bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6
Condition: PT-NANBH
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: 8 weeks SOF/LED; 12 weeks SOF/LED
Intervention description: Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.; Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Intervention MeSH terms: Ledipasvir, sofosbuvir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatitis C, genotype 6

Summary:

      The primary objectives of this study are to describe the efficacy of:

        1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6

        2. 12-week treatment of SOF/LED for all other HCV-6 populations
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, age ≥18 years

          2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as
             genotype 6

          3. Selected to start on treatment by their treating providers

          4. Willing and able to provide informed consent

          5. Able to comply with dosing instructions for study drug administration and able to
             complete the study schedule of assessments

          6. Females of childbearing potential must have a negative serum pregnancy test at
             Screening and a negative pregnancy test on Baseline

          7. Male subjects and female subjects of childbearing potential who engage in heterosexual
             intercourse must agree to use protocol specified method(s) of contraception

          8. Lactating females must agree to discontinue nursing before the study drug is
             administered

        Exclusion Criteria:

          1. Previous recipient of a liver transplant

          2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)
Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Ranibizumab
Intervention description: Intravitreal injections of 0.5 mg Ranibizumab
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 332.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Macular degeneration,; age-related macular degeneration (ARMD),; vision loss,; macula damage,; retina damage,; dry macular degeneration,; wet macular degeneration,; AMD

Summary:

      The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab
      (either monthly injections or injections as-needed based on the stability of a patient's
      vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was
      to provide long-term safety data in the treatment of Chinese patients with wet AMD.
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Patients with visual impairment due to neovascular AMD

          -  A qualifying vision score at study entry Key Exclusion criteria

          -  Active infection or inflammation either eye at study entry

          -  Uncontrolled glaucoma in either eye

          -  Any disorder in the study eye which may affect vision

          -  Use of any systemic anti-vascular endothelial growth factor (VEGF)-drugs within 3
             months prior to study entry

          -  Previous treatment of the study eye for wet AMD

          -  Any surgery in the study eye 3 months prior to or planned with 6 month after study
             entry
Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; Placebo
Intervention description: Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration; Dose-match placebo
Intervention MeSH terms: Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 641.0
Sex: All
Minimum age: 18 Years
Maximum age: 54 Years
Healthy volunteers: No
Keywords: Stage 1; Stage 2; Hypertension

Summary:

      The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of
      therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with
      stage 1 or stage 2 essential hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients, of age 18 - 54 years

          -  Patients diagnosed with stage 1 or stage 2 essential hypertension

          -  Normal physical examination findings and electrocardiogram (ECG) results or abnormal
             findings judged by the Investigator to be not clinically significant

        Exclusion Criteria:

          -  Secondary hypertension or severe hypertension

          -  History of Type 1 diabetes mellitus

          -  A medical contraindication to discontinuing a current antihypertensive therapy

          -  Clinically significant respiratory disease that prohibit use of a beta blocker
Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Intervention: Exparel
Intervention description: For the treatment group a total of 40 cc consisting of 20 cc of 1.3% Exparel® and 20 cc of 0.5 % marcaine will be administered to the ACL harvest site, into the periosteum surrounding the distal tibial tunnel site, and in the proximity of the skin incisions. No infiltration of Exparel will be provided intra-articularly.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine
      Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps
      tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes.
      Patients will be randomized into treatment and control arms. The treatment arm will include
      40 patients receiving liposomal bupivacaine intra-operatively in addition to the current
      standard pain control regimen. The control group will include 40 patients receiving the
      standard post-operative pain control regimen. Patients will be assessed to identify
      differences in post-operative pain, satisfaction, as well as concomitant pain medication use.
      Post-operative range of motion will also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages between 18 and 50 chronological years undergoing ACL reconstruction using a
             quadriceps tendon or BTB autograft.

        Exclusion Criteria:

          -  Patients with known allergies to local anesthetics

          -  pregnant patients

          -  patients with a history of liver disease

          -  patients undergoing bilateral procedures

          -  Patients undergoing revision ACL surgery and patients undergoing ACL reconstruction
             using pediatric physeal sparing techniques

          -  Patients will also be excluded if any clinically significant event or condition is
             discovered during the time of, or after surgery that may render them medically
             unstable, or subject them to a surgical complication.
Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
Condition: Smoking Cessation
Intervention: Integrated Smoking Cessation and Financial Counseling; Waitlist Integrated Smoking Cessation and Financial Counseling; Nicotine Replacement Therapy (NRT)
Intervention description: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.; Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.; Participants in both arms will be eligible to receive a free four-week supply of NRT.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 410.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking Cassation; Immigrants; Economic Disparity

Summary:

      This is a 24 month pilot project that will implement and evaluate an innovative program that
      integrates financial counseling with smoking cessation counseling for low-income immigrants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smokes ≥5 cigarettes per day

          -  Born outside the U.S.

          -  Interested in receiving smoking and financial counseling

          -  Self-reported income below 200% of the current federal poverty level for a given
             household composition

          -  New York City resident

          -  English or Spanish language

          -  Able to provide informed consent, and

          -  Does not have a representative who manages his/her funds (to ensure the participant
             has the ability to manage household money). We will exclude participants who report
             being pregnant or breastfeeding (unable to receive NRT).

        Hospital staff participants:

          -  Must be current medical or non-medical provider or administrator at Bellevue Hospital
             or New York University Lutheran Medical Center

        Exclusion Criteria:

          -  We will exclude participants who report being pregnant or breastfeeding.
Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab
Condition: Exudative Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization
Intervention: ranibizumab
Intervention description: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: age-related macular degeneration; choroidal neovascularization; ranibizumab; indocyanine angiography

Summary:

      Exudative age-related macular degeneration (ARMD) is complicated by choroidal
      neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the
      gold standard treatment, recurrence is the main limitation of the treatment. The changes of
      the CNV vascular structure is expected to provide information regarding recurrence. In the
      eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the
      vascular changes after ranibizumab injections will be investigated prospectively.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age >= 50

          2. Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is
             20/400 or better

          3. Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography
             (ICGA) is more then 1/2 disc area.

          4. Area of CNV clearly visible in ICGA is more than half of the total CNV area.

        Exclusion Criteria:

          1. CNV caused by other than age-related macular degeneration. (polypoidal choroidal
             vascularization, retinal angiomatous proliferation, degenerative myopia etc)

          2. Blocked fluorescence in ICGA is more than half of the total CNV area.

          3. Disciform scar

          4. Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months

          5. Previous any treatment of photodynamic therapy or photocoagulation

          6. Previous intraocular or periocular injection of steroid within 3 months

          7. Previous intraocular surgery except cataract surgery

          8. Vitreo-retinal interface disease on the macula

          9. Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic
             retinopathy, etc.)

         10. Uncontrolled periocular or intraocular infection

         11. History of hypersensitivity to ranibizumab treatment

         12. Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)
Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures
Condition: Laryngoscopic Surgical Procedures
Intervention: Deep Neuromuscular Blockade; Moderate Neuromuscular Blockade; Sugammadex; Rocuronium
Intervention description: During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2).
At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2.; - During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: "surgical conditions"; "deep neuromuscular blockade"; "deep neuromuscular paralysis"

Summary:

      It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex
      as an reversal in endolaryngeal surgery.

      We will conduct a clinical study aiming to compare two treatment strategies; Deep
      neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will
      offer better stillness. We will also descriptively examine if patients would be safely
      discharged from a recovery room.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 - 60 years; ASA I-III.

          -  Subjects have been planned for elective endolaryngeal. Procedures (Direct Laryngoscopy
             with laser (micro-)surgery in patients with Tis, T1, T2, supraglottis and glottis
             carcinoma)

        Exclusion Criteria:

          -  Any renal impairment (CrCL < 80 ml/ min)

          -  Any hepatic impairment; Child Pugh A, B or C

          -  BMI > 30 kg m2

          -  Known or suspected generalized neuromuscular disorders

          -  Allergies to Rocuronium, Sugammadex, Sevoflurane, Propofol, fentanyl used during
             general anesthesia

          -  Hypersensitivity to the active substance or to any of the excipients

          -  Female patient who are pregnant and breastfeeding.

          -  Patient with poor Glasgow Coma Score and mental derangement who is unable to give
             informed consent.

          -  Patient with Tracheostomy tube.
Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery
Condition: Thrombophilia Due to Acquired Antithrombin III Deficiency
MeSH terms: Thrombophilia; Antithrombin III Deficiency
Intervention: Recombinant antithrombin (rhAT)
Intervention description: Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
Intervention MeSH terms: Antithrombins; Antithrombin III
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: antithrombin; Heparin Resistant; Cardiac Surgery

Summary:

      The objective of this study is to prospectively evaluate the response of recombinant
      antithrombin (rAT) (ATRYN) in patients who are heparin resistant and are scheduled to undergo
      cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB)

          -  Heparin resistant according to this definition: initial activated clotting time (ACT)
             after an intravenous loading dose of heparin (300 u/kg) is less than 480 seconds

        Exclusion criteria:

          -  current use of one or more of these medications:

               -  warfarin (within 3 days of surgery);

               -  streptokinase;

               -  tissue plasminogen activator;

               -  abciximab,

               -  eptifibatide,

               -  tirofiban or

               -  clopidogrel.

          -  known hypersensitivity to goat or goat milk proteins,

          -  patients with pre-existing coagulopathy defined as a history of bleeding or laboratory
             bleeding disorder (e.g., von Willebrand disease, platelet disorder) and

          -  patients receiving direct thrombin inhibitors
Effects of Kuvan on Melatonin Secretion
Condition: Phenylketonuria (PKU)
MeSH terms: Phenylketonurias
Intervention: Kuvan; Large Neutral Amino Acid Therapy
Intervention description: Dosed at 20 mg/kg; PO; Phase 3, Phase 4; Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tetrahydrobiopterin; Kuvan; Phenylketonuria (PKU); Large Neutral Amino Acids; Serotonin; Dopamine; Melatonin

Summary:

      This study examines the effect of tetrahydrobiopterin (Kuvan) and Large Neutral Amino Acid
      (LNAA) therapy on melatonin and dopamine levels in individuals with Phenylketonuria (PKU).
      The investigators hypothesize that Kuvan therapy will improve melatonin secretion and urine
      dopamine levels to some extent. However significantly greater responses in melatonin and
      dopamine secretions may be observed with combined treatment with Kuvan and supplementation of
      LNAA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult English-speaking patients who have confirmed PKU, and have tolerated Kuvan
             therapy at 20 mg/kg/day in the past, and are currently on the LNAA supplements will be
             considered as candidates for the study.

          -  Subjects must be able to stop LNAA therapy for 4 weeks.

          -  This will be determined by the subjects themselves, based on their past personal
             experiences.

        Exclusion Criteria:

          -  Individuals who have never taken Kuvan, who have never been on LNAA therapy, who are
             under the age of 18, or who do not speak English will be excluded.

          -  Subjects who cannot stop LNAA therapy for 4 weeks will be excluded.
Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Placebo; Tobi Podhaler
Intervention description: one dose (4 capsules) of placebo; The capsule containing the study medication has to be released from the blister card, be inserted into the Podhaler device, actuated and the study drug be inhaled according to instructions for use
Intervention MeSH terms: Tobramycin
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Human factors, TOBI® Podhaler™, Instructions For use, IFU, CF patients

Summary:

      The purpose of this actual use human factors (HF) study is to validate the approved US TOBI
      Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates
      the information necessary to achieve safe and effective use of the Podhaler device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 6 years and older at screening

          -  Confirmed diagnosis of CF

          -  Pulmonary function FEV1 value at least 25% of normal predicted values

          -  Must be physically and cognitively able to read, alone or with the assistance of their
             caregiver

        Exclusion Criteria:

          -  Subjects currently enrolled in studies that are not considered observational
             noninvestigational studies.

          -  Subjects who have used the Podhaler device previously

          -  Hemoptysis more than 60mL at any time within 30 days prior to study drug
             administration

          -  History of hypersensitivity to inhaled dry powder

          -  Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax