bioihbjkbjnl/mcl2 huggingface dataset:
Advancing Tobacco Use Treatment for African American Smokers
Condition: Smoking Cessation
Intervention: Chantix; Placebo
Intervention description: A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.; Health education counseling will be provided to all participants.
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 500.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking; quit smoking; smoking treatment

Summary:

      The purpose of this study is to examine whether or not providing Chantix (varenicline) will
      help African American smokers quit smoking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Self-identified African American

          -  Smokes ≥ 1 cigarette per day (cpd)

          -  Smoke on ≥ 25 days of the past 30 days

          -  Functioning telephone

          -  Interested in quitting smoking

          -  Interested in taking 3 months of varenicline

          -  Willing to complete all study visits

        Exclusion Criteria:

          -  Renal impairment

          -  Evidence or history of clinically significant allergic reactions to varenicline

          -  A cardiovascular event in the past month

          -  History of alcohol or drug dependence in the past year

          -  Major depressive disorder in the last year requiring treatment

          -  History of panic disorder, psychosis, bipolar disorder, or eating disorders

          -  Use of tobacco products other than cigarettes in past 30 days

          -  Use of pharmacotherapy in the month prior to enrollment, including prior use of
             varenicline

          -  Pregnant, contemplating getting pregnant, or breastfeeding

          -  Plans to move from Kansas City during the treatment and follow-up phase

          -  Another household member enrolled in the study

          -  Evidence of current severe major depressive disorder or suicidal ideation
A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Epoetin beta
Intervention description: Epoetin beta 30,000 or 60,000 IU per week SC injection
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase IV, prospective, multi-center, open-label study to assess the effectiveness
      and safety profile of epoetin beta (Recormon®) for treatment of symptomatic anemia in adult
      participants associated with low/intermediate-1-risk MDS. After screening, eligible
      participants will be treated with epoetin beta as recommended in the approved label and
      international guidelines for the use of epoetin in MDS participants and the dosage will be
      adjusted on the basis of erythroid response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants with low or intermediate-1 risk MDS

          -  No previous treatment with hematopoietic growth factors within 3 months prior to
             screening

          -  Symptomatic anemia (hemoglobin <10 g/dL) as determined by investigator

          -  Serum erythropoietin <500 milliunits/milliliter (mU/mL) within 14 days prior to the
             first dose of study treatment

          -  Require no red blood cell transfusion or dependent on <4 units within 8 weeks prior to
             screening

          -  Clinically stable for at least 1 month prior to entry into the study

          -  For female participants of childbearing potential and male participants with partners
             of childbearing potential, agreement (by participants and/or partner) to use highly
             effective form(s) of contraception

        Exclusion Criteria:

          -  Contraindications and/or known hypersensitivity to the active substance and/or any of
             the excipients of epoetin beta treatment

          -  Poorly controlled hypertension as assessed by the investigator

          -  History of Acute Myeloid Leukemia (AML) or high risk for AML

          -  Administration of another investigational drug within 1 month before screening or
             planned during the study period

          -  Previously documented evidence of Pure Red Cell Aplasia (PRCA)
A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Intrathecal morphine sulfate (ITM); Bupivacaine hydrochloride; ropivacaine hydrochloride
Intervention description: Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion; Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion; Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
Intervention MeSH terms: Morphine; Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: post c section pain; pain control after baby; nerve block for post delivery pain

Summary:

      the purpose of this study is to compare opioid consumption in morphine equivalents between
      the groups that received postoperative analgesia with intrathecal morphine versus US guided
      QL blocks versus US guided QL catheters
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elective C section via Pfannenstiel incision

          -  Living singleton pregnancy

          -  Gestation week at least 37 weeks

          -  American Society of Anesthesiologists (ASA) status 1, 2 and 3

          -  Primary and secondary C sections

        Exclusion Criteria:

          -  Chronic pain

          -  Opioid tolerant patients

          -  Allergy to drugs used in the study.

          -  Cognitive dysfunction

          -  BMI > 40

          -  Coagulation disorder

          -  Local infection

          -  Inability to tolerate oral medication

          -  Previous intra-abdominal surgery

          -  Patients who will receive a combined spinal epidural for their C section

          -  Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.-
             local wound infiltration by surgeon)

          -  Patients who received sedation or general anesthesia during their C section
             (midazolam, ketamine, fentanyl, propofol, hydromorphone)
Persistent Postpartum Hypertension Pilot Trial
Condition: Hypertension in Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Intervention: Nifedipine Extended-Release Tablets
Intervention description: Antihypertensive
Intervention MeSH terms: Nifedipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment Arm vs Active Control Arm
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This study is a pilot, open-label, randomized controlled trial of postpartum women with
      hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the
      study to provide data that may provide guidance regarding blood pressure management of
      patients with non-severe postpartum hypertension. There are limited guidelines for best
      practice with persistent, non-severe hypertension, and treatment in this situation is usually
      at the provider's discretion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Antepartum diagnosis of gestational hypertension

          -  preeclampsia

          -  superimposed preeclampsia without antepartum chronic hypertension medication

          -  Delivery at 23 weeks or greater

          -  Persistent elevation in BP >24 hours postpartum (>140/90 mm Hg) (2 or more BP >4 hours
             apart)

          -  18 years or older

          -  English speaking

        Exclusion Criteria:

          -  Need for continuation of antepartum antihypertensive medication

          -  Contraindication of calcium channel blocker use

          -  Severe range (160/110 mm Hg) blood pressure requiring treatment >24 hours after
             delivery

          -  Requires a 2nd oral antihypertensive medication for blood pressure control inpatient

          -  Acute cardiomyopathy or heart failure

          -  Creatinine ≥1.5

          -  Blood pressure <90/60 within 24 hours of discharge
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: Ferric Citrate
Intervention description: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Intervention model description: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Healthy volunteers: No

Summary:

      Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4
      "Real World" Experience Study from Kaiser Permanente Southern California
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or
             calcium carbonate

          -  Mean serum phosphorus 4.0-<8.0 mg/dl for 6 months prior to enrollment

          -  No allergy to iron

          -  Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment

          -  Mean PTH < 1000 pg/ml for 6 months prior to enrollment

          -  Mean ferritin < 1500 ng/ml and mean iron sat < 50% for 6 months prior to enrollment

        Exclusion Criteria:

          -  History of gastrointestinal bleeding within past 6 months

          -  History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery
             within past 6 months

          -  Acute kidney injury equal to or less than 3 months before the initial screening date

          -  Active malignancy

          -  Functioning renal transplant

          -  Patients with iron overload syndrome (e.g., Hemochromatosis)

          -  History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease

          -  Active or past history of calciphylaxis
Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy
Condition: Wheezing; Allergy
MeSH terms: Respiratory Sounds
Intervention: Cholecalciferol; Cholecalciferol
Intervention description: Once the dietary intake of vitamin D has exceeded 200 IU/Day, the infants will receive placebo until they are 6 months of age adjusted for prematurity; Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Maximum age: 1 Year
Healthy volunteers: No

Summary:

      The goal of this study is to identify a vitamin D supplementation strategy that best promotes
      the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational
      age). This is a high risk population that seems to have unique vitamin D needs, and
      inappropriate supplementation may promote wheezing or allergy. The results of this study will
      help form nutritional recommendations for the approximately 100,000 black infants born at
      30-36 weeks gestational age in the U.S. every year.
    

Eligibility criteria:

        Inclusion criteria:

          1. 28 0/7-36 6/7 weeks gestational age (GA) at birth;

          2. family identifies the child as black or African American;

          3. < 28 days of supplemental oxygen (subsequent oxygen therapy for < 72 hrs for a brief
             subsequent illness or surgery will be allowed);

          4. admitted to a participating site NICU, special care nursery, transitional care
             nursery, or well-baby nursery as a neonate; and

          5. < 40 weeks corrected GA at enrollment.

        Exclusion criteria:

          1. BPD (> 28 days of supplemental oxygen);

          2. pre-existing diagnosis of moderate to severe osteopenia of prematurity and/or alkaline
             phosphatase > 700;

          3. history of fracture;

          4. gastrointestinal surgery, including for NEC;

          5. known gastrointestinal malabsorption;

          6. major congenital anomaly;

          7. congenital pulmonary or airway disorder (e.g., cystic fibrosis, tracheomalacia,
             swallowing disorder, bronchopulmonary sequestration);

          8. documented wheezing or stridor prior to enrollment;

          9. previous vit. D supplementation with > 400 IU/day;

         10. family plans to move more than 60 miles from CWRU or other pre-defined radius at other
             sites;

         11. baseline hypo- or hypercalcemia, hypo- or hyperphosphatemia; and

         12. baseline 25(OH) D level < 10 ng/ml.
Anterior Cruciate Ligament Pain Study
Condition: Anterior Cruciate Ligament Reconstruction
Intervention: Ropivacaine 0.5%; Percocet 7.5/325; Naprosyn 500 mg
Intervention description: Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.; Percocet 7.5/325 will taken as needed up to every four hours.; Naprosyn 500 mg will be taken twice daily.
Intervention MeSH terms: Naproxen; Acetaminophen, hydrocodone drug combination; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 115.0
Sex: All
Healthy volunteers: No

Summary:

      The objective of this study is to compare the pain control benefit of two different types of
      nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory
             Orthopaedic and Spine Center

          -  Patients willing and able to provide written informed consent

          -  Parents willing and able to provide written informed consent for minors

        Exclusion Criteria:

          -  Patients who are pregnant or lactating

          -  Patients with liver dysfunction or renal failure

          -  Patients with a known allergy to ropivacaine

          -  Patients with a local infection

          -  Patients who take chronic pain medications

          -  Patients with an opioid tolerance

          -  Patients with known coagulopathy or bleeding risk.

          -  Patients who are getting neuraxial anesthesia for surgery
D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions
Condition: Schizophrenia; Schizoaffective Disorder; Delusional Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Delusions; Schizophrenia, Paranoid
Intervention: D-Cycloserine; Placebo; Cognitive Behavioral Therapy
Intervention description: Participants will receive 10 administrations of 50 mg of D-Cycloserine by mouth one hour before CBT sessions, weekly, in weeks 3-12.; Participants will receive 12 weekly administrations of placebo by mouth 1 hour before CBT sessions, from weeks 1-12.; Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
Intervention MeSH terms: Cycloserine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: Schizophrenia; Delusions; D-Cycloserine; CBT

Summary:

      This study is a placebo-controlled 12 week trial of DCS augmentation of once-weekly CBT
      sessions in 60 schizophrenia subjects with antipsychotic-resistant delusions. In addition to
      testing efficacy, this trial will characterize DCS effects in terms of time course and
      persistence of response and will examine DCS effects on memory consolidation and cognitive
      flexibility as possible mediators of DCS enhancement of CBT for delusions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-68

          -  Diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder

          -  Treated with any antipsychotic except clozapine for at least 8 weeks or antipsychotic
             naive for lifetime

          -  Willing to participate in CBT

          -  Sufficient proficiency in English to complete assessments

          -  Score of at least 3 on the SAPS at two assessments, four weeks apart

        Exclusion Criteria:

          -  Current treatment with clozapine

          -  SSRI treatment

          -  Active alcohol or other substance abuse within six weeks

          -  Unstable medical illness

          -  Pregnant or nursing

          -  Anemia

          -  Renal insufficiency
Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks
Condition: Full-thickness Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Intervention: Arthroscopic Rotator Cuff Repair; Ropivacaine; Saline
Intervention description: During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.; The study group will receive a pump with study drug attached to a catheter placed into the shoulder area by the anesthesiologist.; The control group will receive a pump with saine attached to a catheter placed into the shoulder area by the anesthesiologist.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an
      outpatient basis. Postoperative pain control regimens can include narcotic pain medicine,
      non-steroidal anti-inflammatory medications and regional anesthesia such as an interscalene
      block (ISB). Regional blocks such as ISB can safely provide complete pain relief for the
      shoulder and upper extremity for eight to twelve hours1. However, the shoulder is still very
      painful when the block wears off. The purpose of this study is to:

        1. Examine the efficacy of continuous infusion scalene block ropivacaine catheters during
           the first two days after arthroscopic rotator cuff repair.

        2. Examine narcotic consumption after continuous infusion scalene block ropivacaine and
           placebo catheters after arthroscopic rotator cuff repair.

        3. Evaluate for any continued pain relief benefit of continuous infusion scalene block
           ropivacaine catheters during the three days after the infusion catheters have finished.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be eligible for inclusion in the study if they have a full-thickness
             rotator cuff tear that has been deemed reparable by preoperative MRI. They will be
             included in the study if they are medically stable to undergo the surgery and consent
             to involvement in the study.

        Exclusion Criteria:

          1. Prior surgery on the involved shoulder

          2. Preoperative MRI suggesting that the rotator cuff tear is irreparable

          3. Patients with known allergies to oxycodone, ropivacaine or a similar drug

          4. Workman's compensation patients

          5. Patients who do not fill out their visual analog scores or their medication diaries

          6. Patients with labral or subscapularis tears requiring repair