bioihbjkbjnl/mcl2 huggingface dataset:
Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood
Condition: Contraception
Intervention: Subcutaneous depot medroxyprogesterone acetate
Intervention description: Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 401.0
Sex: Female
Minimum age: 15 Years
Maximum age: 44 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraceptive Methods; Female Contraception; Contraceptive satisfaction; Injectable contraception; Birth control

Summary:

      This randomized clinical trial will study subcutaneous depot medroxyprogesterone acetate
      (DMPA sc) self-administration at two Planned Parenthood affiliates serving diverse patient
      populations. Prior studies demonstrate that DMPA self-injection is safe, effective, feasible,
      and acceptable for women and adolescents. A total of 400 female patients (ages 15-44)
      requesting DMPA will be randomized to self-administration of DMPA sc or clinic administration
      (usual care). Subjects will be followed for one year. The primary study outcome is DMPA
      continuation at one year by self-report in both study arms. Secondary outcomes include
      patient-reported satisfaction with treatment; satisfaction with home use; and costs
      associated with contraceptive care. The investigators hypothesize higher continuation rates
      among self-injection users compared to patients who receive standard care. Secondary
      exploratory hypotheses include higher patient satisfaction and lower costs associated with
      contraceptive care among self-injection users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females ages 15-44

          -  Current or past users of DMPA or desires initiation of DMPA for contraception

          -  Can understand spoken and written English or Spanish

          -  Willing to consider/attempt DMPA self-injection

          -  Willing to be randomized to either self- or clinic administration of DMPA

          -  Do not want to become pregnant in the next 12 months

          -  Willing to provide contact information and to complete three surveys at baseline, 6
             months, and 12 months

          -  Have consistent access to a working telephone, email, and Internet

          -  No contraindications to DMPA use

        Exclusion Criteria:

          -  Suspected or confirmed pregnancy

          -  Vaginal bleeding of unknown etiology

          -  Known or suspected breast cancer

          -  Acute liver disease

          -  High blood pressure (Systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg)

          -  Known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA

          -  Desire for pregnancy within one year
Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection
Condition: Emergent Coronary Procedure
MeSH terms: Kidney Diseases
Intervention: Sodium bicarbonate; Sodium Chloride
Intervention description: 8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure; 8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 59.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Patients undergoing an emergent coronary procedure

Summary:

      This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients
      undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing an emergent coronary procedure(within 60 minutes from admission)

        Exclusion Criteria:

          -  On dialysis

          -  Pregnancy

          -  Past use of bicarbonate or N-Acetyl-Cystein in 48hr

          -  Past exposure to contrast media in 48hr

          -  Circulatory insufficiency with lactic acidosis.
Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
Condition: Pain
Intervention: Intravenous ibuprofen
Intervention description: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the safety of a single dose of
      intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of
      postoperative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for surgery with anticipated need for postoperative analgesia

        Exclusion Criteria:

          1. Patients with inadequate IV access

          2. Patients <18 years of age

          3. History or allergy or hypersensitivity to any component of intravenous ibuprofen,
             aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)

          4. Active hemorrhage or clinically significant bleeding

          5. Pregnant or nursing

          6. Patients in the peri-operative period in the setting of coronary artery bypass graft
             (CABG) surgery

          7. Inability to understand the requirements of the study, be willing to provide written
             informed consent (as evidenced by signature on an informed consent document approved
             by an Institutional Review Board [IRB]), and agree to abide by the study restrictions

          8. Refusal to provide written authorization for use and disclosure of protected health
             information
A Non-inferiority Trial on Pain Relief During Oocyte Retrieval
Condition: Infertility
MeSH terms: Infertility
Intervention: fentanyl; pethidine; Diazepam; Midazolam
Intervention description: arm A receiving iv fentanyl; arm B receiving iv pethidine; arm B receiving iv diazepam; arm A receiving iv midazolam
Intervention MeSH terms: Midazolam; Fentanyl; Diazepam; Meperidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 170.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: fentanyl; midazolam; pethidine; diazepam

Summary:

      The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in
      terms of the pain levels and post-operative side effects of TUGOR
    

Eligibility criteria:

        Inclusion Criteria:

          -  presence of both ovaries;

          -  body mass index less than 30

          -  written informed consent and

          -  Chinese

        Exclusion Criteria:

          -  IVF cycle converted from ovulation induction or intrauterine insemination cycles;

          -  patient requests general anaesthesia for TUGOR;

          -  history of drug sensitivity to lignocaine/fentanyl/midazolam/diazepam/pethidine;

          -  less than 3 dominant follicles present;

          -  dominant follicles present in one ovary only and

          -  TUGOR performed on one side only.
VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo of vildagliptin; vildagliptin; Metformin
Intervention description: One tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.; Twice daily (bid) regimen during or after meals at the same time as vildagliptin.
Intervention MeSH terms: Metformin; Vildagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2004.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Vildagliptin; Elderly Patients

Summary:

      The purpose of this study was to determine whether the initiation of a vildagliptin plus
      metformin combination regimen would result in more durable glycemic control than metformin
      monotherapy in treatment-naïve patients with type-2 diabetes mellitus (T2DM).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Type 2 Diabetes Mellitus (T2DM) diagnosed ≤ 24 months ago

          -  glycosylated hemoglobin (HbA1c) ≥6.5% and ≤7.5% at Visit 1

          -  Treatment-naïve.

          -  Body mass index (BMI) ≥22 and ≤40 kg/m2 at Visit 1

        Key Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Fasting plasma glucose (FPG) ≥ 270 mg/dL (≥ 15.0 mmol/L)

          -  Previous or current participation in any vildagliptin clinical study.

          -  History of hypersensitivity to dipeptidyl peptidase-4 (DPP-4) inhibitors.

          -  Concurrent medical condition that may interfere with the interpretation of efficacy
             and safety data during the study.

          -  Donation of blood or significant blood loss equaling to at least one unit of blood
             within the past 2 weeks of start of study or a blood transfusion within the past 12
             weeks or planned regular transfusions during the study period.
A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
Condition: Cataracts
MeSH terms: Cataract
Intervention: Ketorolac Tromethamine 0.45%; bromfenac 0.09%; nepafenac 0.1%
Intervention description: One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery; One day pre operative 1 drop BID then 3 doses pre op day of surgery; One drop BID, 1 day pre operative and then 3 doses the day of surgery
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Nepafenac; Bromfenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will
      be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects
      will be instructed to begin dosing the study medication in the operative eye the day before
      surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop
      of study medication will be instilled by operating room staff approximately every 15 minutes
      for a total of 3 doses. At the designated time a paracentesis will be performed at the start
      of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample
      will be immediately stored on dry ice and shipped to a laboratory for analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be 18 years of age or older.

          -  Scheduled for cataract surgery by phacoemulsification.

          -  Subject must be willing to comply with all study requirements and be willing to give
             informed consent.

        Exclusion Criteria:

          -  Any subject that has a history of uveitis or active iritis.

          -  Subject can have no previous eye surgery, with the exception of refractive surgery,
             but not within 6 months.

          -  No ocular use of prostaglandins within 2 weeks of surgery.

          -  Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory
             (NSAIDS) or immunosuppressants within 14 days prior to surgery.

          -  Contraindications to NSAIDS.

          -  Active ocular infection.
Low Doses of Ketamine and Postoperative Quality of Recovery
Condition: Postoperative Pain; Postoperative Nausea and Vomiting
MeSH terms: Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Ketamine 0.4 mg/kg; Normal saline; Ketamine 0.2 mg/kg
Intervention description: Intravenous ketamine 0.4 mg/kg after induction of anesthesia; Intravenous normal saline 0.9% 5 mL; Intravenous ketamine 0.2 mg/kg after induction of anesthesia
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Intravenous anesthesia; Postoperative nausea vomiting; Postoperative pain; Patient satisfaction; Quality of health care; Ketamine

Summary:

      There are evidences that intraoperative administration of low doses of ketamine may
      contribute to control the postoperative pain by acting on the N-methyl-D-aspartate (NMDA)
      channel, reducing the effects related to the tolerance and hyperalgesia induced by opioids.
      This study aims to evaluate the effects of administration of this agent not only as an
      analgesic but also its role in the quality of recovery from anesthesia, which includes
      observation of emotional, psychological and physical aspects. Patients who were scheduled to
      undergo total intravenous anesthesia (TIVA) for laparoscopic cholecystectomy will be enrolled
      in this clinical study. After induction of anesthesia, patients will receive one of three
      solutions according to the randomly selected group: ketamine 0,2 mg/kg; ketamine 0,4 mg/kg or
      saline. In the recovery room and on the ward, data related to the presence of pain, analgesic
      consumption, the incidence of nausea and vomiting, dizziness or hallucinations will be
      recorded. The next day, the quality of recovery will be evaluated by application of the
      questionnaire QoR40 (Quality of Recovery Questionnaire-40).
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists physical status I or II

          -  Patients scheduled to undergo laparoscopic cholecystectomy

        Exclusion Criteria:

          -  Patients who refuse to participate in the study

          -  Patients who are not able to communicate due to alterations in the level of
             consciousness, or neurologic, or psychiatric disease

          -  Contraindication of any of the drugs used in the study

          -  Patients who are superobese (BMI>40)

          -  History of alcohol or drug dependence
Antipsychotic Effects on Brain Function in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Aripiprazole; Risperidone; Modafinil
Intervention description: Week One, Risperidone 1 mg po qd; Week Two, 2 mg po qd; Week Three, 4 mg po qd; Week Four, 6 mg po qd; Week Five (and thereafter), 8 mg po qd.; Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication.
Intervention MeSH terms: Risperidone; Aripiprazole; Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: cognition; executive function; prefrontal cortex; locus coeruleus

Summary:

      The purpose of the study is to determine whether two commonly-prescribed antipsychotic
      medications (aripiprazole and risperidone) have different effects on brain function and
      cognition in schizophrenia patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  less than 40 years old;

          -  currently meet criteria for schizophrenia, schizophreniform disorder or
             schizoaffective disorder from the DSM-IV-TR;

          -  require new or changed treatment with antipsychotic medication.

        Exclusion Criteria:

          -  older than 40 years;

          -  in current antipsychotic treatment that is satisfactory;

          -  treatment-refractory psychosis;

          -  active substance-related disorder;

          -  clinically-unstable (e.g. acute symptoms requiring emergent or acute-care, including
             acute suicide risk);

          -  neurological illness or poorly-controlled medical illness;

          -  currently taking medications for serious medical illness which have significant
             interactions with modafinil;

          -  active pregnancy;

          -  intelligence less than 70 (on standard test);

          -  contraindications for fMRI (e.g. claustrophobia, metal foreign bodies, etc.);

          -  uncorrectable visual acuity impairment.
Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia
Condition: Hyperglycemia Steroid-induced; Insulin Resistance, Diabetes
MeSH terms: Insulin Resistance; Hyperglycemia
Intervention: NPH Insulin; glargine; Insulin Aspart
Intervention description: Intermediate acting insulin; basal insulin; prandial insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients receiving single dose steroids who become hyperglycemic will be randomized to two treatment arms in a parallel design: (1) NPH added to basal/bolus insulin; (2) increase in doses of basal and bolus insulin
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: steroid; prednisone; methylprednisolone; hyperglycemia; insulin; hypoglycemia

Summary:

      Glucocorticoids are known to cause an increase in insulin resistance, leading to
      hyperglycemia, in both diabetic and non-diabetic patients. In both the inpatient and
      outpatient setting, steroids are used for their anti-inflammatory property to treat a variety
      of conditions. There is a paucity of information regarding the best way to treat
      steroid-induced hyperglycemia. In this study we will compare (1) the addition of NPH insulin,
      an intermediate-acting insulin, given at the time of steroid administration to the patient's
      standard basal/bolus insulin to (2) modification of the standard basal-bolus insulin regimen
      which will consist primarily increasing the prandial doses at lunch and supper in order to
      determine which regimen is superior for glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients receiving once daily dosing of methylprednisolone or prednisone in a dose of
             10 mg/day or greater

          -  Hyperglycemic (Glucose level > 126 mg/dL)

          -  Diabetic and nondiabetic patients

          -  Expected duration of hospital stay and time on steroids >= 3 days

          -  Patient of appropriate caregiver able to give Informed Consent

        Exclusion Criteria:

          -  Patients with 2 or more doses of methylprednisolone/prednisone per day

          -  Steroids other than methylprednisolone or prednisone

          -  Pregnancy

          -  estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2
The Response of Pathogens to the Respective or Combined Treatment of SRP and Local Minocycline in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Intervention: minocycline; surface and root planning
Intervention description: Periocline dental ointment; surface and root planning
Intervention MeSH terms: Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 70.0
Sex: All
Healthy volunteers: No
Keywords: Chronic periodontitis; Minocycline; Surface and root planning; Pocket depth; Sulcus bleeding index; Prevotella intermedia

Summary:

      To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO)
      and surface and root planning (SRP) by assessing both clinical parameters and the loads of
      four main periodontal pathogens in treating chronic periodontitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with moderate or severe chronic periodontal disease, and exhibited bleeding
             on probing and attachment loss, with radiographic alveolar bone loss in four or more
             teeth

        Exclusion Criteria:

          -  pregnant, had used antibiotics within the last 3 months, had periodontal therapy in
             the past 6 months or had systemic diseases such as heart disease or hypertension
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Pregnancy in Diabetics; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Neutral Protamine Hagedorn (NPH); Detemir insulin
Intervention description: NPH will peak between 4-12 hours after injection with a duration of action around 14 hours; Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
Intervention MeSH terms: Protamines
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregnancy

Summary:

      To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases
      rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2
      Diabetes Mellitus (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Preexisting type 2 diabetes mellitus requiring medical treatment or

          -  overt diabetes diagnosed prior to 20 weeks of gestation using either Hemoglobin A1c
             (HBA1C) ≥ 6.5 or fasting glucose ≥126 mg/dl or random blood glucose ≥ 200 mg/dl or two
             step method ( 50g glucose challenge test (GCT) >135 mg/dl followed by 100 GCT with at
             least 2 values above thresholds: Fasting Blood Glucose (FBG) >90, 1 hr >180, 2 hr >
             155, 3 hr > 140 mg/dl).

          -  Gestational age ≤20 weeks

          -  Willing to start insulin therapy or to continue insulin treatment during pregnancy

          -  Singleton or twin pregnancy

        Exclusion Criteria:

          -  Known allergy/prior adverse reaction to NPH/detemir

          -  Patients <18y

          -  Known major fetal anomalies

          -  Diabetic nephropathy (Creatinine (Cr)≥1.5)

          -  Diabetic proliferative retinopathy

          -  Patients with Type 1 diabetes or gestational diabetes