bioihbjkbjnl/mcl2 huggingface dataset:
Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
Condition: Infertility
MeSH terms: Infertility
Intervention: Decapeptyl Daily; pregnyl
Intervention description: Decapeptyl 0.2 mg SC once 1day; 5000 IU SC
Intervention MeSH terms: Triptorelin Pamoate; Chorionic Gonadotropin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Female
Maximum age: 38 Years
Healthy volunteers: No
Keywords: ovarian hyper stimulation syndrome (OHSS); metaphase II oocytes (MII); good quality embryo's; implantation; pregnancy

Summary:

      The purpose of this study is to see whether patients triggered with only human Chorion
      Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate
      than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intra-cytoplasmic sperm injection (ICSI) patients below 38 years

          -  1,2 or 3 rd IVF-cycle

        Exclusion Criteria:

          -  polycystic ovary syndrome (PCOS) patients

          -  patients with endocrinological diseases or problems
Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects
Condition: HIV
Intervention: Truvada; Combivir; Trizivir
Intervention description: Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months; Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months; Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)
Intervention MeSH terms: Tenofovir; Lamivudine; Emtricitabine; Zidovudine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Abacavir; Dideoxynucleosides; Lamivudine, zidovudine drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: treatment experienced

Summary:

      Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to
      switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on
      Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after
      randomization to either continuing on trizivir or combivir, or to switching to Truvada.
      Measurements include maximal or peak oxygen consumption, lactate production and clearance,
      subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat
      contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is
      that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors
      (NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction
      in several organ systems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  infection with human immunodeficiency virus (HIV) with undetectable viral load

          -  on Combivir or trizivir

          -  able to exercise and sign consent

        Exclusion Criteria:

          -  other active illness

          -  contraindication to magnetic resonance imaging (MRI) scanning or maximal exercise.
NSAID Use in Postpartum Hypertensive Women
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Acetaminophen; NSAID
Intervention description: Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements; Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 36.0
Sex: Female
Minimum age: 14 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and
      deliver an infant via vaginal delivery will be placed into two groups in the postpartum
      period. One group will receive Ibuprofen for pain control and the other group will be given
      Tylenol. Blood pressures during the postpartum period will then be collected and compared in
      order to see if NSAIDs use increases blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  vaginal delivery

          -  diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia

          -  preeclampsia without severe features

          -  preeclampsia with severe features gestational hypertension without severe range blood
             pressures

          -  gestational hypertension with severe range blood pressures

          -  singleton pregnancies

        Exclusion Criteria:

          -  Cesarean Delivery

          -  no diagnosis of hypertensive disorder

          -  chronic or acute renal disease

          -  allergy to ibuprofen or acetaminophen

          -  lupus

          -  multiple order pregnancies (twins, triplets)

          -  Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/
             current use of illegal drugs
Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Blood draw for future biomarker analysis
Intervention description: Each participant was required to undergo blood draw for future genetic testing and biomarker analysis as mentioned in the informed consent form (ICF).
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To collect blood samples in a new cohort of Relapsing Forms of Multiple Sclerosis (RMS)
      participants who had developed immune thrombocytopenic purpura (ITP) after LEMTRADA
      treatment, for future Deoxyribonucleic acid (DNA) analysis as part of a global biomarker
      project assessing pre-identified candidate single nucleotide polymorphisms (SNPs) associated
      to the development of ITP after LEMTRADA treatment in RMS participants.
    

Eligibility criteria:

        Inclusion criteria :

          -  Male and female adult participants who had been treated with LEMTRADA, with
             development of ITP subsequent to treatment. Participants does not need to be currently
             on LEMTRADA treatment.

          -  Participants who had signed the study ICF.

        Exclusion criteria:

        - Not applicable

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain
Condition: Typical Facial Pain; Atypical Facial Pain
MeSH terms: Facies; Facial Pain
Intervention: Bupivacaine; Triamcinolone; Dexamethasone
Intervention description: 4 mL of 0.25% bupivacaine; 40 mg of Triamcinolone; 4 mg of Dexamethasone
Intervention MeSH terms: Dexamethasone; Triamcinolone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by
      unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal
      nerve. Current treatment strategies include oral medications as first line therapy with
      surgical interventions reserved for those patients who are refractory to medications or
      unable to tolerate medication side effects. Despite these current treatment options, many
      patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine
      adjustment of the needle tip and direct observation of the medicine.

      Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic
      nerve pain with great success. Steroids can be short or long acting in duration with varying
      side effects. If there exists a difference in duration of action, using the longer acting
      drug will provide a greater period of symptom relief for the patient and may allow the
      patient to undergo fewer interventional procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients presenting to the Northwestern Pain Center who are eligible and scheduled
             to receive a ultrasound-guided trigeminal nerve block.

        Exclusion Criteria:

          -  Exclusion is the same for patients who are not eligible for ultrasound guided nerve
             blocks.
Symptom Management After Breast Cancer Surgery
Condition: Neuropathic Pain; Postmastectomy Pain
MeSH terms: Neuralgia
Intervention: Lidoderm patch; Placebo patch
Intervention description: 1 patch was applied topically to the affected site(s) for 12 hours each day.; 1 patch was applied topically to the affected site(s) for 12 hours each day.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; neuropathic pain; topical lidocaine; postmastectomy pain; breast symptoms; breast pain

Summary:

      This trial is part of a larger, longitudinal study of symptoms that occur in the breast
      surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop
      pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a
      lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women
      who wear the lidocaine patch will report a decrease in pain and decreased interference with
      function compared to women who wear the placebo patch.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult women >18 years who develop neuropathic pain in the breast scar area and/or
             ipsilateral arm following breast cancer surgery

          -  Has a healed incision(s)

          -  Has no recurrent disease in the painful area

          -  Is able to read, write and understand English

        Exclusion Criteria:

          -  Presence of another type of pain that is more severe than the neuropathic pain

          -  Use of an opioid analgesic of greater than 60 mg codeine/day

          -  Is actively trying to become pregnant

          -  Has a medical contraindication to the use of lidocaine

          -  Has an allergy to lidocaine

          -  Is taking a coanalgesic for neuropathic pain.
Acute Effect of Exenatide on Brain Glucose Metabolism
Condition: Impaired Glucose Tolerance (IGT); Diabetes
MeSH terms: Glucose Intolerance
Intervention: Exenatide; Placebo
Intervention description: Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study; Placebo was administered in random order 30 min before OGTT-PET study in the same subject
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Impaired glucose tolerance (IGT); Diabetes

Summary:

      This research study will examine brain glucose metabolism after an overnight fast to
      determine the effect of exenatide on brain glucose metabolism and lipid metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males age 18-65 years old

          2. Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2

          3. 2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having
             impaired glucose tolerance or newly diagnosed type 2 diabetes.

          4. Patients must have BMI of 25-40 kg/m2

          5. Patients must have no known severe liver or kidney disease, cancer, neurologic,
             psychiatric or systemic disease, ability to understand the study.

          6. Only patients whose body weight has been stable (±3-4 pounds) over the three months
             prior to study will be included.

          7. Patients must have the following laboratory values:

               -  Hematocrit ≥ 34 vol%

               -  Serum creatinine* ≤ 1.5 mg/dl in males and

               -  Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT):
                  ≤ 2.5 times upper limit of normal

               -  Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT): ≤ 2.5
                  times upper limit of normal

               -  Alkaline phosphatase ≤ 2.5 times upper limit of normal

               -  If serum creatinine is ≤ 1.5 mg/dl in males, the PI can grant an exception and
                  not exclude the patient if the Glomerular filtration rate (GFR) is >70 ml/min

        Exclusion Criteria:

        Patients are excluded from participation in the study if they meet any of the following
        criteria:

          1. Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease)

          2. Patients with BMI over 40 and under 25

          3. Patient with age below 18 yrs and over 65 yrs

          4. Female subjects

          5. Patients with type 1 diabetes

          6. Patients treated for type 2 diabetes

          7. Subjects with normal glucose tolerance (NGT)
Voluven® in Paediatric Patients
Condition: Cardiac Surgery; Cardiopulmonary Bypass
Intervention: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L); Human serum albumin (HSA 50g/L)
Intervention description: Study medication will be given as part of the priming of the ECC and for plasma volume replacement after start of ECC up to the maximum dosage of 50 mL/kg body weight/day.; Human serum albumin (HSA 50g/L)
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during
      elective open-heart surgery in pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female paediatric patient, 2 to 12 years of age, suffering from congenital
             heart-disease and undergoing elective open-heart surgery requiring ECC;

          -  Signed parental written informed consent and patient assent where achievable

        Exclusion Criteria:

          -  Known contraindication against scheduled concomitant medication;

          -  Total ECC volume < 400 mL;

          -  ASA > III
Posterior Cruciate Retaining (PCR) Versus Posterior Cruciate Substituting (PCS) Total Knee Arthroplasty (TKA)
Condition: Arthroplasty, Replacement, Knee; Knee Arthroplasty, Total
Intervention: SCORPIO™
Intervention description: subjects randomized at surgery to receive 1 of the 2 specified implants
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior
      Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty
      (TKA) as the primary outcome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  scheduled for primary TKA

          -  non-inflammatory arthritis

          -  intact Posterior Cruciate Ligament at the time of surgery

        Exclusion Criteria:

          -  required bone grafting of either the femur or tibia

          -  varus or valgus deformity of > 15 degrees

          -  previous high tibial osteotomy

          -  unable to understand or comply with the study requirements

          -  unable to provide signed informed consent
Effect of Ketamine on Postoperative Clinical Outcomes
Condition: Colorectal Surgery
Intervention: Placebo; Ketamine high-dose; Ketamine low-dose
Intervention description: Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate; Loading: 1 mg/Kg Infusion: 10 mcg/kg/min; Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: opioid; Fentanyl; Anesthetic adjuvant; Pain management; Perioperative outcomes; Constipation; Ileus; Colorectal

Summary:

      The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic
      adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management
      and on the later recovery after surgery in patients undergoing colorectal surgery.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients scheduled to undergo small and/or large partial bowel resection via
             laparotomy or laparoscopy

          2. Willingness and ability to sign an informed consent document

          3. No allergies to anesthetic or analgesic medications

          4. 18 - 80 years of age

          5. American Society of Anesthesiologists (ASA) Class I - III adults of either sex

        Exclusion Criteria

          1. Inability to comprehend the pain assessment tools

          2. Patients with known allergy, hypersensitivity or contraindications to anesthetic or
             analgesic medications

          3. Patients with clinically-significant heart disease including arrhythmias and
             significant hypertension, brain aneurysms, prior history of cerebral vascular accident
             (CVA), or chronic renal insufficiency

          4. Prior abdominal surgery

          5. History of abdominal carcinomatosis

          6. History of radiation enteritis;

          7. Patients with history of hepatic, renal, cardiac failure, organ transplant, or
             diabetes

          8. Patients with seizures

          9. Morbid obesity (body mass index >40)

         10. Pregnant or lactating women

         11. Subjects with a history of alcohol or drug abuse within the past 3 months

         12. Any other conditions or use of any medication which may interfere with the conduct of
             the study

         13. Prophylactic Nasogastric Tube (NGT) use

         14. Individuals with significant manic disorders including: schizophrenia, or bipolar
             disorder or psychosis

         15. Individuals with asthma and/or thyroid diseases
Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant
Condition: Hepatitis C; Transplantation Disease Transmission
MeSH terms: Hepatitis C
Intervention: Sofosbuvir/Velpatasvir; Sofosbuvir/Velpatasvir/Voxilaprevir
Intervention description: Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.; Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir.
Dosage: 400mg/100mg/100mg daily for 12 weeks.
Intervention MeSH terms: Sofosbuvir; Velpatasvir; Sofosbuvir-velpatasvir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Healthy volunteers: No

Summary:

      In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with
      livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be
      given to the study subjects shortly after transplant to protect them from developing the
      problems HCV can cause to the liver.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a
             potential suitable living donor or for simultaneous liver kidney transplant;

          -  HCV non-infected at the time of transplant. Subjects who were previously HCV infected
             but who have had documented SVR12 are eligible to participate;

          -  Agree to use two methods of birth control during the study;

          -  Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface
             antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or
             minimal fibrosis (F1). For kidney transplant: kidney donor profile index < 85%.

        Exclusion Criteria:

          -  Donor and/or recipient HIV infection

          -  Subject pregnant or nursing

          -  Donor and/or recipient Hepatitis B surface antigen positive

          -  Kidney-pancreas transplant

          -  Single organ liver recipients who received hemodialysis for more than 7 days prior to
             liver transplantation

          -  Kidney recipients: on dialysis for > 5 years at time of Screening; subjects sensitized
             with panel reactive antibody > 80%; for single organ kidney transplant, subjects with
             advanced liver fibrosis (Knodell stage 3) or cirrhosis

          -  Individuals being treated with and needing to continue rifabutin, rifampin,
             carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum
             perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton
             pump inhibitors (See Concomitant Medications).

          -  Individuals treated with amiodarone within 42 days of organ transplant.