bioihbjkbjnl/mcl2 huggingface dataset:
Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage
Condition: Miscarriage in First Trimester
MeSH terms: Abortion, Spontaneous
Intervention: Misoprostol 400mcg Tab; Misoprostol 200mcg Tab
Intervention description: 400µg of misoprostol (2 tablets); 200µg of misoprostol (1 tablet)
Intervention MeSH terms: Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Patients, operators and statistical analysis were performed blindly.
Enrollment: 211.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: misoprostol; miscarriage

Summary:

      Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg
      of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been
      recommended by some international guidelines . So far, there are no recent studies comparing
      cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6
      hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not
      inferior to 400µg regimen), costs reductions and lower side effects may be issued without
      losing quality of cervix dilatation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients admitted at the Gynecological emergency Unit at Hospital de Clínicas de
             Porto Alegre scheduled for uterine evacuation with <12 weeks of gestation.

        Exclusion Criteria:

          -  patients who do not wish to participate in the project;

          -  patients with ectopic pregnancy;

          -  patients with comorbidities (heart failure congestive, chronic obstructive pulmonary
             disease);

          -  patients with hypovolemic shock;

          -  patients with cervical incompetence;

          -  patients with infected miscarriage/abortion (presence of fever, pus from the cervix,
             leukocytosis [> 14000]);

          -  patients with twin pregnancy;

          -  patients with Marfan syndrome;

          -  patients allergic to misoprostol;

          -  patients with coagulopathy;

          -  patients with opening of cervical internal os (4 mm of dilatation at the time of
             consultation);

          -  patients with previous surgery of the cervix (conization);

          -  patients with concomitant use of IUDs.
Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Glimepiride
Intervention description: 5 mg, oral tablet, once daily; 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
Intervention MeSH terms: Glimepiride; Saxagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 957.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; elderly patients; saxagliptin; randomised; double-blind

Summary:

      This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride
      in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on
      metformin monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Established clinical diagnosis of type 2 diabetes. Treatment with a stable metformin
             monotherapy, for at least 8 weeks prior to Visit 1

          -  HbA1c ≥7.0% and ≤9.0%

        Exclusion Criteria:

          -  Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
             Current use of any injectable or oral antihyperglycemic agent excluding metformin.

          -  Renal impairment as defined by a creatinine clearance <60 mL/min

          -  Individuals who, in the opinion of the investigator, in which participation in this
             study may pose a significant risk to the patient and could render the patient unable
             to successfully complete the study
Alternative Antibiotic Regime in the Treatment of GAgP
Condition: Generalized Aggressive Periodontitis; Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Intervention: Amoxicillin; Metronidazole; Moxifloxacin
Intervention description: 500 mg, 3 times per day for 7 days; 500 mg, 3 times per day, for 7 days; 400 mg, once in a day for 7 days.
Intervention MeSH terms: Amoxicillin; Moxifloxacin; Metronidazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Aggressive periodontitis; amoxicillin; metronidazole; moxifloxacin; nonsurgical periodontal debridement.

Summary:

      The objective of this randomized clinical study was to evaluate the effect of systemic
      administration of moxifloxacin compared to amoxicillin plus metronidazole combined with
      non-surgical treatment in patients with generalized aggressive periodontitis (GAgP) in
      6-month follow-up.

      A total of 40 systemically healthy patients with GAgP will evaluate in this randomized
      clinical trial. Periodontal parameters (plaque index, gingival index, probing depth, bleeding
      on probing, clinical attachment level) will be recorded at baseline, 1st, 3rd and 6th month.
      Patients will receive either 400 mg moxifloxacin per os once daily or 500 mg metronidazole
      and 500 mg amoxicillin per os three times daily for 7 days consecutively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The periodontal diagnosis of subjects with GAgP was established on the basis of
             clinical and radiographic criteria defined by the 1999 International World Workshop
             for a Classification of Periodontal Diseases and Conditions.

          -  Patients were included if they were between 18 and 35 years of age and otherwise
             healthy.

        Exclusion Criteria:

          -  if the patients had any known systemic diseases or conditions that can/could influence
             the periodontal status (cancer, cardiovascular and respiratory diseases)

          -  history of hepatitis or HIV infection,

          -  immunosuppressive chemotherapy

          -  current pregnancy, planning a pregnancy or lactation

          -  requirement for antibiotic prophylaxis

          -  oral diseases other than GAgP, ongoing orthodontic therapy

          -  a history of antibiotic therapy or periodontal treatment within the preceding six
             months.

          -  Subjects were excluded if they had known allergies to quinolones or penicillin or
             metronidazole

          -  Not willing to participate to the study.

          -  Not accept to sign written informed consent
Growth Hormone and Endothelial Function in Children
Condition: Growth Hormone Deficiency; Panhypopituitarism; Short Stature
MeSH terms: Dwarfism
Intervention: growth hormone
Intervention description: Growth Hormone treatment
Intervention MeSH terms: Hormones
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: growth hormone; endothelial function

Summary:

      Objective: This study is designed to determine whether growth hormone treatment in children 8
      to 18 years of age alters function of the lining of the arteries. This may play a role in
      increasing or decreasing the risk of heart disease.

      Methods. Twenty children, for whom growth hormone therapy will be otherwise provided, will be
      studied before and 3 months after starting growth hormone. Subjects can be on other hormonal
      replacements but no other medications.

      Each study will be done in the fasting state. The blood vessel function will be determined by
      measuring the change in forearm blood flow before and after blocking flow to the arm for 5
      minutes. Blood will be drawn after the test to measure glucose, insulin and fats.
    

Eligibility criteria:

        Inclusion Criteria:

          -  isolated growth hormone deficiency (peak growth hormone level less than 10 ng/ml in
             response to arginine-insulin stimulation with cortisol responses and thyroid function
             tests), panhypopituitarism with appropriate thyroxine (normal free T4 level) and
             cortisol replacement (8-12 mg/m2/day) and non classic growth hormone deficiency
             (growth velocity less than 5 cm/year; peak growth hormone >10 ng/ml).

        Exclusion Criteria:

          -  Taking medications other than the appropriate hormonal replacement(L-thyroxine,
             cortisol, estrogen or testosterone, DDAVP)
P4 (Pregabalin for Peripheral Posttraumatic Pain)
Condition: Neuralgia
MeSH terms: Neuralgia
Intervention: pregabalin; Placebo
Intervention description: pregabalin; placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international

Summary:

      To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic
      peripheral neuropathic pain
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including
             post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain,
             confirmed by a qualified pain specialist and persisting for a minimum of 3 months
             following the traumatic event

        Exclusion Criteria:

          -  Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome
             (CRPS, Type I or Type II)

          -  NeP not due to trauma, and not peripheral pain
Anesthetic Topical Adhesive (Synera™) to Reduce Injection Pain With Subcutaneous Multiple Sclerosis Medications
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Anesthetic Topical Adhesive Synera
Intervention description: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.
For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week
Intervention MeSH terms: Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if applying an anesthetic topical adhesive, Synera®, will
      reduce the injection pain. Relieving injection site pain may improve the tolerability of
      Multiple Sclerosis medications.

      Study Hypothesis: Pre-medication with Synera will have a significant effect on pain ratings
      as measured by the visual analog scale and Local injection site reaction scale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Multiple Sclerosis based on McDonald or Poser criteria (no
             sub-type restrictions)

          -  Aged >18

          -  Regular use of one of the follow Multiple Sclerosis medication treatments: interferon
             beta subcutaneous (15 subjects, Betaseron, Extavia or Rebif), or glatiramer acetate
             subcutaneous (15 subjects, Copaxone).

          -  No change in disease modifying therapy in 60 days.

          -  Mean score of ≥1.0 on Local Injection Site Reaction scale and Mean Pain Upon Injection
             score ≥4.0 during baseline period.

          -  At least 4 valid diary entries over screening period.

          -  No Multiple Sclerosis exacerbation for 60 days prior to screening.

          -  Written informed consent

        Exclusion Criteria:

          -  Females who are breast-feeding, pregnant or have potential to become pregnant during
             the course of the study (fertile and unwilling/unable to use effective contraceptive
             measures).

          -  Cognitive deficits that would interfere with the subject's ability to give informed
             consent or perform study testing.

          -  Concurrent application of any topical medication to treat injection site reactions
             from screening through final visit.

          -  History of allergy to lidocaine, tetracaine or PABA (para-amino benzoic acid)
             containing products.

          -  Patients receiving class 1 antiarrhythmic agents (i.e. tocainide, mexiletine)

          -  Any other serious and/or unstable medical condition
The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)
Condition: Diabetes Mellitus Non-insulin-dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin
Intervention description: Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the
      safety and tolerability of Sitagliptin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either:

               -  Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months)

               -  Or On A Single AHa
Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules
Condition: Rabies
MeSH terms: Rabies
Intervention: Purified Chick Embryo Cell Inactivated Rabies Vaccine
Intervention description: Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rabies; rabies vaccines; post-exposure prophylaxis

Summary:

      This study was planned to establish the non-inferiority of Rabipur administered as simulated
      post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females of age ≥ 18 years.

          2. Individuals who had given written consent.

          3. Individuals in good health and available for all the visits scheduled in the study.

        Exclusion Criteria:

          1. Pregnancy or unwillingness to practice acceptable contraception.

          2. A history of Rabies vaccination.

          3. History of allergy to egg protein.

          4. Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine
             component.

          5. A significant acute or chronic infectious disease or use of antibiotics that may
             impact the subject's safety and /or immunogenicity in the Investigators opinion at the
             time of enrolment.

          6. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination.

          7. Treatment with an anti-malarial drug, up to two months prior to the study.

          8. Individuals who received any other vaccines within 28 days prior to enrollment.

          9. Subjects who have received blood, blood products and/or plasma derivatives or any
             parenteral immunoglobulin preparation in the past 12 weeks.

         10. Any planned surgery during the study period.

         11. Subjects who have cancer disorders excluding nonmelanotic skin cancer.
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Drug Hypersensitivity
Intervention: Elestat; Pataday
Intervention description: Elestat BID for 2 days; Pataday QD for 2 days
Intervention MeSH terms: Olopatadine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effects of two marked ocular anti-allergy
      medications in cat sensitive subjects with allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented history of ocular allergy to cats.

          -  Positive skin prick allergen reaction to cat dander.

        Exclusion Criteria:

          -  Use of any topical or systemic corticosteroids, immunosuppressive agents,
             antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to
             enrollment into the study.

          -  History of severe asthma, reactive airway disease or bronchial obstruction.

          -  Ocular surgery or trauma in the last year.
Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients
Condition: Liver Transplantation
Intervention: tacrolimus; mycophenolate mofetil; Prednisone
Intervention description: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.; Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.; Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Liver; Transplant; Corticosteroid withdrawal; Tacrolimus; CellCept; MMF; Mycophenolate mofetil

Summary:

      To determine the safety and efficacy of early corticosteroid discontinuation in liver
      transplant recipients more than 90 days post transplant, utilizing a combination of two drugs
      (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than 90 days post transplant.

          -  Free from rejection within the last 30 days.

          -  Patient with primary diagnosis of AIH will be evaluated on an individual basis.

          -  Negative pregnancy test.

          -  Practicing an acceptable method of birth control.

          -  Capable of providing written informed consent.

        Exclusion Criteria:

          -  Rejection within the last 30 days.

          -  Patients with AIH unable to discontinue corticosteroids.

          -  Patients currently receiving systemic corticosteroids for other medical diseases in
             which the physician feels discontinuation is contraindicated.

          -  Known sensitivity or contraindication to tacrolimus or MMF.

          -  Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.

          -  Pregnant or lactating.
Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Cimzia; Placebo
Intervention description: prefilled 200mg Cimzia syringe SC q 2 weeks; prefilled saline syringe
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: rheumatoid arthritis; anti-TNF therapy

Summary:

      Purpose of the study is to determine if Cimzia is safe and effective in subjects who have
      received previous treatment with a TNF-alpha inhibitor other than Cimzia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of RA at least 6 months

          -  Have received treatment with a TNF-alpha inhibitor

          -  Be receiving Methotrexate (with folic acid)at a dose of at least 10mg/week or another
             non-biologic DMARD if Methotrexate intolerant *Have at least 6 tender joint and 6
             swollen joints*

          -  Have an CRP greater than or equal to ULN

          -  Availability of a chest x-ray that shows no evidence of active TB or infection

        Exclusion Criteria:

          -  Prior exposure to Cimzia

          -  Prior treatment with B-cell depleting therapy

          -  No significant response to previous TNF inhibitor

          -  Congestive heart failure

          -  Clinically abnormal laboratory tests

          -  History of cancer

          -  Active TB