bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Study of BTA798 in Asthmatic Adults With Symptomatic Human Rhinovirus Infection
Condition: Rhinovirus
MeSH terms: Infections; Asthma
Intervention: BTA798; Placebo
Intervention description: BTA798 twice daily; Placebo twice daily
Phase: Phase 2
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: Human rhinovirus; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen

Summary:

      This study aims to evaluate the safety, tolerability and effectiveness of BTA798 on

        -  shortening the length and reducing the symptoms of human rhinovirus infection (also
           known as the common cold),

        -  controlling asthma symptoms, and

        -  lowering the risk of asthma symptoms worsening in subjects with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 18-70 years

          -  Diagnosis of asthma consistent with Global Initiative for Asthma (GINA) steps 1 to 3

          -  Presumptive human rhinovirus infection

        Exclusion Criteria:

          -  Current severe asthma exacerbation

          -  Severe asthma, GINA steps 4 or higher

          -  Uncontrolled or clinically significant medical condition, disease or event which could
             impact subject safety and/or study evaluations and/or compliance to the protocol

          -  Current smoker, ex-smoker of <1 year, or history of smoking >/=10 pack years.
Can Oral T3 Normalize Thyroid Hormone Levels Following Cardiopulmonary Bypass in Children?
Condition: Low T3 Syndrome
MeSH terms: Euthyroid Sick Syndromes
Intervention: Oral T3 Low dose; Placebo; Oral T3 high dose
Intervention description: Comparison of different dosages of drug. Low dose group oral T3 is 0.5 mcg/kg q24h; Comparison of different dosages of drug. In low dose group, placebo was given alternately with oral T3 every 12h with a total 3 doses for placebo and 3 doses for oral T3; Comparison of different dosages of drugs. Oral T3 high dose is 0.5 mcg/kg q12h
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 1 Day
Maximum age: 24 Months
Healthy volunteers: No
Keywords: congenital heart surgery, thyroid hormones

Summary:

      Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill.
      This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary
      bypass. Previous largest study,Triiodothyronine for Infants and Children Undergoing
      Cardiopulmonary bypass (TRICC) study showed T3 supplementation decreased time to extubation
      for infants less than 5 months undergoing cardiopulmonary bypass. Intravenous regiment was
      known effective in maintaining T3 levels during pediatric cardiac surgery. This drug
      preparation however is not commonly used in many countries due to the relatively high costs
      and/or the simple lack of availability. The use of oral T3 to treat postoperative low T3
      levels in pediatric patients has not been reported so far, although recent adult studies
      showed benefit in using oral T3 after cardiac surgery. The purpose of this study was to
      determine if oral T3 supplementation could prevent the decline of serum T3 in children less
      than 2 years of age undergoing congenital heart surgery using CPB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients between 0-2 years of age

          -  Aristotle score of 6 and above

          -  underwent cardiac surgery using cardiopulmonary bypass

        Exclusion Criteria:

          -  birth weight less than 2 kg for neonates

          -  preoperative tachyarrhythmia or need for anti arrhythmic treatment

          -  clinical sepsis confirmed by culture

          -  preoperative renal insufficiency

          -  known thyroid and metabolic disorder

          -  any contraindication for oral T3 administration
Effects Of tDCS With Physical Therapy On Rehabilitation In Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: tDCS; Physiotherapy
Intervention description: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability.; Physiotherapy protocol followed the guidelines outlined in clinical practice guideline for physical therapy in Parkinson disease of the Royal Dutch society for physical therapy (Keus, 2007). This guideline proposes some objectives for motor rehabilitation in patients with PD, such as: flexibility, strength, coordination, balance, posture and gait. The difficulty of exercises ranged according with Hoehn and Yahr (HY) staging scale. In this way, each stage of HY had a specific physical therapy protocol following the guideline.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson, rehabilitation, tDCS

Summary:

      The present study aims to investigate the effect of transcranial direct current stimulation
      (tDCS) associated with physiotherapy in parkinson´s rehabilitation. Previous studies showed
      that tDCS could reduce the bradykinesia, one of the symptom of Parkinson disease. In this
      way, this study will combine tDCS with physiotherapy in order to enhance the motor
      rehabilitation and the quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

        Parkinson disease comproved by a neurologist Regular treatment with dopamine or other drugs
        against parkinson -

        Exclusion Criteria:

        pregnant history of convulsion metal implant in the region of skull or face change in
        medication during the study realize other physical therapy in the same time of the study
        previous surgery for parkinson disease

        -
Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: ambrisentan
Intervention description: 1, 2.5, 5, and 10 mg ambrisentan given orally once daily
Intervention MeSH terms: Ambrisentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      AMB-220-E is an international, multicenter, open-label study examining the long-term safety
      of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study
      NCT00046319, "A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging,
      Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to
      Severe Pulmonary Arterial Hypertension".
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have completed Visit 14/Week 24 of the NCT00046319 study.

          -  Women of childbearing potential must have a negative urine pregnancy test at the
             Screening/Enrollment Visit and agree to use a reliable double barrier method of
             contraception until study completion and for >=4 weeks following their final study
             visit.

          -  Must have completed the Down-titration Period of NCT00046319 prior to enrollment in
             AMB-220-E and will meet the following additional criteria:

          -  Subjects with a diagnosis of HIV must have stable disease status at the time of
             Screening/Enrollment.

          -  Must be stable on conventional therapy for PAH for >=4 weeks prior to the Screening
             Visit.

        Exclusion Criteria:

          -  Chronic prostanoid therapy, or other investigational prostacyclin derivative within 4
             weeks prior to the Screening Visit.

          -  Intravenous inotrope use within 2 weeks prior to the Screening Visit.

          -  Females who are pregnant or breastfeeding.

          -  Contraindication to treatment with an endothelin receptor antagonist (ERA).
Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects
Condition: Hypercatabolic Status Related to Severe Burn
MeSH terms: Burns
Intervention: BVS857; placebo
Intervention description: Group 1A&1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.; Group 1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Burn, Severe burn, Lean body mass, Cachexia, Hypermetabolism, Catabolism, Wound healing

Summary:

      Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15
      weeks
    

Eligibility criteria:

        Inclusion Criteria:

          -  Burn injury comprising 2nd degree deep partial thickness and/or 3rd degree full
             thickness burns, ≥20% total body surface area with expected need for surgical
             intervention and not exceeding the sum of age plus burn size of 100 (Baux score)

          -  Dosing must occur within 8-12 days post-burn

          -  Subjects must weigh at least 45kgs (for group 1 with doses of 0.03mg/kg) and be under
             100 kg to participate in the study

        Exclusion Criteria:

          -  Spinal cord injury

          -  Hypoxic brain injury (Glasgow Coma Scale (GCS) <8) at screening

          -  True conductive electric burn with suspected neurologic injury

          -  Uncontrolled diabetes with HbA1c > 10% at screening, or known history of hypoglycemia,

          -  History of or active peripheral neuropathy or seizure disorder

          -  Systemic corticosteroids : > 10mg/d of prednisone or equivalent, other investigational
             treatments (excluding investigational dressings), medications for weight loss
             including megestrol acetate, androgens or oral beta agonists
Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke
Condition: Stroke, Acute
MeSH terms: Stroke
Intervention: Trans-Sodium Crocetinate; Placebo
Intervention description: In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance.; The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.
Intervention MeSH terms: Trans-sodium crocetinate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, randomized, placebo-controlled, double-blind, parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: TSC injections will be prepared and injected by unblinded personnel on each ambulance. All other study personnel will be blinded
Enrollment: 6.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will assess the potential efficacy and safety of TSC as early treatment for both
      ischemic and hemorrhagic stroke when administered while subject is in ambulance being
      transported to hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 40-85, inclusive

          2. Last known well time 15-120 minutes before anticipated study drug injection

          3. Suspected stroke identified by the LAPSS

          4. Moderate to severe motor deficit, with Los Angeles Motor Scale (LAMS) 2 or higher

          5. No seizure

        Exclusion Criteria:

          1. Coma

          2. Rapidly improving neurologic deficit

          3. History of seizures or epilepsy

          4. Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound
             the neurological or functional outcome evaluations

          5. SBP < 90 or > 220

          6. Major head trauma in the last 24 hours

          7. Recent stroke within 30 days

          8. Known to be pregnant or lactating
Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Nesiritide; Placebo
Intervention description: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.; Infusion of 72 hours of saline solution (packaged to match active comparator)
Intervention MeSH terms: Natriuretic Peptide, Brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of intravenous human beta natriuretic
      peptide (BNP, Nesiritide) as compared to placebo to prevent adverse post acute myocardial
      infarction left ventricular remodeling.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients with acute ST elevation myocardial infarction with > or = 2 mm ST elevation
             in one or any combination of anterior leads, with successful revascularization (TIMI
             grade 3 flow) of the lesion within 24 hours of symptoms and consented within 24 hours
             of procedure.

        Exclusion criteria:

          -  Cardiogenic shock or hypotension, Systolic BP< 90 mmHg or overt Congestive Heart
             Failure (CHF)

          -  Previous history of MI (Myocardial Infarction)

          -  Previous ECG suggesting previous MI

          -  Known Ejection Fraction (EF) < 30%

          -  Atrial fibrillation

          -  Previously known significant valvular disease (Grade III, IV), cardiomyopathy and
             congenital heart disease.

          -  Hemoglobin <10 mg/dL

          -  Pregnant women/nursing mothers

          -  Participants still menstruating and have not been surgically sterilized must have a
             negative pregnancy test prior to participating in this study.

          -  Unable to undergo cardiac MRI (Magnetic Resonance Imaging).

          -  Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial
             fibrillation or other arrhythmia, cerebral aneurysm clips or severe claustrophobia.
Two and Three Dimensional Contrast-enhanced Ultrasound for Screening of Renal Cell Carcinoma Recurrence Following Cryoablation
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Recurrence
Intervention: Optison
Intervention description: Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cryosurgery; ultrasonography

Summary:

      The purpose of the proposed trial is to determine whether contrast-enhanced ultrasound (CEUS)
      can be used to assess the recurrence of renal cell carcinoma (RCC) after cryoablation
      compared to contrast enhanced CT or MR (the standard evaluation). This study involves the
      off-label use of an FDA-approved ultrasound contrast agent, Optison that flows in the
      vascularity. CEUS will be performed by both two and three dimensional ultrasound to examine
      post-cryoablation vascularity changes to screen for recurrent disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously received cryotherapy of RCC.

          -  Be scheduled for contrast-enhanced MRI/CT to monitoring of RCC recurrence as part of
             their 8, 12, 18, 24, or 36 month CT/MRI follow up.

          -  Be at least 18 years of age.

          -  Be medically stable.

          -  If a female of child-bearing age, must have a negative pregnancy test.

          -  Have signed Informed Consent to participate in the study.

        Exclusion Criteria:

          -  Females who are pregnant or nursing.

          -  Patients who are medically unstable, patients who are seriously or terminally ill, and
             patients whose clinical course is unpredictable. For example:

          -  Patients on life support or in a critical care unit.

          -  Patients with unstable occlusive disease (eg, crescendo angina)

          -  Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular
             tachycardia.

          -  Patients with uncontrolled congestive heart failure (NYHA Class IV)

          -  Patients with recent cerebral hemorrhage.

          -  Patients with known sensitivities to albumin, blood, or blood products

          -  Patients who have undergone surgery within 24 hours prior to the study sonographic
             examination.

          -  Patients with known hypersensitivity to perflutren

          -  Patients with cardiac shunts.

          -  Patients with congenital heart defects.

          -  Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary
             emboli.

          -  Patients with respiratory distress syndrome.
Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: VEGF Trap Eye
Intervention description: Intravitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 157.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: VEGF Trap-Eye; Macular Degeneration; AMD; Neovascular Age-Related Macular Degeneration

Summary:

      Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective
      is to assess long-term safety and tolerability of continuing intravitreal treatment in
      subjects with wet age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior participation in VEGF Trap-Eye Phase I and II studies

        Exclusion Criteria:

          -  Any ocular or systemic adverse events that would preclude participation

          -  Presence of any condition that would jeopardize subject's participation
Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
Condition: Obesity
MeSH terms: Obesity
Intervention: LIK066; Carbohydrate 50%; Carbohydrate 25%; Carbohydrate 8%; Carbohydrate 0%; Psyllium; Calcium carbonate
Intervention description: LIK066 50 mg tablets. Open-label, bulk, blister-pack.; 50% carbohydrate in breakfast meal; 25% carbohydrate in breakfast meal; 8% carbohydrate in breakfast meal; 0% carbohydrate in breakfast meal; Powder 6 grams; Liquid 1 gram (4 mL equivalent sugar free)
Intervention MeSH terms: Licogliflozin; Calcium Carbonate; Psyllium; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: obesity; overweight; body mass index; BMI; diarrhea

Summary:

      The purpose of this study was to determine if LIK066 taken with a meal containing low
      carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to
      assess the potential effects of supplements such as psyllium or calcium carbonate on
      alleviating diarrhea associated with LIK066.
    

Eligibility criteria:

        Inclusion Criteria:

          -  obese and overweight, BMI 25-50, HbA1C <10%

        Exclusion Criteria:

          -  Preexisting, clinically significant cardiovascular, liver, renal, or GI disease that
             is considered unstable; pregnancy, Type 1 diabetes; Other protocol-defined
             inclusion/exclusion criteria may apply
The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD9164; Tiotropium; Placebo
Intervention description: Solution for inhalation through nebulization, single dose; Dry powder for inhalation, single dose; Placebo
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD); efficacy; safety; inhalation; long-acting muscarinic receptor antagonist (LAMA)

Summary:

      Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with
      deteriorating lung function over the years. Patients with COPD experience symptoms of
      shortness of breath, cough and sputum production. This study is to assess the treatment
      effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg)
      and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator.
      25 patients are to participate in the study and all will be recruited in Sweden. Each patient
      will visit the study doctor 9 times during the study, whereof 5 visits will be overnight
      visits. All examinations, treatment and the follow-up is free of charge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of COPD

          -  FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-
             bronchodilator FEV1/FVC < 70%

        Exclusion Criteria:

          -  Any clinically relevant abnormal findings at screening examinations

          -  Any clinically significant disease or disorder