bioihbjkbjnl/mcl2 huggingface dataset:
Alendronate to Prevent Loss of Bronchoprotection in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against
      stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA)
      and inhaled corticosteroids (ICS) has become the most commonly used asthma controller
      medication class in the United States, but unfortunately, even when LABAs are added to ICS
      and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular use
      of beta-agonists, both short and long-acting, reduces the ability of these agents to protect
      against the airway narrowing that occurs in asthma in response to bronchoconstrictor stimuli.
      We refer to this reduced effect as loss of bronchoprotection. In this proof of concept trial
      we aim to determine if alendronate, which diminishes beta-2 adrenergic receptor
      internalization, can reduce the loss of bronchoprotection that occurs with regular use of
      LABAs, even when used in combination with ICS.
    


Intervention name(s): Alendronate; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Fasomax
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Multicenter, Open Label, Single Dose Study to Evaluate the Effect of Renal Insufficiency on the Pharmacokinetics of SK 0403
Condition: Type 2 Diabetes Mellitus
MeSH terms: Renal Insufficiency; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are
      planned (5 groups of 6 subjects each.)
    

Detailed description: 
      This is a Phase 1, multicenter, open label, single dose study. A total of 30 subjects are
      planned (5 groups of 6 subjects each) as follows:

      Group A: Subjects with ESRD who are receiving hemodialysis treatment

      Group B: Subjects with severe renal impairment

      Group C: Subjects with moderate renal impairment

      Group D: Subjects with mild renal impairment

      Group E: Healthy subjects
    

Intervention name(s): SK-0403
Intervention type(s): Drug
Intervention description(s): SK-0403 400 mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels
      (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2
      of this study is to access the pharmacokinetics (what the body does to the study medication)
      comparability of the 1.4 mg/kg dose of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328.
    

Detailed description: 
      This is a single-dose and randomized (study medication is assigned by chance) study. This
      study will be conducted in 2 parts (Part 1 and Part 2). Approximately 144 participants will
      be enrolled in this study (24 participants in Part 1 and 120 participants in Part 2). Part 1
      is the double-blind (neither physician nor participants know the treatment that the
      participant receives) and staggered parallel (a clinical study comparing the response in two
      or more groups of participants receiving different treatments) part of the study.
      Participants in Part 1 will receive either 1.4 or 2.8 mg/kg of either Sp2/0-derived CNTO 328
      or CHO-derived CNTO 328 or placebo. Part 2 is the open-label (all people know the identity of
      the intervention) part of the study. Participants in Part 2 will receive 1.4 mg/kg of either
      Sp2/0-derived or CHO-derived CNTO 328. Safety will be evaluated by the assessment of adverse
      events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory
      tests which will be monitored throughout the study. The total duration of study participation
      for each participant will be approximately 199 days including a screening phase (within 30
      days before the first study medication administration) and a treatment phase (inpatient
      [hospitalization period] 12 days and outpatient [follow-up] visits up to 169 days).
    

Intervention name(s): CNTO 328 (Sp2/0-derived); CNTO 328 (CHO-derived); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single-dose of Sp2/0-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.; Participants will receive a single-dose of CHO-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.; Participants will receive a single-dose of matching placebo intravenously in Part 1.
Other intervention name(s): SILTUXIMAB; SILTUXIMAB
Intervention MeSH terms: Siltuximab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; CNTO 328; Sp2/0-derived CNTO 328; CHO-derived CNTO 328; Safety; Pharmacokinetics
Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome.
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Sleepiness
Study type: Observational

Summary: 
      Presently, there isn't any international recommendation to evaluate vigilance in Obstructive
      Sleep Apnea Syndrome. The French Society of Sleep Research and Medicine (SFRMS) recommend
      evaluating professional driver with a MWT but no recommendation exists for other patients.
      After a minimal treatment of 4 weeks, the physician has to evaluate the drowsiness risk of
      these patients using either an objective test like the MWT or a subjective one. In the
      university hospital Amiens-Picardie, since the 01/01/2015, every patient with an Obstructive
      Sleep Apnea Syndrome diagnosed by a polysomnography or a ventilatory polygraphy had a MWT
      after 4 weeks of treatment. At each time of the evaluation, Epworth Sleepiness Scale,
      tiredness score of Pichot, and depressive score of Beck are performed.
    


Intervention name(s): Epworth Sleepiness Scale
Intervention type(s): Diagnostic Test
Intervention description(s): Maintenance Wakefulness Test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all patients more than 18 years treated by CPAP for Obstructive Sleep Apnea Syndrome
        diagnosed at the Sleep Medicine Unity of the Amiens Hospital having a MWT between the
        01/01/15 and 31/12/16 were included. Patients were excluded if they had an Central Apnea
        Syndrome, Central Hypersomnia, no driving license or if they refused.
Efficacy and Safety of Addition of IL-2 to Pegylated Interferon Alpha 2a and Ribavirin in HIV/HCV Coinfected Patients
Condition: HIV Infections; Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; HIV Infections; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this pilot study is to evaluate efficacy and safety of addition of IL-2 to
      pegylated interferon alpha 2a and ribavirin in HIV-HCV coinfected patients non-responders
      after three months of standard therapy with pegylated interferon alpha 2a and ribavirin. IL-2
      may enhance numbers and function of CD4 T lymphocytes and specific anti-HCV immune responses
      and could participate to the control of HCV replication
    

Detailed description: 
      This pilot study evaluate efficacy and safety of addition of IL-2 to pegylated interferon
      alpha 2a and ribavirin in HIV-HCV coinfected patients non-responders after three months of
      standard therapy with pegylated interferon alpha 2a and ribavirin Eligible patients should
      have CD4 cells count higher than 300/mm³ if pretreated by antiretroviral therapy or higher
      than 400/mm³ if naive of antiretroviral therapy, Metavir score with histological fibrosis
      score F1, F2 or F3.

      Recombinant IL-2 will be given subcutaneously at a dose of 3 MUI twice daily for 5 days every
      8 weeks for 5 cycles from week 14 to week 46. This national multicenter study will enroll
      around 75 patients in order to give IL-2 to 20 non-responders.

      The primary endpoint is sustained virologic response, defined by undetectable serum HCV-RNA
      at week 72, six months after the end of therapy
    

Intervention name(s): Interleukin 2; pegylated interferon alpha 2a; ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Interleukin-2
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; HIV infection; Interleukin-2; Pegylated interferon alpha 2 a; ribavirin
PRP vs Bevacizumab for PDR Treatment
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Protocol S by DRCR.net has shown that receive Ranibizumab as anti-vascular endothelial growth
      factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior
      to those in eyes that receive standard prompt PRP therapy, however with some visual
      functional benefits and less complications with Ranibizumab arm.

      Applying Protocol S in real world scenario may add cost burden to the patient as patients
      need about 7 injections per year which will cost the patient about 7000 US dollars a year as
      minimum The primary objective of this protocol is to determine the visual acuity outcomes at
      1 year in eyes with proliferative diabetic retinopathy (PDR) using Bevacizumab 1.25 mg
      instead of Ranbizumab to lower the cost burden
    


Intervention name(s): Bevacizumab; Panretinal photocoagulation
Intervention type(s): Drug; Procedure
Intervention description(s): Drug: 1.25-mg Bevacizumab Intravitreal injection of 1.25 mg Bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
Other: Deferred panretinal photocoagulation PRP is deferred until failure/futility criteria for intravitreal injection are met.; Panretinal photocoagulation (full session completed within 42 days).
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Methylphenidate Raclopride Positron Emission Tomography (PET) Test - 11
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate PET methodology to study in vivo synaptic dopamine
      release.
    

Detailed description: 
      The objective of this study is to evaluate PET methodology to study in vivo synaptic dopamine
      release.
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Masking: Double
Primary purpose: Diagnostic
PLAC1 in Reproduction
Condition: Pregnancy
Study type: Observational

Summary: 
      The PLAC1 gene is a recently described X-linked gene that maps to a region of the X
      chromosome thought to be important for normal fetal and placental development. Elevated
      levels of PLAC1 mRNA were detected in preeclampsia and appeared to be directly related to
      disease severity. PLAC1 may serve as a useful marker of placental dysfunction or threatened
      pregnancy.

      The objective of this study is to measure the prevalence of circulating anti-PLAC1 antibodies
      in pregnant maternal serum and correlate it with pregnancy outcome. It is likely that women
      with these antibodies are at higher risk for adverse pregnancy outcomes. Approximately 5% (50
      of 1000) will be expected to have anti-PLAC1 antibodies based on previously reported data.
      The prevalence of these antibodies and their clinical impact on pregnancy outcomes will be
      determined.

      1000 healthy, multiparous and primigravid women will be screened for anti-PLAC1 antibodies at
      their routine prenatal clinic visits. Subjects will be enrolled at their first clinic visit
      at USF Health, South Tampa Center, Department of Obstetrics. Blood (1.0 ml) will be obtained
      as part of the routine blood draw at the time of enrollment. Blood will only be collected
      when drawn as part of routine laboratory testing as determined by the primary care provider.

      Additional blood samples (1.0 ml) will be collected throughout pregnancy at the same time
      blood is obtained for routine or otherwise clinically indicated laboratory testing. A maximum
      of 5 samples will be collected through the pregnancy.

      Maternal demographic data will be collected and patients will be followed longitudinally to
      the completion of pregnancy to ascertain their clinical status during pregnancy, onset of
      premature labor, premature rupture of membranes, delivery date, and gestational age at
      delivery.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women at USF coming in for their first prenatal appointment
      
Keywords: PLAC1; pregnant; first prenatal visit; pre-eclampsia
Study of Anaesthesia Costs and Recovery Profiles
Condition: Anaesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the perioperative hemodynamic parameters, recovery
      profiles and cost containment of sevoflurane and propofol based general anesthesia for
      otorhinolaryngeal surgery.
    

Detailed description: 
      Sevoflurane and propofol are two basic drugs in the maintenance of anaesthesia. In this study
      we compared the perioperative hemodynamic parameters, recovery profiles and cost containment
      of sevoflurane and propofol based general anaesthesia for otorhinolaryngeal surgery. Patients
      were equally divided into four anaesthetic subgroups. In groups A and C anaesthesia was based
      on sevoflurane or propofol, respectively, without bispectral index (BIS) and train-of-for
      monitor (TOF) monitoring. In groups B and D anaesthesia was based on sevoflurane or propofol,
      respectively, with BIS and TOF monitoring. Drug consumption, recovery profiles and
      anaesthesia costs were analysed.

      ECG, main arterial pressure (MAP), heart rate, oxygen saturation of peripheral haemoglobin
      (SpO2), pressure of end-tidal carbon dioxide was monitored continuously and registered at 5
      min intervals during anaesthesia. Each group received propofol for anaesthesia induction. In
      group A and B anaesthesia was maintained with sevoflurane, in groups C and D with propofol.
      In groups B and D the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien)
      and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical)
      were monitored too. BIS and TOF values were recorded at 5 min intervals.
    

Intervention name(s): Sevoflurane group A; Sevoflurane group B; Propofol group C; Propofol group D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was adjusted for the same MAP range.; In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.; In this group anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol dosing was adjusted for the same MAP range.; In this group anaesthesia was maintained with propofol. Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.
Other intervention name(s): Sevorane anaesthesia; Sevorane anaesthesia with BIS and TOF monitoring; Propofol anaesthesia; Propofol anaesthesia with BIS and TOF monitoring
Intervention MeSH terms: Anesthetics; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: anaesthesia; costs; recovery profiles
ARDS Prediction Score in Critically Ill Patients in China
Condition: ARDS; Septic Shock
MeSH terms: Shock, Septic; Critical Illness
Study type: Observational

Summary: 
      ARDS is a severe disease, it's important to predict the incidence of ARDS.
    

Detailed description: 
      From January 1 to January 31, 2012 and from January 1 to January 10, 2013 , all patients
      admit to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly
      medical history, Ventilator indications, Ventilator data, other respiratory treatments,
      weaning outcome and 28 day mortality will be recorded.
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        patients have the risk of ARDS
      
Keywords: mechanical ventilation, ARDS, Ventilator strategy, outcome
The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area:
Condition: Diabetic Foot; Wound Heal
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional

Summary: 
      Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic
      foot ulcer surface area.

      Participants: The forty five patients will assigned randomly into three equal groups, each
      group consist of 15 patients, group A received laser therapy in sequential mode, group B
      received laser therapy in separate mode and the control group C receive traditional wound
      care
    

Detailed description: 
      Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic
      foot ulcer surface area.

      Participants: The forty five patients will assigned randomly into three equal groups, each
      group consist of 15 patients, group A received laser therapy in sequential mode, group B
      received laser therapy in separate mode and the control group C receive traditional wound
      care Outcomes: the primary outcomes were the wound surface area measurement, % of wound
      complete closure and % of days needed for surface area reduction before and after receiving
      the treatment protocol for two consequetive months, and the secondary outcomes were % of
      wound cause and location frequencies
    

Intervention name(s): laser therapy
Intervention type(s): Device
Intervention description(s): All patients received 2 sessions of laser therapy / week in two consecutive months of treatment aiming complete wound closure , patients received & infrared laser therapy plus traditional wound care:
(I) Use red & infrared laser therapy device with 4 different wavelengths in a synchronized mode:
980 nm for wound decontamination, improve circulation, lymphatic drainage
915 nm enhances O2 delivery
810 nm increases ATP production
650 nm accelerate surface healing, tissue regeneration plus traditional wound treatment mentioned before
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 650 nm laser; infrared laser; chronic diabetic foot ulcer; wound surface area
A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
Condition: HIV-1
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load
      response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the
      dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability
      of UK-453,061 in asymptomatic HIV infected subjects.
    


Intervention name(s): UK-453,061; UK-453,061
Intervention type(s): Drug; Drug
Intervention description(s): Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days; Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
In-Patient Study In Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a placebo-controlled study to assess the safety and tolerability of a novel
      antipsychotic medication, (773812) when given to schizophrenic patients for twenty-eight
      days. Assessments include blood sampling to determine drug concentrations, psychiatric
      assessments while under treatment, and movement assessments to evaluate potential side
      effects.
    


Intervention name(s): SB773812
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; safety; tolerability; pharmacokinetics
Coughing in Infratentorial Brain Lesion Patients
Condition: Stroke
Study type: Observational

Summary: 
      To record diaphragm excursion in infratentorial brain lesions patients with dysphagia during
      coughing and compare them to those with supratentorial brain lesion patients with dysphasia
      and those with no dysphagia at a university affiliated rehabilitation department.
    

Detailed description: 
      Our previous work has shown that stroke patients with dysphagia have impaired diaphragm
      excursion in comparison to those with no dysphagia. It has been postulated that respiratory
      and cough function are primarily controlled by respiratory and swallowing centers located in
      the brainstem.We postulated that those with infratentorial brain lesions would have more
      impaired cough and respiratory function than those with non-brainstem lesions and
      supratentorial brain lesions.

      However there has been no studies whether those with infratentorial brain lesions have more
      impaired cough function and decreased diaphragm excursion than those with supratentorial
      brain lesions.
    

Intervention name(s): Not applicable (observational study with no active intervention)
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Dysphagia patients due to brain lesions at a university affiliated hospital
      
Keywords: brainstem; diaphragm; deglutition disorder; sonography