bioihbjkbjnl/mcl2 huggingface dataset:
Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP
Condition: Diabetic Peripheral Neuropathic Pain (DPN); Postherpetic Neuralgia (PHN); HIV-related Neuropathic Pain (HIV); Chemotherapy Induced Neuropathic Pain
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: Pregabalin
Intervention description: Pregabalin will be administered orally, twice a day for 12 weeks, including 4-week dose adjustment phase followed by 8-week maintenance phase. The minimum allowable pregabalin dose during the trial will be 75 mg BID (150 mg/day) and the maximum allowable dose will be 300 mg BID (600 mg/day).
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic
      neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy
      induced peripheral neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are diagnosed with neuropathic pain associated with diabetic peripheral
             neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral
             neuropathy, and chemotherapy induced peripheral neuropathy.

        Exclusion Criteria:

          -  Severe Pain associated with conditions other than Diabetic Peripheral Neuropathy,
             Post-Herpetic Neuralgia, Human Immunodeficiency virus related peripheral neuropathy,
             and chemotherapy induced peripheral neuropathy that may confound assessment or self
             evaluation of the neuropathic pain.

          -  Skin Condition in the affected dermatome that (in the judgment of the investigator)
             could alter sensation.
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
Condition: Colonic Neoplasms; Rectal Neoplasms; Diverticulitis; Inflammatory Bowel Diseases; Rectal Prolapse
MeSH terms: Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Inflammatory Bowel Diseases; Diverticulitis; Rectal Prolapse; Prolapse
Intervention: Compression Anastomosis Device; follow-up colonoscopy
Intervention description: Restoring intestinal continuity using the NITI CAR27 device; endoscopic exploration of anastomosis after complete healing
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: anastomotic leakage; bleeding from the anastomotic region; anastomotic stenosis

Summary:

      After resection of diseased segments of the large intestine, the continuity of the intestine
      has to be restored. This can be done by suturing or with so called stapling devices. In
      addition since 2 centuries compression rings are used to connect the intestine after
      resection. The NITICAR27 device is a novel compression anastomosis device. The investigators
      want to prove if this novel device can be compared to commonly used stapling devices
      concerning anastomotic leakage, bleeding and stenosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  benign and malign lesions of the colon and rectum

        Exclusion Criteria:

          -  advanced peritonitis (putrid, feculent)
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
Condition: Migraine; Migraine Disorders; Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Erenumab
Intervention description: Erenumab was supplied as a pre-filled pen (auto-injector) for subcutaneous injection.
Intervention MeSH terms: Erenumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 701.0
Sex: All
Minimum age: 18 Years
Maximum age: 67 Years
Healthy volunteers: No
Keywords: migraine; episodic migraine; chronic migraine; headache; erenumab; AMG334; aimovig; monoclonal antibody; CGRP-receptor antibody

Summary:

      This is a 128-week open-label study to assess the long-term safety and tolerabilty of the
      monoclonal antibody erenumab in migraine patients.
    

Eligibility criteria:

        The study population consisted of patients with a documented history of episodic (4 - 14
        baseline migraine days) or chronic migraine (≥15 baseline headache days), who had been
        successfully randomized to clinical trial CAMG334ADE01.

        Key inclusion Criteria:

          -  Signed informed consent must be obtained prior to participation in the study

          -  Patient is capable of understanding the nature, significance and implications of the
             clinical trial.

          -  Adults ≥18 years of age upon entry into screening

        Key exclusion Criteria:

          -  Use of a prophylactic migraine medication within five plasma clearance half-lives, or
             a device or procedure within one month prior to the start of the Open-label Treatment
             Epoch. This exclusion criteria does not apply to erenumab or topiramate administered
             within clinical trial CAMG334ADE01

          -  Any prior exposure to (investigational) prophylactic migraine products targeting the
             CGRP pathway, other than erenumab.
PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: PV-Isolation RF; PV-Isolation Cryo
Intervention description: Radiofrequency; Cryo-Balloon
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 322.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: catheter ablation; randomized; cryo; radiofrequency; atrial fibrillation; cryo-balloon; PV-Isolation

Summary:

      This study is designed as a randomized, controlled, prospective, non-inferiority clinical
      trial, where the efficacy and safety of the cryoballoon ablation system (CE certificated)
      will be compared to the standard ablation technique (segmental isolation of the pulmonary
      veins) with radiofrequency energy. The primary study aim is to investigate whether the new
      cryoballoon ablation catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable
      Sheath, CryoCath Technologies Inc., Montreal, Canada) is at least as effective as
      radiofrequency (RF) segmental isolation in electrically disconnecting the pulmonary veins
      (PV) for the treatment of paroxysmal atrial fibrillation (AF) with respect to the absence of
      atrial arrhythmias without persistent complications after six and twelve months. Furthermore,
      the differences in terms of procedural complications such as pulmonary vein stenosis, phrenic
      nerve injuries, cerebrovascular accidents (CVA), pericardial tamponade, pain scores during
      the procedure, levels of cardiac inflammatory markers are compared between the treatment
      groups. The short and long-term clinical success as well as the costs of both systems will
      also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented paroxysmal PAF: PAF diagnosis, 2 episodes of PAF within the last 3 months,
             at least 1 episode of PAF must be documented.

          -  Age 18-75

          -  Documented effectiveness failure of at least 1 AAD including beta-blockers

        Exclusion Criteria:

          -  AAD usage < 3 half life periods (except beta-blocker)

          -  LA size > 55 mm

          -  LA thrombus

          -  Previous LA ablation/surgery, structural heart disease, heart failure class III-IV

          -  Hypertrophic cardiomyopathy

          -  Mitral prosthesis

          -  Unstable angina

          -  Uncontrolled hyperthyroidism

          -  Stroke or TIA within 6 months

          -  Myocardial infarction within 2 months

          -  Cardiac surgery within 3 months

          -  Thrombocytosis, thrombocytopenia

          -  Any condition contraindicating chronic anticoagulation

          -  EF < 40%

          -  Pregnancy

          -  Life expectancy < 1 year
Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery
Condition: Pain
Intervention: Lidocaine; Placebo
Intervention description: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW); Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Lidocaine; Mastectomy; Pain

Summary:

      The aim of this study is to determine if perioperative systemic lidocaine administration will
      decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In
      addition, patients receiving systemic lidocaine will have a lower incidence of
      post-mastectomy pain syndrome.

      This study will have 2 groups. Participants will be randomized into one of each group. The
      first group will be administered the drug lidocaine prior to surgery and the second group
      Group B will be administered saline (salt water). This is a blinded study which means the
      participant will not know which group they have been assigned. The subjects participation
      will last 12 months (surveys post operatively).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 18-65 years

          -  Gender: Female

          -  ASA Physical Status I-III

          -  Non-pregnant

          -  Surgery: Unilateral total or segmental mastectomy

          -  Language: English speaking

          -  Consent: Obtained

        Exclusion Criteria:

          -  Age: Under 18 or over 65 years

          -  ASA Physical Status >III

          -  Pregnancy

          -  Language: Non-English speaking

          -  Allergy to Lidocaine or amide local anesthetics

          -  Contraindication to succinylcholine

          -  History and/or EKG evidence of conduction defect

          -  Renal failure (Creatinine >1.7 mg/dL)

          -  Patient expected to remain intubated after procedure

          -  Chronic home opioid or steroid use

          -  Opioid use within one week prior to procedure

          -  Drug or alcohol abuse

          -  Inability to use PCA
A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Placebo; ibandronate
Intervention description: po monthly for 12 months; 150mg po monthly for 12 months
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 140.0
Sex: Female
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in
      the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will
      be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and
      calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target
      sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  post-menopausal women, 50-85 years of age;

          -  any inflammatory rheumatoid disease including polymyalgia rheumatica;

          -  receiving treatment with 5-15 mg/day of prednisolone.

        Exclusion Criteria:

          -  previous treatment with an iv bisphosphonate at any time;

          -  previous treatment with an oral bisphosphonate within the last 6 months, >1 month of
             treatment within last year, or >3 months of treatment within last 2 years;

          -  treatment with parathyroid hormone in last 2 years;

          -  inability to stand or sit in an upright position for at least 60 minutes;

          -  inability to swallow a tablet whole;

          -  history of major gastrointestinal disease.
Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: rasagiline (Pharmacodynamics); Placebo
Intervention description: Rasagiline 1 mg/day for 12 weeks; Placebo 1 tablet each day
Intervention MeSH terms: Rasagiline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Cognitive impairments; Negative symptoms

Summary:

      This is a study of a new medication for the treatment of cognitive impairments (thinking
      difficulties) and negative symptoms in people with schizophrenia. The new medication is
      rasagiline. Rasagiline is a drug which has been approved by the Food and Drug Administration
      for the treatment of Parkinson's disease. It is used to treat cognitive problems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.

          -  Current treatment with one or more second generation antipsychotics, except
             ziprasidone

          -  On same second generation antipsychotic(s)for at least 56 days

          -  On same dose of second generation antipsychotic(s)for at least 30 days

          -  22-item SANS: Total score (i.e.all items minus global items and poverty of content of
             speech)greater than 20 or global Rating of Affective Flattening greater than or equal
             to 3 or global Rating of alogia greater than or equal to 3

          -  BPRS: Sum of the four positive symptom items less than or equal to 16 (items
             4,11,12,15)

          -  BPRS: Sum of the four Anxiety/Depression Factor items less than or equal to 14 (items
             1,2,5,9)

          -  Simpson-Angus Scale: Total score less than or equal to 8

        Exclusion Criteria:

          -  DSM-IV Major Depressive Disorder within last 6 months

          -  Current treatment with ziprasidone

          -  DSM-IV diagnosis of alcohol or substance dependence within the last 6 months

          -  DSM-IV criteria for alcohol or substance abuse within the last month

          -  evidence of illicit substance use, as identified with urine toxicology screen

          -  History of an organic brain disorder, mental retardation,epilepsy, or a medical
             condition, whose pathology or treatment could alter the presentation or treatment of
             schizophrenia or significantly increase the risk associated with the proposed
             treatment protocol. See those listed below

          -  Uncontrolled hypertension defined as BP exceeding 145/90 on 3 consecutive readings
             despite adequate treatment, pheochromocytoma, melanoma, hepatic insufficiency

          -  Pregnancy or lactation in females

          -  Pheochromocytoma

          -  Melanoma

          -  Hepatic insufficiency
Buffered Lidocaine in Paracervical Blocks
Condition: Pain
Intervention: Lidocaine; Lidocaine-Sodium Bicarbonate
Intervention description: Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain; Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
Intervention MeSH terms: Lidocaine; Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A statistician not involved with the conduct of the study will use a computer random number generator to generate random permuted blocks. This statistician will place allocation assignment cards in sequentially numbered, sealed, opaque envelopes. A different randomization scheme will be used for each location, one at the Kapi'olani office and one at the Queen's office.
A clinic staff member not involved with the conduct of the study will be trained specifically in the opening of the allocation envelopes. The staff member will be trained to open the envelope and remove the study card to read the allocation group: buffered lidocaine or plain lidocaine. The clinic staff member will then prepare the buffered lidocaine or plain lidocaine in an unlabeled syringe, and place it on the surgical tray.
Enrollment: 98.0
Sex: Female
Minimum age: 14 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      For pain relief during a first trimester surgical aspiration, most providers use the
      paracervical block, either alone or in combination with other pain control techniques. Some
      providers use buffered lidocaine due to a belief that it decreases pain. Others use plain
      lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain
      lidocaine in a two site injection. Few studies have compared buffered versus unbuffered
      lidocaine for paracervical blocks during first trimester uterine aspirations. This study
      seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for
      paracervical blocks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women 14 years and older

          -  Desiring uterine aspiration for pregnancy or surgical management of a miscarriage

          -  Gestational age up to 13 weeks and 6 days to be established by best dating (i.e. last
             menstrual period or earliest ultrasound)

          -  Treatment plan involves outpatient uterine aspiration

          -  Participant able to provide informed consent in English and willing to participate in
             the study

        Exclusion Criteria:

          -  Unable to read, speak, or understand English

          -  Unable to provide informed consent

          -  Currently incarcerated

          -  Under the age of 14 years

          -  Contraindications to receiving lidocaine or buffered lidocaine
A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Bydureon
Intervention description: exenatide once weekly
Intervention MeSH terms: Exenatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 19 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus, T2DM, GLP-1, GLP-1 Once weekly, Exenatide

Summary:

      As current study is conducted to provide additional information regarding safety and efficacy
      Bydureon, exenatide once weekly for injectable suspension, in the Korean population open
      label, non-comparative, multi-centre design is used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 19-75 years of age

          -  diagnosed with type 2 diabetes mellitus

          -  Patients who have not achieved adequate glycaemic control on maximally tolerated doses
             of these oral therapies;

               -  Metformin

               -  Sulphonylurea

               -  Thiazolidinedione

               -  Metformin and sulphonylurea

               -  Metformin and thiazolidinedione

        Exclusion Criteria:

          -  Has been treated, is currently being treated, or is expected to require or undergo
             treatment with any of the following medications:

               1. Alpha glucosidase inhibitor or meglitinide within 30 days of screening;

               2. Insulin within 2 weeks prior to screening or insulin for longer than 1 week
                  within 3 months of screening;

               3. DPP-4 inhibitors within 30 days of screening;

               4. Regular use (> 14 days) of drugs that directly affect gastrointestinal motility
                  within 3 months of screening;

               5. Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or
                  intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have
                  a high rate of systemic absorption within 3 months of screening;

               6. GLP-1 receptor agonist except exenatide within 3 months of screening;

          -  diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis;

          -  type 2 diabetes by beta-cell dysfunction requiring insulin treatment

          -  Has ever used exenatide

          -  Pregnant or breast feeding patients

          -  Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper
             limit of normal

          -  End-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min)