bioihbjkbjnl/mcl2 huggingface dataset:
The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
Condition: Tardive Dyskinesia (TD)
MeSH terms: Dyskinesias; Tardive Dyskinesia; Substance Withdrawal Syndrome
Intervention: Valbenazine; Placebo oral capsule
Intervention description: vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the
      potential for clinical dependence and withdrawal symptoms associated with valbenazine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of childbearing potential must agree to use hormonal or two forms of
             nonhormonal contraception (dual contraception) consistently during the screening,
             treatment, and follow-up periods of the study.

          2. Have one of the following clinical diagnoses for at least 3 months before screening:
             Schizophrenia, Schizoaffective Disorder, or Mood Disorder

          3. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before
             screening.

          4. Be on stable doses if using maintenance medication(s) for schizophrenia or
             schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on
             stable doses of a mood stabilizer.

          5. Be in general good health.

          6. Have adequate hearing, vision, and language skills to perform the procedures specified
             in the protocol.

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month
             before screening.

          2. Have a known history of substance (drug) dependence, or substance or alcohol abuse.

          3. Have a significant risk of suicidal or violent behavior.

          4. Have a known history of neuroleptic malignant syndrome.

          5. Have a known history of long QT syndrome or cardiac arrhythmia.

          6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).

          7. Have ever taken valbenazine (INGREZZA or NBI-98854) or participated in a valbenazine
             clinical study.

          8. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study.

          9. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

         10. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg,
             tetrabenazine, deutetrabenazine).

         11. Are currently pregnant or breastfeeding.

         12. Have HIV or hepatitis B.
Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Vildagliptin (LAF237); Placebo; Insulin; Metformin
Intervention description: Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily; Matching placebo of vildagliptin 50 mg twice daily; Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.
The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion.; Patients continued their prescribed metformin dose, if applicable.
Intervention MeSH terms: Metformin; Vildagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus (DM) ,; diabetes,; noninsulin-dependent diabetes mellitus (NIDDM),; adult-onset diabetes,; high blood sugar,; T2DM

Summary:

      The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid
      add-on therapy to improve overall glycemic control in patients with T2DM inadequately
      controlled by insulin, with or without concomitant metformin treatment. It was agreed with
      PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety
      data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of T2DM by standard criteria.

          -  HbA1c ≥ 7.0 to ≤ 10% at Visit 1.

          -  Age: ≥ 20 to < 75 years old at Visit 1.

          -  BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.

        Exclusion Criteria:

          -  FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit 1.

          -  Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or
             secondary forms of diabetes.

          -  Significant heart diseases

          -  Hepatic disorder

        Other protocol defined inclusion/exclusion criteria may apply
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients
Condition: HIV, Combination Therapy
Intervention: Atazanavir; Ritonavir (heat-stable); Raltegravir; Tenofovir/Emtricitabine
Intervention description: Capsules, Oral, 300mg, Once daily, 48 weeks; Tablets, Oral, 100 mg, Once daily, 48 weeks; Tablets, Oral, 400 mg, Twice daily, 48 weeks; Tablets, Oral, 300/200 mg, Once daily, 48 weeks
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Emtricitabine; Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether HIV-1-infected patients, who are
      virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus
      any third agent but are experiencing safety and/or tolerability issues, will maintain
      virologic suppression after switching to a regimen of heat-stable ritonavir boosted
      atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Current treatment regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs)
             plus any third agent for at least 3 months immediately prior to screening

          -  Virologic suppression (HIV-1 RNA <50 c/mL) for at least 3 months immediately prior to
             screening

          -  Virologic suppression (HIV-1 RNA <40 c/mL) using the Abbott m2000rt® polymerase chain
             reaction assay during screening period

          -  Treatment-related safety and/or tolerability issues to a regimen consisting of 2 NRTIs
             plus any third agent

        Key Exclusion Criteria

          -  History of switch in highly active antiretroviral therapy due to virologic failure

          -  History of genotypic resistance to any component of the study regimen (atazanavir,
             raltegravir, tenofovir/emtricitabine)

          -  History of exposure to atazanavir/ritonavir or raltegravir prior to entering the study

          -  Experiencing safety and/or tolerability issues to tenofovir/emtricitabine or
             raltegravir

          -  Switch of any component of HIV antiretroviral medication regimen in the last 3 months
             immediately prior to or during the screening period
Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD
Condition: COPD
MeSH terms: Respiratory Aspiration
Intervention: Trelegy Ellipta 100/62.5/25Mcg Inh 30D; Ventolin 90Mcg/Actuation Inhalation Aerosol
Intervention description: Administration of Trelegy in all patients; 2 hours after the administration of Trelegy, administer Ventolin in all patients
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label comparative design
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: DPI; PIF; FEV1

Summary:

      The purpose of the study is to determine whether PIF is clinically important when using the
      Ellipta DPI device. In addition, the study will validate the best/most clinically appropriate
      way to perform a PIF maneuver, to determine the testing capabilities of the preferred PIF
      maneuver and to relate this PIF measurement to meaningful clinical outcomes in COPD patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  smoking history >10 pack years

          -  pre-bronchodilator FEV1 <60% predicted

          -  post-bronchodilator FEV1/FVC <70%

          -  female participants are eligible to participate if they are not pregnant, not
             breastfeeding, and at least one of the following conditions applies:

          -  not a woman of childbearing potential OR

          -  agree to follow the contraceptive guidance during the treatment period and until the
             safety follow-up contact after the last dose of study treatment

          -  stratification requiring at least 1/3 of patients having a PIF of < 60L/min (AM
             pre-dose based on using the level 2 InCheck Dial resistance setting with a sharp
             maximal effort starting after exhaling fully)

        Exclusion Criteria:

          -  any subject with unstable disease, including

          -  COPD exacerbation in the last 6 weeks

          -  upper respiratory tract in in the last 4 weeks

          -  COPD or upper respiratory tract infection during run-in (subjects may be re-screened x
             1 when stable after an acute event)

          -  pulmonary disease other than COPD

          -  any lung resection

          -  unstable cardiac conditions (at the discretion of the investigator)

          -  other unstable medical conditions (at the discretion of the investigator)
Local Minocycline to Reduce Future Inflammation and Bone Loss in Periodontal Maintenance Patients
Condition: Moderate to Advanced Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Inflammation
Intervention: locally-applied minocycline HCl (1 mg); scaling and root planing (Sc/RP)
Intervention MeSH terms: Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of local application of minocycline
      microspheres on the periodontal inflammation and bone loss prevention in patients diagnosed
      with moderate-severe chronic periodontitis within a periodontal maintenance program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of moderate-severe chronic periodontitis

          -  attending regular periodontal maintenance visits at UNMC COD

          -  one quadrant with at least one > 5 mm interproximal pocket and 3 posterior teeth

        Exclusion Criteria:

          -  systemic diseases which impact periodontal inflammation and bone turnover

          -  drugs which significantly impact periodontal inflammation and bone turnover

          -  surgical periodontal therapy within the last year

          -  pregnant or breast-feeding females
Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction
Condition: Anterior Cruciate Ligament Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: 30 ml of 0.2% ropivacaine; 15 ml of 0.2% ropivacaine; 100 mcg clonidine; High-frequency linear ultrasound transducer
Intervention MeSH terms: Clonidine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 125.0
Sex: All
Minimum age: 16 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Femoral Nerve Block; Adductor Canal Block

Summary:

      This study will examine the potential differences between femoral nerve blockade (FNB) and
      adductor canal blockade (ACB) for pain control and quadriceps muscle activation for patients
      following anterior cruciate ligament (ACL) reconstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males & Females ages 16-30 yrs

          -  Undergoing ACL reconstruction by Co-Investigator (Walter Lowe)

          -  Receiving peri-operative FNB or ACB

        Exclusion Criteria:

          -  Not enrolled within the COFAKS study

          -  Receiving intrathecal nerve blockade or no blockade
Network-Level Effects of Nitrous Oxide in the Human Brain
Condition: Healthy
Intervention: Nitrous Oxide Gas for Inhalation
Intervention description: Each volunteer will participate in one scanning visit in which simultaneous functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) data will be collected wherein they receive placebo (20 minutes) followed by inhaled nitrous oxide at subanesthetic levels (35% inhaled concentration) over 40 minutes.
Intervention MeSH terms: Nitrous Oxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 21 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to understand how a commonly used drug, nitrous oxide, acts on
      the brain to reduce pain. Nitrous oxide is commonly used in anesthesiology but there is
      limited knowledge on how this drug affects functional networks in the brain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Body mass index <30

          2. Must be right-handed

          3. Must be capable of giving written informed consent

        Exclusion Criteria:

          1. History of obstructive sleep apnea;

          2. History of a difficult airway with a previous anesthetic

          3. Gastroesophageal reflux;

          4. Hypertension or other cardiovascular abnormalities;

          5. Pulmonary hypertension;

          6. History of recreational drug use;

          7. History of chronic alcohol abuse

          8. Having any chronic medical illness involving pain;

          9. History of major depression;

         10. History of psychosis or bipolar disorder;

         11. History of methylenetetrahydrofolate reductase deficiency;

         12. History of a known hypersensitivity to ketamine, midazolam, Zofran, labetalol or
             glycopyrrolate

         13. History of seizures or other neurologic disorders;

         14. Pregnant or nursing mothers;

         15. Tattoos on the head or neck region - all other tattoos are subject to determination by
             investigators;

         16. Contraindications to neuroimaging methods;

         17. Any impairment, activity or situation that in the judgment of the Study Coordinator or
             Principal Investigators would prevent satisfactory completion of the study protocol.
Medication Abortion Via Pharmacy Dispensing
Condition: Pregnancy Related; Abortion Early
Intervention: Mifepristone; Training on mifepristone dispensing
Intervention description: Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit; Pharmacists were offered a training on medication abortion and mifepristone dispensing
Intervention MeSH terms: Mifepristone
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective cohort
Masking: None (Open Label)
Enrollment: 326.0
Sex: Female
Minimum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: medication abortion; mifepristone

Summary:

      This mixed-methods study follows a prospective cohort of patients receiving Mifeprex ®
      (mifepristone) for medication abortion dispensed by pharmacists after undergoing standard
      clinical evaluation. Women participating in this study will obtain mifepristone and
      misoprostol from the pharmacy instead of in the clinic. To assess feasibility, acceptability,
      and effectiveness of pharmacy dispensing of mifepristone, the study will survey patients,
      evaluate their clinical outcomes from electronic health records, and survey and interview
      pharmacists at study sites.
    

Eligibility criteria:

        Patient Inclusion Criteria:

          -  Women seeking medication abortion through 70 days gestation

          -  Eligible for Mifeprex® at a study clinical site

          -  English or Spanish speaking

          -  Willing and able to participate in the study, including willing to go to the study
             pharmacy to obtain mifepristone

        Patient Exclusion Criteria:

          -  Not pregnant

          -  Not seeking medication abortion

          -  Under the age of 15

          -  Contraindications for medication abortion

               -  All pharmacists providing services at one of the study pharmacies during the
                  study are eligible for the pharmacist survey and interview.
A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: IgPro10
Intervention description: IgPro10 will be administrated by IV infusion either a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first treatment.
Intervention MeSH terms: Immunoglobulins, Intravenous
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: ITP

Summary:

      It is known that intravenous immunoglobulins can induce hemolysis, but the mechanism is not
      known in detail. The primary objective of this study was to investigate the specificity of
      antigens on red blood cells in patients with chronic immune thrombocytopenic purpura (ITP)
      who have shown signs of clinically relevant hemolysis following treatment with the
      intravenous immunoglobin Privigen®. The study was to explore potential mechanisms of
      hemolysis by analysis of the specificity of the antibodies possibly involved. To distinguish
      between clinically non-relevant hemolysis and a relevant intravascular hemolysis, an
      independent adjudication by a committee was performed for each patient with signs of
      hemolysis determined in the laboratory or in the clinic.

      This study was requested as a post-marketing commitment study by the United States Food and
      Drug Administration (FDA). By September 2014, no case of clinically significant intravascular
      hemolysis was found, and the FDA agreed to halt the study and analyze all hemolysis-relevant
      endpoints using FDA criteria for hemolysis in addition to analyses planned in the protocol.
      The study was not restarted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic ITP

          -  Age of 18 to 65 years

          -  Platelet count of ≤ 30 x 10^9/L at screening

        Exclusion Criteria:

          -  Planned splenectomy throughout the study period

          -  Treatment with immunoglobulin G for intravenous administration (IVIG) or anti-D
             immunoglobulin within 3 weeks prior to screening

          -  Use of drugs that have any pharmacological effect on the blood clotting system within
             3 weeks prior to screening

          -  Known allergy or other severe reactions to blood products including intolerability to
             previous IVIG

          -  Known hyperprolinemia

          -  Red blood cell transfusion or erythropoietin treatment within the last 14 days
Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)
Condition: Healthy
Intervention: recombinant human hyaluronidase
Intervention description: 150 Units in 1mL
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hylenex; subcutaneous infusion; hyaluronidase; rHuPH20; recombinant human hyaluronidase

Summary:

      Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates
      of different solutions subcutaneously (SC) infused and preceded by human recombinant
      hyaluronidase (hylenex) 150 units.

      In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR)
      solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one
      thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150
      units of hylenex.

      In Stage 2, the comparison will be NS solution and buffered NS solution.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, 18 to 60 years of age.

          2. Intact normal skin without in the areas intended for infusion.

          3. No fluid intake for 12 hours prior to the start of the study infusion.

          4. Vital signs (Blood Pressure (BP), Heart Rate (HR), Respiratory Rate (RR)) within
             normal range.

          5. Metabolic panel within normal range.

          6. A negative urine or serum pregnancy test.

          7. Signed, written Institutional Review Board (IRB)-approved informed consent.

        Exclusion Criteria:

          1. Lower extremity edema.

          2. Lower extremity pathology that could interfere with study outcome.

          3. Rales on lung auscultation.

          4. History of cardiovascular disease.

          5. Allergy to hyaluronidase.

          6. Allergy to bee or vespid venom.

          7. Pregnancy or breast-feeding woman.

          8. Use of any investigational drug or device within 30 days of enrollment.