bioihbjkbjnl/mcl2 huggingface dataset:
Assessing a Risk Model for G6PD Deficiency
Condition: Malaria, Vivax; G6PD Deficiency
MeSH terms: Malaria, Vivax; Glucosephosphate Dehydrogenase Deficiency
Intervention: primaquine; chloroquine + primaquine
Intervention description: Participants receive primaquine for 14 days at 0.5 mg/Kg. Drug administration will be directly observed.; Participants will receive chloroquine for 3 days concomitant with primaquine for 14 days at 0.5 mg/Kg. Drug administration will be directly observed.
Intervention MeSH terms: Chloroquine; Primaquine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized into one of two arms. 1a will receive primaquine for 14 days, and Arm 1b will receive chloroquine for 3 days and concomitant primaquine for 14 days.
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A clinical study designed to develop and inform an individual risk of hemolysis model based
      on individual red blood cell G6PD levels. Volunteers who are eligible to treatment with
      primaquine as per national guidelines and with confirmed normal G6PD levels as per the
      fluorescent spot test will be exposed to treatment regimens of either primaquine alone for 14
      days or 3 day chloroquine with concomitant primaquine for 14 days. The volunteers will be
      followed intensively during treatment and for 14 days after treatment for haematologic
      measures, G6PD quantification, and drug level assays.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous G6PD test at Shoklo Malaria Research Unit (SMRU) clinic with one of following
             results: 1) G6PD homozygous wildtype females (G6PD genotype normal) 2) G6PD
             heterozygous females with a normal FST (G6PD genotype abnormal with G6PD activity ≥40%
             and ≤80% of normal ) 3) G6PD hemizygous wildtype males (G6PD genotype normal)

          -  Willing to participate and sign informed consent form

          -  Willing to allow donated samples to be used in future research

          -  Aged ≥18 years

          -  Ability (in the investigators' opinion) and willing to comply with all study
             requirements

        Exclusion Criteria:

        All participants:

          -  Malaria or other illness

          -  Recent history (within 20 days) of anti-malarial treatment

          -  History of allergy or adverse reaction to chloroquine or primaquine

          -  Blood transfusion in the past 3 months

          -  G6PD activity less than 40% normal activity or 3.00 IU/gHb by the quantitative G6PD
             spectrophotometric assay

          -  Haemoglobin ≤10 g/dL

          -  Presence of any condition which in the judgment of the investigator would place the
             subject at undue risk or interfere with the results of the study

        Female participants only:

          -  Pregnancy at the time of screening

          -  Breastfeeding
Topical Intranasal Tranexamic Acid for Epistaxis in the Emergency Department
Condition: Epistaxis
MeSH terms: Epistaxis; Emergencies
Intervention: Tranexamic Acid; 0.9% Sodium Chloride
Intervention description: TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).; 0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
Intervention MeSH terms: Tranexamic Acid
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: 18 Years
Healthy volunteers: No
Keywords: tranexamic acid; epistaxis; emergency medicine; intranasal; TXA

Summary:

      It is estimated that epistaxis results in 4.5 million emergency department visits per year
      throughout the United States. Due to the adverse effects of standard treatment options for
      epistaxis, tranexamic acid (TXA) may be considered an attractive option. In previous studies,
      when used with nasal packing, TXA showed faster time to control of bleeding. The goal of this
      study is to determine the efficacy and safety of topical intranasal TXA applied via atomizer
      for patients with epistaxis who present to the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with anterior epistaxis

        Exclusion Criteria:

          -  Unable to consent, do not have a valid telephone number, pregnant women, prisoners,
             cognitively impaired individuals, diagnosis of posterior epistaxis, major trauma,
             bleeding disorder (such as thrombocytopenia or hemophilia), hemodynamically unstable,
             or had a known hypersensitivity to study medication
Cardiovascular Effects of Chronic Sildenafil in Men With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Endothelial Dysfunction
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sildenafil; Placebo
Intervention description: 100 mg daily (3 capsules/day); Placebo 100 mg (3 capsules/day)
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 59.0
Sex: Male
Minimum age: 35 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; Endothelial dysfunction; Sildenafil

Summary:

      Type 2 Diabetes Mellitus (T2DM) represents a model of endothelial dysfunction, where chronic
      nitric oxide deprivation, hyperglycaemia and hyperinsulinemia and fibrogenic mediators lead
      to cardiovascular remodelling associated with diabetic cardiomyopathy and in consequence to
      secondary complications of diabetes. Specific anti-oxidative and anti-fibrotic therapies are
      not currently available. Sildenafil (Viagra) has demonstrated the capability of significantly
      improving endothelial dysfunction and cardiac fibrosis in experimental animal models.

      The purpose of the present study is performed to establish the effect of chronic high dose
      sildenafil treatment on heart performance in diabetic subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes mellitus

          -  Patients age 35-75

          -  Metabolic control of diabetes by diet or oral treatment (unmodified in the last 3
             months)

          -  Blood pressure <160/100 mmHg, including subjects with controlled hypertension, treated
             with ACE-inhibitors/sartans, unmodified in the last 3 months

        Exclusion Criteria:

          -  Participation in another study with an investigational drug or device

          -  HbA1c >12%

          -  Alterations during ECG stress examination

          -  Current use of nitrate agents

          -  Proliferative retinopathy

          -  Patients with history of cardiovascular and malignant disease

          -  Psychosocial disturbance

          -  Alcohol or drug dependence

          -  Allergy or hypersensitivity to sildenafil or other Phosphodiesterase inhibitors.
Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers
Condition: Cigarette Smoking
Intervention: Low-nitrosamine smokefree tobacco product for oral use; Non-tobacco, non-nicotine placebo product
Intervention description: Smokeless tobacco in paper sachets containing 1.0 or 0.5 g of the product. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.; Placebo product in paper sachets containing 1.0 or 0.5 g. Product made of cocoa bean fibers and oat fibers. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking; Smoking cessation; Smokeless tobacco; Snus

Summary:

      The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for
      oral use ("snus") can increase the quit rate among cigarette smokers who wish to stop smoking
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cigarette smoker who smoke more than 9 cigarettes per day (average during past month)

          -  Daily smoking more than 1 year

          -  Motivated to quit smoking using a smokefree tobacco product

          -  Good general health

        Exclusion Criteria:

          -  Use of smokefree/smokeless tobacco during past 6 months or any type of pharmaceutical
             product for smoking cessation during past 3 months

          -  Unable to refrain from nicotine replacement therapy during the study

          -  Current oral condition that could be made worse by study interventions

          -  History of clinically significant renal, hepatic, neurological, or chronic pulmonary
             disease that in the judgement of the investigator might preclude participation

          -  History of significant cardiovascular disease, including myocardial infarction, within
             the last 3 months, significant cardiac arrythmias, or poorly controlled hypertension
             that in the judgement of the investigator might preclude participation

          -  History of alcohol or substance abuse other than cigarette smoking within the past
             year
Open-Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Tamoxifen When Coadministered To Healthy Post-Menopausal Female Subjects
Condition: Pharmacokinetics
Intervention: Tamoxifen; Tamoxifen and Desvenlafaxine Succinate Sustained Release
Intervention description: Period 1-Tamoxifen 40mg on study day 1.; Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7.
Intervention MeSH terms: Tamoxifen; Desvenlafaxine Succinate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetic; safety and tolerability; genetic testing; CYP 2D6

Summary:

      The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on
      the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy
      post-menopausal female subjects. This study will also evaluate the safety and tolerability of
      Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy post-menopausal female subjects, at least 45 years of age, with confirmed
             post-menopausal status

          -  Hysterectomized subjects

          -  Body Mass Index (BMI) less than or equal to 34.0 kg/m2

          -  Nonsmoker or smoker of fewer than 5 cigarettes per day as determined by history

          -  An informed consent document signed and dated by the subject

        Exclusion Criteria:

          -  History of significant blood, kidney, endocrine, lung, gastrointestinal, heart, liver,
             psychiatric, neurologic, or allergic disease

          -  Presence or history of deep vein thrombosis or transient ischemic attack

          -  History of seizure disorder

          -  Presence or history of glaucoma or increased intraocular pressure

          -  Allergy to or unable to tolerate tamoxifen, desvenlafaxine, or venlafaxine

          -  History of substance abuse within 1 year of study

          -  A positive urine drug screen

          -  Treatment with an investigational drug within 30 days

          -  Consumption of grapefruit or grapefruit related citrus fruits

          -  12 lead ECG demonstrating QTc >450 msec at screening

          -  Pregnant or nursing females

          -  Use of prescription or nonprescription drugs and dietary supplements

          -  History of sensitivity to heparin or heparin induced thrombocytopenia

          -  Severe acute or chronic medical or psychiatric condition or laboratory abnormality

          -  Use of CYP 2D6 inhibitors and CYP 3A4 inhibitors/inducers
A Clinical Trial to Study the Effects of Two Drugs, Lycopene and Prednisolone in Patients With Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Intervention: lycopene; Prednisolone
Intervention description: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.; Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.
Intervention MeSH terms: Prednisolone; Lycopene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Antioxidant; Lycopene; Prednisolone

Summary:

      Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous
      disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for
      the treatment of oral lichen planus. Half of participants (total number of participants was
      twenty eight) were received lycopene and the other half were received prednisolone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject had symptomatic i.e. burning sensation and/or pain secondary to oral lichen
             planus.

          -  Subject had clinically & histo-pathologically diagnosed as oral lichen planus.

          -  Subject had not on any treatment for the same or treatment likely to modify their oral
             lichen planus (e.g. systemic steroids, antifungals, immunosuppressant's,
             anti-oxidant).

        Exclusion Criteria:

          -  Suffering from any systemic disease/s such as diabetes, hypertension, cardiovascular,
             respiratory system disease, renal dysfunction, liver disorders, malignancy, active
             peptic ulcer diseases, acute gastrointestinal diseases, anemia and glaucoma, etc.

          -  Suffering from serious or recurrent infection, immunodeficiency or HIV.

          -  Pregnant or breast feeding (including women who wish to be pregnant during the study
             period).

          -  Any other mucosal diseases or any other skin diseases which might be associated with
             oral lesions.

          -  On any drug therapy which might be causes lichen planus like lesions.

          -  Known allergy or contraindication to study medications.
Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
Condition: Cryptogenic Symptomatic Transient Ischemic Attack; Cryptogenic Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Ischemic Attack, Transient; Ischemia
Intervention: Reveal® XT Insertable Cardiac Monitor
Intervention description: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 447.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: atrial fibrillation; cryptogenic stroke; continuous monitoring; implantable loop recorder; insertable cardiac monitor

Summary:

      The 2006 American Heart Association / American Stroke Association Council on Stroke
      Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic
      recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in
      order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation
      (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin
      for stroke prevention. Physicians can best optimize the use of medicines only if they can
      precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the
      time to first AF by 6 months' continuous rhythm monitoring versus control treatment in
      subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history
      of AF.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic
             stroke.

        Exclusion Criteria:

          1. Known etiology of TIA or stroke.

          2. Untreated hyperthyroidism.

          3. Myocardial infarction less than 1 month prior to stroke or TIA.

          4. Coronary bypass grafting less than 1 month prior to stroke or TIA.

          5. Valvular disease requiring immediate surgical intervention.

          6. History of AF or atrial flutter.

          7. Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral
             anticoagulation (OAC).

          8. Permanent indication for OAC at enrollment.

          9. Permanent contra-indication for OAC.

         10. Included in another clinical trial.

         11. Life expectancy less than 1 year.

         12. Pregnant.

         13. Indicated for Implantable Pulse Generator (IPG), Implantable
             Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an
             implantable hemodynamic monitoring system.

         14. Not fit, unable or unwilling to follow the required procedures of the protocol.
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Condition: Menorrhagia; Metrorrhagia; Medicated Intrauterine Devices
MeSH terms: Menorrhagia; Metrorrhagia; Hemorrhage
Intervention: Tamoxifen; Placebo (for Tamoxifen)
Intervention description: 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course; Sugar pill manufactured to mimic the tamoxifen 10mg tablet
Intervention MeSH terms: Tamoxifen
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: Female
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: levonorgestrel; breakthrough bleeding

Summary:

      This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in
      new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of
      participants will receive a course of tamoxifen three weeks after insertion of the IUD, while
      the other half of participants will receive a course of placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  initiating use of 52mg levonorgestrel-releasing IUD for contraceptive purposes

          -  access to reliable cell phone

          -  willing to receive and respond to daily text or email message to assess bleeding

        Exclusion Criteria:

          -  using IUD for indication other than contraception

          -  postpartum within 6 months, pregnant, or breastfeeding

          -  removal and replacement of IUD

          -  undiagnosed abnormal uterine bleeding prior to placement of IUD

          -  bleeding dyscrasia

          -  anti-coagulation use

          -  active cervicitis

          -  allergy to tamoxifen

          -  history of venous thromboembolism

          -  personal history of breast or uterine malignancy

          -  use of medication contraindicated with use of tamoxifen (coumadin, letrozole,
             bromocriptine, rifampicin, aminoglutethimide, phenobarbital)
Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis
Condition: Ascites; Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Intervention: Albumin; Intravenous Saline Infusion (Albumin placebo); Midodrine; Oral tablet (Midodrine placebo); Octreotide LAR; Saline injection (Octreotide LAR placebo); Large Volume Paracentesis
Intervention description: Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed; Intravenous saline Infusion (Albumin placebo); Midodrine oral tablet at 10 mg three times a day.; Oral tablet (Midodrine placebo) three times a day; Octreotide LAR 20 mg intramuscular injection every 30 days; Saline intramuscular injection 5 cc every 30 days.; Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.
Intervention MeSH terms: Octreotide; Midodrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: albumin; ascites; paracentesis

Summary:

      This clinical trial compares a combination of two drugs that constrict blood vessels
      (Octreotide LAR and Midodrine) to albumin after large volume paracentesis. Subjects have
      cirrhosis and ascites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cirrhosis of any etiology

          -  Age 18-80 years

          -  Moderate to severe ascites

        Exclusion Criteria:

          -  No or small ascites

          -  Severe hepatic hydrothorax

          -  Recent GI (gastrointestinal) hemorrhage

          -  Active bacterial infection

          -  Cardiac failure

          -  Organic renal disease

          -  Hepatocellular carcinoma

          -  Severe comorbidity (advanced neoplasia)

          -  Serum creatinine > 3 mg/dl

          -  Pregnancy