bioihbjkbjnl/mcl2 huggingface dataset:
Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Ga-68 labeled PSMA-11; Positron emission tomography-computed tomography (PET/CT); Positron emission tomography-magnetic resonance imaging (PET/MRI)
Intervention description: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.; Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session; A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session
Intervention MeSH terms: Edetic Acid; Gallium 68 PSMA-11
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 485.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators are imaging patients with prostate cancer using a new Positron Emission
      Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect
      prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male, age >= 18.

          2. Histopathologically proven prostate adenocarcinoma.

          3. Concern for metastatic disease in one of the following settings:

               1. Initial staging with intermediate to high risk prostate cancer.

               2. Biochemical recurrence after initial therapy.

          4. Ability to understand a written informed consent document, and the willingness to sign
             it.

        Exclusion Criteria:

        1. Patient unlikely to comply with study procedures, restrictions and requirements and
        judged by the Investigator to be unsuitable for study participation.
Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin degludec; insulin glargine; insulin aspart
Intervention description: Injected subcutaneously (under the skin) once daily; Insulin glargine injected subcutaneously (under the skin) once daily; At least three daily doses at meal-time
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 493.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and in the United States of America (USA). The aim of this
      trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with
      type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based
             therapies

          -  Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH
             insulin) using one or two daily injections and with three or more daily meal-time
             insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human
             insulin) used as bolus insulin therapy

          -  HbA1c maximum 10.0 % by central laboratory analysis

          -  Body Mass Index (BMI) below or equal to 35.0 kg/m^2

          -  Ability to self-manage insulin therapy as assessed by confirmation (verbal
             confirmation at screening visit) of a changed insulin dose in the preceding two months
             prior to screening

          -  Ability and willingness to adhere to the protocol including performance of self
             measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

        Exclusion Criteria:

          -  Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering
             drug other than insulin

          -  Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke;
             decompensated heart failure New York Heart Association (NYHA) class III or IV;
             myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or
             angioplasty

          -  Uncontrolled treated/ untreated severe hypertension (systolic blood pressure above or
             equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or
             equal to 100 mmHg)

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements

          -  Cancer and medical history of cancer (except basal cell skin cancer or squamous cell
             skin cancer)
Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum
Condition: Hyperemesis Gravidarum
MeSH terms: Hyperemesis Gravidarum
Intervention: Clonidine
Intervention description: transdermal clonidine patch 5 mg q. 5 days
Intervention MeSH terms: Clonidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: Female
Healthy volunteers: No
Keywords: Hyperemesis Gravidarum; treatment; transdermal clonidine

Summary:

      CLONEMESI is an academic, independent, randomized placebo-controlled trial to assess the
      effect of transdermal (TD) clonidine in improving the symptoms of severe Hyperemesis
      Gravidarum(HG) affecting women in their 6th-12th week of pregnancy. The study has a crossover
      design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gestational age 6-12 weeks and a major grade of HG clinical severity defined as
             follows:

          -  a PUQE score index ≥ 13 associated to one or more of the following conditions:

          -  weight loss > 5% of pregravidic weight,

          -  electrolyte disturbances,

          -  dehydration,

          -  duration of symptoms > 10 days ,

          -  inadequate food and drink intake

        Exclusion Criteria:

          -  Language barrier.
A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Entecavir + Tenofovir; Adefovir + continuing Lamivudine
Intervention description: Tablets, Oral Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks; Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
Intervention MeSH terms: Tenofovir; Lamivudine; Entecavir; Adefovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to find out whether a combination of entecavir
      (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added
      to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant
      against lamivudine. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic HBV infection

          -  History of lamivudine (LVD) treatment, and lamivudine resistance (LVDr), receiving LVD
             at screening visit

          -  Compensated liver function

          -  HBV DNA ≥ 172,000 IU/mL

          -  Hepatitis B e-antigen (HBeAg)-positive or HBeAg-negative

        Exclusion Criteria:

          -  Evidence of decompensated cirrhosis

          -  Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
             hepatitis D virus (HDV)

          -  Recent history of pancreatitis

          -  Serum alpha fetoprotein > 100 ng/mL

          -  Except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral
             agents with activity against hepatitis B
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.
Condition: Bacterial Infections; Diabetic Foot; Osteomyelitis
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Osteomyelitis; Diabetic Foot
Intervention: Tigecycline; Ertapenem
Intervention description: 150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis; Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
Intervention MeSH terms: Ertapenem; Tigecycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1061.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic foot infection; Osteomyelitis; Diabetes Complications; Foot ulcer; Skin infection

Summary:

      The purpose of this study was to look at the safety and effectiveness of a once-daily dose of
      tigecycline compared to ertapenem for the treatment of diabetic foot infections. The
      co-primary efficacy endpoints were not met.
    

Eligibility criteria:

        Main inclusion criteria:

          -  Men and women aged 18 or older with diabetes and a qualifying foot infection. People
             with evidence of a diabetic foot infection with osteomyelitis may qualify for the
             osteomyelitis substudy arm.

        Main exclusion criteria:

          -  People with additional significant disease, infection with resistant pathogens,
             contraindication, or hypersensitivity to any test article or related antibiotic.
Combined Medication for Improved Analgesia in Superficial Pain
Condition: Pain
Intervention: Diclofenac and Atropine combination drug; Placebo
Intervention description: Diclofenac will be associated with a small dose of atropine 1.2mg; For each capsule of active medication, a capsule of placebo will be provided, identical looking.
Intervention MeSH terms: Diclofenac; Atropine; Analgesics
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This research study is being done to assess if a combination of medications can enhance the
      relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The
      investigators also want to find out if certain genes may be linked to individual differences
      in experienced efficacy of pain killers. The combination of medications under investigation
      is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug
      Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain
      types of poisoning, heartbeat problems, and other diseases but atropine is not approved to
      treat pain. However, atropine has been used for many years in different European countries to
      treat painful conditions such as stomach cramps.This research study will compare diclofenac
      and atropine to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female healthy volunteers.

          -  18-40 years of age.

          -  Ability to read and understand English; English can be a second language provided that
             the participant feels that he/she understand all the questions used in the assessment
             measures.

        Exclusion Criteria:

          -  Chronic pain condition or chronic or current treatment with any pain medication.

          -  Presence of any illness or medication use that is judged to interfere with the trial.
             For example: psychiatric disorder, medication that can influence cognition or
             emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or
             opioids.

          -  Unwillingness to receive brief pain stimulation administered by a heat probe on the
             hand.

          -  Allergy or contra-indication to receiving nonsteroidal anti-inflammatory medication
             and atropine (Treatment with antidepressants, neuroleptics, antihistaminic, levodopa,
             anti-acids. Pregnancy, breast-feeding, myasthenia gravis, pyloric stenosis,
             gastro-esophageal reflux, gastric ulcer, constipation, prostatic enlargement,
             glaucoma, cardio-pulmonary condition -including tachycardia, arrhythmia,
             arteriosclerosis-, hyperthyroidism, high blood pressure, genetic disease, kidney
             failure)
Study of Eteplirsen in DMD Patients
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: eteplirsen
Intervention description: Eteplirsen 30 mg/kg will be administered as an IV infusion once a week for 96 weeks, followed by a safety extension (not to exceed 48 weeks).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: Male
Minimum age: 7 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: DMD, Duchenne, Eteplirsen, dystrophy, dystrophin, exon 51

Summary:

      The main objective of this study is to provide evidence of efficacy of eteplirsen (AVI-4658)
      in Duchenne muscular dystrophy (DMD) patients that are amenable to skipping exon 51.
      Additional objectives include evaluation of safety, biomarkers and the long-term effects of
      eteplirsen up to 96 weeks, followed by a safety extension (not to exceed 48 weeks).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male 7-16 years old

          -  Diagnosed with DMD, genotypically confirmed

          -  Stable dose of corticosteroids for at least 24 weeks

          -  Have intact right and left alternative upper muscle groups

          -  Mean 6MWT greater than 300m (primary analysis on 300 to 450 meters)

          -  Stable pulmonary and cardiac function: predicted FVC equal to or greater than 50% and
             LVEF of greater than 50%

        Exclusion Criteria:

          -  Previous treatment with drisapersen or any other RNA antisense agent or any gene
             therapy within the last 6 months

          -  Participation in any other DMD interventional clinical study within 12 weeks

          -  Major surgery within 3 months

          -  Presence of other clinically significant illness

          -  Major change in the physical therapy regime within 3 months

        Other inclusion/exclusion criteria apply.
An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))
Condition: Proteinuria
MeSH terms: Proteinuria
Intervention: Losartan Potassium; Comparator: Placebo (Losartan); Comparator: amlodipine besylate; Comparator: Placebo (amlodipine besylate); Placebo (Losartan); Enalapril Maleate
Intervention description: Losartan Use During the Double-Blind Treatment Phase:
Losartan potassium was administered orally as tablets; 25 or 50 milligrams (mg); or as a liquid suspension 2.5 mg/mL prepared for participants who weighed less than 25 kilograms (kg) or for those participants unable to swallow tablets. During the double-blind period, participants were initially randomized to either a once-daily weight-dependent dose of approximately 0.7 mg/kg (25 mg tablet; up to 50 mg per day) and at 2-weeks the dose was increased to a once-daily maximum weight-dependent dose of 1.4 mg/kg. The maximum dose of losartan, as specified in the protocol, was 50 mg/day (if the patient weighed <50 kg)
or 100 mg/day (if the patient weighed ≥50 kg).
Losartan Use During the Treatment Extension Phase:
Dose modifications of the drug were left up to the discretion of the Investigators based on each participant's level of tolerance.; Placebo (losartan suspension), administered orally, once daily for 12 weeks; Amlodipine besylate (1 mg/mL) liquid suspension, oral administration, titrated to 0.2 mg/kg/day (5 mg maximum dose) per day for 12 Weeks; Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks; Normotensive patients randomized to losartan placebo for 12 weeks.; Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.
Intervention MeSH terms: Losartan; Amlodipine; Enalapril; Enalaprilat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 306.0
Sex: All
Minimum age: 12 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is 1 to 17 years of age

          -  Able to provide a first-morning urine sample each day during the study

          -  Documented history of proteinuria associated with chronic kidney disease of any origin

          -  Signed consent of parent and/or legal guardian

        Exclusion Criteria:

          -  Pregnant and/or nursing

          -  Requires more than 2 medications to control high blood pressure

          -  Has undergone major organ transplantation (e.g. heart, kidney, liver)

          -  Known sensitivity to losartan or other similar drugs, or any history of angioneurotic
             edema

          -  Known sensitivity to amlodipine or other calcium channel blocker

          -  Requires cyclosporine to treat renal disease (kidney disease)
Effects of SAMe in Patients With Alcoholic Liver Disease
Condition: Liver Disease, Alcoholic
MeSH terms: Liver Diseases; Liver Diseases, Alcoholic
Intervention: S-adenosylmethionine; Placebo
Intervention description: Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks.; Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alcoholic Liver Disease (ALD); S-adenosylmethionine; SAMe

Summary:

      Prior studies in animal models have established that the pathogenesis of alcoholic liver
      disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic
      methionine metabolism. The hypothesis of the clinical study was that provision of the
      methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine
      metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to
      determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by
      comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics
      without liver disease, and normal healthy subjects, and b) to determine the treatment effects
      of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical
      features of liver injury in ALD patients.
    

Eligibility criteria:

        Inclusion Criteria

          -  ALD) a history of chronic alcoholism according to established AUDIT and WHO criteria
             with the presence of clinical and laboratory features of established liver disease.
             Also, willingness to undergo liver biopsies at start and completion of the study, and
             to comply with study medication or placebo and required clinic visits and blood
             sampling.

          -  a history of chronic alcoholism without evidence of liver disease;

          -  healthy subjects without history of alcoholism or presence of liver disease.

        Exclusion Criteria:

          -  viral Hepatitis B or C

          -  hemochromatosis

          -  Wilson Disease

          -  sclerosing cholangitis

          -  primary biliary cirrhosis

          -  other chronic disease

          -  renal insufficiency
Study of Oral Fampridine-SR in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fampridine-SR; Placebo
Intervention description: Tablets, 10 mg, twice daily, 14 weeks; sugar pill, twice a day (b.i.d.)
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Walking Ability

Summary:

      To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in
      patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled,
      parallel group study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a confirmed diagnosis of multiple sclerosis

          -  Are able to walk with or without an assistive device

        Exclusion Criteria:

          -  Pregnancy, breastfeeding or females of childbearing potential not using adequate birth
             control

          -  Participating in other investigational drug trials

          -  A medical history or clinical findings that preclude entry into the study

          -  A medication history that precludes entry into the study

          -  Previously treated with 4-aminopyridine (4-AP)