bioihbjkbjnl/mcl2 huggingface dataset:
Brain GABA Levels and Treatment Response in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Escitalopram
Intervention description: Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: depression; biology

Summary:

      This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to
      treatment with escitalopram in people with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet diagnostic criteria for current Major Depressive Disorder

          -  Men or women aged 18-65

          -  Medication-free for one week prior to the start of the study

          -  Agrees to use an effective form of contraception throughout the study

        Exclusion Criteria:

          -  Anyone who is suicidal

          -  Pregnant or breastfeeding women

          -  Anyone with a serious or unstable medical illness, including cardiovascular, hepatic,
             renal, respiratory, endocrine, neurologic or hematologic disease

          -  Anyone with a history of seizure disorder or hypothyroidism

          -  Anyone with a history of psychiatric disorders including bipolar disorder,
             schizophrenia, psychoses, or substance abuse (including alcohol abuse active within
             the last 12 months)

          -  Anyone with a history of intolerance or multiple adverse drug reactions or allergy to
             (es)citalopram.

          -  Patients who are currently taking medications active on GABA, including
             benzodiazepines.
Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ropivacaine
Intervention description: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adductor canal block, nerve block

Summary:

      This is a randomized noninferiority interventional study to determine the equivalence of two
      adductor canal block (ACB) methods: mid-thigh and distal thigh in patients undergoing medial
      foot, medial ankle, or medial leg surgery. Sixty eight patients will be identified during
      their orthopedic presurgical clinic visit, anesthesia preoperative clinic visit or Day
      Surgery Unit (Zale Lipshy Hospital, Clements University Hospital, and University of Texas
      Southwestern Outpatient Surgery Center) for eligibility. Eligible individuals may be
      introduced to the study in the orthopedic presurgical clinic or the anesthesia preoperative
      clinic by staff. After consent patients will be randomized (break-seal method) to receive
      either a mid-thigh or distal thigh block using ropivacaine prior to foot, ankle, or leg
      surgery. The following measurements will be obtained to determine the change in sensory
      distribution: pinprick test with Neuropen, maximum voluntary isometric contraction before and
      after block, postoperative pain scores (24 hrs and at discharge) and postoperative opiate
      consumption.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 18 years or older

          -  Individuals undergoing surgery of the medial foot, medial ankle, or medial leg for
             which the anesthetic plan includes an adductor canal nerve block

        Exclusion Criteria:

          1. Any known deficit of the ipsilateral lumbar nerve roots, ipsilateral lumbar plexus,
             ipsilateral femoral nerve, obturator nerve or saphenous nerve including diabetic
             peripheral neuropathy

          2. Any local disorder of the skin or otherwise where blockade is to be performed

          3. Body mass index >50

          4. American Society of Anesthesiologists (ASA) classification greater than 3

          5. Allergy to amide local anesthetic medications

          6. Pregnancy

          7. Incarceration

          8. Inability to understand study procedures including inability to understand the English
             language
Moxifloxacin vs. Polytrim for Conjunctivitis
Condition: Conjunctivitis
MeSH terms: Conjunctivitis
Intervention: moxifloxacin; polytrim
Intervention description: 1-2 drops three times a day for 8-10 days.; 1-2 drops four times a day for 8-10 days.
Intervention MeSH terms: Moxifloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and
      Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications
      are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study
      will investigate if both of the medications are equally good.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1 - 18 years of age with presumed bacterial conjunctivitis.

        Exclusion Criteria:

          -  Previous antibiotics or to receive systemic antibiotic.
Examining the Effects of Antipsychotic Medications on Insulin Sensitivity
Condition: Diabetes
MeSH terms: Insulin Resistance
Intervention: Olanzapine; Aripiprazole
Intervention description: Single intramuscular 10-mg dose; Single intramuscular 9.75-mg dose
Intervention MeSH terms: Olanzapine; Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Insulin Resistance; Antipsychotic Medications

Summary:

      This study will examine the effects of two different antipsychotic medications on control of
      blood sugar in people who are at risk of diabetes but mentally healthy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prediabetic, defined as 2-hour post-load serum glucose between 140 and 199 mg/dl on a
             75-gram standard oral glucose tolerance test (OGTT) within the past 90 days

          -  Family history of type 2 diabetes mellitus

          -  Body mass index (BMI) between 25 and 35 kg/m2

          -  English speaker

          -  Nonsmoker

        Exclusion Criteria:

          -  History of Axis I mood, anxiety, or psychotic disorder, confirmed by Structured
             Clinical Interview for DSM-IV

          -  Use of psychotropic drugs
Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Memantine; Placebo
Intervention description: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.; Placebo distribution is planned to mimic the active drug.
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Major depressive disorder; Rehabilitating; Elderly; Apathy

Summary:

      This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes
      and preventing major depressive disorder in older adults who have been admitted to a
      rehabilitation hospital for a hip fracture or cardiopulmonary condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission to a skilled nursing facility for rehabilitation within 3 months of recent
             disabling medical event (e.g., hip fracture)

          -  Medically stable (e.g., no active seizures, delirium, unstable pulse/blood pressure)

        Exclusion Criteria:

          -  Aphasia or cognitive impairments sufficiently severe to prevent valid assessment
             (e.g., a score of less than 22 on the Mini Mental State Examination)

          -  Current major depressive episode

          -  History of or current psychosis or mania

          -  Current substance or alcohol abuse or dependence (within 3 months of study entry)

          -  Current use of memantine

          -  Sensitivity or contraindication to memantine

          -  End-stage kidney, liver, heart, or lung disease

          -  Recent hemorrhagic stroke

          -  A FIM score of greater than 70 (on a 91 point scale)
Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema
Condition: ACE Inhibitor-associated Angioedema
MeSH terms: Angioedema
Intervention: icatibant; Placebo
Intervention description: Subcutaneous at time 0 and 6 hours; Subcutaneous at time 0 and 6 hours
Intervention MeSH terms: Icatibant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ACE inhibitor; Angioedema; Bradykinin; Swelling

Summary:

      Individuals with heart disease or high blood pressure are often prescribed angiotensin
      converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors
      can be associated with angioedema, a rare but life-threatening condition that causes swelling
      of the face and other body parts. This study will evaluate the effectiveness of the drug
      HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the
      condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject has ongoing angioedema while taking an ACE inhibitor.

          -  The subject is between 18 and 80 years of age.

        Exclusion Criteria:

          -  The subject has had angioedema while not taking an ACE inhibitor.

          -  The subject's angioedema only involves the bowel.

          -  The subject is known to be pregnant or has a positive urine pregnancy test.

          -  The subject has started on an oral contraceptive within the last 6 months.
Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization
Condition: COVID; Coronavirus; Coronavirus Infection; AKI; Acute Kidney Injury
MeSH terms: Coronavirus Infections; Acute Kidney Injury; Wounds and Injuries
Intervention: Sodium bicarbonate; Standard of Care
Intervention description: Sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.; Standard of Care treatment
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 (control) will receive standard of care treatment for coronavirus according to institutional protocols.
Group 2 (treatment) will receive sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour.
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Kidney Injury; AKI; COVID-19; Coronavirus; Sodium Bicarbonate

Summary:

      Our overarching goal is to improve the outcomes of critically ill COVID-19 patients with or
      at risk for development of acute kidney injury (AKI). The objective of this study is to
      determine the role of a protocol to manage urine alkalization using a simple medication that
      has been used for a very long time, is safe, and without significant side-effects. We aim to
      determine the feasibility and safety of a urine alkalinization protocol for the prevention of
      AKI in patients testing positive for COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed COVID-19 positive

          -  Admission to ICU or step-down unit

          -  Age ≥ 18 years old

        Exclusion Criteria:

          -  Stage 3 AKI by KDIGO criteria

          -  CKD stage 4-5

          -  Contraindications to Na bicarbonate therapy (e.g. met. alkalosis, severe heart
             failure)

          -  Urine pH > 7.0
Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy
Condition: Chronic Hepatitis C; Genotype 1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Educational Intervention; Patient education and management skills training
Intervention description: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.; Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Peginterferon alfa-2b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV; Genotype1; Naive; Partial responder; Relapser

Summary:

      The purpose of this study is to evaluate the impact of a physician directed education program
      on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated
      interferon, ribavirin and boceprevir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic Hepatitis C (HCV) genotype 1

          -  Detectable HCV-RNA within 180 days of screening

          -  Age ≥ 18 years

          -  Weight > 40 kg

          -  Patient and partner(s) must agree to use acceptable methods of contraception

          -  Written informed consent

        Exclusion Criteria:

          -  Known co-infection with HIV or HBV

          -  Previous interferon or ribavirin regimen requiring discontinuation for an adverse
             event considered related to ribavirin and/or interferon

          -  Currently taking or planning on taking any prohibited medications

          -  Evidence of decompensated liver disease including the presence of clinical ascites,
             bleeding varices, or hepatic encephalopathy

          -  Diabetes and/or hypertension with clinically significant ocular examination findings

          -  Pre-existing psychiatric condition(s)

          -  History of severe and uncontrolled psychiatric disorders

          -  Active alcohol or drug abuse (not including marijuana)

          -  Pre-existing medical condition that could interfere with the patient's participation
             in the study

          -  Chronic obstructive pulmonary disease

          -  Abnormal lab values
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera/Rituxan]; methotrexate
Intervention description: 1000mg iv on days 1 and 15; 10-25mg weekly
Intervention MeSH terms: Rituximab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of MabThera in patients with active
      rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with
      methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on
      days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly).
      After the initial study period of 24 weeks, eligible patients may receive up to 3
      re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the
      target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  receiving out-patient treatment;

          -  experienced an inadequate response to previous or current treatment with methotrexate.

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than RA, or significant systemic involvement
             secondary to RA;

          -  history of, or current, inflammatory joint disease other than RA;

          -  previous treatment with any cell-depleting therapies.
A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic
Condition: Schizophrenia; Schizoaffective Disorder; First Episode Psychosis
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Intervention: Digital Medicine System; Aripiprazole; Olanzapine; Quetiapine; Risperidone
Intervention description: DMS components: a CoE product consisting of an approved antipsychotic medicinal product co-encapsulated with Conformité Européenne (CE)-marked miniature ingestible event marker in tablet; a CE-marked compatible medical device (a Proteus Patch [Disposable Wearable Sensor Version 5]); proprietary medical software (a local and remote computing application).; Dosage determined by the healthcare professionals.; Dosage determined by the healthcare professionals.; Dosage determined by the healthcare professionals.; Dosage determined by the healthcare professionals.
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Digital Medicine System

Summary:

      Digital medicine systems (DMS) have been designed to assist individuals with the management
      of their daily health, wellness, and medication use. The DMS is being developed as a
      healthcare management tool to precisely measure medication adherence and to potentially
      enhance adherence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant was prescribed aripiprazole, olanzapine, quetiapine, or risperidone.

          -  Participant possessed a smartphone, or a smartphone provided by the Sponsor, and was
             willing to download and interact with the DMS app.

          -  Skin on the anterior chest just above the lower edge of the rib cage was free of any
             dermatological problems (for example, open wounds, warts, rashes, atopic dermatitis).

        Exclusion Criteria:

          -  Participant with a known allergy to adhesive tape or any pertinent components of the
             patch or CoE product.

          -  Prisoners could not be enrolled into this trial.

          -  Participant who was hospitalized due to mental or physical illness (inpatient) at the
             time of screening/baseline.

          -  Any participant who, through religious or lifestyle choices, would not take gelatin
             capsules.

          -  Female of childbearing potential who was breast-feeding and/or who had a positive
             pregnancy test result prior to receiving trial enrollment, or who planned to become
             pregnancy during the trial.
PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Calcitriol 3 mcg/g ointment
Intervention description: Topical ointment; twice daily application
Intervention MeSH terms: Calcitriol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the calcitriol absorption in pediatric subjects
      is comparable to that in adults and adolescents, with no significant impact on
      calcium/phosphorus metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female pediatric subjects, 2 to 12 years of age inclusive at screening

          -  Clinical diagnosis of plaque type psoriasis involving 3% through 35% body surface area
             at screening and baseline (excluding face and scalp)

        Exclusion Criteria:

          -  Subjects with guttate or pustular psoriasis, erythrodermic psoriasis or active
             infection

          -  Vitamin D deficiency at screening

          -  Subjects with hypercalcemia and out of range urinary calcium/creatinine ratio at
             screening

          -  Subjects with secondary hyperparathyroidism at screening