bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain
Condition: Pain; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Tramadol hydrochloride; Acetaminophen
Intervention description: Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.; Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Intervention MeSH terms: Acetaminophen; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pain; Fibromyalgia; Ultracet; Tramadol Hydrochloride; Acetaminophen

Summary:

      The purpose of this study is to evaluate the analgesic effect of combination of tramadol
      hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic
      widespread pain and presence of tender points).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must meet the American College of Rheumatology 1990 criteria for the
             classification of fibromyalgia (that are, Participants must have had widespread pain
             [pain in three quadrants and in the axial skeleton] for at least three months and pain
             on digital palpation in 11 or more of the 18 tender-point sites

          -  Female participants must not be pregnant, breast feeding or postmenopausal for at
             least one year

          -  Participant must be able to take oral medication

          -  Participants must have completed the Screening or wash-out procedures and have a
             visual analog scale score greater than or equal to 40 milliliter

          -  Fail to non-opioid analgesics

        Exclusion Criteria:

          -  Participants who previously failed tramadol hydrochloride therapy or those who
             discontinued tramadol hydrochloride due to adverse events

          -  Participants diagnosed with either any active connective tissue or musculo-skeletal
             diseases, or malignancy or history of malignancy within past 5 years, or painful,
             symptomatic osteoarthritis, or regional periarticular pain syndromes,
             spondyloarthropathy and major endocrine disease

          -  Participants who currently have more severe pain than the pain of fibromyalgia

          -  Participants who have taken antidepressants, cyclobenzaprine or anti-epileptic drugs
             for pain within three weeks of the Treatment Phase

          -  Participants who have taken short-acting analgesics, topical medications and
             anesthetics and/or muscle relaxants for a period of less than 21 days of the given
             medication prior to the Treatment Phase
Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment
Condition: Hepatitis C, Chronic; Lung Transplant
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: Epclusa
Intervention description: Patients will be treated with this drug for 12 weeks post lung transplant.
Intervention MeSH terms: Sofosbuvir-velpatasvir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate whether treatment with Epclusa
      (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C
      infection is feasible, safe and effective at curing HCV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV RNA >= 10^3 IU/ml at screening

          -  Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6
             months prior to screening

          -  HCV Genotype 1, 2, 3, 4, 5 or 6

          -  Otherwise eligible for lung transplant at study site

        Exclusion Criteria:

          -  Age <18

          -  Treatment with any of the following agents:

               -  Amiodarone. Subjects previously treated with amiodarone must have stopped the
                  amiodarone at least 60 days prior to day 1 SOF/VEL

               -  Carbamazepine, phenytoin, phenobarbital, oxcarbazepine

               -  Rifabutin, rifampin or rifapentine

               -  HIV regimens containing tenofovir or tipranavir/ritonavir

               -  St John's wort

               -  PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole,
                  dexlansoprazole, rabeprazole

               -  Modafinil

          -  Have any serious or active medical or psychiatric illness which, in the opinion of the
             investigator, would interfere with subject treatment, assessment or compliance

          -  Hepatitis B surface antigen positive

          -  History of hepatic encephalopathy or variceal hemorrhage

          -  Abnormal hematological and biochemical parameters, including:

               -  Hemoglobin <8g/dL

               -  Platelets <= 50,000/mm^3

               -  ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline
                  phosphatase >=10 times ULN

               -  Total bilirubin >3mg/dL

               -  Severe renal impairment, ie creatinine clearance (CrCl) <30mL/min

          -  Pregnant women or women planning to become pregnant

          -  Women or are breastfeeding

          -  Active or recent history (<=1 year) of drug or alcohol abuse
Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
Condition: Obstruction; Catheter, Infusion Catheter (Vascular); Catheter; Complications (Indwelling Catheter)
Intervention: Heparinized saline catheter flush; Saline-only catheter flush
Intervention description: The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months; The intervention group will have their port catheters flushed with saline only.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safest and most effective flushing solution for
      maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The complication
      rate in patients whose ports are flushed with saline only will be compared to the
      complication rate in patients whose ports are flushed with a combination of saline and
      heparinized saline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to read and understand English

          -  Has a BioFlo implanted port in place less than one (1) year

          -  Evidence of a patent BioFlo port catheter prior to enrollment in the study

          -  Is receiving active treatment (i.e., receiving a therapeutic drug) through the BioFlo
             implanted port

          -  Current treatment protocol projected to continue for a minimum of three (3) months

          -  Anticipates receiving care at the identified centers for 12 months following
             enrollment in the study

          -  Does not receive care of BioFlo implanted port at any other facility

        Exclusion Criteria:

          -  Has documented heparin platelet antibody (i.e., could not be randomized to either
             group) or other allergy to heparin

          -  Receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin)

          -  Does not meet one or more of the inclusion criteria
Study of the Durability of Glycemic Control With Nateglinide
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Nateglinide; Glimepiride
Intervention description: Nateglinide 90~120mg three times a day; Glimepiride 1~2mg once a day
Intervention MeSH terms: Glimepiride; Nateglinide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Nateglinide; Pancreatic beta cell function

Summary:

      This multi-center, randomized controlled study aims to evaluate the durability and efficacy
      of nateglinide therapy for long term glycemic control compared with glimepiride.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes mellitus

          -  age>=18years

          -  no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy

               -  metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day,
                  gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or
                  sulfonylurea <6months)

          -  6.5% ≤ HbA1c ≤ 8.5%

               -  patients on no anti hyperglycemic agent for 3 months : HbA1c at screening

               -  patients on oral hypoglycemic therapy in 3months : HbA1c after wash-out

        Exclusion Criteria:

          -  attending other clinical trials in 3months

          -  type I diabetes mellitus

          -  taking systemic steroid in 1month or requiring steroid therapy during clinical trial

          -  acute myocardial infarction in 6months

          -  alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis

          -  severe liver disease or AST, ALT ≥ 2.5 x ULN

          -  renal insufficiency (serum creatinine > 2.0mg/dl)

          -  other severe diabetic complication

          -  drug hypersensitivity history to nateglinide or sulfonylurea

          -  pregnant or plan to become pregnant during the clinical trial, lactation
Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series
Condition: Stroke
MeSH terms: Stroke
Intervention: Tibion Bionic Leg
Intervention description: A programmable, carbon-fiber robotic leg orthosis (Tibion Bionic Leg, Tibion Corporation, Sunnyvale, CA) was used during therapy to actively supplement concentric and eccentric quadriceps function on the participant's impaired side. The device uses internal sensors at the foot and knee joint to detect intention of movement and, once a variable force threshold is passed, the devices provides appropriate assistive and resistive adjustments.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 40 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Stroke; Tibion; Bionics; Rehab; Therapy; Robotics; Intention

Summary:

      This pilot study examined the effect of task-oriented mobility training in three persons
      chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion
      Bionic Leg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Aged 40 to 60 years

          -  One year status post-stroke

          -  Able to walk at least 10 meters

          -  Independence in self-care

        Exclusion Criteria:

          -  Medically unstable

          -  Major cardiopulmonary deficiency

          -  Major depression

          -  Significant cognitive deficit

          -  Currently receiving gait training

          -  Younger than 40 years of age

          -  Older than 60 years of age

          -  Unable to walk at least 10 meters
Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis
Condition: Pulmonary Infections; Pseudomonas Aeruginosa in Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Respiratory Aspiration; Fibrosis
Intervention: TBM100
Intervention description: Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Tobramycin Inhalation powder; Cystic fibrosis; Lung disease; Anti-bacterial agents

Summary:

      This study assessed the long term safety data for the use of tobramycin inhalation powder in
      patients suffering from cystic fibrosis who have a chronic pulmonary infection with
      Pseudomonas aeruginosa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Cystic Fibrosis

          -  FEV1 at screening must be between 25 and 75 percent of normal predicted values for
             age, sex and height based on the Knudson equation

          -  Pseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture or
             bronchoalveolar lavage within 6 months prior to screening and in the
             sputum/deep-throat cough swab culture at screening

        Exclusion Criteria:

          -  History of sputum culture or deep cough throat swab culture yielding Burkholderia
             cenocepacia complex within 2 years prior to screening and /or sputum culture yielding
             Burkholderia cenocepacia at screening

          -  Hemoptysis more than 60mL at any time within 30 days prior to study drug
             administration

          -  History of hearing loss or chronic tinnitus deemed clinically significant

          -  Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis
             defined as 2+ or greater proteinuria at screening

          -  Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics

          -  Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal
             antibiotic

          -  Any use of inhaled or systemic anti-pseudomonal antibiotic within 28 days prior to
             study drug administration

          -  Use of loop diuretics within 7 days prior to study drug administration

        Other protocol-defined inclusion/exclusion criteria may apply.
Genetic Basis for Variation in the Renal Elimination of Metformin
Condition: Other Conditions That May Be A Focus of Clinical Attention
Intervention: Metformin
Intervention description: Subjects will be given a single oral dose of 850 mg of metformin
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Control

Summary:

      The current study is part of a large multi-investigator grant to look at the pharmacogenetics
      of a number of membrane transporters. We will study individuals with particular genotypes of
      the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation
      in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent,
      metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects have previously participated in the Study Of Pharmacogenetics In Ethnically
             Diverse Populations (SOPHIE) study.

          -  18-40 years old

          -  Possess a pre-specified genotype for OCT2

        Exclusion Criteria:

          -  Taking any regular medications other than vitamins.

          -  Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to
             higher than double the respective normal value, or elevated creatinine concentrations
             (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)

          -  Pregnant or breastfeeding
Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone ER
Intervention description: The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone extended-release (ER); Antipsychotic agents

Summary:

      The purpose of this study is to evaluate efficacy, safety and tolerability of flexible,
      once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from
      Argentina and Colombia that previously failed treatment with other antipsychotic agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient meets the criteria for schizophrenia

          -  Patient is previously non-acute and has been given an adequate dose of an appropriate
             oral antipsychotic for an adequate period of time prior to enrollment, but previous
             treatment is considered unsuccessful due to one or more of the following reasons: lack
             of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons
             to switch to another antipsychotic medication

          -  Patient is healthy on the basis of a physical examination and vital signs at screening

          -  Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or,
             if sexually active, agree to practice an effective method of birth control before
             entry and throughout the study

        Exclusion Criteria:

          -  Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting
             injections during the last 3 months

          -  Patients with serious unstable medical condition, including known clinically relevant
             laboratory abnormalities

          -  Patients with history or current symptoms of tardive dyskinesia and neuroleptic
             malignant syndrome

          -  Patients judged to be at high risk for adverse events, violence, or self-harm

          -  Patients with known hypersensitivity to paliperidone ER or to risperidone

          -  Patients with a current use or known history (over the past 6 months) of substance
             dependence
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
Condition: Schizophrenia; Psychotic Disorders; Substance Abuse; Alcohol Abuse
MeSH terms: Alcoholism; Substance-Related Disorders; Schizophrenia; Psychotic Disorders
Intervention: Risperidone Long Acting; oral risperidone
Intervention description: Dose 25.00, 37.50 or 50.00 mg q two weeks; 0.50-6.00 mg oral risperidone daily
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Risperidone; Schizophrenia; Substance Use Disorder; Alcohol Use Disorder; Treatment; Schizoaffective Disorder

Summary:

      The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to
      risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with
      schizophrenia or schizoaffective disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-65

          -  Schizophrenia or schizoaffective disorder

          -  Meets the Structured Clinical Interview for DSM-IV (SCID) criteria for an alcohol use
             disorder

          -  Alcohol use on at least 5 days during the 4 weeks prior to randomization

          -  Patient is medically stable to start either form of risperidone.

        Exclusion Criteria:

          -  Current treatment with clozapine.

          -  Current treatment with injectable risperidone long-acting.

          -  Currently pregnant, planning to become pregnant, or unwilling to use an acceptable
             form of birth control.

          -  Change in medications (dose of current medication, discontinuation of medication, or
             new medication) in past 30 days.

          -  History of or current breast cancer.

          -  History of intolerance of or allergy to risperidone or risperidone long-acting.

          -  Currently residing in a residential program designed to treat substance use disorders.

          -  Current treatment with long-acting, injectable antipsychotic medication will require a
             review by the medication adjustment group before entering the client into the study.

          -  Past treatment with risperidone long-acting will require a review by the medication
             adjustment group before entering the client into the study.

          -  Treatment at baseline with a second antipsychotic medication will require a review by
             the medication adjustment group before entering the client into the study.

          -  Treatment at baseline with a psychotropic agent proposed to curtail substance use will
             require a review by the medication adjustment group before entering the client into
             the study.

          -  Patients who, in the opinion of the investigator, are judged unsuitable to participate
             in the study.