bioihbjkbjnl/mcl2 huggingface dataset:
Different Safety Profile of Risperidone and Paliperidone Extended-release
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: risperidone; paliperidone ER; placebo
Intervention description: risperidone 3mg, PO, 3 times; paliperidone ER 6mg, PO,3 times; lactose PO, 3times
Intervention MeSH terms: Risperidone; Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cognitive function; subjective experiences; neuroleptic-induced deficit syndrome; paliperidone extended-release; risperidone

Summary:

      The main objective of this study was to assess subjective experiences related to secondary
      negative symptoms and cognitive performance in healthy volunteers in response to multiple
      doses of paliperidone ER and risperidone in a double-blind, placebo-controlled trial. Adverse
      events caused by these drugs were also evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-38 years and meet no DSM-IV diagnostic criteria as assessed by using the
             Structured Clinical Interview for DSM-IV, research version

        Exclusion Criteria:

        Anyone who:

          -  Participated in other clinical trials within 30 days from the start of this clinical
             trial or is currently participating in one

          -  Has progressive disease or in unstable medical condition unfit for the trial

          -  Has been diagnosed in psychiatric terms in the past, depends on psychotropic
             substance, or has overdosed or depended on the substance or alcohol (except for coffee
             or tobacco) within 1 month from the trial start

          -  Is suicidal or highly probable of suicides; OR

          -  Has test results considered clinically meaningful
SERETIDE 100/50 bd (Twice Daily) Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults
Condition: Asthma
MeSH terms: Asthma
Intervention: Salmeterol xinafoate/fluticasone propionate combination; Fluticasone propionate
Intervention description: SFC 100; FP 100
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: persistent; moderate; asthma; adults; Initial; Maintenance; Therapy

Summary:

      This study will compare during 12 weeks, two treatment strategies for Initial Maintenance
      Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination
      in adults with moderate persistent asthma
    

Eligibility criteria:

        Inclusion criteria:

          -  male or female ≥ 18

          -  documented history of asthma

          -  reversibility FEV1 or PEF ≥ 12% (post 400µg salbu)

          -  moderate asthma (daily symptoms, daily rescue use, PEF = 60-80% predicted value)

          -  naive or ≥ 4weeks-free ICS (inhaled corticosteroids)

        Exclusion criteria:

          -  respiratory disorder

          -  FEV1<60% predicted

          -  exacerbation/respiratory infection ≤ 4 weeks

          -  oral/parenteral/depot corticosteroids ≤ 6 months

          -  LABA/oral β2 agonist/ ALT/ theophylline ≤ 4 weeks

          -  smoker or former smoker ≥ 5 packs year
Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Placebo; OROS-methylphenidate
Intervention description: Placebo (sugar pill); 18 mg to 54 mg once a day for 1 week
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate; Attention; Working Memory

Summary:

      This study investigates whether OROS-methylphenidate improves performance on different
      aspects of attention and memory in children with Attention-Deficit Hyperactivity Disorder
      (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets Diagnostic and Statistical Manual-IV Edition (DSM-IV) Criteria for ADHD.Combined
             Type

          -  Parent and Teacher Ratings >85 percentile on inattention and/or
             hyperactivity/impulsivity scales

          -  Estimated Intelligence Quotient (IQ) > 80 on Wechsler Abbreviated Scale of
             Intelligence or similar IQ test

        Exclusion Criteria:

          -  Past or current diagnosis of Tourette syndrome or chronic tic disorder, Pervasive
             Developmental Disorder (PDD), Cerebral Palsy, Head Injury requiring hospitalization,
             psychotic disorder, hypertension, glaucoma, cardiovascular disease, severe narrowing
             of the gastrointestinal tract, or epilepsy

          -  Current diagnosis of bipolar disorder, obsessive-compulsive disorder serious enough to
             warrant separate treatment, suicidal or homicidal behavior or ideation

          -  Use within 14-days of a monoamine oxidase inhibitor

          -  History of side effects on any methylphenidate preparation that required stopping the
             medication

          -  Inability to swallow a capsule or tablet

          -  Chronic treatment with coumarin, clonidine, or tricyclic antidepressants
D2560C00015 FluMist Annual Safety Study 2018
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Intervention: Bivalent influenza vaccine; Placebo
Intervention description: A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1.; A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.
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
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bivalent.; Influenza.; FluMist Quadrivalent.; Vaccine Prevention in Healthy Adults.

Summary:

      This prospective annual release study is designed to evaluate the safety of 2 new influenza
      virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza
      season.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 through 49 years

          -  Written informed consent

          -  Subject available by telephone

          -  Ability to understand and comply with the requirements of the protocol, as judged by
             the Investigator

        Exclusion Criteria:

          -  Concurrent enrollment in another clinical study up to 180 days after receipt of
             investigational product (Day 181)

          -  History of hypersensitivity to any component of the vaccine, including egg or egg
             protein or serious, life threatening, or severe reactions to previous influenza
             vaccinations

          -  Any condition for which the inactivated influenza vaccine is indicated, including
             chronic disorders of the pulmonary or cardiovascular systems (example (eg], asthma),
             chronic metabolic diseases (eg, diabetes mellitus), renaldysfunction, or
             hemoglobinopathies that required regular medical follow-up or hospitalization during
             the preceding year

          -  Acute febrile (greater than [>]100.0 degrees Fahrenheit [F] oral or equivalent) and/or
             clinically significant respiratory illness (example, cough or sore throat) within 14
             days to randomization

          -  Any known immunosuppressive condition or immune deficiency diseases, including human
             immunodeficiency virus infection, or ongoing immunosuppressive therapy

          -  History of Guillain-Barre syndrome.
IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy
Condition: Pain
Intervention: IV acetaminophen; placebo
Intervention description: The patients in the treatment arm will receive 1000mg of IV acetaminophen.; The patients in the placebo arm will receive normal saline.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 183.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Laparoscopic Hysterectomy; IV acetaminophen; Postoperative pain control; Surgery

Summary:

      The objective of this study is to quantify the change in post-operative pain scores and
      narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to
      placebo in women undergoing laparoscopic hysterectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18-75

          -  Ability to read and write in English (our post-operative pain log is only available in
             English)

          -  Planning a laparoscopic hysterectomy (includes total laparoscopic hysterectomy,
             laparoscopic supracervical hysterectomy, laparoscopically assisted vaginal
             hysterectomy, with or without salpingooophorectomy)

        Exclusion Criteria:

          -  Answering yes to any of the following questions: "Do you have a history of liver
             disease, kidney disease, hepatitis C, history of liver failure, greater than 3 drinks
             per day or being have you ever been told by your doctor that they should not take
             acetaminophen"

          -  History of cardiac arrhythmia

          -  History of jaundice

          -  Acute abdominal inflammatory or infectious process at time of surgery

          -  Known malignancy at time of surgery

          -  Known pregnancy at time of surgery

          -  Plan to perform additional significant surgical procedure at the time of hysterectomy
             such as extensive excision of endometriosis on bowel or bladder or pelvic
             reconstructive procedure

          -  >6cm abdominal incision in order to remove the uterus at time of study-related
             hysterectomy

          -  Regular use of narcotic pain medication (defined as use on most days of the week at
             any point in the past 3 months)

          -  Allergy to acetaminophen

          -  Women who weigh less than 50 kilograms on the day of surgery.
High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population
Condition: Helicobacter Pylori Infection
MeSH terms: Infections
Intervention: Amoxicillin; Omeprazole; Clarithromycin
Intervention description: 1 g; 40 mg. Patients were asked to take omeprazole one hour prior to food intake, while antibiotics were taken after meals.; 500 mg twice daily
Intervention MeSH terms: Amoxicillin; Clarithromycin; Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: high-dose dual therapy; standard triple therapy; helicobacter pylori eradication; clarithromycin resistance

Summary:

      A phase 4 prospective, randomized, open-label clinical trial evaluating the efficacy of high
      dose dual therapy vs standard triple therapy in a diverse, urban New York City population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Treatment-naïve

          -  Clinical diagnosis of helicobacter pylori infection based on urea breath test,
             endoscopy or stool antigen test

          -  Subject willing to participate and able to provide informed consent.

        Exclusion Criteria:

          -  Prior helicobacter pylori treatment failure

          -  Antibiotic exposure within the past 4 weeks of helicobacter pylori diagnosis

          -  Pregnancy or breastfeeding

          -  Penicillin allergy

          -  History of active or non-gastric malignancy

          -  Severe illness requiring hospitalization during treatment period

          -  Starting additional antibiotic while on treatment
Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
Condition: Inflammation; Barrett's Esophagus
MeSH terms: Barrett Esophagus; Esophagitis; Inflammation
Intervention: dexlansoprazole; Omeprazole
Intervention description: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months; Escalating doses of omeprazole (20-60 mg/day) for 6 months
Intervention MeSH terms: Omeprazole; Dexlansoprazole; Lansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Barrett's Esophagus; Radiofrequency ablation; Patients post-radiofrequency ablation for Barrett's Esophagus.

Summary:

      The investigators hypothesize that intensive acid suppression with a long acting high potency
      proton pump inhibitor (PPI) drug dexlansoprazole will lead to a greater decrease in levels of
      inflammatory mediators (compared to conventional PPIs) in the esophagus, which could
      potentially lead to decreased recurrence of intestinal metaplasia following endoscopic
      ablation.
    

Eligibility criteria:

        Patients who have undergone ablation for Barrett's Esophagus (BE) and High Grade Dysplasia
        (HGD) or Low Grade Dysplasia (LGD) with Photodynamic Therapy (PDT)/Radiofrequency ablation
        and endoscopic mucosal resection who have no endoscopic and histologic evidence of
        specialized intestinal metaplasia on biopsies from the esophagus on two successive
        endoscopies post ablation will be offered enrollment in the study.

        Inclusion criteria:

          1. Absence of intestinal metaplasia on endoscopy (under Narrow Band Imaging) and on
             histology (from biopsies taken from gastroesophageal junction and distal esophagus) on
             two successive surveillance endoscopies.

          2. Able to consent to study

          3. Males and females age 18-90

          4. Life expectancy of 5 years or greater.

        Exclusion criteria:

          1. Pregnancy

          2. Inability to consent for the procedure

          3. Anticoagulation therapy precluding performance of ambulatory pH monitoring and/or
             biopsies

          4. Intolerance to proton pump inhibitors

          5. Elevation in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), (liver
             enzymes), bilirubin or alkaline phosphatase more than five times the upper limit of
             normal.
Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Methadone; Morphine
Intervention description: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.; To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.
Intervention MeSH terms: Morphine; Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 31.0
Sex: All
Minimum age: 2 Hours
Maximum age: 28 Days
Healthy volunteers: No
Keywords: NAS; NICU; EMMC

Summary:

      Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter
      duration of opiate medication treatment and fewer infants treated with a second drug.
    

Eligibility criteria:

        Inclusion Criteria:

        i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores > 8 in an 8
        hour time period, AND

        ii. Gestation => 35 weeks at entry defined by best obstetrical and physical exam criteria,
        AND

        iii. Medically stable condition in the opinion of the attending neonatologist, other than
        opiate withdrawal, AND

        iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine.

        Exclusion Criteria:

        i. Gestation < 35 weeks at entry defined by best obstetrical and physical exam criteria.

        ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected,

        iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis,
        intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission
        to the NICU.

        iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal
        course

        v. Mother consistently taking prescribed benzodiazepine at the time of delivery
Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Intervention: elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)
Intervention description: Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor
Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).
Intervention MeSH terms: Grazoprevir
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: hemodialysis; peritoneal dialysis; renal failure; kidney transplant

Summary:

      Proof of concept, open-label single center study for the donation of HCV positive kidneys to
      HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission
      upon transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must meet Massachusetts General Hospital (MGH) transplant center criteria and already
             be listed for isolated kidney transplant

          2. No available living kidney donor

          3. Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤
             1095 days of accrued transplant waiting time if blood type B or O.

          4. On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate
             <15mL/min/1.73m2 at the time of screening

          5. Weight ≥ 50kg

          6. Serum alanine transaminase (ALT) within normal limits

        Exclusion Criteria:

          1. AB blood type

          2. Body mass index (BMI > 35

          3. History of liver disease

          4. Pregnant or nursing (lactating) women

          5. Cardiomyopathy (LV ejection fraction < 50%)

          6. Positive crossmatch or positive donor specific antibodies

          7. Human immunodeficiency virus (HIV) positive

          8. Hepatitis C virus (HCV) RNA positive

          9. Hepatitis B virus (HBV) surface antigen positive

         10. Any contraindication to kidney transplant per MGH center protocol
Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Total knee replacement with NexGen CR knee prosthesis; Total knee replacement(TKR) with Nexgen CR-flex
Intervention description: comparison of functional outcome in patients receiving either NexGen posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis; TKR using Nexgen CR-flex implant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this prospective, randomized study was to compare pain, functional outcome and
      ranges of motion of the knees in patients receiving either a standard posterior
      cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  osteoarthritis that was severe enough to warrant total knee arthroplasty after an
             adequate trial of nonoperative therapy, and the need for bilateral total knee
             arthroplasties

        Exclusion Criteria:

          -  inflammatory arthritis

          -  osteoarthritis of the hip causing pain or restricted mobility

          -  a foot or ankle disorder which limited walking

          -  dementia or a neurological disorder including a past history of stroke which affected
             mobility