bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders
Condition: Posttraumatic Stress Disorder; Anxiety Disorder
MeSH terms: Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Propranolol; Reactivation; Mifepristone; Intranasal oxytocin
Intervention description: 40mg single pill; subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2); 1800mg, 9 tablets; 32 IU, 8 self-administered intranasal sprays, 4 in each nostril
Intervention MeSH terms: Propranolol; Oxytocin; Mifepristone
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Posttraumatic Stress Disorder; PTSD; Anxiety; Fear of spiders; Reconsolidation; Reconsolidation blockade

Summary:

      The aim of this project is to create fear conditioning paradigm within which the relative
      strengths of various novel pharmacological and behavioral interventions can be tested. These
      interventions are intended to reduce the fearfulness associated with fear conditioning by
      blocking a memory process known as reconsolidation. In fear conditioning, a "conditioned"
      stimulus (CS) is paired with an aversive "unconditioned" stimulus (US) such as an electric
      shock, until presentation of the CS alone comes to elicit a fear conditioned response (CR).
      The investigators hypothesize that by using a more highly prepared CS (i.e. video of
      spiders); more sensitive subjects (individuals with stronger acquired CRs); and additional
      experimental probes for the presence of the latent CR, the investigators may develop a normal
      human paradigm that is not plagued by previously observed floor effects (i.e. intervention is
      100% effective), within which both the established techniques of propranolol and delayed
      extinction will produce significant, but only partial, CR reduction. This would leave room to
      test and compare potentially more powerful candidate reconsolidation-blocking or
      memory-updating interventions. To achieve these aims, subjects will undergo a four-day fear
      conditioning and delayed extinction protocol. Skin conductance response data will be gathered
      across the different phases of the experiment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-35

          -  Top half of the normal human distribution of the Spider Phobia Questionnaire-15

        Exclusion Criteria:'

          -  Any criteria for diagnosable spider phobia

          -  Any current Axis I mental disorder on the Structured Clinical Interview for DSM-IV
             (SCID)

          -  Presence of drugs of abuse (e.g. opiates, marijuana, cocaine, or amphetamines) per
             urine screen

          -  Non-English speaking (due to lack of validated questionnaires/instruments in other
             languages)
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
Condition: Hernia; Surgical Wound Dehiscence
MeSH terms: Hernia; Surgical Wound Dehiscence; Surgical Wound
Intervention: Strattice(TM) Reconstructive Tissue Matrix; Suture/suture with absorbable mesh
Intervention description: Strattice(TM) TM will be used to support the repair of abdominal wall defect; Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dehiscence; laparotomy; Hernia repair; surgical wound; surgical mesh

Summary:

      The objective of this study is to compare the incidence of post-repair wound related
      complications, including hernia occurrence/recurrence, between challenging abdominal wall
      defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by
      standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair
      will reduce the incidence of these post-repair complications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults (18years of age or older) who is able to provide written informed consent for
             study participation

          -  has need of surgical intervention for repair of (potentially) contaminated abdominal
             wall defect of >3cm and <22cm in length, where the viscera have not been exposed for
             more than 15 days in case of open abdomen(skin and fascia open).

          -  Is willing and able to return for all scheduled & required study visit.

        Exclusion Criteria: at the time of randomization

          -  severe systemic sepsis

          -  frank pus in the wound, a fistula that will not be closed at the time of surgery or
             intra-abdominal abscess in surgical area,

          -  ongoing necrotizing pancreatitis,

          -  Is on chronic immunosuppressive therapy, or other medication that influences wound
             healing

          -  requires only short-term temporary closure,

          -  requires a synthetic, non-absorbable mesh to close the abdominal wall defect

          -  is unable to undergo general anesthesia,

          -  has other major organ system dysfunction or disorder that would jeopardize subject
             completing the 24 month study.

          -  Is unable to undergo an MRI scan
Adherence in Topical Treatment of Psoriasis
Condition: Adherence
MeSH terms: Psoriasis
Intervention: Calcipotriene + Betamethasone Dipropionate; App
Intervention description: Participants received Calcipotriene + Betamethasone Dipropionate once daily when needed for the entire study period.; App named MyPso SmarTopTM Version 1.0 (LEO Pharma) was used for 28 days by participants in the intervention arm.
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 134.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: psoriasis

Summary:

      Medical adherence to topical corticosteroid products in psoriasis patients is a main
      determinant for poor treatment effect.

      The investigators aim to test if a multifaceted intervention delivered in an app (MyPso
      QualityCareTM owned by Leo Pharma) for smartphones combined with an Electronic Monitor (EM)
      (Teslo) can improve medical adherence among psoriasis patients treated with a topical
      calcipotriol/betamethasone dipropionate foam combination (Cal/BD) (Enstilar©).

      The study is classified as a phase 4 study, since it is studied if improved use of Enstilar©
      results in improved treatment outcomes.

      Link to published study protocol:

      https://bmcdermatol.biomedcentral.com/articles/10.1186/s12895-018-0071-3

      Link to published results from the study:

      https://onlinelibrary.wiley.com/doi/abs/10.1111/bjd.16667
    

Eligibility criteria:

        Inclusion Criteria:

          -  Psoriasis patients aged 18-75 years with mild-moderate psoriasis. It is mandatory that
             patients have a smartphone and basic skills for use of the smartphone.

        Exclusion Criteria:

          -  aged under 18 and above 75 years, guttate psoriasis, severe degree of psoriasis, i.e.
             pustular and erythrodermic psoriasis, lack of smartphone and user skills for the
             smartphone
Acetaminophen (Tylenol) for Mood and Memory Changes Associated With Corticosteroid Therapy
Condition: Asthma; Rheumatic Disease
MeSH terms: Rheumatic Diseases; Collagen Diseases
Intervention: Drug: Acetaminophen, Drug: Placebo
Intervention description: Acetaminophen: Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days, not exceeding 4,000 mg/day. Placebo: Participants will be given placebo(two 500 mg tablets) four times daily for 7 days
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acetaminophen; corticosteroids; prednisone

Summary:

      Studies in humans and animals support that stress and/or elevations in corticosteroids lead
      to changes in hippocampal structure and functioning. This is important as patients with major
      depression frequently have elevated cortisol, and millions of patients receive prescription
      corticosteroids (e.g. prednisone). Both depression and corticosteroid therapy are associated
      with memory impairment and hippocampal atrophy. Our research uses corticosteroid-treated
      patients to explore interventions that might protect the brain from the effects of stress or
      corticosteroids. We propose to give 30 corticosteroid-treated asthma patients acetaminophen
      or placebo. Between group differences in mood, memory and other neurocognitive measures will
      serve as outcome measures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65

          -  Scheduled to receive at least 20 mg/day of prednisone for at least 7 days

          -  Baseline Rey Auditory Verbal Learning Test (RAVLT) total score of ≥40

        Exclusion Criteria:

          -  History of allergic reaction or other contraindication to acetaminophen therapy

          -  Acetaminophen use within 24 hours of study entry

          -  History of liver disease or alcohol use of greater than 3 drinks/day

          -  Severe or unstable medical condition (e.g., recent myocardial infarction,renal
             failure, diabetes with poor glycemic control)

          -  Pregnant or lactating female

          -  Patient has mental retardation, dementia, or other severe cognitive disorder
The Use of Statins Following a Left Atrial Catheter Ablation Procedure to Prevent Atrial Fibrillation
Condition: Atrial Fibrillation; Arrhythmia; Inflammation; Endothelial Dysfunction
MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac; Inflammation
Intervention: Atorvastatin; Placebo
Intervention description: 80 mg tablet taken by mouth daily for 90 days; Placebo tablet taken by mouth once daily for 90 days
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Arrhythmia; Pulmonary Vein Isolation; Left atrial catheter ablation; Inflammation; Endothelial dysfunction

Summary:

      To investigate whether statin therapy utilizing the drug Lipitor (atorvastatin) might be
      effective in preventing short-and long-term atrial fibrillation (AF) following a left atrial
      ablation procedure. We further hypothesize this reduction will result from diminished
      peri-procedural inflammation, which will be reflected in lower C-Reactive Protein (CRP)
      values in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients > or = to 18 years of age

          -  Clinically indicated left atrial ablation procedure for atrial fibrillation

        Exclusion Criteria:

          -  Known malignancy

          -  Known inflammatory disease

          -  Surgery or trauma or myocardial infarction in the previous month

          -  Known contraindication to statin therapy

          -  Elevated liver enzymes above two times the upper limit of normal

          -  Patients already receiving therapy with any statin, niacin or fibrates at the time of
             their randomization
An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer
Condition: Cancer; Pain
MeSH terms: Breakthrough Pain
Intervention: Hydromorphone HCl OROS
Intervention description: Hydromorphone HCl OROS 8 mg once daily for 2 weeks.
Intervention MeSH terms: Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hydromorphone hydrochloride Oral Osmotic System; Jurnista

Summary:

      The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride
      (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency
      for the management of breakthrough pain after the administration of hydromorphone HCl OROS in
      Korean cancer participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cancer participants administering only strong oral opioid analgesic for cancer pain
             control

          -  Participants administering short-acting narcotic analgesics at least twice daily due
             to breakthrough pain for 3 days just before Visit 2 (Day 1)

          -  Participants sufficiently capable of complying overall study requirements including
             participant diary for pain at the discretion of the Investigators

          -  Abstinent or surgically sterile female participants

        Exclusion Criteria:

          -  Participants with cancer pain who are potentially unresponsive to narcotic analgesics

          -  Participants with presence or history of drug or alcohol abuse within the past 6
             months

          -  Participants with hypersensitivity to hydromorphone HCl

          -  Participants with history of colectomy (surgery to remove part or all of the colon)

          -  Participants with severe digestive tract disease which might interfere with oral
             analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel
             movement, ileus, and severe enterostenosis that can influence absorption and passing
             through of oral medication
Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Propanolol; Placebo; Cognitive therapy workbook
Intervention description: Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.; Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.; Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
Intervention MeSH terms: Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Propanolol; Beta Blockers; Reconsolidation; Cognitive Therapy; PTSD

Summary:

      This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in
      people with post-traumatic stress disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of PTSD or meets the five of the six diagnostic criteria for PTSD
             (event, hyperarousal, re-experiencing, duration, and distress/impaired functioning
             symptom criteria), but not the avoidance/numbing symptom criteria

        Exclusion Criteria:

          -  Past or current asthma

          -  Diabetes or heart disease

          -  Currently pregnant or breastfeeding

          -  Concurrent use of daily benzodiazepine; daily use of antidepressant medication allowed
             if dose has been stable for the 3 months before study entry

          -  Exposure therapy or additional cognitive therapy during the course of the study
             (supportive psychotherapy is allowed if ongoing for at least 3 months before study
             entry)

          -  Substance abuse

          -  Current use of beta blockers, amiodarone, chlorpromazine, cimetidine, clonidine, or
             digoxin
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Condition: Post-Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: ibandronate [Bonviva/Boniva]; ibandronate [Bonviva/Boniva]; Alendronate
Intervention description: 3mg intravenous (iv) injection every 3 months; 3mg intravenous (iv) infusion every 3 months; 70mg per oral (po) weekly
Intervention MeSH terms: Alendronate; Ibandronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 801.0
Sex: Female
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This 3 arm study will evaluate renal safety after administration of an intravenous (iv)
      injection or infusion of Bonviva, compared to oral alendronate, in patients with
      postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized
      to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months,
      or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12
      months, and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients, >=60 years of age;

          -  >=5 years postmenopausal;

          -  confirmed osteoporosis, at increased risk for renal disease.

        Exclusion Criteria:

          -  inability to stand or sit upright for 30 minutes;

          -  hypersensitivity to bisphosphonates;

          -  malignant disease (other than successfully resected basal cell cancer) within previous
             10 years, or breast cancer diagnosed within previous 20 years;

          -  previous administration of an i.v. bisphosphonate;

          -  oral bisphosphonate treatment other than study medication within 30 days prior to the
             baseline dosing visit and during the study;

          -  history of major upper gastrointestinal disease.
Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.
Condition: Pain, Acute
MeSH terms: Acute Pain
Intervention: Bupivacaine; Fentanyl
Intervention MeSH terms: Fentanyl; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior
      studies in labor epidurals have demonstrated that a programmed intermittent bolus application
      of local anesthesia can improve pain control by reducing the amount of local anesthetic
      required as well as improve patient satisfaction when compared to continuous epidural
      infusions. The effects of programmed intermittent bolus of epidural local anesthetics
      compared to continuous epidural infusions in a surgical setting have yet to be elucidated.
      Our goal is to evaluate the use of programmed intermittent bolus compared to continuous
      epidural infusion in a surgical patient population. We plan to enroll patients already
      undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology,
      urological where epidural anesthesia can be employed. The primary endpoints of the study will
      be the total local anesthetic consumption and total opioid consumption as surrogate markers
      for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional
      measurements, patient satisfaction, and incidence of hypotension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesia physical classification I - III, scheduled for surgery
             with anticipated an epidural anesthesia (including but not limited to colorectal,
             surgical oncology, urology, gynecology) as part of their perioperative treatment

        Exclusion Criteria:

          -  Age younger than 18 years of age, non-English speaking, contraindication for neuraxial
             anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to
             local anesthetic), preexisting neurologic deficits, inability to consent due to
             cognitive dysfunction, patients with pain numeric rating score > 5 each day for
             greater than 3 months, daily opioid consumption > 100 oral morphine equivalents for 14
             consecutive days prior to surgery, patient refusal.
Short Course Glucocorticoid Treatment for PTSD
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: prednisone; placebo
Intervention description: 20mg x 2 weeks; placebo
Intervention MeSH terms: Prednisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate if a 2-wk course of 20mg/day of oral prednisone
      in addition to standard care will result in reduced PTSD symptoms or symptom severity
      compared to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for
             PTSD w/ symptom exacerbation (CAPS score ≥ 50)

          -  Stable on other psychotropic meds x1 month

        Exclusion Criteria:

          -  Current or past history of bipolar, schizophrenic, or other psychotic disorder

          -  Organic mental disorder

          -  Alcohol or substance abuse in last 3 months

          -  Clinically significant hepatic or renal disease or other acute or unstable medical
             condition

          -  Chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes,
             rheumatologic diseases