bioihbjkbjnl/mcl2 huggingface dataset:
A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: teriparatide
Intervention description: 20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
Intervention MeSH terms: Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: osteoporosis, teriparatide, postmenopausal, MRI, finite element analysis

Summary:

      The purpose of this study is to use imaging technologies to demonstrate the effects of
      teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women
      with osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postmenopausal (after the "change of life") women with osteoporosis

          -  between the ages of 45-85

          -  have low bone mass as determined by a bone density test

          -  have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score
             of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior
             fracture (with a T-score of -3.0 or lower at these same sites)

          -  could have taken up to 5 years total of certain oral osteoporosis medications such as
             alendronate, risedronate, or ibandronate

        Exclusion Criteria:

          -  have conditions that would affect the bone in the region of the wrist or have had a
             previous fracture of either wrist which might affect results of study

          -  have a metal implant or have had a hip replacement in either hip which might affect
             results of study

          -  have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous
             bone tumor, or x-ray treatment to the skeleton

          -  currently have active or suspected diseases that affect the bone, other than
             osteoporosis

          -  have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory
             values
Non Invasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema
Condition: Acute Cardiogenic Pulmonary Edema
MeSH terms: Pulmonary Edema; Edema
Intervention: standard therapy (ST); CPAP; BIPAP
Intervention description: standard medical therapy; Non-invasive mechanical ventilation (CPAP); Non-invasive mechanical ventilation (BIPAP)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CPE; CPAP; BiPAP; non invasive mechanical ventilation

Summary:

      Cardiogenic pulmonary edema (CPE) is a common medical emergency and noninvasive ventilation
      (NIV) in addition to conventional medical treatment might be beneficial for patients with
      CPE.
    

Eligibility criteria:

        Inclusion Criteria:

          1. CPE confirmed radiologically and/or clinically

          2. Severe acute respiratory failure (partial arterial oxygen (PaO2)/Fraction of inspired
             oxygen (FIO2) less than 250)

          3. Dyspnea of sudden onset with respiratory

          4. Systolic blood pressure < 180 mmHg

        Exclusion Criteria:

          1. Immediate need for endotracheal intubation:

               -  Severe sensorial impairment

               -  Shock

               -  Ventricular arrhythmias,

               -  Life-threatening hypoxia (SpO2 [oxygen saturation as indicated by pulse oximetry]
                  less than 80% with oxygen)

               -  Acute myocardial infarction necessitating thrombolysis

               -  Cardiac or respiratory arrest

          2. Severe chronic renal failure

          3. Pneumothorax.

          4. Contraindication of non invasive ventilation (NIV)
Penicillin Allergy Testing in STD Clinics
Condition: Penicillin Allergy
MeSH terms: Hypersensitivity; Drug Hypersensitivity
Intervention: Penicillin Major Determinant (PrePen) Skin Testing; Direct Oral challenge
Intervention description: Skin testing followed by oral challenge with amoxicillin 250 mg single dose; Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Intervention MeSH terms: Penicillins; Penicillin G
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 284.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Demonstration project to implement penicillin allergy testing in STD outpatients using a
      questionnaire and pen allergy testing
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior history of PCN allergy

        Exclusion Criteria:

          -  No immunodeficiency or contraindication to skin testing
Fall Prevention in Older Adults With OAB
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine
Intervention description: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
Intervention MeSH terms: Fesoterodine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: prospective cohort design examining effects in adults aged 65 and older with OAB undergoing treatment with medication in a clinical setting. A follow up period of 8 weeks has been selected because this is the period of maximal drop in adherence.
Masking: None (Open Label)
Enrollment: 74.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      Though OAB treatment may improve physical activity, there is a lack of easily administered
      instruments for measuring physical activity in older adults. Aim is to validate instruments
      to measure physical activity and preference for medication, and to determine the effect of
      preference for anti-cholinergic medication on adherence, physical activity, and falls risk.
      It's plan a prospective cohort study of adults aged 65 or older with OAB undergoing treatment
      with anti-cholinergic medication.
    

Eligibility criteria:

        Inclusion Criteria:

        adults aged 65 or older, urinary urgency of quite a bit severity or more on the Overactive
        Bladder Questionnaire-Short Form (OABq-SF), eligible for pharmacologic therapy for
        overactive bladder

        Exclusion Criteria:

        predominant stress incontinence (on UDI-6), current/recent use (6 m) or contraindication to
        anti-cholinergic medication, severe voiding difficulties, men on 5-alpha reductase
        inhibitors, severe neurologic disease, recent anti-incontinence or prolapse surgery, other
        urinary tract conditions such as calculus or recurrent UTI.
Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male; Pain, Postoperative
Intervention: Liposomal Bupivacaine; Standard Bupivacaine
Intervention description: After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.; After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study model is a randomized double blind control trial.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      The study is a drug trial comparing the post-operative pain control provided by liposomal
      bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the
      local anesthetic) for men undergoing testicular sperm extraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men scheduled for surgical sperm retrieval for infertility

          -  Men 18 years and older who can provide informed consent

          -  No documented allergy to bupivacaine or celecoxib

        Exclusion Criteria:

          -  Prior history of substance abuse

          -  Any narcotic use within the last 3 months

          -  Concomitant use of aspirin

          -  Any of the following comorbidities: renal failure, heart disease, peptic ulcer
             disease, cerebrovascular disease, significant liver disease, untreated depression,
             chronic pain disorder, or bleeding diatheses

          -  Medical history or concurrent illness that the investigator considers sufficiently
             serious to interfere with the conduct, completion, or results of this trial, or
             constitutes an unacceptable risk to the subject
Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)
Condition: Controlled Ovarian Stimulation; Infertility
MeSH terms: Infertility
Intervention: recombinant luteinizing hormone (r-LH); recombinant human chorionic gonadotropin (r-hCG)
Intervention description: administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14); administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
Intervention MeSH terms: Chorionic Gonadotropin; Hormones
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: COS; ART; Infertility

Summary:

      The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study
      to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human
      chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in
      normogonadotrophic women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who plan to undergo IVF or ICSI treatment

          -  Woman's age > 18 years but ≤ 35 years

          -  Regular menstrual cycle (25-34 days)

          -  BMI 18 to 30 inclusive

          -  Signed patient information and informed consent forms

        Exclusion Criteria:

          -  PCOS

          -  More than 2 prior IVF/ICSI attempts

          -  Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders,
             according to the Investigator's assessment.
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Hepatitis B vaccine
Intervention description: Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: hepatitis B; hepatitis B vaccine; immunogenicity; adults

Summary:

      The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody
      persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine
      with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young
      adults, and the comparative immunogenicity among the three groups will be measured at 1 mon
      post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore,
      the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects aged between 16 and 25 as established by medical history and clinical
             examination

          -  Written informed consent will be obtained from each subject before the serum screening
             of HBV markers

          -  Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody

          -  Have never been immunized with HBV vaccine before

        Exclusion Criteria:

          -  Subject has a medical history of allergic to any ingredient of vaccine

          -  Family history of seizures or progressive neurological disease

          -  Autoimmune disease or immunodeficiency

          -  Women with pregnant

          -  Bleeding disorder diagnosed by a doctor

          -  Chronic diseases: hepatitis, tumor, tuberculosis,et.al

          -  Any prior administration of immunoglobulins or blood products in the last 3 mon before
             recruitment

          -  Subjects had a medical history of serious adverse reactions to vaccines
Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Intervention: ropivacaine; morphine sulfate; ketorolac; epinephrine; cefuroxime
Intervention description: 300mg (0.75%, 40cc) intraoperative periarticular injection; 10mg intraoperative periarticular injection; 30 mg intraoperative periarticular injection; 300 microgram (1:1000) intraoperative periarticular injection; 750mg intraoperative periarticular injection
Intervention MeSH terms: Cefuroxime; Cefuroxime axetil; Ketorolac; Epinephrine; Morphine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 81 Years
Healthy volunteers: No
Keywords: periarticular multimodal drug injection

Summary:

      The purpose of this study is to determine whether periarticular multimodal drug injection
      (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for
      whom contemporary pain control protocols using the continuous femoral nerve block,
      intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We
      hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer
      and would provide better functional recovery and patient satisfaction. We also hypothesized
      that the incidence of side effects and complications of the PMDI would be similar to the
      No-PMDI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary osteoarthritis

          -  Scheduled for elective total knee arthroplasty

          -  Signed written informed consent

          -  Spinal anesthesia

        Exclusion Criteria:

          -  Patients refusing consents

          -  inability to use the outcome assessment tools

          -  Contraindications to regional anesthesia

          -  severe cardiovascular disease

          -  allergy or contraindication to drugs used in this study

          -  pre-existing neurologic disease including psychiatric disorder

          -  drug abuser
Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: diclofenac sodium topical gel; Placebo
Intervention description: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo; a placebo gel is applied 1-4 times per day for two weeks.
Intervention MeSH terms: Diclofenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple sclerosis; diclofenac; subcutaneous injection; glatiramer acetate; Copaxone

Summary:

      The purpose of this study is to assess the effect of Diclofenac Sodium Topical Gel (DSTG) on
      injection site reaction following self-administer glatiramer acetate in people with Multiple
      Sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Multiple Sclerosis (MS) made at least 3 months prior based on McDonald or
             Poser criteria.

          -  Age 18 or more

          -  Ongoing treatment with glatiramer acetate (Copaxone) for three months or more.

          -  No MS exacerbation for 60 days prior to screening.

          -  Mean score of greater than or equal to 1.0 on screening Local Injection Site Reaction
             scale of last 3 days.

          -  Written informed consent.

        Exclusion Criteria:

          -  Regular use of any non-steroidal anti-inflammatory drug (NDAID), except Asprin (<325
             mg daily), between screening and end of study.

          -  Any contraindication to Diclofenac Sodium Topical Gel (DSTG)

               -  allergy to DSTG or any NSAID.

               -  history of asthma, urticaria, or other allergic reaction after taking any NSAID.

          -  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 preform study testing.

          -  Any other serious and/or unstable medical condition.
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501
Condition: Retraction of Colostomy
Intervention: Group 1 Standard of Care; Group 2 EXPAREL
Intervention description: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.; Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ileostomy reversal

Summary:

      This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome
      injectable suspension) to determine if total opioid consumption is reduced when using
      EXPAREL, therefore possibly reducing total hospitalization costs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years of age or older.

          -  Patients scheduled to undergo ileostomy reversal.

          -  Ability to provide informed consent, adhere to study visit schedule, and complete all
             assessments.

        Exclusion Criteria:

          -  Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance
             to any local anesthetic, opioid, or propofol.

          -  Patients who abuse alcohol or other drug substance.

          -  Patients with severe hepatic impairment.

          -  Patients currently pregnant or who may become pregnant during the course of the study
             or who are unwilling to use acceptable means of contraception for at least one month
             before and one month after dosing.

          -  Patients with any psychiatric, psychological, or other condition that the Investigator
             feels may make the patient an inappropriate candidate for this clinical study.

          -  Patients who have participated in an EXPAREL study within the last 30 days.

          -  Patients who have received an investigational drug within 30 days prior to study drug
             administration, or planned administration of another investigational product or
             procedure during the patient's participation in this study.

        In addition, the patient will be ineligible if he/she meets the following criteria during
        surgery:

          -  Patients who have any concurrent surgical procedure.

          -  Patients who receive intraoperative administration of opioids (other than fentanyl or
             analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.

          -  Patients who receive Entereg(R).