bioihbjkbjnl/mcl2 huggingface dataset:
The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI
Condition: Infertility
MeSH terms: Infertility
Intervention: fix dose r-FSH (Gonal-f); r-LH supplementation; r-FSH (Gonal-f)
Intervention description: recombinant follicle stimulation; recombinant luteinizing hormone; recombinant follicle stimulation hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: Female
Minimum age: 23 Years
Maximum age: 39 Years
Healthy volunteers: No
Keywords: ICSI; Suboptimal Ovarian Response; rLH

Summary:

      The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who
      had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH
      (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The
      investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the
      control groups regarding the results of IVF in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 23-39

          -  Body mass index between 18 and 30 kg/m2

          -  Baseline FSH ≤12 IU/l, E2 ≤ 80 pg/ml

          -  The presence of both ovaries and uterine cavity capable of sustaining a pregnancy

          -  Who had regular menstrual cycles (21-35 days) Confirmed absence of pregnancy and
             sufficient number of antral follicles on the transvaginal US examination on the 3rd
             day of menstruation

          -  Who were having their first or second IVF trial.

        Exclusion Criteria:

          -  Grade III-IV endometriosis

          -  Clinically significant condition preventing them from undergoing gonadotrophin
             treatment

          -  More than two previous assisted cycles

          -  Who had a single ovary

          -  Unexplained gynaecological bleeding

          -  Polycystic ovary or an ovarian cyst of unknown aetiology

          -  Previously diagnosed with a space occupying lesion like submucous myoma , polyps,
             septum, synechia in the uterine cavity

          -  Have a chromosomal anomaly.
Smoking Cessation Study In Healthy Adolescent Smokers
Condition: Smoking Cessation
Intervention: Varenicline 1mg BID; Varenicline 0.5mg BID; Placebo
Intervention description: Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52; Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52; Oral placebo for twelve weeks,follow-up through Week 52
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 312.0
Sex: All
Minimum age: 12 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: smoking cessation in adolescents

Summary:

      The study is designed to see if varenicline combined with age appropriate (adolescent)
      smoking cessation counseling will help teens quit smoking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects between the ages of 12 and 19, inclusive.

          -  Subjects smoking at least an average of 5 cigarettes per day, motivated to stop
             smoking,

          -  Subjects must have at least one prior failed attempt to quit smoking.

        Exclusion Criteria:

          -  Subjects with history, current diagnosis, or treatment of major depression disorder,
             anxiety disorders, panic disorder, hostility or aggression disorder,
             perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality
             disorder, eating disorder or severe emotional problems (in the past year).

          -  Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months
             due to suicidal ideation or suicidal behavior; subjects considered to have serious
             suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation
             or behavior identified at the screening or baseline visit.

          -  Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3
             months prior to screening.
Clinical Evaluation of Narrow Band Imaging Colonoscope
Condition: Colonic Neoplasms
MeSH terms: Colonic Neoplasms
Intervention: Narrow band imaging colonoscope
Intervention description: Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 284.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: colonic neoplasms; colonoscopy; narrow band imaging; diagnostic techniques

Summary:

      The purpose of the study is to determine if colonoscopic examination using a colonoscope with
      a narrow band imaging light is more effective at detecting polyps compared to a colonoscope
      with standard full spectrum white light.
    

Eligibility criteria:

        Inclusion Criteria:

          -  referred for elective outpatient colonoscopy

        Exclusion Criteria:

          -  known inflammatory bowel disease

          -  personal or family history of polyposis syndrome

          -  referral for resection of a known lesion
Safety and Efficacy of Oral TXA in Reducing Blood Loss and Transfusion in Hip Fractures
Condition: Hip Fractures; Blood Loss
MeSH terms: Hemorrhage; Fractures, Bone; Hip Fractures
Intervention: Tranexamic Acid; Placebo
Intervention description: 2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively.; 2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the safety and efficacy of Tranexamic acid
      (TXA) in reducing blood loss and transfusion requirements for patients with osteoporotic hip
      fractures. In addition to assessing blood loss in these patients, complications associated
      with TXA use would be characterized including systemic (pulmonary embolism, deep venous
      thrombosis, myocardial infarction, stroke) and surgical site (hematoma, infection) events,
      need for re-hospitalization or re-operation and 30 day mortality.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients presenting with femoral neck, intertrochanteric and subtrochanteric femur
        fractures Patients age 18 and older Low energy injury

        Exclusion Criteria:

        Pregnant or breast-feeding women Allergy to tranexamic acid Acquired disturbances of color
        vision Thrombophilia Antithrombin deficiency Factor V Leiden Antiphospholipid Syndrome
        Protein C and S deficiency History of heparin induced thrombocytopenia Sickle cell anemia
        Myeloproliferative disorders International Normalized Ratio (INR) > 1.4 Partial
        Thromboplastin Time (PTT) > 1.4 times normal A history of arterial or venous
        thromboembolism Cerebral Vascular Accident Deep Vein Thrombosis Pulmonary Embolism
        Subarachnoid hemorrhage Active intravascular clotting Participation in another clinical
        trial
Time Interval for Endoscopic Variceal Ligation
Condition: Variceal Bleeding
Intervention: Endoscopic Variceal Ligation
Intervention description: Ligation of esophageal varices
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gastrointestinal hemorrhage; esophageal varices; gastrointestinal endoscopy; ligation

Summary:

      Patients with liver disease frequently present to the hospital with bleeding from dilated
      veins in their foodpipe (called esophageal varices). The current standard of care is to
      perform endoscopic variceal ligation (placing rubber bands around the varices through an
      endoscope)in patients presenting with bleeding varices. Patients generally receive ligation
      at the time they come in with bleeding and then return at regular intervals to have repeat
      ligation in order to eradicate the varices. However there have been no studies to determine
      the appropriate intervals for esophageal variceal ligation until eradication. We will conduct
      a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients
      that have presented with bleeding varices. Our hypothesis is that one-week ligation will
      achieve more rapid eradication than the two-week interval with a greater proportion of
      patients achieving variceal eradication at 4 weeks after the index bleeding episode.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who presented with acute upper GI bleeding due to esophageal varices and
             underwent successful endoscopic variceal ligation.

          -  Patients who would normally receive repeat endoscopic ligation therapy to eradicate
             varices.

        Exclusion Criteria:

          -  Persistent bleeding despite endoscopic and medical therapy

          -  Platelet count < 40,000
Randomized Trial of Wound Infiltration With Extended-release Bupivacaine Before Laparoscopic or Robotic Hysterectomy
Condition: Pain, Postoperative; Surgical Procedure, Unspecified
MeSH terms: Pain, Postoperative
Intervention: Liposomal Bupivacaine; Bupivacaine HCl
Intervention description: pre-incision infiltration with liposomal bupivacaine; pre-incision infiltration with bupivacaine HCl
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 64.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Laparoscopy; Robotic Surgical Procedures; Hysterectomy; Anesthetics, Local; Bupivacaine; Pain, Postoperative

Summary:

      The investigators are studying ways to improve pain control after surgery. One way to
      decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the
      operating room. There is an FDA approved extended-release version of a commonly used local
      anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are
      studying whether using the extended-release medication (Exparel) will give better pain relief
      after laparoscopic and robotic-assisted hysterectomies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Benign indication for surgery

          2. Planned multiport laparoscopic or robotic assisted hysterectomy

          3. Non-pregnant

          4. Able to provide informed consent

          5. Owns smartphone or computer with internet access

          6. Willing to provide contact phone number and accept SMS text messages

          7. Ability to speak and read English (because texts and online surveys will be in English
             only)

        Exclusion Criteria:

          1. Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel
             surgery)

          2. Contraindication to study drug

               1. Severe Hepatic disease

               2. Severe Kidney disease

               3. Current use of monoamine oxidase inhibitors

               4. Current use of tricyclic antidepressants

          3. History of substance or alcohol abuse within the past 2 years
EXPAREL® for Pain After Tonsillectomy
Condition: Tonsillectomy; Tonsillitis; Post-operative Pain
MeSH terms: Tonsillitis; Pain, Postoperative
Intervention: Liposomal Bupivacaine
Intervention description: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Liposomal Bupivacaine

Summary:

      The purpose of this study is to determine whether liposomal bupivacaine (long acting
      injectable anesthetic) provides greater post operative pain relief compared to the standard
      post operative pain regiment for tonsillectomy patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring
             bilateral tonsillectomy

          -  Willing and able to understand and provide written informed consent

        Exclusion Criteria:

          -  Known pregnancy

          -  Women who are currently nursing a child

          -  History of coagulopathy; such as hemophilia or Von Willebrand disease, or any
             congenital or acquired bleeding disorder

          -  Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or
             medications similar in class to these medications will exclude the patient from
             participation

          -  Inability to provide informed consent (patients under guardianship)

          -  Known hypersensitivity to local anesthetics

          -  History of cardiac disease; such as current impaired cardiovascular function, past
             history of myocardial infarction, congenital heart disease, current cardiac symptoms,
             i.e. angina, shortness of breath, or chest pain as determined by history or review of
             the medical record.

          -  History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive
             pulmonary disease (COPD), or interstitial lung disease as determined by history or
             review of the medical record.

          -  Impaired renal function as documented in the medical record in the last 3 months with
             a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60
             mL/min/body surface area (BSA) as determined by history or review of the medical
             record.

          -  History of or current hepatic disease as documented by liver function test abnormality
             in the last 3 months as determined by history or review of the medical record.
Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin
Condition: Healthy
Intervention: Pitavastatin (NK-104); Darunavir/Ritonavir (Prezista)
Intervention description: Pitavastatin (NK-104) 4mg once daily (QD); Darunavir/Ritonavir (Prezista) 800 mg/100 mg
Intervention MeSH terms: Ritonavir; Darunavir; Pitavastatin
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

Summary:

      This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug
      interaction study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult male or female volunteer aged 18 to 45 years, inclusive.

          -  Subject has a body mass index of 18 to 30 kg/m2, inclusive.

          -  Subject has normal hematology, serum chemistry, and urinalysis test results

          -  Subject is able and willing to abstain from alcohol, grapefruit, caffeine or caffeine
             containing products, St John's wort, and herbal supplements for 4 days before Day 1
             and until completion of the study

          -  Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of
             study drug and until study completion.

        Exclusion Criteria:

          -  Subject has had any surgery of the gastrointestinal tract likely to affect drug
             absorption, distribution, metabolism, or excretion.

          -  Subject has had a previous allergy or intolerance to treatment with pitavastatin,
             darunavir, ritonavir, sulfonamides, or any drugs in these classes.

          -  Subject has a history of drug or alcohol abuse.

          -  Subject has had a clinically significant illness within 4 weeks before the first dose
             of study drug.
Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
Condition: Chronic Heart Failure With Reduced Systolic Function
MeSH terms: Heart Failure
Intervention: Dapagliflozin; Dapagliflozin matching placebo
Intervention MeSH terms: Dapagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 263.0
Sex: All
Minimum age: 19 Years
Maximum age: 119 Years
Healthy volunteers: No
Keywords: heart failure; dapagliflozin; Sodium-glucose co-transporter-2 (SGLT-2) inhibitors

Summary:

      The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared
      with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and
      quality of life in patients with chronic heart failure with reduced systolic function.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Established diagnosis of New York Heart Association (NYHA) Class II or Class III heart
             failure (left ventricular ejection fraction ≤40% due to either ischemic or
             non-ischemic etiology) with reduced systolic function for at least 16 weeks prior to
             enrollment

          2. No change in diuretic management for at least 1 week prior to enrollment

          3. Brain natriuretic peptide (BNP) ≥100 pg/mL and/or N-terminal pro b-type natriuretic
             peptide (NTproBNP) ≥ 400 pg/mL at enrollment

        Exclusion Criteria:

          1. History of type 1 diabetes

          2. Estimated glomerular filtration rate (eGFR) < 30 at enrollment

          3. Hospitalization for heart failure within the 30 days prior to enrollment

          4. Admission for an acute coronary syndrome (ST-elevation myocardial infarction,
             non-ST-elevation myocardial infarction, or unstable angina), percutaneous coronary
             intervention, or cardiac surgery within the 30 days prior to enrollment

          5. Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the
             screening visit

          6. Planned cardiovascular revascularization (percutaneous intervention or surgical) or
             major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular
             assist device, cardiac transplantation, or any other surgery requiring thoracotomy)
             within the 90 days after enrollment

          7. Patients who are volume depleted based upon physical examination at the time of
             screening or randomization
Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
Condition: Retinal Vein Occlusions
MeSH terms: Macular Edema; Retinal Vein Occlusion
Intervention: Avastin; Osurdex; Avastin
Intervention description: 1.25mg intravitreally; 0.7mg intravitreally; 1.25mg intravitreally
Intervention MeSH terms: Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Comparative study to see if treating with Osurdex in addition to Avastin in patients with
      retinal vein occlusions helps increased visual acuity outcomes
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female age 18 years or older

          -  Branch retinal vein occlusion or central retinal vein occlusion of less than one year
             duration

          -  Best correct visual acuity of greater than 24 and less than 80

          -  Presence of macular edema defined as OCT central subfield thickness of >250

        Exclusion Criteria:

          -  intravitreal anti-VEGF treatment in study eye within six weeks of baseline

          -  intravitreal steroid treatment in the study eye within eight weeks of baseline visit

          -  PRP in the study eye within 4 month of baseline visit

          -  Active iris neovascularization in study eye

          -  Uncontrolled systemic disease

          -  Known history of IOP elevation in response to corticosteroid treatment that is not
             controlled on 2 glaucoma medications