bioihbjkbjnl/mcl2 huggingface dataset:
Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain
Condition: Post-mastectomy Pain Syndrome; Chronic Post-surgical Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves.
      During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy
      and radiotherapy after surgery worsen the injury experienced by these nerves. These nerves
      eventually become abnormal and provide pain signals to the brain well beyond the healing
      period after surgery. Patients with these abnormal nerves suffer from chronic pain in the
      breast area that persists for several years after surgery. Chronic pain is associated with a
      reduced quality of life, daily functioning, psychological distress, and contributes to
      excessive health care expenditures. There is encouraging data suggesting that an infusion of
      Lidocaine during surgery and Pregabalin given around the time of surgery can prevent the
      development of chronic pain after breast cancer surgery. A large randomized controlled trial
      is needed to determine the efficacy of these two interventions on reducing chronic pain after
      breast cancer surgery (e.g. within 3 months of surgery). A pilot trial is first needed to
      determine the feasibility of undertaking such a trial.
    


Intervention name(s): Intraoperative Intravenous Lidocaine Infusion; Perioperative Pregabalin; Perioperative Pregabalin Placebo; Intraoperative Intravenous Lidocaine Placebo Infusion
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lidocaine 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.; Pregabalin 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.; Pregabalin placebo 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.; Lidocaine placebo 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.
Other intervention name(s): Xylocaine; Lyrica
Intervention MeSH terms: Lidocaine; Pregabalin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Local Anesthesia With Needle-free Injection System
Condition: Pediatric Anesthesia; Local Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study was to compare the pain during needle insertion and injection in
      mandibular molars anesthetized with either traditional syringe (control) or Comfort in System
      (experimental).
    


Intervention name(s): Comfort-in injection system; conventional injection with dental needle
Intervention type(s): Device; Other
Intervention description(s): local anesthesia during dental treatment; for local anesthesia during dental treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: needle-free injection; pain
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to demonstrate the efficacy of SPD489 compared with
      placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating
      Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as
      days during which at least 1 binge episode occurs) per week as assessed by clinical interview
      based on subject diary
    

Detailed description: 
      Not Required
    

Intervention name(s): SPD489 (Lisdexamfetamine dimesylate); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 or 70 mg administered orally, once-daily for up to 12 weeks; Administered once-daily, orally, for up to 12 weeks
Other intervention name(s): Vyvanse, Venvanse, LDX
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Nerve Stimulator Versus Ultrasound-guided Infraclavicular Block
Condition: Pain
Study type: Interventional

Summary: 
      The investigators compared the postoperative analgesia of nerve stimulator-guided and
      ultrasound-guided infraclavicular block for upper extremity surgery.
    

Detailed description: 
      Ultrasound (US)-guided peripheral nerve block has increased in popularity. It has many
      advantages such as improved success rate, faster onset time, fewer needle passes, shorter
      performance time, and reduced procedural pain and vascular puncture. However, there is no
      information about postoperative analgesia.

      Therefore, the investigators tested whether ultrasound-guided peripheral nerve block enhanced
      the postoperative analgesia for upper extremity surgery compared with nerve stimulator (NS)
      guidance.
    

Intervention name(s): NS-guided infraclavicular block; US-guided infraclavicular block
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients received a standard single injection infraclavicular block using the lateral sagittal approach of Klaastad. The infraclavicular brachial plexus is identified using an insulated needle connected to a nerve stimulator. Placement of the needle is considered adequate if motor response of radial nerve in the hand or wrist is still present at 0.2 - 0.5mA. Ropivacaine 0.5% 35ml is used.; Infraclavicular block is performed under ultrasound guidance. Linear probe is placed in a parasagittal positon below the clavicle medial to the coracoid process and adjusted to achieve a cross-sectional image of the axillary artery. Using in-plane technique, an 22-gauge insulated needle is advanced caudally and posteriorly to the axillary artery. Subsequently, 35 ml of 0.5% ropivacaine is incrementally injected.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nerve stimulator; ultrasound
A Single Dose Study of MK-8266 (MK-8266-001)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A three panel study, to determine if MK-8266 given as a single dose is sufficiently safe and
      well tolerated. Panel A and B will consist of healthy young males and Panel C will consist of
      subjects with mild to moderate hypertension. The primary hypotheses for the study are that
      MK-8266 given as single doses is sufficiently safe and well tolerated to permit continued
      clinical investigation in healthy young male volunteers and male participants with
      mild-to-moderate hypertension and that in males with mild to moderate hypertension, at a
      single oral dose of MK-8266 that is sufficiently safe and well-tolerated, postdose mean
      time-weighted average across 24 hours of aortic augmentation index (TWA0-12hrs AIx) is
      reduced compared to placebo. A mean decrease of ≥ 5 percentage points is considered
      clinically meaningful.
    

Detailed description: 
      Three panels, each consisting of either 8 or 9 participants (8 healthy young males in Panel A
      and Panel B; and 9 participants with mild to moderate hypertension in Panel C) will be
      randomized to receive either MK-8266 or matching placebo in either a 6:2 ratio (Panel A and
      Panel B) or 6:3 ratio (Panel C), respectively, in up to 5 treatment (1 to 5) periods in Panel
      A and up to 4 treatment (1 to 4) periods in Panel B and Panel C. In all panels, doses will be
      escalated in a rising, fixed sequence. Some participants took study drug after fasting and
      some with food.
    

Intervention name(s): MK-8266 0.1 mg; MK-8266 1.0 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral doses of 0.1 to 1.2 mg of MK-8266 in 0.1 capsule form. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant. Some participants will receive study drug with food.; MK-8266 1.0 mg oral capsule. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant.; Placebo to match MK-8266 0.1 or 1.0 mg. Participants will fast for 8 hours prior to dosing. There will be at least a 7- day washout period between doses for any given participant.
Other intervention name(s): MK-8266
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Accuracy of CardioWatch 287-2 During Profound Hypoxia
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      In an individual's SpO2 range from 100 to 73 %, this study calibrates and evaluates the
      accuracy of SpO2 measurement by CW2 in comparison to reference pulse oximeter (Nellcor PM10)
      or CO-oximetry, Pulse rate (PR) and respiratory rate (RR) were calibrated based on the same
      Nellcor equipment and the frequency of end-tidal CO2 respectively.
    

Detailed description: 
      The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular
      requirements for basic safety and essential performance of pulse oximeter equipment ISO
      80601-2-61:2017, Corrected version 2018-02 and ISO 80601-2-55.

      SpO2: Testing to confirm the accuracy of the SpO2 monitoring according to ISO 80601-2-61
      Clause 201.12.1.101 201.12.1.101

      RR Testing: Testing to confirm the accuracy of the respiration rate monitoring according to
      ISO 80601-2-55. Volunteers respirated spontaneously, no efforts were made to include all
      ranges of respiration during the study.

      PR Testing: Testing to confirm the accuracy of the PR monitoring according to ISO 80601-2-61
      Clause 201.12.1.104. No efforts were made to influence PRs of volunteers.

      An accelerometer and PPG filters are built in CW2 in order to form the basis to exclude
      non-eligible test results.
    

Intervention name(s): CardioWatch 287-2
Intervention type(s): Device
Intervention description(s): CardioWatch 287-2 (CW2 Test Device or CW2). This medical device is based on the precursor CardioWatch 287-1 approved by EU-MDR under number 20M00011CRT01, CW2 has two red, two infrared and two green LEDs, and two photosensors compared to its precursor.
Intervention model: Single Group Assignment
Intervention model description: A sample size of twelve subjects was planned in both the non-invasive study and invasive study, as recommended by the FDA Guidance for Industry and FDA Staff Pulse Oximeters - Premarket Notification Submissions [510(k)s]. Of these subjects, at least a minimum of 2 subjects or 15% of the analyzed population needed to have a dark skin pigmentation and at least 30 % of one gender is preferred.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: oxygen saturation; heart rate; respiratory rate; SpO2; wrist wearable; PPG; Corsano; CardioWatch 287-2; accuracy
Curcumin Pharmacokinetics
Condition: Comparative Multidose Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Each year, there are about 150,000 new colorectal cancer (CRC) cases and 50,000 CRC deaths in
      the United States. A safe and effective preventive agent could reduce the burden of
      colorectal cancer as well as reduce the costs associated with screening patients who are at
      high risk of developing CRC. Preclinical studies strongly suggest that curcumin is active
      against multiple pathways implicated in tumor initiation, progression, and metastasis.
      However, little is know how curcumin performs in humans. The investigators propose to enroll
      12 healthy volunteers who will undergo blood draw and rectal biopsy after 7 days of curcumin
      administration. The investigators will look at curcumin preparations with low and high oral
      bioavailability and calculate the blood and rectal tissue concentrations associated with
      these two formulations to determine which preparation produces the highest tissue
      concentrations.
    


Intervention name(s): curcumin
Intervention type(s): Drug
Intervention description(s): standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Pharmacokinetics; Dietary Supplements; Curcumin
Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Non-Fasting Conditions
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200
      capsules and Rebetol 200 mg capsules in females under non-fasting conditions.
    


Intervention name(s): Ribavirin 200 Capsules (Geneva Pharmaceutical, U.S.A.); Rebetol 200 Capsules (Schering Corporation, U.S.A.)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sitagliptin (DPP-4 Inhibitor) and NPH Insulin in Patients With T2D
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the short and long term effects of inhibitor of the DPP-IV enzyme, sitagliptin ,
      with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea plus
      biguanide: effects on beta cell function and on metabolic profile.
    

Detailed description: 
      Glucose control is fundamental in the treatment of type 2 diabetes (DM2). Studies suggest
      that drugs that boost levels of glucagon-like peptide (GLP-1) improve glycemic control and
      have long-term beneficial effect on the function of pancreatic beta cells. Objective: To
      compare the short and long term effects of sitagliptin (which inhibits the DPP-IV enzyme,
      increasing the levels of GLP-1) with bedtime NPH insulin in patients with T2D inadequately
      controlled with sulphonylurea plus biguanide. Effects on beta cell function and on metabolic
      profile were analyzed. Methods: 40 patients with DM2, HbA1c between 6.6 to 10%, in use of
      metformin and glibenclamide will be randomized to the addition of sitagliptin (Sitagliptin
      Group) or of bedtime NPH insulin (NPH Group). Measurements of HbA1c, metabolic and hormonal
      profile at fasting and post-meal (every 30 minutes for 4 hours) will be evaluated before and
      after 6 months (short term) and 12 months (long term) of adding sitagliptin or NPH insulin.
    

Intervention name(s): sitagliptin; NPH insulin
Intervention type(s): Drug; Drug
Intervention description(s): patients with type 2 diabetes,inadequately controlled with metformin plus glyburide, HbA1c between 6.6 to 10%, will be randomized to the addition of sitagliptin (Sitagliptin Group) or of bedtime NPH insulin (NPH Group) during one year; patients with type 2 diabetes,inadequately controlled with metformin plus glyburide, HbA1c between 6.6 to 10%, will be randomized to the addition of sitagliptin (Sitagliptin Group) or of bedtime NPH insulin (NPH Group) during one year
Other intervention name(s): DPP-4 inhibitor; long-acting insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Sitagliptin Phosphate; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef; Insulin, Long-Acting; Dipeptidyl-Peptidase IV Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; sitagliptin; NPH insulin; GLP-1
Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the
      immune system in different ways and stop tumor cells from growing.

      PURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive
      immunotherapy in treating patients with stage III or stage IV ovarian cancer or primary
      peritoneal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety and toxicity of autologous CD4-positive antigen-specific T cells in
           patients with stage III or IV ovarian epithelial cancer or primary peritoneal cavity
           cancer.

        -  Determine the duration of in vivo persistence of this drug in these patients.

      Secondary

        -  Determine the antitumor effect of this drug in these patients.

      OUTLINE: This is a dose-escalation study.

      Patients undergo leukapheresis for collection of T cells. Responder T cells are stimulated in
      vitro with autologous peripheral blood mononuclear cell-derived dendritic cells pulsed with
      NY-ESO-1 immunogenic peptides. Patients receive autologous CD4-positive antigen-specific T
      cells IV over 30 minutes.

      Cohorts of 3-6 patients receive escalating doses of autologous CD4-positive antigen-specific
      T cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
      preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

      Patients are followed at 4, 8, and 12 weeks and then periodically thereafter for survival.

      PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.
    

Intervention name(s): therapeutic autologous lymphocytes
Intervention type(s): Biological
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; peritoneal cavity cancer
Irinotecan in Treating Asian Patients With Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in
      treating Asian patients with solid tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan
           hydrochloride according to the genotype status of Asian patients with solid tumors.

      Secondary

        -  To investigate the pharmacokinetics of irinotecan hydrochloride and its metabolites
           SN-38 and SN-38G.

        -  To evaluate time to tumor response, response duration, and time to progression in these
           patients.

      OUTLINE: Patients are stratified according to genotype status (UGT1A1*28 vs UGT1A1*6)

      Patients receive irinotecan hydrochloride IV once weekly for 3 weeks. Treatment repeats every
      4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

      Patients undergo blood sample collection periodically for pharmacogenetic, pharmacokinetic,
      and pharmacodynamic studies.
    

Intervention name(s): irinotecan hydrochloride; pharmacogenomic studies; pharmacological study
Intervention type(s): Drug; Other; Other
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY
Condition: Breast Neoplasm Female
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      INTRODUCTION: Breast cancer is one of the pathologies affecting women worldwide, with a high
      mortality rate of 14,206 per 100,000 women per year. However, Pilates was used as a
      therapeutic treatment for women who underwent a modified radical mastectomy, being associated
      with the alterations when in the postoperative sequels.

      OBJECTIVE: to evaluate the Pilates Method in the functionality of women submitted to modified
      radical mastectomy.

      METHOD: This is a quantitative clinical trial, in the form of women included in the project,
      to undergo a physical therapy rehabilitation program through the Pilates Method for 2 months,
      where they were evaluated before and after the procedure for measurement and comparison
      obtained.

      CONCLUSION: In this way, the pilates method is presented as an instrument used for the
      rehabilitation of mastectomized women.
    


Intervention name(s): Pliates method treatment
Intervention type(s): Other
Intervention description(s): The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months.
Intervention model: Single Group Assignment
Intervention model description: The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer.; Exercise Therapy; Modified Radical Mastectomy