bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold
Condition: Healthy
MeSH terms: Hypersensitivity
Intervention: Intervention 1; Washout Period; Intervention 2
Intervention description: Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing on intervention 1 (Day 1).; The wash-out period will be between intervention 1 and intervention 2. 13 days in length.; Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing on intervention 2 (Day 14).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Volunteers

Summary:

      Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain.The
      vast majority of basic science studies suggested a large effect of oxytocin in minimizing
      acute pain.Few studies have demonstrated an association between plasma levels of oxytocin and
      pain in humans. Since addictive properties of oxytocin have not been described, the drug may
      have important application in the management of acute and chronic pain. No studies have
      examined the effect of intranasal oxytocin on pain sensitivity and threshold.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males and females volunteers, English speaking

        Exclusion Criteria:

          -  Pregnancy, lactation, allergy to preservatives, mental disease, any chronic pain and
             any current use of analgesics, anxiety or depression.
Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Engerix™-B
Intervention description: Intramuscular injection, 1 dose
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 20 Years
Maximum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B vaccine; Challenge dose

Summary:

      The current study will evaluate immunological memory to hepatitis B antigen in subjects who
      received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in
      the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values
      at the previous long-term time point. All participating subjects will receive a challenge
      dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of
      this study. No new subjects will be recruited in this long-term follow-up study. Blood
      sampling will be done one month after the administration of the challenge dose. The Protocol
      Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  A male or female adult who received the complete neonatal primary vaccination course
             of hepatitis B vaccine in primary study approximately 20 years earlier.

          -  Documented level of anti-HBs antibody concentrations < specified concentration at the
             previous long-term time point for which serological results are available for that
             subject.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  If the subject is female, she must be of non-childbearing potential or if she is of
             childbearing potential, she must practice adequate contraception for 30 days prior to
             vaccination, have a negative pregnancy test and continue such precautions for 2 months
             after completion of the hepatitis B challenge dose.

        Exclusion Criteria:

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the hepatitis B vaccine challenge
             dose.

          -  Administration of a vaccine not foreseen by the study protocol during the study
             period.

          -  Administration of immunoglobulins and/or any blood products during the study period.

          -  Drug and/or alcohol abuse.
Safety and Efficacy of Iron Sucrose in Children
Condition: Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Venofer (iron sucrose injection); Venofer (iron sucrose injection); Venofer (iron sucrose injection)
Intervention description: 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously; 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously; 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 2 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Iron; Anemia; CKD

Summary:

      Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney
      disease (CKD) patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 2 to 21 years of age

          -  Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months
             for ≥ 3 months

          -  Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) <60

          -  Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL

          -  Ferritin ≤ 800 ng/mL

          -  Transferrin saturation (TSAT) ≥ 20% to ≤ 50%

          -  Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying
             screening visit

        Exclusion Criteria:

          -  Known hypersensitivity to iron sucrose

          -  Severe diseased of the liver, cardiovascular system, or hemopoietic system

          -  Serious infection requiring hospitalization

          -  Significant blood loss within the last 3 months

          -  Bleeding disorders

          -  Pregnancy / Lactation

          -  Actively being treated for asthma

          -  Hemoglobinopathy

          -  Receiving a myelosuppressive drug
Evaluating the Effectiveness of Escitalopram to Prevent Depression in Head and Neck Cancer Patients Receiving Treatment
Condition: Depression
MeSH terms: Head and Neck Neoplasms; Depression; Depressive Disorder
Intervention: Escitalopram; Placebo
Intervention description: Participants take 10 mg for 1 week and then 20 mg for 15 weeks.; Placebo distribution matches the active medication.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Antidepressant; Major depression; Prevention; Head and neck cancer

Summary:

      This study will evaluate the effectiveness of escitalopram to prevent depression in head and
      neck cancer patients receiving treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed or recurrent epidermoid cancer of the head and neck

          -  Requires more than minimal therapy for treatment

          -  Able to read and write in English

          -  Willing to use an effective form of birth control throughout the study

        Exclusion Criteria:

          -  Meets MINI criteria for major depression, schizophrenia, or bipolar illness or scores
             24 or less

          -  Suicidal or psychotic

          -  Current allergy or hypersensitivity to citalopram or other SSRIs

          -  Treated with monoamine oxidase inhibitors 14 days prior to study entry

          -  Use of antidepressants within 1 week of study entry

          -  Pregnant or breastfeeding

          -  History of an adequate cancer operation, radiation, or chemotherapy within 6 months of
             study entry

          -  Diagnosed with melanoma or lymphoma cancer of the head and neck

          -  Currently participating in another research study involving a therapeutic intervention
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
Condition: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Foetal Growth Problem; Small for Gestational Age; Genetic Disorder; Turner Syndrome; Chronic Kidney Disease; Chronic Renal Insufficiency; Delivery Systems
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Turner Syndrome; Genetic Diseases, Inborn
Intervention: Norditropin NordiFlex®
Intervention description: Daily administration by a subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This study is conducted in Europe. The aim of this study is to compare the easiness of use of
      Norditropin NordiFlex® device to the device previously used by patients or parents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children who can receive Norditropin® (somatropin) treatment according to the product
             labelling

          -  Treated with growth hormone for at least one year

        Exclusion Criteria:

          -  Contraindications to Norditropin® growth hormone therapy

          -  Known or suspected hypersensitivity to somatropin or related products

          -  The receipt of any investigational medicinal product within 3 months prior to study
             start

          -  Life threatening disease, for example cancer

          -  Pregnancy or the intention of becoming pregnant
Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Carvedilol CR; Atenolol
Intervention description: Dose titration of 20mg by mouth once daily for 1 week, then 40mg by mouth once daily for 1 week, then 80mg by mouth once daily for 2 weeks; Dose titration of 25mg by mouth once daily for 1 week, then 50mg by mouth once daily for 1 week, then 100mg by mouth once daily for 2 weeks
Intervention MeSH terms: Atenolol; Carvedilol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to determine whether atenolol or controlled release
      carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure
      measured in the aorta, a large blood vessel carrying blood away from the heart, may be a
      better measure of the harmful effects of high blood pressure on the body's organs. In the
      past, blood pressure has only been measured in the arms. However, blood pressure in the arms
      may not accurately reflect the blood pressure in the aorta and thus may mislead doctors
      treating high blood pressure. For this reason, we are testing whether two different
      medications for blood pressure, both in a class called beta blockers, have similar effects on
      blood pressure in the arm and aorta.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Hypertension (untreated or treated with no more then one anti-hypertensive drug)

        Exclusion Criteria:

          -  Secondary forms of hypertension (including sleep apnea)

          -  Patients currently treated with two or more antihypertensive drugs

          -  Patients taking antihypertensive drugs with properly measured clinic systolic blood
             pressure greater then 170mmHg

          -  Isolated systolic hypertension

          -  Other diseases requiring treatment with blood pressure lowering medications

          -  Heart rate less then 55 beats/min (in the absence of beta-blocker therapy)

          -  Known cardiovascular disease including history of angina pectoris, heart failure,
             presence of a cardiac pacemaker, history of myocardial infarction or revascularization
             procedure, or cerebrovascular disease (including stroke and TIA)

          -  Known diabetes mellitus (Type 1 or 2)

          -  Renal insufficiency defined as a serum creatinine greater then 1.5mg/dL in males and
             1.4mg/dL in females

          -  Primary renal disease

          -  Pregnancy or lactation

          -  History of Raynaud's syndrome

          -  Alcoholism and recreational drug use (due to compliance concerns)
Self-management of Low Molecular Weight Heparin Therapy
Condition: Thromboembolism
MeSH terms: Thromboembolism
Intervention: patient education
Intervention description: Possible, individualized interventions:
Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material
Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)
Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom
First self-injection under control of a specially trained pharmacist
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heparin, Low-Molecular-Weight; compliance; drug safety; self-administration; ambulatory Care; Pharmaceutical Services

Summary:

      There is very little data available on compliance with self-injected low molecular weight
      heparins (LMWH), but what there is, definitely shows that compliance represents a significant
      problem. We therefore aim to a) record drug use problems of patients including compliance, b)
      develop a "SOP" for first instruction by a pharmacist and for subsequent pharmaceutical care
      and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control)
      provided in the pharmacy to patients with a prescription for a LMWH as an outpatient
      treatment.

      Hypothesis:

      Intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight
      heparins results in improved compliance, more safety and satisfaction as well as in fewer
      complications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are recruited from orthopedic clinics, an emergency department and from
             community pharmacies with a prescription for a LMWH as an outpatient treatment.

          -  self-application of the LMWH

          -  german / english speaking

             -> clinical setting:

          -  Dalteparin

             -> daily life setting:

          -  all LMWH (ready-to-use syringes)

          -  control group: self-application or application by another person (family member,
             medical person, etc.)

        Exclusion Criteria:

        - patient's home far away from study center
Bone Microarchitecture in Osteopenic Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: placebo; risedronate
Intervention description: oral tablet once a month for 12 months; tablet, 150 mg once a month for 12 months
Intervention MeSH terms: Risedronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: Female
Minimum age: 40 Years
Maximum age: 57 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to compare the difference in bone microarchitecture of the
      distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg
      taken once a month compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female: 40 and 57 years of age inclusive

          -  cessation of menstruation (surgical or natural) between 12 and 36 months prior to
             study enrollment

          -  have osteopenia defines as having the following: have osteopenia defined as having the
             following:

          -  Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a
             total hip T score of greater than -2.5 OR

          -  Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less
             than -2.5;

          -  have a body mass index (BMI) between 18 and 30 kg/m2.

        Exclusion Criteria:

          -  history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia

          -  use of medications within 3 months of starting study drug that impact bone metabolism
             such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and
             parathyroid hormone

          -  hypocalcemia or hypercalcemia of any cause
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
Condition: Meningococcal Infections; Meningitis
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined; Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined; Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined; Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined; Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Intervention description: 0.5 mL, Subcutaneous; 0.1 mL, Subcutaneous; 0.05 mL, Intradermal; 0.1 mL, Intradermal; 0.15 mL, Intradermal
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menomune® - A/C/Y/W-135; Meningococcal Infections; Meningitis

Summary:

      The objective of this trial is to study the administration of the Menomune vaccine given
      intradermally and low-dose subcutaneously versus standard subcutaneously. This study will
      describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard
      dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose)
      and a low dose (2/10th of standard dose) subcutaneously.

      The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal
      (ID) routes at different dosages
    

Eligibility criteria:

        Inclusion Criteria :

          -  18 to 55 years of age.

          -  Willing to return for 3 follow-up visits and comply with a 30 day follow-up period.

          -  Signed an informed consent form.

        Exclusion Criteria :

          -  Allergy to any component of the vaccine and latex.

          -  Known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood
             products within the previous two months.

          -  History of serious chronic diseases (such as cardiac or renal disease).

          -  Acute febrile illness at the time of visit.

          -  Pregnancy.

          -  Receipt of any vaccine within the 28 days prior to enrollment.

          -  Receipt of meningococcal vaccine (example in Military) within the past 5 years or
             history of meningococcal disease.
A Randomized Controlled Trial of Treatment of Bacterial Vaginosis
Condition: Bacterial Vaginoses
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: Metronidazole; Placebo
Intervention description: Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days; Participants in this arm will receive placebo
Intervention MeSH terms: Metronidazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Bacterial Vaginoses; Cesarean delivery; Surgical site infection; Endometritis; Infection; Vaginitis

Summary:

      This is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant
      women who are diagnosed with Bacterial Vaginosis (BV) in the late 3rd trimester (>34 weeks).
      During routine clinic visit after 34 weeks, prospective patients will be counseled about the
      study. Patients who agree to be enrolled, will sign informed consent. Following enrollment,
      patients will be screened for BV. Those patients who are BV positive by clinical diagnosis,
      will be randomized to receive either metronidazole 500 mg BID orally for 7 days or
      identically appearing placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women 18 to ≤50 years with the ability to give informed consent.

          -  Patients expected to have a vaginal delivery with no obstetric contraindication for
             vaginal delivery at time of screening.

          -  Diagnosed with bacterial BV per Amsel criteria at time of screening in clinic.

          -  Gestational age ≥ 35 weeks

        Exclusion Criteria:

          -  Plan for elective cesarean delivery

          -  Allergy or contraindications to metronidazole

          -  Receipt of metronidazole or clindamycin on admission for delivery for other
             indications.

          -  Hemodialysis

          -  Severe liver dysfunction

          -  Patient reports BV to nurse or clinician provider at current clinic visit or has been
             treated for BV within the past 3 months.