bioihbjkbjnl/mcl2 huggingface dataset:
Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy; Tractional Retinal Detachment
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Retinal Detachment
Intervention: Conbercept
Intervention description: Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.
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: Conbercept; Proliferative diabetic retinopathy; Silicone oil tamponade

Summary:

      To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment
      of severe proliferative diabetic retinopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of either sex aged ≥ 18 years.

          2. Diagnosis of diabetes mellitus (type 1 or type 2);

          3. Active proliferative diabetic retinopathy was clinically evident;

          4. Study eyes required a vitrectomy and silicone oil tamponade due to vitreous hemorrhage
             with significant fibrous proliferation, tractional retinal detachment in the posterior
             pole or complicated retinal detachment, which can be detected by B-scan
             ultrasonography.

          5. Ability to give informed consent.

        Exclusion Criteria:

          1. Coexistent ocular disease that may interfere with visual outcome;

          2. Prior vitreoretinal surgery or anti-vascular endothelial growth factor (VEGF)
             pharmacotherapy in either eye;

          3. A macula-involving retinal detachment for >6 months in the study eye;

          4. Iris or angle neovascularization and neovascular glaucoma;

          5. known allergy to any components of conbercept formulation

          6. severe external ocular infection;

          7. pregnancy or current oral contraceptive intake;

          8. usage of anticoagulant or antiplatelet therapy;

          9. preoperative or postoperative poor diabetes control [serum hemoglobin A1c (HbA1c)
             >11.0%];

         10. uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting
             abnormal coagulation-associated blood diseases;

         11. <6 months of follow-up post initial surgery.
Osteoarthritis Shoulder Injection Study
Condition: Glenohumeral Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Triamcinolone
Intervention description: Ultrasound guided glenohumeral shoulder joint injection
Intervention MeSH terms: Triamcinolone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ultrasound guided injection

Summary:

      The purpose of this study is to determine the most effective intraarticular steroid dose for
      the treatment of glenohumeral osteoarthritis. The investigators aim to randomize patients
      into low, medium, and high dose groups of injectable corticosteroids as these doses are
      typically used in the standard of care for our patients. To date there has been no study to
      evaluate which dose is most efficient with the fewest side effects for glenohumeral
      osteoarthritis. The investigators objective will be to provide ultrasound guided
      intraarticular glenohumeral injections of these randomized concentrations and to evaluate
      pain and function before and following injection with the Shoulder Pain and Disability Index
      (SPADI). The investigators hypothesize that the low dose steroid will provide equivalent
      improvement of the pain and function to the medium and high doses, while minimizing side
      effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An X-ray within a year with Radiographic evidence of OA

          -  18 years of age or older

          -  Clinical diagnosis established due to symptoms that will include pain attributed to
             glenohumeral osteoarthritis, pain with range of motion, and/or functional limitations
             longer than 3 months.

        Exclusion Criteria:

          -  Previous guided steroid injection of the glenohumeral joint within 3 months

          -  Previous diagnosis of inflammatory arthritis, rotator cuff tear, or immunocompromised

          -  Previous shoulder surgery

          -  Allergy to steroid or lidocaine

          -  A Kellgren and Lawrence classification of 1 or less on radiograph

          -  Non-English Speaking

          -  Inability to provide informed consent
Efficacy of Oral vs. Intravenous Acetaminophen
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Oral Acetaminophen; Intravenous acetaminophen
Intervention description: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision; 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Acetaminophen; Postoperative pain; Sinus Surgery

Summary:

      The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the
      management of postoperative pain is understudied and largely unknown. In this observer
      blinded randomized clinical trial, investigators aim to determine the comparative efficacy of
      PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients aged 18 years or older

          -  Undergoing elective sinus surgery at Zale Lipshy Hospital

        Exclusion Criteria:

          -  Inability of the patient to follow directions or comprehend either English or Spanish
             language.

               -  Disorders of the liver which would make acetaminophen contraindicated (such as
                  hepatitis, liver failure, prior liver transplant, etc).

               -  Patients with chronic pain manifest by a baseline pain score > 4/10

               -  Chronic opioid use (>2 weeks continuously), or illicit drug abuse

               -  Body weight < 50 kg.

               -  Patients with contraindications to any of the study drugs (such as Malignant
                  Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).

               -  Patients who have taken analgesic medications on the morning of surgery (prior to
                  arrival).

               -  Allergy to acetaminophen
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.
Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy
Condition: Morbid Obesity; High BMI
MeSH terms: Obesity, Morbid
Intervention: Bupivacaine
Intervention description: Bupivacaine Hcl 0.25% Inj
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: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Sleeve gastrectomy; Quadratus lumborum block; Bariatric surgery

Summary:

      The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in
      which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus
      lumborum muscle. This results in posterior spread of local anesthetic through the middle
      layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral
      space resulting in potentially longer-lasting and denser analgesia than wound infiltration.
      The QL 2 block derives from the TAP block, which is also a fascial plane block that is
      commonly used to treat pain following surgery involving the anterior abdominal wall. However,
      the QL block's more posterior location has recently been shown to provide a longer lasting
      and more profound analgesic effect than the TAP block, possibly by communicating with the
      paravertebral space. Although the TAP has been shown to be effective in a variety of surgical
      procedures involving an anterior abdominal wall incision including laparoscopic bariatric
      surgery the QL 2 block has until now, not been studied in the context of bariatric surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled to undergo laparoscopic gastric sleeve gastrectomy

          -  18-65 years of age

          -  BMI> 35 kg/m2.

        Exclusion Criteria:

          -  Contraindications to administration of local anesthesia (e.g. local anesthetic
             allergy)

          -  Contraindication/allergy to acetaminophen or ketorolac

          -  History of substance abuse or chronic opioid use

          -  Coagulopathy

          -  Patients receiving systemic anticoagulation

          -  Local infection

          -  ASA 4
Multi-center Study to Evaluate the Safety of Apixaban (BMS-562247) in Indian Subjects Undergoing Elective Total Knee Replacement or Total Hip Replacement Surgery
Condition: Anticoagulation
Intervention: Apixaban
Intervention MeSH terms: Apixaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 557.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this protocol is to evaluate the safety of Apixaban in prophylaxis of
      Venous Thromboembolism (VTE) in Indian patients undergoing elective total knee or hip
      replacement
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Subjects undergoing elective total knee or hip replacement or a revision of at least
             one component of a total knee or hip replacement

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Known or suspected, acquired or bleeding or coagulation disorder in the subject or a
             first degree relative

          -  Active bleeding or at high risk for bleeding.

          -  Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
             other than the elective knee/hip surgery

          -  Active hepatobiliary disease

          -  Hemoglobin <9 g/dL

          -  Platelet count <100,000/mm3

          -  Creatinine clearance <30 mL/min
A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Condition: Generalized Pustular Psoriasis; Erythrodermic Psoriasis
MeSH terms: Psoriasis
Intervention: Ixekizumab
Intervention description: Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Generalized Pustular Psoriasis (GPP); Erythrodermic Psoriasis (EP); Japan

Summary:

      The reason for this study is to see if the study drug ixekizumab is safe and effective in
      participants with generalized pustular psoriasis and erythrodermic psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with GPP or EP based on an investigator-confirmed diagnosis and meet the
             associated criteria

               -  GPP: Meet the criteria for GPP set by Ministry of Health, Labour and Welfare
                  (MHLW) at screening and baseline regardless of IL-36 mutation status.

               -  EP: Diagnosed to have BSA ≥80% involvement (with inflammatory erythema) at
                  screening and baseline.

          -  Candidates for phototherapy and/or systemic therapy

          -  Men must agree to use a reliable method of birth control during the study

          -  Women must agree to use birth control or remain abstinent during the study and for at
             least 12 weeks after stopping treatment

        Exclusion Criteria:

          -  History of drug-induced psoriasis

          -  Concurrent or recent use of any biologic agent

          -  Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks
             prior to enrollment and during the study

          -  Have previously received ixekizumab

          -  Serious disorder or illness other than psoriasis

          -  Serious infection within the last 12 weeks

          -  Breastfeeding or nursing (lactating) women
NAS Treatment - Opiate Versus Non-Opiate
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Morphine; Clonidine
Intervention description: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.
Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue.; Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.
Intervention MeSH terms: Clonidine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 1 Day
Maximum age: 7 Days
Healthy volunteers: No
Keywords: Prenatal opiate exposure; neonatal withdrawal; Pharmacologic treatment

Summary:

      The purpose of this study is to compare two different medicines to treat babies with opiate
      withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a
      non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine
      is another drug, but is different from morphine. It is also used for babies, and even adults
      for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if
      one may be better than the other.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) >or= 35 wks

          -  Known prenatal opiate exposure (maternal history, positive opiate screen, positive
             neonatal urine or meconium screen)

          -  Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for
             treatment

        Exclusion Criteria:

          -  Seizures

          -  Major congenital malformations

          -  Unlikely to survive

          -  Parents not able to understand English
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: TWINRIX™; Engerix™-B; HAVRIX™; HB VAX PRO™; Vaqta™
Intervention description: Intramuscular injection, 3 doses; Intramuscular injection, 3 doses; Intramuscular injection, 2 doses; Intramuscular injection, 3 doses; Intramuscular injection, 2 doses
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 596.0
Sex: All
Minimum age: 41 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Combined hepatitis A and hepatitis B vaccine; Hepatitis B; Hepatitis A; Monovalent hepatitis A and hepatitis B vaccines

Summary:

      The focus of this study is to evaluate how risk factors like age, gender, body mass index,
      smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated
      with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and
      B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been
      updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  Healthy and non-healthy male or female aged 41 years or older at the time of the first
             vaccination.

          -  Written informed consent obtained from the subject.

          -  No serological signs of hepatitis A or B infection at screening.

          -  If the subject is female, she must be of non-childbearing potential or, if of
             childbearing potential, she must be abstinent or have used adequate contraceptive
             precautions for 30 days prior to vaccination, have a negative pregnancy test and must
             agree to continue such precautions for two months after completion of the vaccination
             series.

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  History of any hepatitis A or hepatitis B vaccination or infection, since the primary
             vaccination study 100382.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Acute disease at the time of enrolment. .

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions during the primary vaccination period.
Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients
Condition: Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Intervention: Chlorhexidine Gluconate 2% Wipe; Theraworx Bath Wipes
Intervention description: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery.; Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      Intervention: This study will involve three different study arms with different interventions
      prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus
      chlorhexidine wipes

      Study Design: Single center RCT

      Sample Size: 500 patients, aged 18+

      Objectives: Primary Objectives:

        1. Monitor for safety and adverse effects.

        2. Evaluate for differences in peri-operative skin cultures between treatment groups;

        3. Compare surgical site infection rates between groups.

      Secondary Objectives:

        1. Assess for patient compliance for each different treatment arms.

        2. Measure patient satisfaction.

        3. Measure nurse satisfaction.

        4. Visual assessment of wound healing

      Expected Results: We expect no statistically significant difference in peri-operative
      cultures or surgical site infection rates between groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patient between ages 18-64

          -  Scheduled and deemed healthy enough to undergo orthopaedic surgery

          -  Willing and able to comply with protocol

        Exclusion Criteria:

          -  Clinical signs of infection

          -  Contraindication to CHG or Theraworx

          -  Previous allergic reaction to CHG or Theraworx

          -  Surgeon's Discretion