anosmia; Head Trauma
MeSH terms: Craniocerebral Trauma; Anosmia; Wounds and Injuries
Intervention: N Acetyl Cysteine; Placebo oral capsule
Intervention description: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days; 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare administration of N-Acetyl Cysteine (NAC) versus placebo for the
      treatment of olfactory loss due to head injury. The hypothesis is that treatment with NAC
      acutely after head injury will result in improved olfactory function
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to Ryder Trauma Center for observation acutely following head injury (i.e.
             concussion), with documented hyposmia or anosmia by University of Pennsylvania Smell
             Identification Test (SIT).

          -  Male or female, aged 18 years or older

          -  Provision of signed and dated informed consent form

          -  Stated willingness to comply with all study procedures and availability for the
             duration of the study

          -  Ability to take oral medication and be willing to adhere to the NAC regimen

          -  For females of reproductive potential: use of highly effective contraception for at
             least 1 month prior to screening and agreement to use such a method during study
             participation and for an additional 4 weeks after the end of NAC administration

        Exclusion Criteria:

          -  Severe trauma requiring ongoing inpatient treatment beyond 48 hours

          -  Pregnancy (based on urine screening) or lactation

          -  Known allergic reactions to components of NAC, such as Mucomyst

          -  Currently taking nitrates such as nitroglycerine and/or isosorbide regularly

          -  Currently taking azathioprine (Imuran) or cyclophosphamide (Cytoxan)

          -  Known diagnosis of cystinuria (renal condition in which cysteine supplement should be
             avoided)

          -  Febrile illness within 1 week

          -  Treatment with another investigational drug or other intervention within 3 months

          -  Active sinonasal disease by imaging and/or nasal exam, i.e. rhinosinusitis, nasal
             polyps

          -  Adults unable to consent

          -  Prisoners, employees or subordinates

          -  Individuals who are not yet adults (infants, children, teenagers). This population is
             excluded because efficacy has not yet been established in adults.
Naltrexone & SSRI in Alcoholics With Depression/PTSD
Condition: Alcoholism; Depression; PTSD
MeSH terms: Alcoholism; Depression; Depressive Disorder
Intervention: paroxetine; desipramine; Naltrexone; Placebo
Intervention description: paroxetine (40mg/day); 200 mg per day; 50 mg per day; placebo
Intervention MeSH terms: Naltrexone; Paroxetine; Desipramine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: SSRI; treatment; naltrexone; alcohol dependence; Desipramine; depression; PTSD

Summary:

      The purpose of this study is to evaluate the efficacy of naltrexone in combination with an
      SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression.

      We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in
      alcohol consumption than that seen with treatment with SSRI alone, or with a combination of
      another class of antidepressant and naltrexone. We also hypothesize that SSRI will be
      effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of alcohol dependence and current DSM-IV depressive disorder or PTSD

          -  a recent episode of heavy drinking

          -  outpatient, sober from alcohol and other abused substance for at least 2 days before
             randomization

          -  stable medication regiment for at least 2 weeks

          -  women on adequate methods of contraception

        Exclusion Criteria:

          -  current opioid dependence or abuse

          -  history (within the last 3 months) of opioid dependence or abuse

          -  pregnant

          -  history of psychotic disorders or current treatment with antipsychotic medications

          -  medication thought to influence drinking including: acamprosate, disulfiram,
             naltrexone, ondansetron, valproic acid or tegretol

          -  current (within the lst 6 months) use of MAO inhibitors

          -  suicidal active ideation or intent

          -  significant underlying medical condition

          -  history of cardiac condition abnormalities
The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial
Condition: Gram-Negative Bacterial Infections; Sepsis
MeSH terms: Sepsis; Bacterial Infections; Gram-Negative Bacterial Infections
Intervention: Polymyxin -B fiber hemoperfusion system
Intervention description: two hours treatment for two days
Intervention MeSH terms: Polymyxins; Polymyxin B
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acute renal failure; lipopolysaccharide; tubular apoptosis; Polymyxin-B fiber; Severe sepsis from gram negative infection

Summary:

      Aim of the study is to verify whether Polymyxin-B hemoperfusion protects from renal
      dysfunction in patients with severe sepsis from gram negative infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Endotoxemia associated to severe sepsis

        Exclusion Criteria:

          -  Age < 18 years old

          -  Organ transplantation

          -  Hemorrhagic shock

          -  Thrombophilia

          -  Chronic renal failure

          -  Cardiogenic shock

          -  APACHE II score > 30

          -  Lack of consent
Southern Bone & Joint Study - Brimless Sockets
Condition: Socket Designs of Transfemoral Amputees.
Intervention: Standard of care socket; Prosthetic brimless socket
Intervention description: Amputees' preferred socket.; Study socket
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators are comparing a new type of prosthetic socket for above knee amputees to
      the standard of care. The hypothesis is that the new type of socket will show equivalence to
      the standard of care using our designated outcome measures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unilateral transfemoral or knee-disarticulation amputee

          -  18 to 85 years of age

          -  K3 (variable cadence and community) ambulators;

          -  Be able to independently provide informed consent

          -  Be willing to comply with study procedures.

        Exclusion Criteria:

          -  History of chronic skin breakdown on the residual limb

          -  Conditions that would prevent participation and pose increased risk (e.g. unstable
             cardiovascular conditions that preclude physical activity such as walking)

          -  Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate

          -  Unwillingness/inability to follow instructions
PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Cardiovascular Diseases
Intervention: pioglitazone; Sublingual nitroglycerine
Intervention description: daily dose, 30 mg daily for 2 weeks followed by 45 mg daily until completing 3 months unless higher dose not tolerated in which case patient remained at 30 mg daily; Used during nitroglycerin-mediated dilatation vascular function measures in both arms of the study if patient's blood pressure permitted. One single tablet was used per vascular test performed.
Intervention MeSH terms: Pioglitazone; Nitroglycerin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 143.0
Sex: All
Minimum age: 21 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      Patients with rheumatoid arthritis have a significantly higher risk to develop heart attacks
      and other complications of their blood vessels. New therapies are needed to prevent this
      complication. The purpose of this study is to establish the role of the medication
      pioglitazone in improving the function of the blood vessels and heart and decreasing the risk
      of future atherosclerosis development in individuals with rheumatoid arthritis. As a
      secondary aim-point, we will evaluate the efficacy of pioglitazone in improving rheumatoid
      arthritis disease activity and markers of inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women on adequate contraception if they are of child-bearing age.

          -  Meet revised ACR criteria for RA.

          -  Stable doses of DMARDS,biologic agents and or corticosteroids for at least 3 months.

        Exclusion Criteria:

          -  Pregnant or lactating women.

          -  Current smokers or individuals who smoked in the last 6 months.

          -  Diagnosis of Diabetes, heart failure, or infection.

          -  Current diagnosis of malignant disease except for basal cell or squamous cell
             carcinoma of the skin.

          -  No active liver disease.

          -  No cholesterol-lowering medications or oral hypoglycemic agents.
Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy
Condition: Hip Disease
Intervention: Bupivacaine + dexamethasone; Ultrasound
Intervention description: Anesthetic that will help treat pain and sensation after hip arthroscopy; Ultrasound will help guide the anesthesiologist in performing the nerve block
Intervention MeSH terms: Dexamethasone; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Hip arthroscopy is performed frequently and the postoperative course often involves moderate
      to severe pain. There remains no definitive perioperative pain regimen that has been proven
      to be effective and safe for this ambulatory procedure. Some institutions perform peripheral
      nerve blocks either preoperatively or postoperatively as a rescue block. All of these PNBs
      lead to quadriceps weakness which may impede earlier mobilization and physical therapy. While
      some case reports exist, there have not been any studies evaluating the QLB for hip
      arthroscopy patients. As previously mentioned, the technique is easy to perform,
      well-tolerated by patients, and avoids side effects such as hypotension, urinary retention,
      or the quadriceps weakness associated with lumbar plexus blockade.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for hip arthroscopy

          -  Ability to follow study protocol

          -  English Speaking

        Exclusion Criteria:

          -  Hepatic or renal insufficiency

          -  Younger than 18 years old and older than 80

          -  Allergy or intolerance to one of the study medications

          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

          -  Chronic opioid use (daily opioids use for longer than 3 months)

          -  Patients contraindicated to undergo a spinal anesthetic

          -  Non English Speakers
Treatment of Adrenal Insufficiency in Children
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Intervention: Infacort®
Intervention description: dry granule formulation of hydrocortisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 1 Week
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      The study will be conducted in a total of 24 subjects before their 6th birthday, requiring
      replacement therapy for adrenal insufficiency due to either CAH, primary adrenal failure or
      hypopituitarism.

      The study will consist of three consecutive cohorts. Cohort 1 will include 12 subjects aged
      between 2 and < 6 years. If no safety concerns emerge, then 6 subjects aged 28 days to <2
      years will be enrolled (Cohort 2). A review of accumulated data will be undertaken and only
      if again no safety concerns emerge, then 6 neonates aged from birth to <28 days will be
      enrolled (Cohort 3).

      The decision to continue after each cohort will be based on the recommendation of an
      Independent Data Monitoring Committee (IDMC).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female children less than 6 years of age.

          2. A diagnosis of adrenal insufficiency as confirmed by an inappropriately low cortisol
             usually with other supporting tests.

          3. Receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without
             fludrocortisone).

          4. Adequately hydrated and nourished.

          5. Ability of parents/carers to understand and give written Informed Consent

        Exclusion Criteria:

          1. Clinically evident acute adrenal insufficiency (adrenal crisis).

          2. Inability of the child to take oral therapy.

          3. Concomitant therapy (other than that required to treat adrenal insufficiency, Vitamin
             D, Fluoride, Thyroxine and growth hormone).

          4. Subjects with clinical signs of acute infection or fever on Day 1.

          5. Any surgical or medical condition which in the opinion of the investigator may place
             the subject at higher risk from his/her participation in the study.

          6. Parents/carers of subjects unwilling to consent to saving and propagation of
             pseudonymised medical data for study reasons.

          7. Subjects who are dependent on the investigator or the sponsor.
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Condition: Cystic Fibrosis; Pancreatic Exocrine Insufficiency
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: Pancrelipase Delayed Release
Intervention description: 3,000, 6,000 and 12,000 unit Lipase Capsules
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 1 Month
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Pancreatic Exocrine Insufficiency

Summary:

      This study will assess the safety and tolerability of pancrelipase delayed release capsules
      in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic
      Fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene
             analysis

          -  Current or historical human fecal elastase < 50µg/gstool

          -  Weight greater than 3.75 kg

          -  Age 1 month to 6 years

          -  Currently receiving treatment with a commercially available pancreatic enzyme product
             on a stable dose for more than 3 months

          -  Clinically stable condition without evidence of acute respiratory disease or any other
             acute condition

        Exclusion Criteria:

          -  Ileus or acute abdomen

          -  History of fibrosing colonopathy, Celiac disease, gastrectomy, Crohn´s disease and
             small bowel surgery other than minor resection due to meconium ileus without resulting
             in malabsorption syndrome

          -  History of distal ileal obstruction syndrome within 6 months of enrollment

          -  Use of an immunosuppressive drug

          -  Any type of malignancy involving the digestive tract in the last 5 years

          -  Known infection with HIV
Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: BMS-790052 (NS5A Replication Complex Inhibitor); Placebo matching BMS-790052; Pegylated-interferon alfa 2a; Ribavirin
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatitis C virus

Summary:

      The purpose of this study is to compare the sustained virologic response at post treatment
      Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV)
      versus placebo/PegIFNα-2a/RBV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants chronically infected with HCV Genotype 4

          -  HCV RNA viral load of ≥ 10,000 IU/mL

          -  No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent

          -  Results of a liver biopsy obtained within three years prior to enrollment to
             demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are
             permitted, however, and any prior biopsy is permitted

        Exclusion Criteria:

          -  Evidence of decompensated liver disease

          -  Documented or suspected Hepatocellular carcinoma (HCC)

          -  Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1
             (HIV-1)/HIV-2 antibody at screening