bioihbjkbjnl/mcl2 huggingface dataset:
Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: lacosamide; Placebo
Intervention description: 50 or 100mg tablet, 400mg daily, for 12 weeks; 50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide
Intervention MeSH terms: Lacosamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 194.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Osteoarthritis; lacosamide; VIMPAT

Summary:

      The purpose of this trial is to evaluate the effectiveness, safety and tolerability of
      lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has symptomatic osteoarthritis of the knee diagnosed using clinical and
             radiographic evidence as well as ACR criteria with symptom duration of at least 6
             months.

          -  Subject requires therapeutic dose of an NSAID, COX-2 NSAID, and/or
             paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that
             medication at least 5 days per week for the last 4 weeks prior to the screening visit
             (Visit 1).

        Exclusion Criteria:

          -  Subject is not able to withdraw NSAIDs, COX-2 NSAIDs and/or paracetamol

          -  Subject is taking analgesic other than NSAIDs COX-2 NSAIDs and/or paracetamol

          -  Subject is planning to begin or stop treatment with glucosamine and/or chondroitin
             during the trial
Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT
Condition: Feeding Tube
Intervention: PEG-J placement
Intervention description: PEG-J placement
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: PEGJ; PEG-J; Percutaneous Endoscopic Gastrostomy; Feeding tube; Gastroparesis; Acute pancreatitis; Stroke; Respiratory failure; GERD; Balloon; Self-propelled

Summary:

      Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube
      (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration
      rate, and lower rates of short- and long-term complications when compared to standard PEGJ
      feeding tubes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consecutive adult patients (18-80 years of age) with need for post-pyloric feeding
             (patients unable to eat due to stroke, intubated patients with respiratory failure,
             patients with acute pancreatitis, etc).

          -  Ability to give informed consent.

        Exclusion Criteria:

          -  Unable to give informed consent

          -  Pregnant or breastfeeding women (all women of child-bearing age will undergo urine
             pregnancy testing)

          -  Acute gastrointestinal bleeding

          -  Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR >
             1.5), on chronic anticoagulation, or platelet count <50,000

          -  Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or
             other contraindication to endoscopy

          -  Cirrhosis with portal hypertension, varices, and/or ascites

          -  Allergy to egg
A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Bilastine 0.2%; Bilastine 0.4%; Bilastine 0.6%; Bilastine 0%
Intervention description: 1 drop in each eye at 3 separate times during a 25 day period.; 1 drop in each eye at 3 separate times during a 25 day period.; 1 drop in each eye at 3 separate times during a 25 day period.; 1 drop in each eye at 3 separate times during a 25 day period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to
      vehicle for the treatment of the signs and symptoms of allergic conjunctivitis
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  be at least 18 years old

          -  be willing and able to avoid all disallowed medications and contact lenses

          -  must have a pregnancy test if of childbearing potential

          -  must be able to read an eye chart from 10 feet away

        Key Exclusion Criteria:

          -  must not have any allergies to the study medications

          -  must not have any ocular or non ocular condition that investigator feels will
             interfere with study parameters

          -  must not have used immunotherapy in the last 2 years

          -  must not have used an investigational drug or device in the past 30 days or
             concurrently enrolled in another investigational trial
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Condition: Hernioplasty
Intervention: 2 100mg Xaracoll implants; 3 100mg Xaracoll implants; 150mg Bupivacaine HCl injection
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: unilateral inguinal hernioplasty

Summary:

      Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy
      hernioplasty and assess the relative bioavailability of Xaracoll compared to a local
      bupivacaine infiltration.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Man or woman who is ≥ 18 years of age

          2. Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free
             technique)

          3. If female, is nonpregnant

        Exclusion Criteria:

          1. Scheduled for bilateral inguinal hernioplasty or other significant concomitant
             surgical procedures

          2. Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to
             undergo another laparotomy procedure within 30 days postoperatively

          3. Has any clinically significant unstable cardiac, neurological, immunological, renal,
             hepatic or hematological disease or any other condition that, in the opinion of the
             investigator, could compromise the patient's welfare, ability to communicate with the
             study staff or otherwise contraindicate study participation
A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Comparator: placebo (unspecified)
Intervention description: sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.; placebo QD 12-weeks
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 363.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to determine the efficacy and safety of an investigational drug
      in patients with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes mellitus

        Exclusion Criteria:

          -  Patients with type 1 diabetes mellitus
Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction
Condition: Sexual Dysfunction, Physiological
MeSH terms: Sexual Dysfunction, Physiological
Intervention: Vaginal Renewal Program; Vaginal Dilator
Intervention description: The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.; Still vaginal dilator with lubricant.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sexual Dysfunction; Gynecologic cancer; Cancer survivor; Vaginal dilator

Summary:

      This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewal™
      Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water
      based lubricant, on sexual dysfunction, compared to the current standard care for women with
      no evidence of disease after treatment for gynecologic cancers.

      In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients
      are generally asked about sexual function. Those women who report sexual dysfunction will be
      given the option to enroll in the study. After enrollment, the Female Sexual Function Index
      (FSFI) and other quality of life surveys will be administered at baseline. The participants
      will be randomized to either the control arm, composed of standard of care therapy for the
      physical components of sexual dysfunction, or the experimental arm (VRP).

      Throughout the study, the participants will undergo physical exams to assess the rate of
      improvement in their comfort with pelvic exams and changes in vaginal length. They will also
      be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of
      Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of
      improvement in sexual function and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18

          -  History of a gynecologic cancer

          -  No evidence of disease at time of inclusion in the study

          -  Postmenopausal (either surgical or natural menopause)

          -  Self report of sexual dysfunction that did not predate cancer diagnosis

          -  Suspected physical component to sexual dysfunction with the participant, not sexual
             partner

          -  Desire to improve sexual function

          -  ECOG Performance status score of 2 or better

          -  Six months or greater from last surgical and/or radiation treatment

        Exclusion Criteria:

          -  History of sexual reassignment

          -  Presence of vaginal fistula

          -  Does not desire to improve sexual function

          -  Already using the vaginal renewal program

          -  Not fluent in English

          -  Incarceration
Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Condition: Nonmalignant Breast Conditions; Breast Cancer
Intervention: Sodium hypochlorite (Dakin's Solution); Chlorhexidine gluconate disk; Control; Occlusive Adhesive Dressing
Intervention description: 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day; Apply one chlorhexidine disk to the intervention drain site(s) and change every three days; Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.; A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Sodium Hypochlorite; Eusol; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bilateral breast mastectomy; Immediate tissue expanders reconstruction

Summary:

      Surgical site infection (SSI) after breast and axillary surgery occurs more often than for
      other clean surgical procedures. Infection in the setting of a tissue expander can be
      devastating and can lead to early implant loss and failed reconstruction. Surgical drains
      have been noted as a potential source for surgical site infections. Hypothesis: Bacteria
      present in surgical drains after tissue expander reconstruction may be decreased by simple
      and inexpensive local antiseptic interventions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females or males age 18-90 able to give informed consent

          -  Undergoing bilateral mastectomy with immediate expander reconstruction or immediate
             implant reconstruction

          -  May have either malignant or benign breast condition

        Exclusion Criteria:

          -  Antibiotic use in the fourteen days prior to surgical date

          -  Undergoing unilateral tissue expander reconstruction

          -  Documented allergy to chlorhexidine gluconate

          -  Prior radiation therapy to the breast or chest wall (ie for breast conservation or
             mantle radiation for Hodgkin's disease)

          -  Documented allergy to all three of the following antibiotics: cephalosporin,
             trimethoprim/sulfamethoxazole, and levofloxacin

          -  Pregnant women

          -  Vulnerable subjects - prisoners, institutionalized individuals

          -  Non-English speaking patients without adequate interpreter assistance
A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: AZD6765 iv; AZD6765 iv; Placebo
Intervention description: 50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.; 100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.; 0.9 sodium chloride [normal saline] solution for injection by iv infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 542.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Inadequate Response to Antidepressant Therapy; Channel blocker of the NMDA class of glutamate receptors

Summary:

      The purpose of this study is to assess the effect and safety of AZD6765 in patients with
      major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a
      channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated informed consent before initiation of any study-related
             procedures.

          -  Male or female patients aged 18 to 70 years, inclusive.

          -  The patient must have a clinical diagnosis of major depressive disorder with a
             lifetime history of inadequate response to at least 3 antidepressants.

          -  Women of child-bearing potential must have a negative serum pregnancy test and
             confirmed use of a highly effective form of birth control before enrollment for a
             minimum of 3 months before study start.

          -  Outpatient status at screening and randomization visits.

        Exclusion Criteria:

          -  Patients with a history of diagnosed bipolar disorder or schizophrenia or
             schizoaffective disorder or currently exhibiting psychotic features associated with
             their depression; dementia or suspicion thereof.

          -  Patients who have had a suicide attempt within the last 6 months.

          -  Electroconvulsive therapy (ECT), vagal nerve stimulation (VNS) or transcranial
             magnetic stimulation (TMS) or previous treatment with ketamine infusion within the 6
             months prior to screening, or any history of deep brain stimulation.

          -  Patients with any history of seizure disorder (except for febrile seizures in
             childhood).

          -  Pregnancy or lactation.
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: SABER-Bupivacaine Treatment 1a; Placebo SABER-Bupivacaine Treatment 1b; Bupivacaine HCl Treatment 1c; SABER-Bupivacaine Treatment 2a; Placebo SABER-Bupivacaine Treatment 2b; Bupivacaine HCl Treatment 2c
Intervention description: 5.0 ml; 5.0 ml; 20.0 ml; 7.5 ml; 7.5 ml; 20.0 ml
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post operative pain; Local anaesthesia; Postoperative pain after arthroscopic shoulder surgery

Summary:

      The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain
      control in patients undergoing elective arthroscopic shoulder surgery on the basis of
      pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening
      period up to 14 days and a treatment period 14 days with a long term follow up visit at 6
      months. The study will provide further data on safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subacromial impingement syndrome

          -  MRI with intact rotator cuff

          -  Patients suitable for general anaesthesia

        Exclusion Criteria:

          -  Known major joint trauma, infection, avascular necrosis, chronic dislocation,
             inflammatory or degenerative glenohumeral arthropathy, glenohumeral arthritis, frozen
             shoulder or previous surgery of the affected shoulder

          -  Abnormal ECG

          -  Prolonged QT syndrome

          -  Current or regular use of analgesic medication for other indication(s)
A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Xeloda; Taxotere; Herceptin
Intervention description: Participants will receive oral Xeloda, 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle.; Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm.; Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward.
Intervention MeSH terms: Docetaxel; Capecitabine; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin)
      and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with
      previously untreated HER2-positive advanced and/or metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not
             amenable to curative therapy

          -  At least one measurable lesion according to RECIST

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Baseline left ventricular ejection fraction (LVEF) at least 50%

        Exclusion Criteria:

          -  Pregnant, lactating, or women of childbearing potential who are not surgically sterile
             or not willing to use adequate contraceptive methods

          -  Previous treatment with Herceptin or other anti-HER therapies, or any previous
             chemotherapy for advanced or metastatic disease

          -  Past medical history significant for any cardiac or central nervous system (CNS)
             disorders

          -  Poor hematologic, renal, or hepatic function

          -  Chronic corticosteroid therapy