bioihbjkbjnl/mcl2 huggingface dataset:
Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment
Condition: Recurrent Ovarian Cancer; Platinum Sensitive Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Hypersensitivity
Intervention: Carboplatin
Intervention MeSH terms: Carboplatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent Ovarian Cancer; Platinum Sensitive Ovarian Cancer

Summary:

      This is a research study to determine if administering carboplatin at a slower rate when
      re-treating recurrent ovarian cancer patients prior to the development of a hypersensitivity
      reaction will decrease the frequency and severity of future hypersensitivity reactions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have histologically or cytologically confirmed ovarian cancers for
             which carboplatin is an acceptable treatment option. In addition, participants must be
             candidates for systemic chemotherapy as determined by their treating physician.

          -  Participants must have received a carboplatin-containing regimen at initial diagnosis.
             Retreatment is permitted in second or greater line with carboplatin-based
             chemotherapy.

          -  Age ≥ 18 years of age

          -  Eastern Cooperative Oncology Group performance status <2 (see Appendix A).

          -  Women of childbearing potential must have a negative serum pregnancy test within 72
             hours prior to initiating chemotherapy on trial and must agree to practice an
             effective method of birth control, such as an intrauterine device, tubal ligation, or
             oral contraceptives, during the study and for six months after their last treatment.
             Women should not breast-feed while on this study

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Patients must be willing to comply with study design and requirements for
             participating on the study.

          -  Laboratory Criteria for eligibility The following are laboratory criteria for baseline
             absolute neutrophil count, platelet count, and creatinine for inclusion on this study.

        Exclusion Criteria:

          -  Participants who exhibit any of the following conditions at screening will not be
             eligible for admission into the study.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to carboplatin.

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.
A Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks
Condition: Volume Restoration and Shaping of the Buttocks
Intervention: Macrolane VRF30
Intervention description: Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume
      restoration and shaping of the buttocks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 20 years old

          -  willing to undergo augmentation therapy of the buttocks where a maximum total injected
             volume of 400 ml of the study product is judged by the Investigator to be enough to
             achieve full correction

          -  understand and comply with the requirements of the study

          -  be willing to understand and comply with the requirements of the study

          -  be willing to abstain from esthetic surgery and esthetical augmentation procedures
             (other than the study treatment) between the umbilicus and the knees.

          -  be a male or non-pregnant, non breast-feeding female.

          -  give written informed consent to participate in the study

        Exclusion Criteria:

          -  Active skin disease, inflammation or related conditions Tumors or pre-malign tissue
             disorder near or on the area to be treated

          -  scar tissue in the area to be treated

          -  subjects seeking corrections for other body parts then the buttocks anywhere between
             the umbilicus and the knees

          -  subjects with human immunodeficiency virus (HIV) associated lipodystrophy

          -  subjects having undergone liposuction within 6 months prior to inclusion

          -  BMI <20 or expected instable weight

          -  insufficient tissue cover in the area to be treated

          -  excessive skin laxity in the area to be treated

          -  other injectable implant or permanent implant near or in the area to be treated

          -  previous radiation therapy of tumors near or in the area to be treated

          -  concomitant anticoagulant therapy, anti-platelet therapy or a history of bleeding
             disorders.

          -  a presence or history of connective tissue diseases

          -  ongoing immunosuppressive therapy

          -  known allergies or hypersensitivity reactions towards anesthetics

          -  previous inflammatory or hypersensitivity reactions towards products containing
             Hyaluronic acid

          -  any condition which in the opinion of the investigator makes the subject unsuitable
             for inclusion use of any investigational drugs or devices within 30 days prior to
             inclusion.
Blue Light Therapy of C. Acnes
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: 5% Topical Benzoyl Peroxide Gel; Blue Light Therapy
Intervention description: Gel treatment used to treat acne; Blue light therapy treatment for acne
Intervention MeSH terms: Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This proposal aims to investigate a novel light-based treatment to reduce morbidity in
      shoulder surgical patients. This has potential to improve outcomes and reduce health care
      utilization associated with infectious complications of shoulder arthroplasty. Participants
      will be healthy male volunteers at least 18 years of age. They will be on study for
      approximately 2 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male

          -  18 years or older

        Exclusion Criteria:

          -  Allergy to benzoyl peroxide or chlorhexidine

          -  <18 years of age

          -  Previous history of shoulder infections

          -  Antibiotics taken within one month of research visit

          -  Immunocompromised state

          -  Active cancer

          -  Diabetic

          -  Skin lesions or abrasions over the deltopectoral interval

          -  Topical corticosteroid treatment to either shoulder or or systemic corticosteroid
             treatment within 2 weeks of research visit

          -  Topical benzoyl peroxide treatment to either shoulder within 2 weeks of research visit

          -  Blue light therapy treatment to either shoulder within 2 weeks of research visit

          -  Prior incision over the deltopectoral interval of either shoulder

          -  Contraindication to blue light treatment
U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
Condition: Type 2 Diabetes; Insulin Resistance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Intervention: U-500 Insulin delivered by Omnipod (disposable insulin pump)
Intervention description: U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs
Intervention MeSH terms: Insulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 diabetes; Insulin Resistance; Continuous Subcutaneous Insulin Infusion; U-500 Insulin; Omnipod

Summary:

      Patients with Type 2 diabetes and severe insulin resistance with very large insulin
      requirements who have failed all previous insulin regimens using non-concentrated forms of
      insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular
      insulin)infused via insulin pump.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes on stable insulin regimen with or without oral agents for at least 3
             months

          -  HbA1c > 7%

          -  No significant cardiovascular, renal or other serious medical diseases

        Exclusion Criteria:

          -  HbA1c < 7%

          -  Chronic renal, hepatic, cardiovascular, or other serious medical illness

          -  Females of childbearing age not using adequate contraception

          -  Use of GLP mimetic
Peripheral Nerve Blocks for Major Lower Extremity Amputations
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine; Saline Solution
Intervention description: Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.; Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: To randomize patients, consent forms will be pre-labeled with a random subject identification number. This number will serve as the participants' study ID for all data collection in order to maintain privacy and confidentiality. Additionally, this number will be linked to a sealed envelope containing the random treatment group. The study coordinator will create the labels and assemble the envelopes to ensure all investigators remain blind to the treatment groups. This sealed envelope will be given to the anesthesia providers for the amputation. The anesthesia team will then administer the assigned treatment prior to induction of general anesthesia. Half of the patients will be randomized into the treatment group, and half of the patients will be randomized into the control group.
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will be a double-blinded randomized controlled trial analyzing all patients who
      will undergo major lower extremity amputations by the vascular surgery service at University
      of California, San Francisco (UCSF) Fresno between July 2017 and June 2018 to determine if
      regional nerve blocks (sciatic and femoral) have any effect on postoperative pain control,
      narcotic requirements, and length of stay compared with standard post-operative narcotic
      regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients who require major lower extremity amputations

        Exclusion Criteria:

          -  less than 18 years old, pregnant, emergency amputation, staged amputation, amputations
             performed by non-vascular surgeons, patients who are allergic to bupivacaine, patients
             who are unable to communicate symptoms of pain
A Study Comparing CoQ10 Levels While Taking 3 Different Statins
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Pitavastin 4mg; Atorvastatin 20mg; Rosuvastatin 5mg
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: LDL, HDL

Summary:

      The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin
      or Rosuvastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  LDL-C levels of 100-200mg/dl; triglycerides </=200mg/dl at screening visit

          -  Willing to discontinue use of all lipid-altering doses fo medication or supplements
             for the duration of the study

        Exclusion Criteria:

          -  LDL-C <100mg/dl or >200mg/dl, Triglycerides >200mg/dl

          -  History of diabetes mellitus or documented fasting blood glucose >125mg/dl or HbA1c
             >6.4%

          -  History of coronary artery disease

          -  history of chronic renal or hepatic disease

          -  known sensitivity of intolerance to a statin

          -  persistent elevated liver enzymes or CPK (>3 x upper normal limit)

          -  currently taking CoQ10 supplements and unable discontinue for duration of study
3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Finasteride; Placebo
Intervention description: Finasteride 5mg every day by mouth for 3 months; Placebo every day by mouth for 3 months
Intervention MeSH terms: Finasteride
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 383.0
Sex: Male
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Finasteride; Placebo; Prostate cancer; Prostate Specific Antigen (PSA); Men at intermediate risk of prostate cancer; Men scheduled for prostate biopsy

Summary:

      The investigators will propose a novel method to improve prostate cancer screening with PSA,
      using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia
      (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will
      also examine three additional promising tests that may further improve diagnosis of prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention
             Trial (PCPT) prostate cancer risk calculator.
             (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months
             prior to study entry. A description of the frequency of these individuals in the
             population is provided in Specific Aim 2

          2. Patient has been recommended to undergo and plans to have a prostate biopsy.

          3. Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo
             treatment.

          4. No allergy to finasteride or other five alpha reductase inhibitors.

          5. Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month
             treatment period.

          6. Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for
             this age range.)

        Exclusion Criteria:

          1. Risk of cancer greater than 60% or less than 20%.

          2. Prior history of prostate cancer.

          3. Prior treatment with finasteride or dutasteride in the past 6 months

          4. Younger than age 55.
Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections
Condition: Nasolabial Folds
Intervention: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream); benzocaine 20% / lidocaine 6% / tetracaine 4% ointment
Intervention description: Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections; apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections
Intervention MeSH terms: Lidocaine; Tetracaine; Benzocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Nasolabial folds; wrinkles; topical anesthetic

Summary:

      Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane®
      injections for the correction of nasolabial folds.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female Subjects 30 - 65 years of age

          -  Subject undergoing cosmetic dermal filler injections for correction of nasolabial
             folds. Treatment sites should be comparable, requiring the same number of injections
             on each nasolabial fold

          -  Subjects diagnosed with moderate nasolabial folds (Wrinkle Severity Rating Scale of
             grade 3)

        Exclusion Criteria:

          -  Subjects under treatment for a dermatologic condition on the face, which may interfere
             with the safe evaluation of the study treatment (e.g. eczema, psoriasis, severe
             sun-damage, dermatitis), have damaged, denuded or broken skin at the designated
             treatment site and/or have scarring or infection of the area to be treated

          -  Subjects who have taken prescription or non-prescription analgesic medication during
             the 24 hour period prior to the procedure

          -  Subjects with a history of bleeding or clotting disorders

          -  Subjects who have used ASA (aspirin), NSAIDs (Non-Steroidal Anti- inflammatory Drugs),
             anticoagulants, St. John's Wort or high doses of Vitamin E (above the recommended
             daily allowance) within 2 weeks prior to the procedure
Ultrasound-guided Adductor Canal Block for Total Knee Replacement
Condition: Complications; Arthroplasty; Knee Injuries
MeSH terms: Knee Injuries
Intervention: Bupivacaine; Preservative free normal saline
Intervention description: 10 ml of 0.25% bupivacaine; 10 ml of preservative free normal saline
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Total knee arthroplasty is associated with intense early postoperative pain. Fast track
      recovery programs including early therapy protocols and early hospital discharge are being
      implemented at various hospitals. The postoperative analgesic pain regimen should enhance
      functional recovery in addition to providing efficient analgesia with minimal side effects.
      Adductor canal blockade is commonly used to provide postoperative analgesia for total knee
      arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor
      canal block will lower narcotic consumption and improved overall satisfaction compared to
      ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally
      invasive TKA surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants 40 to 75 years old who are presenting for minimally invasive total knee
             arthroplasty under spinal anesthesia

        Exclusion Criteria:

          -  Patient refusal

          -  American Society of Anesthesiologists physical status classification of 4 or higher

          -  Pre-existing neuropathy in the femoral or sciatic distribution

          -  Coagulopathy

          -  Infection at the site

          -  Chronic opioid use (greater than 3 months)

          -  Pregnancy

          -  Medical conditions limiting physical therapy participation

          -  Any other contra-indication to regional anesthesia
Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain
Condition: Central Neuropathic Pain
MeSH terms: Neuralgia
Intervention: Pregabalin; Placebo
Intervention description: Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.; Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post-stroke pain, pregabalin

Summary:

      Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with
      central post stroke pain (CPSP)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive history of clinical stroke at least 4 months prior to randomization CPSP--3
             months prior to screening

        Exclusion Criteria:

          -  History of dementia or any other severe cognitive impairment

          -  Diabetic Peripheral Neuropathy (DPN)