bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Galantamine Treatment on Attention in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Galantamine
Intervention description: Orally administered Galantamine 8 mg/day for the first 4 weeks. Thereafter the dose will be increased to 16 mg/day. If tolerated, the dose of galantamine can be increased up to 24 mg/day.
Intervention MeSH terms: Galantamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; Galantamine; Dementia

Summary:

      This study will examine whether the administration of galantamine is effective for
      improvement of attention and more effective for patients with serious disturbance of
      attention by administering galantamine to patients with Alzheimer's dementia and performing
      an attention test on baseline, week 4 and 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Alzheimer's disease according to the criteria of DSM-IV, NINCDS-ADRDA

          -  K-MMSE (Korean - Mini Mental State Exam) is 10 to 24

          -  Reliable Guardian available to the patients

          -  Patient or guardian provided written informed consent before entering into the
             clinical trial

        Exclusion Criteria:

          -  Acetylcholine esterase inhibitors used to treat dementia taken within 30 days of the
             beginning in this clinical trial

          -  Neurodegenerative diseases (eg Parkinson's disease, Pick's disease, Huntington's
             disease, Down syndrome)

          -  Dementia related to head trauma and dementia related to brain damage due to cerebral
             hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain
             damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due
             to shock)

          -  brain tumor, nerve syphilis, meningitis, encephalitis

          -  epilepsy
Effects of Thiazide Diuretics on Sympathetic Nervous System in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Study#1: chlorthalidone (CTD), titrated dose; Study #1: spironolactone (SP), titrated dose; Study# 2 chlorthalidone (CTD), fixed dose; Study# 2 spironolactone (SP), fixed dose; Study# 2 irbsesartan (IR), fixed dose
Intervention description: Participants in study #1 will receive 3 months of chlorthalidone (12.5-25 mg/d) at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg; Participants in study #1 will receive 3 months spironolactone (25-75 mg/d), at the dose titrated to achieve 24-h ambulatory BP < 130/80 mmHg.; Participants in study #2 will receive 3 months of fixed-dose of CTD, at 25 mg/d.; Participants in study #2 will receive 3 months of fixed-dose SP at 25 mg daily.; Participants in study #2 will receive 3 months of fixed-dose IR at150 mg daily.
Intervention MeSH terms: Chlorthalidone; Spironolactone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Masking description: Capsule was made to appear identical in appearance so that subjects are blinded to treatment assigned.
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Blood Pressure, High

Summary:

      Thiazide medications are often prescribed for individuals with high blood pressure, but
      research has shown that they may increase an individual's risk of developing diabetes. While
      it is unknown exactly how thiazide causes this response, it is likely that the nervous system
      is somehow involved. This study will evaluate the role of the nervous system in sugar
      metabolism, as well as determine the effect of thiazide and other medications on individuals
      with high blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Untreated stage 1 primary hypertension (systolic blood pressure between 140 to 159 mm
             Hg and diastolic blood pressure between 90 to 99 mm Hg)

        Exclusion Criteria:

          -  Cardiopulmonary disease, as determined by medical history or by physical examination

          -  Serum creatinine greater than or equal to 1.5 mg/dL

          -  Diabetes mellitus or other systemic illness

          -  Left ventricular hypertrophy by echocardiography or ECG

          -  Hypersensitivity to chlorthalidone, spironolactone, eplerenone, angiotensin converting
             enzyme (ACE) inhibitors, angiotensin receptor blocker, insulin, Evans blue dye, or
             clonidine

          -  History of substance abuse (other than tobacco)

          -  History of gouty arthritis

          -  History of ACE inhibitor-induced cough or angioedema

          -  Evidence of secondary hypertension

          -  Pregnant
Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Memantine; Placebo
Intervention description: Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.; No active medication, only placebo
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar; Depression; Incomplete Response

Summary:

      The purpose of this study is to investigate whether addition of memantine to bipolar
      depression patients who have had an incomplete response to lamotrigine (Lamictal) which is
      frequently used to treat bipolar depression in the clinical setting. At present, memantine is
      approved for use in the treatment of Alzheimer's disease or dementia, but not for use for the
      treatment of bipolar depression. Subjects will be asked to participate because they are
      suffering from bipolar depression associated and have had an inadequate response to
      lamotrigine. Subjects will have to be on at least 100 mg per day, for at least 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:: 1) age 18 - 65; 2) satisfy DSM-IV-TR criteria for Bipolar Disorder and
        Major Depressive Episode; 3) Lamotrigine Inadequate-Response: Defined as already treated
        with at least 100 mg of lamotrigine for at least 4 weeks but 17 item HDRS rating > 15; 4)
        give informed consent as approved by local IRB; 5) if on other antidepressants or mood
        stabilizers on stable dose for the past 4 weeks.

        Exclusion Criteria:1) comorbid psychotic disorder such as schizophrenia or schizoaffective
        disorder; 2) significant suicidal or homicidal risk; 3) clinically significant medical
        illness; 4) allergy or intolerance to lamotrigine or memantine; 5) pregnancy, planning to
        be pregnant or not using adequate contraception; 6) satisfy criteria for substance
        dependence within 6 months prior to start of the study; and 7) on any medication with
        significant adverse interaction with either lamotrigine or memantine.
Effect of Vitamin D Supplementation on Muscle Mass and Function
Condition: Obesity; Insulin Resistance; Inflammation
MeSH terms: Insulin Resistance; Inflammation
Intervention: Vitamin D; Placebo
Intervention description: 4000 IU of vitamin D per day for 12 weeks.; Placebo (microcrystalline cellulose) ingestion each day for 12 weeks.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 25-hydroxyvitamin D; Parathyroid hormone; Lean mass; Muscular strength; Glucose tolerance

Summary:

      The study was designed to assess the effects of vitamin D supplementation during exercise
      training on body composition, muscle function, and glucose tolerance. The investigators
      hypothesis for these studies is that vitamin D supplementation enhances exercise-induced
      increases in strength and lean mass, potentially through enhancing insulin sensitivity and
      reducing inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physical activity scores in the "low" to "very low" category

          -  Fitness estimations in the "below average" or lower categories

          -  body mass index scores >24.9 indicating overweight or obesity.

        Exclusion Criteria:

          -  Use of tanning booths or other artificial UV light exposure

          -  High baseline vitamin D and calcium intake

          -  Plans to visit sunny/warm destinations during the winter months/study period

          -  History or presence of metabolic disease, type 2 diabetes, eating disorders,
             gastrointestinal disorders, pregnancy or lactation

          -  Use of drugs to treat obesity (last 12 weeks)

          -  Use of over the counter anti-obesity agents (last 12 weeks)

          -  Recent initiation of an exercise program (last four weeks).
Digital Auscultation Test - IPF Data Collection
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Littmann ®
Intervention description: electronic stethoscope
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 274.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The aim of this study is the data collection for patients with IPF and symptom matched
      controls to create a database of lung auscultation sounds and basic patient characteristics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients

          -  Age ≥ 45 years at the day of the study visit

          -  Diagnosis:

               -  For patients with confirmed Idiopathic Pulmonary Fibrosis (IPF) diagnosis - a
                  clinical diagnosis of IPF within the last 24 months from the day of the study
                  visit, according to the American Thoracic Society (ATS)/ European Respiratory
                  Society (ERS) 2011 guideline [P11-07084] or

               -  For the symptom matched control - patients without a IPF diagnosis but with one
                  of the confirmed current conditions as:

                    -  asthma diagnosed according to GINA guidelines,

                    -  COPD diagnosed according to GOLD guidelines,

                         -  pneumonia,

                         -  upper respiratory tract infection, or

                         -  acute bronchitis.

          -  Signed and dated written informed consent in accordance with Good Clinical Practice
             (GCP) and local legislation prior to admission to the study

        Exclusion Criteria:

          -  Any other current respiratory condition other than the pulmonary disease which
             qualified the patient eligibility based on inclusion criterion 3

          -  Any condition, according to investigator's assessment, which will not allow the
             patient to comply with protocol assessments or need a legal representative

          -  Patients with a history of lobectomy, pneumonectomy or lung transplant

          -  Patients with a Body Mass Index (BMI) >30,0 kg/m²

          -  Previous enrolment in this study

          -  Women who are pregnant
Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
Condition: Tourniquet Hypertension; Intraoperative Hypertension; Total Ankle Arthroplasty; Ankle Fusion
MeSH terms: Hypertension
Intervention: Mepivacaine; Perifemoral Injection of Local Anesthetic; Saline
Intervention description: An ultrasound guided injection of mepivacaine superomedially to the femoral artery.; An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.; An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
Intervention MeSH terms: Anesthetics; Mepivacaine; Anesthetics, Local
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Perifemoral; Tourniquet; Mepivacaine; Tourniquet Hypertension

Summary:

      The purpose of this prospective randomized double-blind study is to determine if the novel
      technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral
      artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet
      time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be
      randomized 1:1 to receive either local anesthetic or saline, which will be injected
      superomedially to the femoral artery in an attempt to block sympathetic afferents and
      decrease tourniquet associated hypertension intraoperatively.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients that will be included in the study are English speaking 18-75 year old ASA 1-3
        patients undergoing total ankle arthroplasty.

        Exclusion Criteria:

          1. ASA 4 or 5

          2. Diagnosis of chronic pain

          3. Daily chronic opioid use (over 3 months of continuous opioid use).

          4. Inability to communicate pain scores or need for analgesia.

          5. Infection at the site of block placement

          6. Age under 18 years old or greater than 75 years old

          7. Pregnant women (as determined by standard of care day-of surgery urine bHCG)

          8. Intolerance/allergy to local anesthetics

          9. Weight <50 kg

         10. Suspected, or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years.

         11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the investigator, may interfere with study assessments or compliance.

         12. Current or historical evidence of any clinically significant disease or condition
             that, in the opinion of the investigator, may increase the risk of surgery or
             complicate the subject's postoperative course
Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Desvenlafaxine Succinate Sustained Release; Midazolam
Intervention description: 50 mg DVS SR tablet days 1-6, period 2 only.; 4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.
Intervention MeSH terms: Midazolam; Desvenlafaxine Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: depression

Summary:

      The main purpose of this study is to evaluate the effect of desvenlafaxine administered as
      DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount
      of drug in the body and the effect of the drug will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or non-pregnant, non-lactating women, 18 to 55 years of age inclusive at
             screening.

          -  Healthy as determined by the investigator on the basis of medical history, physical
             examination, clinical laboratory test results, vital signs, and 12-lead
             electrocardiogram (ECG).

          -  Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
             Ilbs).

        Exclusion Criteria:

          -  Presence or history of any significant cardiovascular, hepatic, renal, respiratory,
             gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or
             psychiatric disease.

          -  Presence or history of glaucoma or intraocular pressure.

          -  Any surgical or medical condition that may interfere with the absorption,
             distribution, metabolism, or excretion of the investigational product.

          -  Allergy to midazolam, other benzodiazepine, desvenlafaxine, or venlafaxine.

          -  Acute disease state (eg, nausea, vomiting, fever, or diarrhea) with 7 days before
             study day 1.

          -  Admitted alcohol abuse or history of alcohol use that may interfere with the subject's
             ability to comply with the protocol requirements. History of drug abuse within 1 year
             before study day 1.
Overnight Pain Treatment Investigating Opioids vs. Nonopioids
Condition: Abortion Second Trimester
Intervention: Ibuprofen 600 mg; OxyCODONE 5 Mg Oral Tablet
Intervention description: Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.; Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain.
Intervention MeSH terms: Ibuprofen; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare maximum pain scores between patients seeking induced
      abortion and requiring cervical preparation with osmotic dilators. Patients will be
      randomized to receive prescription for ibuprofen alone or to receive prescription for
      ibuprofen + oxycodone for overnight pain management after cervical preparation with osmotic
      dilators. Data collected in-person and through a text-messaging platform.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English-speaking women

          -  18 years or older

          -  Access to cell phone with text-messaging capability/data

          -  Receiving cervical preparation for induced abortion

          -  Able to complete baseline survey on smartphone/tablet at screening visit

        Exclusion Criteria:

          -  History of opioid or alcohol abuse

          -  Contraindications or allergy to ibuprofen

          -  Contraindications or allergy opioid medications

          -  Seeking uterine evacuation for premature preterm rupture of membranes or advanced -
             cervical dilation or intrauterine fetal demise
The Effects of BAK on the Blood Aqueous Barrier of Pseudophakic Patients
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Intervention: Hydroxypropylmethylcellulose; Carboxymethylcellulose
Intervention description: 22 patients will receive this lubricating drop 4 times a day for 1 month; 22 patients will receive this lubricating drop 4 times a day for 1 month.
Intervention MeSH terms: Carboxymethylcellulose Sodium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dry eye; pseudophakia; cornea; lubricating drop; BAK; blood aqueous barrier; blood-retina barrier

Summary:

      BAK is one of the most frequent preservatives in eye drops. BAK is a quaternary ammonium salt
      with surfactant qualities. It can be bacteriostatic or bactericidal depending on the
      concentrations used. It has been shown to be effective against most bacteria with a few
      exceptions, such as Pseudomonas aeruginosa, or picornaviruses. It as been widely used in
      eyedrops, nose sprays, hand and face washes, mouthwashes, spermicidal creams, and in various
      other cleaners, sanitizers, and disinfectants. BAK gained popularity when it was first
      introduced because it also enhances corneal penetration of some drugs by causing epithelial
      separation.

      It is present in several ophthalmic formulations, including most of the antiglaucoma
      medications. If used chronically, BAK has been found to cause ocular surface changes, such as
      dry eye and punctuate keratitis. BAK has also been suggested to promote a break in the blood
      aqueous barrier, which may lead to undesirable consequences, such as uveitis and cystoid
      macular edema. However, this information is controversial. The purpose of this study is to
      evaluate the consequences of BAK on the blood-retinal and blood-aqueous barriers of
      pseudophakic patients receiving BAK-preserved lubricating drops.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pseudophakic eyes that underwent cataract surgery at least 6 months before.

        Exclusion Criteria:

          -  Use of any eyedrop.

          -  Other conditions associated with a break in the blood-aqueous or blood retina barrier
             (ie diabetes, ARMD, vasculitis, uveitis)

          -  Previous history of cystoid macular edema.

          -  Previous ocular surgery other than cataract surgery.