bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: LUM/IVA; Placebo
Intervention MeSH terms: Ivacaftor
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in
      subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.
      This study is designed to evaluate the effect of LUM/IVA on exercise tolerance in subjects
      with CF, homozygous for the F508del-CFTR mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Homozygous for the F508del-CFTR mutation

          -  Confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative
             pilocarpine iontophoresis

          -  Stable CF disease as judged by the investigator

          -  Forced expiratory volume in 1 second (FEV1) at least 40% and not greater than 90% of
             predicted

        Exclusion Criteria:

          -  History of any comorbidity that might confound the results of the study, interfere
             with the use of cardiopulmonary exercise tests (CPETs) as an assessment, or pose an
             additional risk in administering study drug to the subject

          -  Any previous exposure to LUM or IVA

          -  History of cardiac arrhythmia, ischemic heart disease, congestive heart failure, or
             other clinically significant cardiac condition, or medical condition requiring chronic
             use of a beta blocker, non-dihydropyridine calcium channel blocker, or other cardiac
             medication known to affect exercise tolerance

          -  History of solid organ or hematological transplantation

          -  For subjects under 18 years of age at Screening, except those who have had bilateral
             lens removal, selected findings on a screening ophthalmologic examination will be
             exclusionary

          -  Using or expected to require any concomitant medication that is prohibited in this
             study

          -  History of alcohol or drug abuse, as deemed by the investigator, in the past year,
             including but not limited to cannabis, cocaine, and opiates

          -  Participation in an investigational drug study within 30 days before the Screening
             Visit

          -  Pregnant or nursing females; males with a female partner who is pregnant or nursing

          -  Colonization with organisms associated with a more rapid decline in pulmonary status
Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test
Condition: Skin Irritation
Intervention: Facial Moisturizer with SPF 50+
Intervention description: All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cetaphil Daily Facial Moisturizer with SPF 50+; Hypoallergenicity; Skin Irritation

Summary:

      This study examined the possible sensitization and irritation effects of a moisturizer with
      sunscreen SPF 50+.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18 to 70 years of age in general good health

          -  Can read, understand, and sign informed consent

        Exclusion Criteria:

          -  History of acute or chronic disease

          -  Diagnosed with chronic skin allergies

          -  Pregnant or lactating
Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block
Condition: ACL Surgery
Intervention: ACB within true AC with bupivacaine 0.5% 20cc; ACB proximal to true AC with bupivacaine 0.5% 20cc
Intervention description: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.; Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a prospective, randomized, single blinded trial involving human subjects. The goal of
      this study is to determine an optimal location (proximal or distal) for the nerve block and
      whether it will make a difference in how much opioid the patient will receive during and
      after surgery. Ultrasound will identify the adductor canal and the proximal end of the
      adductor canal/apex of the femoral triangle to determine the location of the blocks.

      Their will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB
      proximal to true AC with bupivacaine 0.5% 20cc
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing unilateral, ACL surgery with allograft.

          -  Patients who consent to be randomized.

          -  Patients must be English proficient.

        Exclusion Criteria:

          -  Patients younger than 18 or older than 75 years of age;

          -  Patients with a history of chronic pain or who are taking medications intended to
             treat chronic pain such as strong opioids;

          -  Patients with history of neurologic disorder that can interfere with pain sensation;

          -  Patients with a history of drug or alcohol abuse;

          -  Patients who are unable to understand or follow instructions;

          -  Patients with an allergy or a contraindication to any of the medications used in the
             study, or patients with a contraindication to any of the study procedures;

          -  Patients with severe liver disease, renal insufficiency, congestive heart failure,
             and/ or significant heart disease;

          -  Patients with a BMI over 42;

          -  Any patient that the investigators feel cannot comply with all study related
             procedures.

          -  Patients who do not tolerate Percocet.
Ultrasound Evaluation of Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: Sulfur Hexafluoride; Ultrasound Elastography; Ultrasound Vascularity; Magnetic Resonance Enterography (MRE)
Intervention description: Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.; Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.; Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.; Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the effectiveness of a new ultrasound technology for
      evaluating Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

        - Crohn's disease patients with involvement of terminal ileum (thickness > 3mm).

        Exclusion Criteria:

          -  Patients with change of medicine or going to surgery over the 6-months follow-up
             period.

          -  Patients with unreliable ultrasound images due to conditions such as large body
             habitus or poor ultrasound imaging window.

          -  Adults lacking capacity to consent.

          -  Vulnerable subjects such as prisoners.

          -  Pregnant women and nursing mothers.

          -  Patients with known or suspected right-to-left, bi-directional, or transient
             right-to-left cardiac shunts.

          -  Patients with history of hypersensitivity allergic reactions to ultrasound contrast
             agents.
The Effect of Ketamine on the Length of Hospital Stay of Patients Hospitalized With Suicidal Ideation.
Condition: Suicidal Ideation
MeSH terms: Suicidal Ideation
Intervention: Ketamine; Normal Saline
Intervention description: IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.; IV infusion of 100 ml of normal saline over 45 minutes.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: ketamine; suicidal ideation; length of stay

Summary:

      This study will evaluate the effect of ketamine on the treatment of patients hospitalized
      with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein.
      The other half will receive a placebo. Because we think that ketamine will improve depression
      and suicidal thoughts, we expect that patients who receive ketamine will require less time in
      the hospital than patients who receive placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women between the ages of 18 and 64

          2. Patients admitted to the University of Mississippi Medical Center inpatient psychiatry
             service with suicidal ideations

        Exclusion Criteria:

          1. Lifetime history of schizophrenia or other primary psychotic disorder

          2. Current psychotic or manic symptoms

          3. Substance use disorder within one month of admission

          4. Positive urine toxicology at admission

          5. Any lifetime abuse of ketamine or phencyclidine

          6. Systolic BP >180 mmHg or diastolic BP >110 mmHg

          7. Any patient who has eaten food within 8 hours prior to receiving the ketamine infusion
             or who has drank clear liquids within 2 hours prior to receiving the infusion

          8. Known central nervous system (CNS) mass

          9. CNS abnormalities

         10. Hydrocephalus

         11. Glaucoma

         12. Acute globe injury

         13. Porphyria

         14. Untreated thyroid disease

         15. Known coronary artery disease with poor functional capacity

         16. Pregnancy

         17. Currently breast-feeding
Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics- the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics
Condition: Insulin Secretion; Insulin Resistance
MeSH terms: Insulin Resistance
Intervention: Sitagliptin
Intervention description: Sitagliptin 100 mg QD for 12 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 25 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: glucagon; dipeptidyl peptidase-4 inhibitor

Summary:

      1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon
           release and improve glucose control in Chinese type 2 diabetic.

        2. There are different effects of Sitagliptin therapy on blood glucose regulation,
           pancreatic alpha & beta cell function are different in lean (BMI<25) and overweight
           (BMI>25) Chinese type 2 diabetics.

        3. The purpose of this study is to determine whether glucagon release may contribute over
           30% to the hyperglycemia in Chinese type 2 diabetics.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age: 25~60 years

          2. Duration of disease < 3 years,no drug treatment for diabetes

          3. Newly diagnosed type 2 diabetic patients (fasting plasma glucose > 7.0mmol/L or/and 2h
             postprandial blood glucose>11.1mmol/L WHO 1999)

          4. Fasting plasma glucose < 10 mmol/L

        Exclusion Criteria:

          1. Type 1 diabetes

          2. DKA, infection and other stress status

          3. Autoimmune disease

          4. Hepatic and renal diseases
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: colesevelam HCl; placebo
Intervention description: Tablets; Matching Tablets
Intervention MeSH terms: Colesevelam Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 194.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric; hypercholesterolemia; colesevelam

Summary:

      This study will evaluate the lipid-lowering effect and safety of colesevelam therapy
      administered to heterozygous familial pediatric patients 10 through 17 years of age who are
      on a stable dose of a pediatric-approved statin monotherapy (atorvastatin, lovastatin,
      simvastatin or pravastatin), or who are treatment naive to lipid-lowering therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients

          -  Ages 10 to 17 years inclusive

          -  Diagnosis of heterozygous familial hypercholesterolemia

          -  On a stable dose of statin monotherapy or are treatment naive to lipid- lowering
             agents

          -  On a low-cholesterol diet

        Exclusion Criteria:

          -  Patients should not have serious concomitant conditions that could interfere with the
             analysis of the results or that could interfere with the well-being of the patients
Liver Safety Under Upfront Arimidex vs Tamoxifen
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Anastrozole; Tamoxifen
Intervention description: 1 mg once daily oral dose; 20 mg once daily oral dose
Intervention MeSH terms: Tamoxifen; Anastrozole
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 384.0
Sex: Female
Healthy volunteers: No
Keywords: Early Breast cancer; adjuvant therapy; hormone receptor; hormonal therapy; anastrozole; tamoxifen

Summary:

      The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20
      mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.

      The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20
      mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test,
      and time to treatment failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven HR+ invasive breast cancer

          -  Completed all primary surgery and chemotherapy (if given), and were candidates to
             receive hormonal adjuvant therapy

          -  Postmenopausal woman

        Exclusion Criteria:

          -  clinical evidence of metastatic disease

          -  previous adjuvant hormonal therapy for breast cancer

          -  liver diseases
CNS Study of Patients Switching From Tacrolimus to Envarsus
Condition: Renal Transplant Patients
Intervention: Envarsus XR
Intervention description: Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pilot study documenting the neurotoxic side effects including tremors in patients
      with a stable graft who are receiving Tacrolimus following kidney transplantation. A
      standardized questionnaire will be used to document these symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplant recipients with stable graft function.

          -  More than 1 months post-transplant.

          -  18+ years of age with some CNS problems secondary to Prograf (tacrolimus).

        Exclusion Criteria:

          -  Multi-organ patients (kidney/pancreas, kidney/liver).

          -  Evidence of graft rejection or treatment of acute rejection within 14 days prior to
             baseline visit.

          -  Inability to self-administer the QOL questionnaires.
Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorders
MeSH terms: Dyssomnias; Parasomnias; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Eszopiclone
Intervention description: The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
Intervention MeSH terms: Eszopiclone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: PTSD; Sleep disturbance; Eszopiclone; Double-blind; Crossover

Summary:

      The purpose of this study is to obtain data investigating the safety and efficacy of
      eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep
      disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine
      correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more
      effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in
      sleep will be associated with improvement in overall PTSD symptoms, and patients with
      PTSD-related sleep disturbances will have abnormal levels of stress hormones.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients 18-64 years of age with a primary diagnosis of PTSD as
             defined by DSM-IV criteria with associated sleep disturbance

        Exclusion Criteria:

          -  Pregnant women, lactating women, and women of childbearing potential who are not using
             medically accepted forms of contraception.

          -  Concurrent use of other psychotropic medications, other than antidepressants at stable
             dose for at least 4 weeks prior to randomization

          -  Serious medical illness or instability

          -  Seizure disorders with the exception of a history of febrile seizures if they occurred
             during childhood

          -  Concurrent psychotherapy initiated within one month of randomization or ongoing
             psychotherapy of any duration directed specifically toward treatment of PTSD and/or
             sleep disturbance

          -  Diagnosis of schizophrenia, mental retardation, OCD, organic medical disorders or
             bipolar disorder, eating disorders in the past 6 months, alcohol or substance abuse in
             the past 3 months, or dependence within the past 6 months.

          -  Patients with significant suicidal ideation or who have enacted suicidal behaviors
             within 6 months prior to intake
The Laparotomy Study
Condition: Gastrointestinal Cancer
MeSH terms: Gastrointestinal Neoplasms
Intervention: Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).; Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Intervention MeSH terms: Rocuronium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between
      optimal surgical conditions and the risk of postoperative residual blockade.

      The aim of the study is to investigate if intense NMB improves surgical conditions during
      operation in patients scheduled for elective open upper abdominal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients > 18 years old

          -  Elective open upper abdominal surgery

          -  Can read and understand Danish

          -  Informed consent

        Exclusion Criteria:

          -  Known allergy to rocuronium or sugammadex

          -  Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or
             hemodialysis

          -  Neuromuscular disease that may interfere with neuromuscular data

          -  Abdominal mesh with size larger than 5*5 cm

          -  Lactating or pregnant