bioihbjkbjnl/mcl2 huggingface dataset:
Use of Bevacizumab in Trabeculectomy Surgery
Condition: Glaucoma; Optic Neuropathy; Fibrosis
MeSH terms: Optic Nerve Diseases; Glaucoma
Intervention: Bevacizumab; Control
Intervention description: Intrableb injection; intrableb BSS injection
Intervention MeSH terms: Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Glaucoma; Elevated Intraocular Pressure (IOP); Optic Neuropathy; Bleb Failure; Avastin (Bevacizumab)

Summary:

      When a patient with glaucoma who has a pressure that is too high and causing damage to their
      vision, despite receiving the maximum amount of medication that can be tolerated, the
      decision is made to have glaucoma surgery. Trabeculectomy is the most common form of glaucoma
      surgery used to treat open angle glaucoma. During trabeculectomy, an opening is created in
      the eye and partially covered with a flap of tissue. This new opening allows fluid to drain
      out of the eye bypassing the clogged drainage channels that are malfunctioning in patients
      with glaucoma. Studies have found that trabeculectomy significantly reduces vision loss and
      lowers eye pressure.

      However, many people need another trabeculectomy or other glaucoma surgery because the
      surgery may fail either early or much later because the body closes the drain created by the
      surgeon. The surgery is also less likely to work in patients with darker pigmentation,
      children who have congenital glaucoma, people with difficult to control glaucoma with new
      blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result,
      the investigators need to find ways to improve the longterm survival of trabeculectomy
      surgery in all patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age more than 18 years old

          -  Patients with glaucoma that is inadequately controlled on maximal tolerated medical
             therapy and scheduled for trabeculectomy surgery (with/without combined cataract
             extraction)

          -  Decision makers fluent in English

          -  Decision makers able to understand and read consent form

        Exclusion Criteria:

          -  Patients with active intraocular inflammation/uveitis or neovascular glaucoma

          -  History of previous trabeculectomy surgery or prior retinal detachment with scleral
             buckle placement in the surgical eye

          -  Aphakia in surgical eye

          -  Pregnant and nursing women

          -  Unable to fulfill inclusion criteria

          -  Refusal of consent
Immunogenicity of Hepatitis B Vaccination Among Drug Users
Condition: Hepatitis B Vaccination
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention description: three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 480.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis B vaccination; Immunogenicity; Randomized controlled trial; Drug abuse

Summary:

      Uptake, adherence, and completion of vaccination among drug users were low, and their immune
      function and immune response to hepatitis B vaccination were also suboptimal, indicating that
      the current practice of hepatitis B vaccination can't protect drug users from HBV infection.

      This is a randomized, open-label, blank-controlled trial, conducted among drug users with
      drug rehabilitation. This study will compare the immunogenicity and safety of three
      intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug
      users
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged between 18 and 70 years at the enrolment

          -  current illicit drug users before drug rehabilitation

          -  negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody
             (anti-HBs) at enrollment

          -  having spent acute physiological detoxification phase

        Exclusion Criteria:

          -  any intolerance or allergy to any component of the vaccine

          -  ongoing opportunistic infection

          -  liver disease

          -  hemopathy

          -  cancer

          -  unexplained fever in the last week before the recruiting
Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Spinal analgesia for labour pain; Epidural analgesia for labour pain
Intervention description: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique; Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be
      compared when given either intrathecally or epidurally in primiparous parturients during
      early phase of the labour.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primiparous parturients

          -  In early phase of labour (cervical dilatation at or under 5 cm)

          -  No prior opioids by any route of administration within past 120 min

          -  Pain at or over 80 mm on 0-100 mm visual analog scale during contraction

        Exclusion Criteria:

          -  Allergy for any of the medications used

          -  Contraindications for epidural/spinal analgesia

          -  BMI at the time of delivery under 20 or over 35 kg/m2
VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo of vildagliptin; vildagliptin; Metformin
Intervention description: One tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.; Twice daily (bid) regimen during or after meals at the same time as vildagliptin.
Intervention MeSH terms: Metformin; Vildagliptin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2004.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Vildagliptin; Elderly Patients

Summary:

      The purpose of this study was to determine whether the initiation of a vildagliptin plus
      metformin combination regimen would result in more durable glycemic control than metformin
      monotherapy in treatment-naïve patients with type-2 diabetes mellitus (T2DM).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Type 2 Diabetes Mellitus (T2DM) diagnosed ≤ 24 months ago

          -  glycosylated hemoglobin (HbA1c) ≥6.5% and ≤7.5% at Visit 1

          -  Treatment-naïve.

          -  Body mass index (BMI) ≥22 and ≤40 kg/m2 at Visit 1

        Key Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Fasting plasma glucose (FPG) ≥ 270 mg/dL (≥ 15.0 mmol/L)

          -  Previous or current participation in any vildagliptin clinical study.

          -  History of hypersensitivity to dipeptidyl peptidase-4 (DPP-4) inhibitors.

          -  Concurrent medical condition that may interfere with the interpretation of efficacy
             and safety data during the study.

          -  Donation of blood or significant blood loss equaling to at least one unit of blood
             within the past 2 weeks of start of study or a blood transfusion within the past 12
             weeks or planned regular transfusions during the study period.
Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women
Condition: Melasma
MeSH terms: Melanosis
Intervention: 20-30% Salicylic Acid peels to the right side of the face; 20-30% Salicylic Acid peels to the left side of the face
Intervention description: Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the right side of the face.; Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the left side of the face
Intervention MeSH terms: Salicylic Acid; Salicylates
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Melasma; Dark spots on the face

Summary:

      This study will enroll 20 adult Hispanic women. Participants will apply 4% hydroquinone cream
      twice daily to affected areas on the face for 14 weeks and half the face will be peeled with
      20-30% salicylic acid every two weeks for a total of 4 peels. The first two peels will be 20%
      salicylic acid and the second two peels will be with 30% salicylic acid. The purpose of the
      study will be to evaluate the safety and efficacy of salicylic acid combined with 4%
      hydroquinone versus 4% hydroquinone alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hispanic women ages 18-65 years of age with moderate to severe melasma

          -  English and Spanish-speaking women

        Exclusion Criteria:

          -  Pregnant or breast-feeding women

          -  Subjects who have used 4% hydroquinone within 3 months of study start

          -  Subjects who have used chemical peels, microdermabrasion or facial laser treatments
             within 9 months of study start
Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery
Condition: Endoscopic Sinus Surgery; Nasal Polyps
MeSH terms: Nasal Polyps
Intervention: Oxymetazoline; Epinephrine
Intervention description: Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.; Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.
Intervention MeSH terms: Phenylephrine; Epinephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effects of Oxymetazoline and Epinephrine (which
      are 2 different nasal decongestants both of which are routinely used before sinus surgery) on
      blood loss and the surgeon's view of the surgical field during sinus surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery
             (ESS) in which the same sinuses and procedures on both sides are the same for CRS with
             or without nasal polyposis.

        Exclusion Criteria:

          -  pregnancy

          -  known coagulopathy

          -  an international normalized ratio greater than 1.3

          -  a partial thromboplastin time greater than 50 seconds

          -  use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses)

          -  use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta)

          -  poorly controlled hypertension with a preoperative systolic blood pressure of 160mm Hg
             or greater or a diastolic blood pressure of 90mm Hg or greater

          -  having any adverse reaction to topical epinephrine or oxymetazoline.
Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: KAD-1229; Placebo; Insulin
Intervention MeSH terms: Mitiglinide
Phase: Phase 4
Study type: Interventional
Enrollment: 178.0
Sex: All
Minimum age: 20 Years
Keywords: Type 2 Diabetes Mellitus; HbA1c

Summary:

      The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination
      therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2
      Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or
      insulin and oral hypoglycemic agent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who has been receiving dietary therapy and a stable dose and regimen of
             insulin over 8 weeks before at the time of an observation term start

          -  Patients whose HbA1c at the time of an observation term start is 7.5% or more and less
             than 10.0%

        Exclusion Criteria:

          -  Type 1 Diabetes Mellitus

          -  Patients with serious diabetic complications and other serious complications
Corticosteroid Dosage for Crohn's Disease Flare
Condition: Crohn's Disease; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Inflammatory Bowel Diseases
Intervention: Corticosteroid
Intervention description: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
Intervention MeSH terms: Prednisone; Methylprednisolone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Corticosteroid

Summary:

      Prospective randomized comparative effectiveness trial designed to compare fixed dosing and
      weight-based dosing of corticosteroids in patients with Crohn's disease flares.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18

          -  Established diagnosis of Crohn's disease

          -  Diagnosis of Crohn's flare

          -  Decision by treating gastroenterologist to start corticosteroid therapy

        Exclusion Criteria:

          -  Patients in whom corticosteroid therapy is contraindicated: immunocompromised (active
             cancer on chemotherapy or radiation treatment), severe liver disease (decompensated
             cirrhosis, active alcoholic hepatitis), end-stage renal disease on dialysis, AIDS or
             AIDS-defining illness; myocardial infarction within the past year; NYHA Class 4 heart
             failure

          -  Patients on systemic corticosteroid therapy currently or within the past 8 weeks

          -  Patients not on stable doses of immunomodulators or biologics for at least 8 weeks

          -  Infectious colitis (e.g., C. difficile, CMV, HSV)

          -  Systemic infections (bacteremia, fungal infections)

          -  Fulminant Crohn's disease

          -  Patients who require imminent surgery

          -  Abscess

          -  Pregnancy

          -  Weight <35 kg
A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Androderm®
Intervention description: Androderm® transdermal dose.
Intervention MeSH terms: Testosterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of a once daily Androderm® dose on Blood Pressure (BP) in
      adult hypogonadal men as measured by 24-hour ABPM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Naïve to testosterone replacement, clomiphene, compounded or over-the-counter
             androgenic steroid derivatives, and dehydroepiandrosterone (DHEA), including
             investigational products that may affect the reproductive hormonal system or has not
             been treated with these compounds in the past 6 months

          -  Male participants willing to minimize the risk of inducing pregnancy for the duration
             of the clinical study and follow-up period

          -  Participant must be 18 to 80 years of age inclusive, at the time of signing the
             informed consent

          -  Body mass index (BMI) < 35 kilograms per metre square (kg/m^2)

          -  Male

        Exclusion Criteria:

          -  Uncontrolled systemic disease or clinically significant disease, in particular, liver,
             kidney or heart disease, including hypertension, congestive heart failure, coronary
             heart disease, chronic atrial fibrillation, sleep apnea or psychiatric illness, that
             in the investigator's opinion, would put the participant at an unacceptable risk with
             exposure to Androderm®

          -  History of prostate (current or in the past) or breast cancer

          -  Had a recent (within 2 years) history of stroke, transient ischemic attack, acute
             coronary event, venous thrombotic, or thromboembolic event

          -  History of alcohol or other substance abuse within the previous 2 years

          -  Known allergy or sensitivity to the study intervention or its components or other
             testosterone replacement medications

          -  Participant who works night shifts or who will need to perform strenuous manual labor
             while wearing the ABPM monitor
Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Tetracaine; Bupivacaine
Intervention description: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.; Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
Intervention MeSH terms: Bupivacaine; Tetracaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No
Keywords: labor pain; combined spinal epidural labor analgesia; CSE analgesia; labor analgesia

Summary:

      The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for
      CSE labor analgesia volume will last a significantly longer period of time that that of
      spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects
      meeting criteria when analgesia is requested will be randomized to receive a combined
      spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or
      bupivacaine 2 mg with fentanyl and epinephrine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  early labor (>=2cm but =<6cm cervical dilation)

          -  at least 12 years of age

          -  have an assigned ASA physical status 1 or 2

          -  singleton pregnancy

        Exclusion Criteria:

          -  contraindications to neuraxial anesthesia

          -  with allergies to drugs used in the study

          -  have an assigned ASA status 3 or 4

          -  advanced labor (> 6cm cervical dilation)

          -  less than 12 years of age

          -  Patients with the potential for distorted epidural anatomy, such as Harrington rods or
             prior back surgery, will also be excluded.
Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction
Condition: Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Intervention: Dexmedetomidine Injection
Intervention description: Dexmedetomidine Injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: This will be a prospective, randomized, placebo-controlled, double-blind clinical trial. The patients will be recruited according to the inclusion criteria and will be distributed to one of the groups according to computer-generated random assignment. The personnel involved in the study, including statisticians, investigators, anaesthetists, surgeons and the patients will be blinded to the specific experimental scheme implementation Patients will be randomized into one of the two groups using a computer based random number generator. https://www.randomizer.org. All recordings would be performed by an anaesthesiologist blinded to the group allocation.
Enrollment: 120.0
Sex: All
Minimum age: 60 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD
      assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years
      undergoing hip surgery under spinal anaesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American society of Anesthesiology (ASA) status of I-III

          -  Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia

        Exclusion Criteria:

          -  Patient not willing to be a part of the study

          -  Patients were aged <60 or >75 years

          -  Patients with accompanying medical conditions that may affect the level of
             consciousness, such as stroke, stupor or dementia, or patients with abnormalities in
             hepatic or renal function, electrolyte imbalance

          -  Patients suffering from preoperative bradycardia [heart rate (HR) <60 bpm] or
             hypotension [mean arterial blood pressure (MAP) <70 mmHg]

          -  Patients who had recently received a sedative or opioid drug

          -  Patients with a MoCA (Montreal Cognitive Assessment) score <26

          -  Patients with persistent hypotension and bradycardia intra-operatively even after
             giving Mephentermine will be excluded from the study