bioihbjkbjnl/mcl2 huggingface dataset:
Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy
Condition: Venous Thromboembolism; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Thromboembolism; Venous Thromboembolism
Intervention: Aspirin
Intervention description: 81 mg aspirin daily
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pilot study to determine the safety and efficacy of low dose aspirin for the
      prevention of venous thromboembolism among women with advanced ovarian cancer receiving
      neoadjuvant chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Khorana score = 1

          -  Over age 18

          -  English-speaking female patients

          -  Able to consent

          -  Receiving neoadjuvant chemotherapy Cancer of primary ovarian, fallopian tube,
             mullerian, or peritoneal origin

        Exclusion Criteria:

          -  Allergy or intolerance to study medication

          -  Indication for a non-aspirin form of antiplatelet (i.e. cardiac stent)

          -  Already on alternative form of anticoagulation

          -  Active bleeding

          -  High risk for active bleeding (i.e. recent intracranial bleed or gastrointestinal
             bleed, known brain metastases)

          -  Thrombocytopenia (platelets <50,000)

          -  Unable to complete medication adherence diary

          -  Unable to take oral medications
Clopidogrel and Aspirin Interaction Study-2
Condition: Drug Action Increased
Intervention: Clopidogrel; Aspirin; Aspirin
Intervention description: 600mg (2 pills); 325mg (1 pill); 81mg (1 pill)
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clopidogrel; Aspirin; Interaction

Summary:

      Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to
      prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky
      cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen
      to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with
      aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients
      with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable patients >1 month post ACS (including ST elevated myocardial infarction, non-ST
             elevated myocardial infarction or unstable angina) or stent

          -  Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week

          -  Written informed consent

        Exclusion Criteria:

          -  Age < 18 years

          -  Liver disease with ALT or bilirubin >2x upper limits of normal (ULN)*

          -  Renal impairment with creatinine clearance <30 ml/min*

          -  Deemed to be at high risk of bleeding (e.g., recent bleeding, platelet count<100x109/L
             or hemoglobin <100g/L)*

          -  Anticoagulant or NSAID therapy within the last 5 days

          -  Antiplatelet agent other than aspirin and clopidogrel within the last 10 days

          -  Uncontrolled hypertension (>=180/110mmHg)

               -  within 3 months of planned randomization
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
Condition: Thrombosis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Thrombosis; Acute Coronary Syndrome
Intervention: Prasugrel; Clopidogrel
Intervention description: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder; Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize
      safety of coronary stenting by reducing heart attacks and repeat interventions while
      simultaneously minimizing adverse bleeding events. This study compares the efficacy of two
      laboratory guided treatment algorithms to personalize antiplatelet medication choice after
      coronary stenting
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients admitted with acute coronary syndrome (unstable angina, non-ST elevation
             myocardial infarction) and referred for coronary angiography.

          -  Current therapy with clopidogrel (at least 300mg loading dose, or 75mg po daily for >5
             days)

          -  Age range 21-75 years.

        Exclusion Criteria:

          -  Unable to give consent

          -  Age younger than 21 years, greater than 75 years

          -  History of stroke

          -  Body weight <60 kg

          -  Acute STEMI,

          -  Thrombocytopenia<100'000,

          -  requirement for chronic warfarin therapy
Evaluating The Safety And Clinical Efficacy Of Elderberry Extract In Patients With Influenza
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Elderberry Extract; Placebos
Intervention description: Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry); Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Elderberry; Influenza

Summary:

      This research is being done to determine if an extract of cooked elderberries will help
      decrease the duration and severity of influenza symptoms in patients with confirmed
      influenza. Involvement in this study requires an initial patient screening at the time of
      their Emergency Department visit in order to confirm eligibility for the study. Once patients
      have been consented and enrolled as a participant, they will be randomized to take by mouth
      either Elderberry Extract or a placebo (a similar appearing and tasting liquid without
      elderberry) for a duration of 5 days. Study information regarding medication adherence, body
      temperature, symptoms, severity of symptoms, and any possible side effects will be collected
      from daily phone surveys conducted by the study coordinator. Participation in the study will
      end after at least 5 days once the patient has not had a temperature above 100°F and has had
      no influenza symptoms for at least 24 hours, or after 21 days in the study, whichever occurs
      first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  With 48 hours or less of an influenza illness documented by polymerase chain reaction

          -  Have AT LEAST 2 of the following 7 influenza symptoms (nasal congestion, sore throat,
             cough, aches and pains, fatigue, headaches, and chills or sweats) graded as either
             moderate or severe

          -  Have access to a phone

          -  Subjects are capable of giving informed consent or have an acceptable legally
             authorized representative capable of giving consent on the subject's behalf with
             informed assent given by subject.

          -  Have been prescribed or offered a prescription for oseltamivir (Tamiflu)

        Exclusion Criteria:

          -  Known allergy to elderberry extract or oseltamivir

          -  Use of antibiotic or antiviral medication on presentation to the study

          -  Women who are pregnant, breastfeeding women, or do not agree to appropriate
             contraception (abstinence, hormonal, intrauterine device, and barrier) to prevent
             pregnancy during the study.

          -  Patients with HIV

          -  Patients with cystic fibrosis

          -  Patients taking elderberry extract
Uterotonic Prophylaxis Trial
Condition: Hemorrhage
MeSH terms: Hemorrhage
Intervention: Methergine; placebo
Intervention description: 0.2 mg of methylergonovine maleate; saline placebo to maintain blinding
Intervention MeSH terms: Methylergonovine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 284.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Excessive bleeding after dilation and evacuation (D&E) requiring interventions is common,
      occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic
      prophylaxis at the time of D&E, particularly with methylergonovine maleate (MM), is a common
      practice among D&E providers despite nearly no evidence for its efficacy. Finding ways to
      decrease excessive bleeding after D&E has the potential both to improve patient safety and to
      reduce costs of provider-initiated interventions. The investigators propose a randomized,
      controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing
      excessive bleeding measured by a composite outcome among women undergoing D&E at 20 to 24
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 20 wks 0 days gestation and 24 wks 0 days gestation

          -  English or Spanish speaking

          -  BP before injection 140/90 or below

          -  18 years old or over

        Exclusion criteria:

          -  hypertension either on the preoperative or operative day (defined as systolic blood
             pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg)

          -  D&E procedures with more than one day of cervical preparation with dilators

          -  use of protease inhibitors

          -  known coagulopathy

          -  known morbidly adherent placenta
Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning
Condition: Healthy
Intervention: Fluoxetine; Bupropion
Intervention description: Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine.; Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion.
Intervention MeSH terms: Bupropion; Fluoxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gonadal Steroid Hormones; Healthy Volunteers; Antidepressant Side Effects; Fluoxetine; Bupropion; Prolactin; Testosterone; Estradiol; Progesterone; Sexual Function; Serotonin Reuptake Inhibitors; 17-OH Pregnenolone

Summary:

      This study will evaluate the effect of antidepressants on sex hormone levels in women and if
      the potential changes in sex hormone levels are related to sexual side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Regular menstrual cycles that are 25 to 35 days in length during the 1 year prior to
             study entry

          -  Willing to engage in sexual activity, alone or with a partner, at least weekly for the
             duration of the study

          -  Willing to use effective birth control (e.g., condom, diaphragm with spermicide, tubal
             ligation, nonhormonal intrauterine device,, partner with vasectomy) for the duration
             of the study

        Exclusion Criteria:

          -  Medical illness that may contribute to sexual dysfunction or affect steroid hormone
             levels

          -  Body mass index (BMI) greater than 30

          -  Elevated testosterone at screening

          -  History of seizure disorder

          -  Consumes more than 10 alcoholic beverages per week
Are Opioids Needed After ACL Reconstruction
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Intervention: Oxycodone; Placebo oral tablet
Intervention description: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10; Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, double-blind, randomized controlled clinical trial
Masking: Double (Participant, Investigator)
Masking description: Both participants and PI (orthopaedic surgeon) will be blinded. Placebo pills will be closely matched to oxycodone pills, so patients will not know to which group they are allocated. The PI will be blinded to group allocation.
Enrollment: 98.0
Sex: All
Minimum age: 14 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Opioids

Summary:

      As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons
      must revisit pain management protocols to reduce unnecessary opioid prescriptions. The
      long-term goal is to reduce opioid use and residual opioids in circulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females

          -  Aged 14-40 years

          -  Scheduled for primary (Anterior cruciate ligament) ACL reconstruction using quadriceps
             tendon autograft.

        Exclusion Criteria:

          -  Revision and/or contralateral ACL reconstruction procedures

          -  Allergies to local anesthetics

          -  Chronic pain medication use

          -  Weight <50 kg, local infections

          -  Known coagulopathies,

          -  Liver dysfunction or renal failure
Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation
Condition: Kidney Transplant Infection
Intervention: Sirolimus; Everolimus; Mycophenolic acid
Intervention description: sirolimus combined to reduced dose of tacrolimus; everolimus combined to reduced dose of tacrolimus; Control arm: mycophenolate combined to regular tacrolimus
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1209.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus
      versus everolimus and tacrolimus versus mycophenolate and tacrolimus.

      The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant
      medical need in the absence of pharmacological prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Recipients, adults of the first living or deceased donor kidney transplant;

          2. Patients who agreed to participate in the study and signed the informed consent form

        Exclusion Criteria:

          1. Receptors with a medical history of nephrotic syndrome or focal and segmental
             glomerulosclerosis confirmed as the etiology of end-stage renal disease;

          2. Receptors with poor understanding about chronic kidney disease and its treatment
             alternatives;

          3. Receptors with early history of non compliance to treatment with immunosuppressive
             drugs;

          4. Retransplantation;

          5. Multi-organ recipients;

          6. Recipients with BMI> 30 kg / m2;

          7. KDPI> 80%;

          8. Cold ischemia time greater than 24 hours;

          9. Receptors with a percentage of anti-HLA antibodies above 50%, either class I or Class
             II;

         10. Women of childbearing potential who do not undertake contraceptive methods (condoms or
             oral contraceptives).

         11. Patients receiving immunosuppressive therapy prior to transplantation, except low dose
             of prednisone;

         12. Patients with severe uncontrolled dyslipidemia;

         13. Patients who have a known contraindication for administration of any of the
             immunosuppressive drugs provided for in this study;
Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
Condition: Hip Osteoarthritis; Primary Total Hip Arthroplasty; Pain
MeSH terms: Osteoarthritis, Hip
Intervention: Suprainguinal fascia iliaca (SIFI) block; Sham block; Ropivacaine; Saline
Intervention description: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.; An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.; Local anesthetic (numbing drug); Salt water placebo
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: suprainguinal fascia iliaca (SIFI); nerve block

Summary:

      The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection
      technique (also called a "nerve block") that numbs the nerves going to the side and front of
      the upper leg will improve pain control after surgery. The SIFI technique uses a numbing
      solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This
      block may affect movement in the leg and make the legs weak. The amount of leg weakness is
      not known and assessment of this will be included in the study. Many institutions use the
      SIFI block for patients having total hip replacements, with the hope of providing good pain
      relief combined with improved mobility after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English speaking

          -  between 18 and 75 years old

          -  American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip
             arthroplasty

        Exclusion Criteria:

          -  ASA 4 or 5

          -  revision hip arthroplasty

          -  diagnosis of chronic pain

          -  daily chronic opioid use (over 3 months of continuous opioid use)

          -  inability to communicate pain scores or need for analgesia

          -  acute hip fracture

          -  Infection at the site of block placement

          -  Age under 18 years old or greater than 75 years old

          -  Pregnant women

          -  Intolerance/allergy to local anesthetics

          -  Weight <50 kg

          -  Suspected, or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years.

          -  Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the investigator, may interfere with study assessments or compliance

          -  Current or historical evidence of any clinically significant disease or condition
             that, in the opinion of the investigator, may increase the risk of surgery or
             complicate the subject's postoperative course.
RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC
Condition: Contraception
Intervention: Copper IUD; Levonorgestrel IUD
Intervention description: Randomization to copper/Paragard IUD for emergency contraception; Randomization to Levonorgestrel/Mirena IUD for emergency contraception
Intervention MeSH terms: Copper; Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 711.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Emergency contraception; Levonorgestrel IUD; Copper IUD

Summary:

      This study is a randomized trial of two IUDs for emergency contraception: the copper IUD, the
      most effective method of emergency contraception vs. the levonorgestrel IUD, the most
      preferred IUD which has never been tested as an emergency contraceptive. This research has
      the potential to increase use of highly effective contraception in a high-risk population and
      lower the persistently elevated rate of U.S. unintended pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females between 18-35 years old

          -  In need of EC (had unprotected intercourse within 120 hours - 5 days)

          -  Desire to prevent pregnancy for 1 year

          -  Fluent in English and/or Spanish

          -  Have a regular menstrual cycle (21-35 days)

          -  Know their last menstrual period (+/-3 days)

          -  Be willing to comply with the study requirements

          -  Desire to initiate an IUD

          -  Negative urine pregnancy test

        Exclusion Criteria:

          -  Current pregnancy

          -  Breastfeeding

          -  Intrauterine infection within the past three months

          -  Sterilization

          -  Already have an IUD or contraception implant (Nexplanon) in place

          -  Vaginal bleeding of unknown etiology

          -  Known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully
             treated at least 7 days prior to study entry)

          -  Known abnormalities of the uterus that distort the uterine cavity

          -  Allergy to copper

          -  Use of oral Emergency Contraception in the preceeding 5 days