bioihbjkbjnl/mcl2 huggingface dataset:
Metformin in Longevity Study (MILES).
Condition: Aging
Intervention: Metformin; Placebo
Intervention description: To determine if treatment with metformin (1700 mg/day) will restore the gene expression profile of older, glucose intolerant adults to that of young healthy subjects.; there is no other name we used for the placebo
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: aging; metformin; prediabetes

Summary:

      Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known
      beneficial effects on glucose metabolism. Evidence from animal models and in vitro studies
      suggest that in addition to its effects on glucose metabolism, metformin may influence
      metabolic and cellular processes associated with the development of age-related conditions,
      such as inflammation, oxidative damage, diminished autophagy, cell senescence and apoptosis.
      As such, metformin is of particular interest in clinical translational research in aging
      since it may influence fundamental aging factors that underlie multiple age-related
      conditions. The investigators therefore propose a pilot study to examine the effect of
      metformin treatment on the biology of aging in humans. Namely, whether treatment with
      metformin will restore the gene expression profile of older adults with impaired glucose
      tolerance (IGT) to that of young healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women;

          2. age >60 years with IGT based on 75g OGTT (fasting plasma glucose < 126 mg/dl, 2-hr
             glucose between 140 - 199 mg/dl);

          3. this definition of IGT will include individuals with combined impaired fasting glucose
             (IFG) and IGT.

        The investigators chose these inclusion criteria in order to study subjects who have
        evidence of impaired glucose regulation, but are not yet diabetic.

        Exclusion Criteria:

          1. Serious chronic or acute illness: cancer, clinically significant congestive heart
             failure, COPD, inflammatory conditions, serum creatinine > 1.4 mg/dl (female) or > 1.5
             mg/dl (male), active liver disease, history of metabolic acidosis, poorly controlled
             hypertension, epilepsy, recent (within 3 months) CVD event (MI, PTCA, CABG, stroke);
             history of bariatric or other gastric surgery, cigarette smoking, binge alcohol use
             (>7 drinks in 24 hrs).

          2. Treatment with drugs known to influence glucose metabolism (other diabetes
             medications, systemic glucocorticoids, pharmacologic doses of niacin)

          3. Hypersensitivity to metformin or any component of the formulation
Ethnic Differences in Response to Topical Capsaicin: A Psychophysical Study on Healthy Subjects
Condition: Healthy
Intervention: Capsaicin; Placebo moisturizing cream
Intervention description: Topical application, 0.1%, Capzasin HP; Chattem Inc., Chattanooga, TN, U.S.A; Placebo moisturizing cream with no active ingredient (Cetaphil; Galderma Laboratories LP, Fort Worth, TX, U.S.A.)
Intervention MeSH terms: Capsaicin
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers

Summary:

      The purpose of this research is to study how people respond differently to capsaicin in
      different racial groups and the effect it has on your pain levels. Capsaicin is a natural
      product made from hot chili peppers that is useful for treating the itch symptoms of skin
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men and women who are between 18 and 50 years of age.

          -  Subjects must be in general good health with no skin disease, disease state or
             physical condition which would impair evaluation of pain perception or which would
             increase their health risk by study participation as determined by the investigators.

          -  Women of childbearing potential will be required to have a negative pregnancy test in
             order to enroll in the study.

        Exclusion Criteria:

          -  Adults over age 50.

          -  Children less than 18 years of age.

          -  Unable to complete the required measures.

          -  Diagnosis of diseases that would affect the measurement of pain perception.

          -  Currently enrolled in any investigational study in which the subject is receiving any
             type of drug, biologic, or non-drug therapy and subjects undergoing treatment with
             another investigational drug or approved therapy for investigational use within 30
             days prior to study participation.

          -  Use of oral analgesic or other medications known to interfere with pain perception in
             the week prior to the study.

          -  Use of emollient on the forearms on the day of the study visit.

          -  Use of medicated topical preparations on the forearms for the week prior to the study.

          -  Known history of neuropathy causing diseases such as uremia.

          -  Known history of uncontrolled thyroid disease.

          -  Known history of diabetes mellitus.

          -  Allergy to capsaicin.

          -  Pregnant women.
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
Condition: Intercritical Gout
MeSH terms: Gout
Intervention: Colchicine (Colcrys®); placebo; allopurinol
Intervention description: daily 0.6 mg colchicine dosing for 16 weeks; daily placebo dosing for 16 weeks; background therapy
Intervention MeSH terms: Colchicine; Allopurinol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Gout

Summary:

      The purpose of this study is to determine if once-daily treatment with colchicine, compared
      to placebo, is effective in preventing gout flares in patients who are initiating therapy
      with allopurinol.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criteria include, but are not limited to the following:

          1. Men and postmenopausal women between the ages of 18 and 70

          2. Meets the ARA criteria for classification of acute gout

          3. Tophi present and/or a history of gout attacks in 2 or 3 joints

          4. Self-reported history of at least 2 gout flares in the prior 12 months

          5. Serum uric acid greater than or equal to 7.5 mg/dL at the first visit

        Exclusion Criteria:

        Exclusion criteria include, but are not limited to the following:

          1. Patients with an acute gout flare within 2 weeks prior to the first visit

          2. Patients with chronic, active gout with at least 1 continuously inflamed joint for at
             least 4 weeks

          3. Patients with more than three joints affected by gout

          4. History of intolerance or allergy to colchicine or allopurinol

          5. Use of allopurinol, benzbromarone, febuxostat, probenecid, or sulfinpyrazone less than
             3 months prior to entering the study

          6. Use of colchicine less than 14 days prior to entering the study
Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: bimatoprost 0.01%; travoprost 0.004%; timolol 0.5%; hypromellose 0.3%
Intervention description: Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.; Travoprost 0.004% administered to both eyes once daily for 12 weeks.; Timolol 0.5% administered to both eyes once daily for 12 weeks.; Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
Intervention MeSH terms: Timolol; Bimatoprost; Travoprost
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared
      to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel forming
      solution) in patients who require IOP lowering therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular hypertension or glaucoma that requires treatment with medication

          -  Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

        Exclusion Criteria:

          -  History of LASIK, LASEK, RK, and/or PRK in the study eye(s)

          -  History of any intraocular surgery or glaucoma laser surgery in the study eye(s)
             within 3 months

          -  Use of topical, periorbital, intravitreal or systemic steroid within 3 months or
             expected use during the course of study
Dexmedetomidine to Prevent Agitation After Free Flap Surgery
Condition: Agitation; Delirium
MeSH terms: Delirium; Psychomotor Agitation
Intervention: Dexmedetomidine; Saline placebo
Intervention description: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.; Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: agitation; delirium; dexmedetomidine; head and neck surgery; microvascular free tissue transfer; flap

Summary:

      Reconstruction using microvascular free tissue flap has been an important management in
      patients with maxillofacial tumor. It is often characterised as long operation time, more
      traumatic and require restriction of patient's head movement postoperatively in order to
      prevent disruption of microvascular anastomosis. Agitation and delirium are common in
      patients with free flap surgery, which may lead to serious consequences such as self
      extubation, injury or even failure of the flap.

      Dexmedetomidine is a sedative and co-analgesic drug with high specificity for
      α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use after
      free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on
      preventing delirium has not been proved.

      The investigators hypothesized that the use of Dexmedetomidine would reduce emergence
      agitation and prevent delirium in patients after free flap surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients undergoing selected maxillofacial surgery with free flap reconstruction

          -  American Society of Anesthesiologist(ASA) classification I and II

        Exclusion Criteria:

          -  bradycardia (< 50 bpm)

          -  severe heart block

          -  low blood pressure(SBP<80mmHg)

          -  Known allergy to alpha 2 agonists
Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
Condition: Dupuytren's Disease
MeSH terms: Dupuytren Contracture; Contracture
Intervention: Clostridial collagenase injectable
Intervention description: Finger manipulation performed 1, 2, or 4 days following collagenase injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: dupuytren; dupuytren's

Summary:

      The purpose of this study is to determine if of manipulation of digits following collagenase
      injection for treatment of Dupuytren's contracture is effected by the amount of time between
      injection and manipulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects (> 18 years) of either gender with an metacarpophalangeal joint
             contracture and a palpable cord of > 20 degrees of a digit (excluding the thumb) due
             to Dupuytren's contracture

        Exclusion Criteria:

          -  Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex
             treatment for Dupuytren's contracture.

          -  Any subject using anti-coagulant therapy other than low dose aspirin (up to
             150mg/day).

          -  Any subject in the opinion of the MD investigators with chronic, severe or terminal
             medical illness which would make them unsuitable for study participation.

          -  Any subject with known allergy to Xiaflex (Clostridial collagenase).

          -  Any subject who cannot conform to the study visit schedule
MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)
Condition: Acute Pulmonary Edema
MeSH terms: Pulmonary Edema; Edema
Intervention: Midazolam; Morphine
Intervention description: Dose use according to the product technical sheet; Dose use according to the product technical sheet
Intervention MeSH terms: Midazolam; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute heart failure; morphine; midazolam; in-hospital mortality

Summary:

      Acute pulmonary edema (APE) is a common condition in the emergency room, associated with
      considerable mortality. The use of intravenous morphine in the treatment of APE remains
      controversial and Benzodiazepines have been suggested as an alternative for morphine to
      relieving dyspnoea and anxiety in the patients with APE. The MIdazolan versus MOrphine in APE
      trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate
      the efficacy and safety of morphine in patients with APE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with acute pulmonary edema with dyspnoea and anxiety

        Exclusion Criteria:

          -  Patients with known severe liver disease.

          -  Patients with known severe renal disease.

          -  Patients with expectation of death from other illness during the course of the trial.
Meropenem Dosage Strategy Based on PPK Model
Condition: Lower Respiratory Tract Infection
MeSH terms: Infections; Respiratory Tract Infections
Intervention: Routine meropenem therapy; Meropenem therapy based on a PPK and PD model
Intervention description: Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician; Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model
Intervention MeSH terms: Meropenem
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 60 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Infection; Meropenem; Pharmacokinetics; Pharmacodynamics

Summary:

      To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a
      population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract
      infection patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sixty years and older patients hospitalized at the Peking University Third Hospital
             with community-acquired or hospital-acquired lower respiratory tract infection.

          -  Bacilli was idolated from lower respiratory tract specimens within 48 hours prior to
             study enrollment.

          -  The pathogen was sensitive to meropenem.

          -  Received broad-spectrum antibiotic therapy less than 24 hours, or no improvement after
             antibiotic therapy and pathogen was resistant to the used antibiotics.

        Exclusion Criteria:

          -  Had documented hypersensitivity to carbapenems.

          -  More than one pathogenic Gram-negative bacillus was isolated lower respiratory tract
             specimens.

          -  Positive HIV antibody titre.

          -  Had known or suspected tuberculosis or other infections caused by Gram-positive cocci,
             viruses or fungi at baseline.
Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-year Period in Patients With Schizophrenia
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Abilify; Risperidal Consta
Intervention description: 10-30 mg once daily for 104 weeks; 25mg, 37.5mg, or 50mg every 2 weeks for 104 weeks
Intervention MeSH terms: Aripiprazole; Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 355.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Relapse; Remission; Treatment Outcome; long-acting injectable

Summary:

      The purpose of this study is to compare the effectiveness of two antipsychotic medications,
      RisperdalÂ® ConstaÂ® versus AbilifyÂ®, over a 2-year treatment period in the long-term
      maintenance of patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with diagnosis of schizophrenia

          -  Patient has had at least 2 psychotic relapses in the two years prior to study entry

          -  patient is not adequately benefiting from their current antipsychotic medication

        Exclusion Criteria:

          -  Patients that have been hospitalized or had major medication changes within 2 months
             of study entry

          -  Patients currently experiencing, or who have experienced worsening of disease symptoms
             within 2 months of study entry

          -  Patients currently using clozapine or carbamazepine

          -  Patients who have undergone electroconvulsive therapy or depot antipsychotic treatment
             within 6 months prior to study entry

          -  pregnant or breast-feeding
Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin lispro mid mixture (MM); Insulin glargine
Intervention description: Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks; Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 484.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: diabetes; type 2

Summary:

      A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral
      antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral
      antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes

          -  Have been receiving oral antihyperglycemic medications (OAM) without insulin including
             at least two of the following at maximally tolerated doses, AND meet the minimum
             dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose,
             according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4
             mg/day rosiglitazone. The OAMs also must be used in accordance with the product label

          -  Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.

        Exclusion Criteria:

          -  Are taking a TZD dose greater than what is indicated in combination with insulin
             according to the TZD label.

          -  Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.

          -  Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in
             the past 6 weeks or for a total of 30 days or more in the last 24 weeks.

          -  Have a body mass index greater than 40 kg/m2.

          -  Have had more than one episode of severe hypoglycemia in the last24 weeks

          -  Are pregnant, intend to be pregnant during the course of the study or are
             breastfeeding

          -  Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
Absorption Comparison on Equivalency Value of Genepro Gen2
Condition: Analysis, Event History; Absorption; Disorder, Protein
Intervention: Genepro Protein; Whey Protein
Intervention description: weekly blood draws to measure blood protein levels; weekly blood draws to measure blood protein levels
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 30 Years
Maximum age: 46 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Genepro Gen2 Absorption and Protein Value Clinical Trial.
    

Eligibility criteria:

        -  20 Post Op Gastric Bypass patients.

          -  10 men,

          -  10 women.

          -  Minimum age 30

          -  Maximum age 46

          -  All participants have been post operation from their weight loss surgery for a minimum
             of 3 months prior to the start of the study and no longer than 12 months at the start
             of the study.

        Exclusion Criteria:

          -  Any digestive distress disorder (IBS, Crones, etc).