bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Risedronate/Cholecalciferol combination; Risedronate
Intervention description: Risendronate/Cholecalciferol combination once a week; Risedronate once a week
Intervention MeSH terms: Cholecalciferol; Vitamin D; Risedronic Acid; Etidronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1053.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Risedronate, cholecalciferol, BMD

Summary:

      The purpose of this study is to evaluate the efficacy and the safety of Risedronate,
      cholecalciferol combination tablet in patients with Osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male osteoporosis patients over 19 years of age

          2. Female osteoporosis patients with menopause

               -  Definition of osteoporosis

                    -  They had a BMD T-score -2.5 or less at mean Lumbar spine(L1-L4), Femoral
                       neck or total. Or evidence of at least one vertebral fracture

               -  Definition of menopause(can be one of three condition)

                    -  For 12months spontaneous amenorrhea

                    -  For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating
                       hormone) is 40mlU/mL and over

                    -  6weeks after bilateral ovariectomy whether hysterectomy or not.

        Exclusion Criteria:

          1. Patients with esophagus disorder (i.e:esophagostenosis)

          2. Patients administered with osteoporosis therapy(except calcium, Vit.D
             medication)within the previous 3 Months

          3. Patients with serum calcium concentrations 8.0mg under

          4. Patients with severe nephropathy (CCr 30mL/min less)

          5. Patients with unable to sit upright or stand for 30minutes
Oral Versus Intravenous Tranexamic Acid
Condition: Blood Loss; Blood Transfusion
MeSH terms: Hemorrhage
Intervention: Tranexamic Acid
Intervention description: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The goal of this randomized clinical control trial is to determine whether oral TXA dosing in
      THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients
      undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are:

      Does oral TXA dosing in THA/TKA result in more blood loss compared to IV TXA dosing?

      Does oral TXA dosing in THA/TKA result in more transfusions compared to IV TXA dosing?

      Participants will be randomly assigned to either get the Oral TXA (1950mg) or the IV TXA (1g)
      on their day of surgery. Researchers will compare these groups to see if any differences
      emerged. 200 THA patients (100 Oral, 100 IV), 200 TKA patients (100 oral, 100 IV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing total hip arthroplasty (THA) through a posterior approach

          -  Patients undergoing total knee arthroplasty (TKA)

          -  Patients between 18-80 years of age

        Exclusion Criteria:

          -  Patients with >80 years of age

          -  Patients with a BMI over 40

          -  Patients undergoing general anesthesia

          -  Patients with a history of major ipsilateral joint surgery

          -  Patients on pre-operative anticoagulation or anti-platelet drugs (other than aspirin)

          -  Patients with a history of bleeding disorders

          -  Patients with platelets less than 100/nl

          -  Patients with new-onset/active atrial fibrillation

          -  Patients with a history of myocardial infarction in the past year

          -  Patients with a history of a stroke in the past year
Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Intervention: Aflibercept; Focal Laser
Intervention description: pro re nata (PRN); Focal laser administered based on pre-specified criteria
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing
      intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009; NCT01363440)
      end-point. Subjects will be treated with intravitreal aflibercept injections pro re nata
      (PRN) based on the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who
      meet re-treatment criteria will be eligible for focal laser treatment every 90 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A subject must meet the following criteria to be eligible for inclusion in the study:

               1. Enrolled and Completed VISTA DME (VGFT-OD-1009) clinical trial

               2. Willing and able to comply with clinic visits and study-related procedures

               3. Provide signed informed consent

               4. Enrollment in the trial within 12 weeks of trial activation.

        Exclusion Criteria:

          -  A subject who meets any of the following criteria will be excluded from the study:

               1. Prior treatment with anti-VEGF therapy in the study eye within 28 days of
                  baseline

               2. Pregnant or breast-feeding women

               3. Sexually active men* or women of childbearing potential** who are unwilling to
                  practice adequate contraception during the study (adequate contraceptive measures
                  include stable use of oral contraceptives or other prescription pharmaceutical
                  contraceptives for 2 or more menstrual cycles prior to screening; intrauterine
                  device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive
                  sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

                    -  Contraception is not required for men with documented vasectomy.
                       **Postmenopausal women must be amenorrheic for at least 12 months in order
                       not to be considered of child bearing potential. Pregnancy testing and
                       contraception are not required for women with documented hysterectomy or
                       tubal ligation.
VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
Condition: Infections, Herpesviridae
MeSH terms: Herpesviridae Infections
Intervention: Valaciclovir; Placebo
Intervention description: Valtrex 1g once daily; placebo
Intervention MeSH terms: Valacyclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: viral shedding; Recurrent; herpes; genital herpes

Summary:

      Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for
      60 days in a two-way crossover study with a washout period of 7 days between treatment
      periods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In overall general good health.

          -  HSV-2 (Herpes Simplex Virus-2) seropositive at screening.

        Exclusion criteria:

          -  have active lesions consistent with genital herpes.

          -  previous history of symptomatic genital herpes.

          -  history of recurrent, undiagnosed symptoms consistent with genital herpes.
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
Condition: Loiasis
MeSH terms: Loiasis
Intervention: Ivermectin
Intervention description: single dose, 150 ug/kg
Intervention MeSH terms: Ivermectin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study seeks to determine which Loa loa antigens are released into circulation when
      infected individuals are treated with ivermectin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Loa loa blood microfilariae of between 5,000 - 18,000 per mL

        Exclusion Criteria:

          -  known allergy to ivermectin; severe comorbidities
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Condition: Foot and Ankle Surgeries; Bunion
MeSH terms: Bunion
Intervention: Tranexamic Acid; Normal saline
Intervention description: administered prior to surgical incision; administered prior to surgical incision
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: foot and ankle surgeries; tranexamic acid; wound healing; blood loss

Summary:

      Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often
      underestimated. However there has been growing emphasis on identification of these injuries
      and practice patterns.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA (American Society of Anesthesiology) class I-IV

          -  age 8-75.

        Exclusion Criteria:

          -  ASA class V

          -  morbid obesity

          -  patient refusal

          -  patients with known coagulopathy disorder

          -  renal insufficiency

          -  hepatic dysfunction

          -  serious cardiac disease

          -  an allergy to TXA or receiving antiplatelet and /or anticoagulant drugs will be
             excluded.
Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab
Condition: Visual Acuity Reduced Transiently; Macular Edema, Cystoid
MeSH terms: Macular Edema; Edema
Intervention: ranibizumab
Intervention description: Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied.
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking description: Observer-masking (assessment of BCVA, macular thickness, capillary drop-out) is done to guard against detection bias.
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema, Ranibizumab, Visual Acuity, Diabetic Control

Summary:

      The aim of the prospective randomized study is to investigate whether a intensified diabetic
      control program leads to better final visual acuity and less frequent diabetic ocular
      complications in patients with diabetic retinopathy when compared with a normal diabetic
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients with diabetic macular edema relevant to visual acuity

          -  OCT central retinal thickness ≥ 250µm

          -  HbA1c > 6,5% at initial visit

          -  BCVA ≤0.8 and ≥0.05

          -  Age ≥18 years

          -  Written patient informed consent given

        Exclusion Criteria:

          -  Previous treatment with intravitreal drugs in last 6 months

          -  Vitreous hemorrhage as a consequence of proliferative retinopathy

          -  Pregnancy

          -  Blood pressure of ≥ 180/100 (or uncontrolled pressures under pharmacological therapy)

          -  Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel
             disease, Addison´s disease, Cushing Syndrome, Uveitis)

          -  Systemic cortisone or anti-VEGF therapy

          -  Acute systemic or ocular infectious diseases
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines
Condition: Transformed Migraine; Chronic Daily Headache
MeSH terms: Migraine Disorders; Headache Disorders; Headache
Intervention: SPG Block with 5% Lidocaine gel; Amitriptyline
Intervention description: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia; The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
Intervention MeSH terms: Lidocaine; Amitriptyline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Migraine Headache; Menstrual Migraine; Vascular Headache; Temporal Lobe Seizure

Summary:

      This study will compare a local anesthetic technique that has been used to treat subjects
      suffering from transformed migraines (chronic migraines) versus medical management with
      traditional antidepressant Amitriptyline / Elavil.

      Subjects will be randomized into one of two treatment groups to compare the safety and
      efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block
      with 5% lidocaine gel into the nasopharynx or medical management with traditional
      antidepressants, Elavil, to produce a reduction in the frequency and severity of the
      headache.

      We propose that there will be a difference in the outcomes when comparing the two methods of
      treating transformed migraines and that one research arm will result in more patient
      satisfaction and greater efficacy in the treatment of subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female age 18-90

          2. Subject have formal medical diagnosis of migraine headache

          3. Subjects currently require treatment for headache

          4. Subjects who have received optimal medical management from migraines including
             triptans (Imitrex, Amerge and Relpax)

          5. Subjects who have recieved optimal medical management for migraines including
             anticonvulsants (Depakote, Lamictal, klonopin

        Exclusion Criteria:

          1. Less than 18 years of age

          2. Subjects will be excluded if they are already being treated with lidocaine (patch or
             other vehicle) for chronic pain

          3. Untreated Heart Failure

          4. Pregnancy

          5. Individuals unwilling to comply with study procedures and follow-up
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
Condition: Homozygous Familial Hypercholesterolemia HoFH
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: evolocumab
Intervention description: Administered by SC injection via autoinjector (AI)/pen
Intervention MeSH terms: Evolocumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 12 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Evolocumab; Hypercholesterolemia

Summary:

      To describe the safety and tolerability of evolocumab in participants with homozygous
      familial hypercholesterolemia (HoFH) in India. All participants will receive evolocumab over
      an 8-week period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 12 to ≤ 80 years of age at the time of signing the informed consent

          -  Diagnosis of HoFH based on low-density lipoprotein cholesterol (LDL-C), familial
             history and xanthoma

          -  On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks
             prior to screening and during the time frame of the trial

          -  Fasting LDL-C at screening > 130 mg/dL (3.4 mmol/L)

          -  Fasting triglycerides at screening ≤ 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

          -  Use of mipomersen or lomitapide within 6 months of screening.

          -  Known active infection or major hematologic, renal, metabolic, gastrointestinal,
             hepatic, or endocrine dysfunction

          -  Currently receiving treatment in another investigational device or drug study, or less
             than 30 days since ending treatment on another investigational device or drug
             study(ies)

          -  Female subject is pregnant or breastfeeding or planning to become pregnant or
             breastfeed

          -  Female subjects of childbearing potential unwilling to use an acceptable method of
             effective contraception

          -  Subject has known sensitivity to any of the products to be administered during dosing

          -  History or evidence of any other clinically significant disorder, condition or disease

          -  Subject has previously received evolocumab or any other proprotein convertase
             subtilisin/kexin type 9 (PKSK-9)-inhibiting therapy
Propofol for Pediatric Tracheal Intubation With Deep Anesthesia During Sevoflurane Induction
Condition: Anesthesia Intubation Complication
Intervention: propofol
Intervention description: Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range
Intervention MeSH terms: Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Intervention model description: This is a single study with 6 parallel groups as noted in the description. With Dixon's Up and Down Method for determining a 50th percentile of a dichotomous outcome, the number of patients required is not known prior to starting a study. Data from Paul and Fisher demonstrated that 6 "crossovers" (change in the dichotomous outcome from one patient to another, indicating change from increasing the dose of the study drug to decreasing it, or visa-versa). When choosing a meaningful starting point near the 50th percentile, the number required is typically 15-20 patients. With 6 study groups, the estimated number of patients required would be 90-120. Please Note: This is not a study where one can perform a power analysis and determine a required N.
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: No
Keywords: intubation of children without neuromuscular blockade

Summary:

      The purpose of this study is to determine the amount of propofol required to achieve 50% of
      patients obtaining a perfect ("excellent") intubation score of 5 on the Steyn modification of
      the Helbo-Hansen Intubation Score, when placing a tracheal tube in children 1-6 years and
      6-12 years (division of age groups at 6th birthday) of age, under a specific induction and
      ventilation sequence as specified in this study design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent / assent

          -  Ages 1-11 years (12 - 132 months)

          -  American Society of Anesthesiology (ASA) physical status 1 or 2, which implies that
             the patient has no comorbidity that limits daily function.

          -  Scheduled for non-emergent surgery/ procedure under general anesthesia in which the
             anesthesia team intends to place an endotracheal tube

          -  Expected routine intubation according to physical exam and history

          -  Weight under 50 kg

        Exclusion Criteria:

          -  Requires neuromuscular blocking agents

          -  Emergent surgery / procedure

          -  Expected difficult intubation

          -  ASA physical status 3 or 4

          -  Weight over 50 kg

          -  Age under 12 months or over 132 months

          -  Allergy to study drugs to be used
Effects of Fish Oil on Post Ablation Arrhythmias
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: LOVAZA Omega 3-acid ethyl esters; LOVAZA; placebo
Intervention description: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.; (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.; Control group will receive placebo before & after ablation.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Radiofrequency Ablation; atrial fibrillation

Summary:

      To determine if peri-operative treatment with omega-3 fatty acids is associated with a
      decrease in the incidence of early recurrences of atrial arrhythmias (within 30 days) and an
      improvement in probability of long-term maintenance of sinus rhythm after radiofrequency
      catheter ablation for Atrial Fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years and < 70 years old

          -  Left atrial size <55 mm

        Exclusion Criteria:

          -  Inability or unwillingness to provide informed consent

          -  Current therapy with omega-3 fatty acids

          -  Current therapy with a statin

          -  Active liver disease

          -  Significant comorbidity such as end-stage renal disease or cirrhosis

          -  Valvular prosthesis