bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fasting Conditions
Condition: Pharmacokinetic Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Study subjects were screened and enrolled for the study. Subjects were housed in the clinical
      facility from not less than 12 hours pre-dose till at least 30 hours post-dose in each
      period. After maintaining at least 10 hours of overnight fast Test or Reference product was
      administered orally (as per the randomization schedule) to each subject with about 240 mL of
      water at ambient temperature in each period by trained study personnel.

      The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were
      collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50,
      10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period
      with a washout period of 7 days between the dosing of two periods. Subjects were continuously
      monitored for well being i.e., blood pressure, radial pulse and oral temperature before
      check-in, prior to drug administration and at regular intervals post dose in each period. The
      concentration of Ropinirole in plasma samples obtained from study subjects was determined
      using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on
      obtained drug concentration data, using appropriate software.
    


Intervention name(s): Ropinirole hydrochloride CR Tablets 2mg
Intervention type(s): Drug
Intervention description(s): Ropinirole is an orally administered non-ergoline dopamine agonist. Ropinirole is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
Other intervention name(s): Test Product; Ropinirole hydrochloride CR Tablets 2mg one Tablet at "0" hour; Reference Product; REQUIP XL Tablets (containing ropinirole 2mg) one Tablet at "0" hour
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Caffeine as a Therapy for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Parkinson's disease is a common neurodegenerative disorder in which patients experience
      progressive motor disability and many disabling non-motor symptoms. Recent studies have
      consistently found that people who do not use caffeine are at higher risk of developing
      Parkinson's disease. This suggests that caffeine may have potential as a treatment for PD.

      In a pilot study of caffeine for daytime sleepiness in PD, there was evident benefit on the
      motor manifestations of disease. There have been other lines of evidence that have suggested
      caffeine could be useful in PD. This study is to evaluate the efficacy of caffeine 200 mg BID
      vs matching placebo for motor and non-motor aspects of disease. This will be in three stages.
      In the first six-month stage, medications will be held constant, to see whether caffeine does
      have motor benefits. Then we will perform a four-year extension stage to define if the
      effects of caffeine persist (or even magnify), and to see if caffeine helps reduce dose of
      other PD meds and/or prevents their side effects. Finally, we will finish with a six-month
      stage in which we will place all patients on caffeine - this will allow us to assess
      caffeine's use in later disease, but more importantly, will assess whether early use of
      caffeine produces long term changes beyond its immediate effects.
    


Intervention name(s): Caffeine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy of MT-4666
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy as assessed by the
      Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of
      MT-4666 or placebo administered daily for 24 weeks to subjects with mild to moderate
      Alzheimer's disease.
    


Intervention name(s): MT-4666; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): low dose, high dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Nicotinic Acetylcholine Receptor Agonist; Cognitive function; Dementia; Central Nervous System Agents
Exploring the Cortical Hemodynamic Response of Excitatory Brain Stimulation: a Pilot Study
Condition: Healthy
Study type: Interventional

Summary: 
      Intermittent theta-burst stimulation (iTBS) is a promising treatment for major depressive
      disorder. However, fewer than 50% of patients show sufficient response. Therefore, the
      optimal treatment protocol is worth investigating. Recent studies show that the relationship
      between stimulation intensity and prefrontal hemodynamic response is not linear but in an
      inverse U-shape by exploring the hemodynamic changes before and after iTBS. Concurrent
      transcranial magnetic stimulation (TMS)/functional near-infrared spectroscopy (fNIRS) setup
      allows the investigators to observe the prefrontal hemodynamic response during stimulation.

      The aim of this study is to investigate the effects of different intensities on brain
      activity during and after the stimulation using fNIRS.
    

Detailed description: 
      Please refer to the full proposal
    

Intervention name(s): Intermittent theta-burst stimulation (iTBS)
Intervention type(s): Device
Intervention description(s): The iTBS will be applied over lDLPFC with three different intensities. The investigators put the NIRS probe under the TMS coil to detect the hemodynamic signal simultaneously, and the applied rMT was adjusted based on Stokes et al., 2007. The equation is AdjMT% = MT + 2.8 * (Dsitex - Dm1), and the thickness of the probe is 6mm, therefore, 2.8*6=16.8(%) were added to the normal intensity.
Other intervention name(s): Transcranial magnetic stimulation (TMS)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Healthy volunteers will receive iTBS three times with three different intensities separated by one week to investigate the prefrontal hemodynamic response to different stimulation intensities.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Theta-Burst stimulation (iTBS); Functional near-infrared spectroscopy (fNIRS); Concurrent TMS/fNIRS; Prefrontal hemodynamic response
Procedural Sedation Using Propofol Versus Midazolam/Ketamine in the Adult Emergency Department
Condition: Procedural Sedation
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of procedural sedation and analgesia (PSA) to accomplish painful procedures in the
      emergency department (ED) has become a standard of practice over the last decade. Substantial
      variance exists regarding usage of medication for PSA, and many anesthetic agents have been
      proposed for this use.

      To our knowledge no head to head study compared the clinical effectiveness, safety profile
      and amnestic properties of midazolam/ketamine vs. propofol regimens for PSA in the adult ED
      setting.

      This prospective randomized trail can will help to evaluate the effectiveness and safety
      profile of Midazolam/katamine regimen for ED PSA in adults and will contribute to the
      discussion regarding propofol roll in the ED.
    


Intervention name(s): Ketamine/Midazolam; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous bolus of midazolam 0.1mg/kg in titrated dose of 1 mg/min until spontaneous eye closure or up to 5mg (whichever comes first) followed by ketamine 0.5-1mg/kg (up to 100mg) in titrated dose of 10mg/30 seconds, to achieve the desired level of sedation; Intravenous bolus of propofol 0.5-1mg/kg in titrated dose of 10mg/30seconds (up to 100mg) to achieve the desired level of sedation
Intervention MeSH terms: Midazolam; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Procedural sedation and analgesia; Emergency Department; propofol versus ketamine and midazolam; painful orthopedic manipulations
Verapamil for Beta Cell Survival Therapy in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall purpose of this trial is to assess the efficacy and safety of using oral
      verapamil in subjects with recent onset T1D in order to downregulate TXNIP and enhance the
      patients' endogenous beta cell mass and insulin production. The objectives are therefore to
      assess parameters of beta cell survival (including new biomarkers), insulin production and
      glucose control and the feasibility of this approach and thereby provide the basis for
      future, larger/expanded, longer-term verapamil studies and the off-label use of this approved
      drug for Type 1 Diabetes (T1D).
    

Detailed description: 
      Loss of pancreatic beta-cell mass is a key factor in T1D, but therapies to halt this process
      are not available. The investigators have discovered thioredoxin-interacting protein (TXNIP),
      as a promising target in this regard and have now found that the commonly used
      anti-hypertensive drug and calcium channel-blocker, verapamil, effectively lowers beta-cell
      TXNIP expression in rodent beta-cells and human islets, promotes beta-cell survival and
      rescues mice from T1D. This makes verapamil a potentially attractive drug for T1D, but
      prospective clinical data are lacking. The investigators primary objective is therefore to
      conduct a randomized, placebo-controlled, double-blind study of the efficacy and safety of
      verapamil in adults with recent-onset T1D and to demonstrate that subjects on oral verapamil
      daily for 12 months will have improved insulin production (as an indirect measure of
      beta-cell mass).

      Results will have major translational implications with potential immediate impact on
      clinical care, encourage large clinical follow-up trials, evaluate markers of beta cell
      health and ultimately help develop a novel therapy that enhances the patient's own beta-cell
      mass and function.
    

Intervention name(s): Verapamil; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Verapamil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: verapamil; type 1 diabetes; diabetes; beta cells; beta cell function; insulin
A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The aim of the study is to compare the effect of asthma care by clinical pharmacist
      intervention versus routine care on asthma control.
    


Intervention name(s): Pharmacist- Intervention; Routine Care
Intervention type(s): Other; Other
Intervention description(s): Patients received additional education on basic facts about asthma, role of medications, the difference between long-term control medications and quick-relief medications, as well as patient skills in the first visit then reinforcement every two weeks.. The importance of proper inhaler technique, avoidance of asthma triggers and self-monitoring of asthma were also highlighted. Visual aids, physical demonstration as well as written information resources were supplied. Asthma care plans were tailored to patient needs and preferences. Patients were informed how to detect early signs of worsening asthma, when and how to seek medical care as appropriate.; Patients received usual care delivered by physician without pharmacist intervention. Patients were prescribed asthma medication with summarized basic information on asthma and medication use. Follow-up visits were not planned on consistent basis, but rather individually according to the disease status. No asthma action plans were provided.
Other intervention name(s): Patient Education; Asthma Action Plan; Shared Decision Making
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
Condition: Diabetes; Diabetes Mellitus, Type 2; Cholesterolemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and
      safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with
      type 2 diabetes (T2D) and elevated LDL-C
    

Detailed description: 
      Assess efficacy of FDC vs. ezetimibe vs. placebo for 12 week LDL-C lowering, changes in
      atherogenic lipids, hsCRP and exploratory glycemic measures as well as safety in patients
      with type 2 diabetes and elevated LDL-C.
    

Intervention name(s): Bempedoic acid + Ezetimibe FDC Oral Tablet; Ezetimibe 10 mg Oral Tablet; Placebo Oral Tablet; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Experimental therapy of bempedoic acid 180 mg + ezetimibe 10 mg FDC tablet; Ezetimibe 10 mg tablet, overencapsulated for blinding purposes; Placebo tablet, matched for the FDC product for blinding purposes; Placebo over-encapsulated for blinding purposes
Other intervention name(s): Zetia
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; cholesterolemia; type 2 diabetes; LDL-C; T2D; diabetes mellitus
Study to Evaluate Cardiac Hemodynamics and Safety of SLV320 in Subjects With Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a randomized, placebo controlled, multi-center, single dose study to evaluate
      cardiac hemodynamics and safety of iv SLV320 in 110 subjects with congestive heart failure
      requiring diuretic treatment. Each subject will receive one dose of SLV320 or placebo or
      furosemide. The study consists of three visits (or study days when in-subjects are included).
      Ambulatory subjects will be in hospital for two nights and one day.
    


Intervention name(s): SLV320
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: congestive heart failure, adenosine receptor blocker, cardiac hemodynamic
Proteomic Assessment of Preterm Birth
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to to collect and store blood samples that will be utilized to
      develop a multimarker test to predict preterm delivery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women who are receiving prenatal care.
      
Biospecimen description: 
      Serum, plasma
    
Keywords: Preterm Birth, Proteomics
MyPatientPal: An App to Help Patients Manage Their Cancer Care
Condition: Cancer
Study type: Interventional

Summary: 
      MyPatientPal was developed in collaboration with both patient and oncologist stakeholders, is
      designed to facilitate such patient self-management through the daily reporting of side
      effects and medications.
    

Detailed description: 
      MyPatientPal is a patient app that is designed to help patients track and manage treatment
      side effects and medication adherence on a daily basis. Side effects (e.g., pain, fatigue,
      diarrhea, nausea) can be physically and emotionally debilitating, and when uncontrolled, can
      cause treatment complications, resulting in unscheduled care costs, patient out-of-pocket
      costs, and delays or discontinuation of treatment. The app allows personalization of daily
      entries such that patients can select the specific medications and dosage and side effects
      (using items from the NCI Common Terminology Criteria for Adverse Events) that they and/or
      their providers want to track. A charting feature provides an easy-to-read display of
      patients' daily reports, summarizing the intensity and frequency of side effects and
      medication use either by week or by month. These reports can also be printed out and shared
      with providers.
    

Intervention name(s): MyPatientPal smartphone app
Intervention type(s): Other
Intervention description(s): All patients in this single-arm study will use a smartphone-based app, MyPatientPal, to enter symptoms and track medications related to their cancer treatment. No drugs will be administered for the purposes of this behavioral study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Acute Physical Exercise on Memory
Condition: Acute Physical Exercise
Study type: Interventional

Summary: 
      An increasing amount of studies show the beneficial effect of regular exercise on cognitive
      and brain functions and especially in the memory domain. Yet little is known of what happens
      within an acute bout of exercise and whether it would also yield cognitive effects. The
      literature clearly shows that molecules such as brain derived neurotrophic factor (BDNF) and
      endocannabinoids (mainly anandamide, AEA) are heavily involved in neural plasticity
      mechanisms and increase when we exercise hinting at possible mechanisms underlying memory
      improvement after exercise.

      This protocol assesses the effects of acute exercise on associative and motor sequence
      memory, their underlying neural activations (measured using fMRI) and blood biomarkers (BDNF
      and AEA). A related aim is to assess the effect of exercise intensity, therefore three
      exercising conditions (rest, moderate intensity and high intensity) were included. Finally, a
      3-month delayed retest visit is also realized to assess effects of acute exercise on
      long-term memory consolidation.
    


Intervention name(s): moderate intensity physical exercise; high intensity physical exercise; rest
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a within-subject study, all participants perform all conditions in cross-over randomized order.
Masking: None (Open Label)
Primary purpose: Other
Keywords: fMRI; BDNF; endocannabinoid; physical exercise
High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will investigate the safety and efficacy of quetiapine in sub-optimally responding
      patients with DSM-IV schizophrenia using a double blind, randomized 12-week trial comparing
      oral doses of 1200 mg/d to 600 mg/d of quetiapine.
    

Detailed description: 
      The study will be conducted at two sites: Manhattan Psychiatric Center (MPC), and the
      Clinical Research and Evaluation Facility at the Nathan S. Kline Institute for Psychiatric
      Research/Rockland Psychiatric Center (NKI). A total of 60 patients will be enrolled, 30 at
      each location. After a screening period of 1 week, all patients will be entering an open
      label, four-week quetiapine treatment period (run-in phase), during which quetiapine will be
      titrated to 600 mg PO daily and other adjunctive antipsychotics will be gradually tapered and
      discontinued. Other concomitant medications such as mood stabilizers will be maintained, if
      their dose has been stable for the preceding 2 months. Patients not responding to quetiapine
      treatment at 600 mg PO (defined as reduction of < 15% change in Positive and Negative
      Syndrome Scale (PANSS) total score between start of run-in to end of week 4) during the
      run-in phase, will be eligible to enter the double blind phase. Study baseline will be Day 7
      of Week 4 of the run-in phase. Patients qualifying for the double-blind phase will be
      randomly assigned to either high dose 1200 mg quetiapine daily (Group A) or to 600 mg
      quetiapine (Group B) daily and treated on the assigned dose in a double blind fashion for 8
      weeks (Week 1 through Week 8 of double blind phase). Measures of extra-pyramidal side
      effects, psychopathology, and safety will be conducted throughout the trial.
    

Intervention name(s): quetiapine; quetiapine
Intervention type(s): Drug; Drug
Intervention description(s): Participant will receive 1200 mg/day of quetiapine in twice daily dosing for 8 weeks.; Participant will receive 600 mg/day of quetiapine for 8 weeks.
Other intervention name(s): Seroquel; Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; quetiapine; schizoaffective disorder