bioihbjkbjnl/mcl2 huggingface dataset:
Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food
Condition: Transfusional Hemosiderosis
MeSH terms: Hemochromatosis; Hemosiderosis
Intervention: deferasirox:
Intervention description: Participants were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.
Intervention MeSH terms: Deferasirox
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Exjade; deferasirox; palatability; tolerability; food; iron overload; Serum Iron overload due to transfusions

Summary:

      This single-arm, open-label, multi-center study enrolled 65 patients from approximately 20
      centers. All patients who met the study criteria and were taking, beginning or resuming
      treatment with Deferasirox were allowed. The study will began with a one month run-in phase,
      where all patients were instructed to take Deferasirox according to their physician's
      prescribing information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with thalassemia major, sickle cell disease (SCD), low or
             intermediate 1 (INT 1) risk myelodysplastic syndrome (MDS) or other anemias and
             transfusional hemosiderosis.

          -  Patients who were on, starting, or resuming treatment with Exjade.

          -  Patients who were >2 years (i.e., 2 years of age or older).

        Exclusion criteria:

          -  Serum creatinine above the upper limit of normal (ULN) for age.

          -  Alanine aminotransferase (ALT) >2.5 times the ULN.-High risk intermediate-2 or high
             risk MDS or acute leukemia.
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Liposomal bupivacaine right injection; Liposomal bupivacaine left injection
Intervention description: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.; Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Only anesthesiologist performing injection will be aware of which side is injected with each drug.
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized controlled pilot study evaluating length of pain control with either
      liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients
      having bilateral mastectomies with immediate reconstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for bilateral mastectomy

        Exclusion Criteria:

          -  allergy to local anesthetics, prior breast surgery, asymmetric surgical plan
Gabapentin for Postop Pain After SSLF
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Intervention: Gabapentin; Placebo oral capsule
Intervention description: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.; Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pelvic Organ Prolapse; postoperative gluteal pain; opioid use

Summary:

      Purpose: To assess the impact of gabapentin versus placebo on overall postoperative pain and
      gluteal pain at 7 days after vaginal sacrospinous ligament suspension for apical pelvic organ
      prolapse.

      Participants: English-speaking women planning to undergo a vaginal SSLF. Concurrent
      procedures can be performed except total vaginal hysterectomy, colpocleisis, anal
      sphincteroplasty, fistula surgery, or urethral diverticulectomy

      Procedures (methods): Patients will be randomized to receive either 2 weeks of gabapentin or
      placebo for 2 weeks post-operatively. Standard of care pain medications will be given to both
      groups. Patients will be followed for 6 weeks post-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women age 18+

          -  English-speaking

          -  Planning to undergo a vaginal SSLF

        Exclusion Criteria:

          -  Pregnant or planning to become pregnant during study participation

          -  Prior vaginal mesh surgery for pelvic organ prolapse

          -  Planning a concurrent total vaginal hysterectomy, colpocleisis (total vaginectomy or
             LeFort colpocleisis), mesh excision, anal sphincteroplasty, fistula repair, or
             urethral diverticulectomy

          -  Cognitive impairment (indicated by a score of 0-2 on Mini-Cog)

          -  Currently taking gabapentin or pregabalin (Lyrica) or previous intolerance to
             gabapentin or pregabalin

          -  Daily use of narcotics for ≥ 2 months

          -  Acute or chronic renal failure based on past medical history (PMH) or glomerular
             filtration rate (GFR) < 30ml/min (see meds info below)

          -  Severe uncontrolled depression or bipolar disease based on PMH

          -  Fall risk if history of fall in last year or current use of cane/walker
Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.
Condition: Surgical Conditions
MeSH terms: Disease
Intervention: Deep neuromuscular block
Intervention description: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A deep neuromuscular block (NMB) is often associated with improved surgical conditions
      especially in laparoscopic surgery. We previously showed that deep NMB is superior to a
      moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia
      and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to
      investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia
      maintenance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with renal or prostatic disease who are will undergo an elective
             laparoscopic renal surgical procedure or laparoscopic prostatectomy;

          -  American Society of Anesthesiologists (ASA) class I-III

          -  > 18 years of age;

          -  Ability to give oral and written informed consent.

        Exclusion Criteria:

          -  Known or suspected neuromuscular disorders impairing neuromuscular function;

          -  Allergies to muscle relaxants, anesthetics or narcotics;

          -  A (family) history of malignant hyperthermia;

          -  Women who are or may be pregnant or are currently breast feeding;

          -  Renal insufficiency, as defined by glomerular filtration rate < 30 ml/h creatinine.

          -  Previous retroperitoneal surgery at the site of the current surgery.

          -  Body mass index > 35 kg/m2
Insulin Glargine Versus Twice-Daily NPH
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Insulin glargine at bedtime instead of NPH; NPH twice-daily
Intervention description: Insulin glargine at bedtime substituting for NPH insulin at bedtime; Addition of morning NPH to bedtime NPH
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Glargine; Type 2 diabetes; Basal insulin

Summary:

      To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH
      insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly
      NPH insulin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 18-75

          -  Type 2 diabetes diagnosed for at least 1 year

          -  Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on stable and maximum-tolerated
             doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime
             injection of NPH insulin

          -  Except for the subject's current bedtime NPH insulin, no other past history of chronic
             insulin use (other than treatment of gestational diabetes or hospitalizations of less
             than 1 week in duration)

          -  Average fasting plasma glucose level <130 mg/dL without fasting hypoglycemia

          -  Hemoglobin A1c between 7.5% and 12%

          -  Body mass index (BMI) between 20 and 40 kg/m2

        Exclusion Criteria:

          -  History of confirmed (or clinical suspicion of ) type 1 diabetes

          -  Female subjects of childbearing potential who are sexually active and not using a
             reliable form of contraception.

          -  Current pregnancy or lactation.

          -  Subjects for whom intensive insulin therapy is contraindicated

          -  Subjects with advanced proliferative diabetic retinopathy

          -  Subjects who are unable to stay on a consistent daily meal schedule

          -  History of any clinically significant renal, hepatic, cardiovascular, neurological,
             endocrinological or other major systemic disease that, in the opinion of the
             investigator, may make implementation of the protocol or interpretation of the data
             difficult.

          -  Subjects who will likely require or initiate therapy with drugs which may interfere
             with glucose metabolism during the course of the study

          -  Subjects who are in another investigational study or have received another
             investigational medication within 30 days of study entry

          -  Subjects who are unable or unwilling to comply with all components of the study
             protocol, including contacting the investigators at specified times and attending all
             scheduled follow-up visits.
Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation
Condition: Induced Abortion
Intervention: Mifepristone; Misoprostol; Placebo
Intervention description: Progesterone antagonist; Prostaglandin E1; Tasteless, odorless, sugar based pill
Intervention MeSH terms: Misoprostol; Mifepristone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A randomized double---blinded comparison of same---day mifepristone and misoprostol with
      misoprostol only for cervical preparation in second---trimester surgical abortion in 100
      women at 14 0/7---19 6/7 weeks gestation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy women

          -  eligible for non---urgent D&E

          -  14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram

        Exclusion Criteria:

          -  emergent need for D&E

          -  fetal demise

          -  intolerance

          -  allergy or contraindication to mifepristone or misoprostol
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
Condition: Child Development
Intervention: Azithromycin; Amoxicillin; Cotrimoxazole; Placebo
Intervention description: Children in this arm will receive Azithromycin once a day.; Children in this arm will receive Amoxicillin twice a day.; Children in this arm will receive co-trimoxazole once a day.; Children in this arm will receive Placebo once a day.
Intervention MeSH terms: Amoxicillin; Azithromycin; Trimethoprim, Sulfamethoxazole Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Households will be randomized to one of four treatment arms (azithromycin, cotrimoxazole, amoxicillin, or placebo), and each child age 6-59 months in the household will receive 5 days of treatment. One child within each of the antibiotic households will be randomly selected to receive placebo instead of the antibiotc, to allow for study of indirect effects of antibiotic use
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blind
Enrollment: 252.0
Sex: All
Minimum age: 6 Months
Maximum age: 59 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: infection; azithromycin; amoxicillin; co-trimoxazole; trachoma; mass treatment

Summary:

      The use of antibiotics has saved millions of human lives, however consumption of antibiotics
      can select for antibiotic resistant organisms and may lead to changes in commensal
      microbiome. This study is designed to estimate the effect of antibiotic consumption on
      microbiome in a rural region of rural Burkina Faso. Changes in the intestinal and
      nasopharyngeal microbiome and resistome following a short course of antibiotics will be
      measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Households will be eligible for inclusion in the study if they have 2 or more children
             aged 6 months to 59 months currently residing in the household. Children from the
             household will be eligible if they are 6-59 months of age and are not currently
             receiving antibiotic treatment

        Exclusion Criteria:

          -  Children who are allergic to any of the study antibiotics will be excluded.
             Individuals aged under 6 months and 5 years or older will be excluded. Children
             already receiving antibiotics for an ongoing disease will be excluded.
Subcutaneous vs. Intramuscular Testosterone
Condition: Testosterone Deficiency; Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Intervention: Testosterone
Intervention description: Testosterone cypionate injection
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: Male
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      In this randomized, cross-over study 20 subjects who are undergoing testosterone (T) therapy
      for the treatment of T deficiency will receive both subcutaneous testosterone therapy and
      intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM
      injection and one group will receive an IM injection followed by a SQ injection. The primary
      objective of this study is to measure testosterone concentration in men after these two
      treatment routes and determine if there are any significant differences due to modes of
      administration. Endpoints will include total serum testosterone and calculated free
      testosterone. A questionnaire will also be administered to assess overall patient experience
      with each route of administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to read, write, and understand English

          -  Age greater than or equal to 18

          -  Diagnosed with testosterone deficiency

          -  Pre-enrollment testosterone concentration of less than 350 ng/dL

          -  Planning to initiate testosterone treatment at MHB

          -  Willing to be followed at MHB for at least one month

          -  Willing to provide informed consent for this study

        Exclusion Criteria:

          -  Previous exposure to exogenous T, clomiphene citrate, or other Selective Estrogen
             Receptor Modulators, unless off therapy for at least 12 weeks

          -  American Urological Association Prostate Symptom score of 15 or greater or significant
             prostatic symptoms

          -  History of carcinoma, tumors or induration of the prostate or the male mammary gland,
             including suspicion thereof

          -  Pre-enrollment serum PSA more than 4 ng/ml

          -  Serious psychiatric disease or uncontrolled medical illness, as suspected from the
             history or clinical examination

          -  Used any sex hormones or steroidal anabolic drug supplements within 28 days before
             pre-enrollment testosterone collection or at any time throughout the study

          -  Incapable of giving informed consent or complying with the protocol
Tobacco and Socioeconomic Disadvantage
Condition: Tobacco Smoking
Intervention: Motivational Interviewing; Nicotine Replacement Therapy Sampling; Referral Only
Intervention description: Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.; Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.; Participants are provided with a written referral for tobacco dependence treatment.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial in which participants are randomized to one of three groups.
Masking: Single (Outcomes Assessor)
Masking description: The individual conducting the outcomes assessment is blind to study condition.
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tobacco; smoking; cigarette

Summary:

      Randomized clinical trial comparing 3 brief interventions designed to increase motivation to
      quit smoking in socioeconomically disadvantaged smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be between the age of 19 and 65

          -  Participants must self-report being a daily smoker and provide biochemical
             verification of smoking status (expired breath carbon monoxide reading >5)

          -  Participants must be at socioeconomic disadvantage, defined as receiving services at a
             New Brunswick, New Jersey based social services agency (i.e., living in New Brunswick
             Housing Authority-run public housing units or requesting social services from the
             community social service agency, "Elijah's Promise")

          -  Participants must be able to speak and read English.

        Exclusion Criteria:

          -  Participants may not be taking FDA approved smoking cessation or anti-psychotic
             medications

          -  Participants may not reported medical issues of potential concern to nicotine
             replacement users (e.g., unstable angina pectoris, myocardial infarction, or
             significant cardiac arrythmia (including atrial fibrillation) in the past 30 days)

          -  Participants may not report pending legal issues with potential to result in
             incarceration.

          -  Participants may not be pregnant or nursing, planning on becoming pregnant in the next
             two months, and must be using effective birth control.
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Intervention: Golimumab
Intervention description: A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Intervention MeSH terms: Golimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to gain insight into the exposure-response relationship of
      golimumab in moderate-to-severe Ulcerative Colitis (UC).

      Patients commencing induction therapy with golimumab will be enrolled into a prospective
      study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC
      disease activity as well as serum golimumab concentrations and the presence of anti-golimumab
      antibodies. Patients already established on stable golimumab maintenance therapy will be
      enrolled into a cross-sectional study with the same evaluations taken at a single time point.
    

Eligibility criteria:

        Inclusion Criteria for cohort 1:

          -  Aged 18 years or over

          -  Moderate-to-severe UC, defined as:

        SCCAI > 5 and, i. A raised fecal calprotectin (> 59 μg/g) or, ii. A raised CRP (> 5 mg/L)
        or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 4 weeks of study
        enrollment

          -  Commencing golimumab treatment

          -  Written informed consent to participate

          -  Sufficient English language skills to understand the patient information sheet and
             consent form

        Inclusion Criteria for cohort 2:

          -  Aged 18 years or over

          -  Receiving golimumab treatment for UC for over 18 weeks (6 injections)

          -  Written informed consent to participate

          -  Sufficient English language skills to understand the patient information sheet and
             consent form

        Exclusion Criteria (cohort 1 only):

          -  Contra-indication to golimumab: tuberculosis or severe infections

          -  Imminent need for colectomy (i.e. colectomy is being planned)

          -  Previous primary non-response to anti-TNF therapy in the opinion of the investigator

          -  Previous treatment with more than one anti-TNF therapy (excluding golimumab)