bioihbjkbjnl/mcl2 huggingface dataset:
Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare and evaluate the safety of AVP-923
      (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.
    


Intervention name(s): AVP-923
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: AVP-923; Dextromethorphan; Quinidine; Pseudobulbar Affect
Phase 1, Safety and Bronchopulmonary PK Study in Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, randomized, PK and safety study in a maximum of 25 healthy
      subjects who have provided a bronchoalveolar lavage (BAL) sample.
    

Detailed description: 
      This is a Phase 1, open-label, randomized, PK and safety study in a maximum of 25 healthy
      subjects who have provided a bronchoalveolar lavage (BAL) sample. The dose planned to be
      administered in this study is an iv infusion of 30 mg TP 6076 q24h for 4 consecutive days
      (starting on Day 1 and ending on Day 4).

      Subjects will be randomized to undergo a BAL at a single time point: either 2, 4, 8, or 24
      hours after the start of the final TP-6076 iv infusion on Day 4. The BAL will be conducted in
      5 different subjects at each of the 4 time points, adding up to a total of 20 subjects.
    

Intervention name(s): TP-6076; Bronchoalveolar lavage
Intervention type(s): Drug; Procedure
Intervention description(s): The dose planned to be administered in this study is an iv infusion of 30 mg TP 6076 q24h for 4 consecutive days (starting on Day 1 and ending on Day 4).; Subjects will be randomized to undergo a BAL at a single time point: either 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.
Other intervention name(s): BAL
Intervention MeSH terms: Dimercaprol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers
Condition: Primary Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate Pharmacokinetic Properties and Safety after
      administration of HCP1306 tablet and Co-administration of HGP0816 tablet, HGP1404 tablet in
      the healthy adults.
    

Detailed description: 
      A Randomized, Open-Label, Two-way Crossover, Single-Dose Study to Compare Pharmacokinetic
      Properties and Safety after administration of HCP1306 tablet and Co-administration of HGP0816
      tablet, HGP1404 tablet in the healthy adults
    

Intervention name(s): HGP0816; HGP1404; HCP1306
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for
      the treatment of signs and symptoms in patients with active RA who failed an adequate trial
      of therapy with at least 1 DMARD in a 12-week therapy.
    


Intervention name(s): Placebo; CP-690,550; CP-690,550; CP-690,550; CP-690,550; CP-690,550
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo BID, 3 blinded tablets administered BID for 12 weeks; 10mg BID, 3 blinded tablets administered BID for 12 weeks; 15mg BID, 3 blinded tablets administered BID for 12 weeks; 1mg BID, 3 blinded tablets administered BID for 12 weeks; 3mg BID, 3 blinded tablets administered BID for 12 weeks; 5mg BID, 3 blinded tablets administered BID for 12 weeks
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 2 monotherapy in Japan
Effects of Flaxseed Supplementation in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and
      anthropocentric measurements in subjects with metabolic syndrome, in a randomized,
      open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received
      30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. Both
      groups will be advised to follow an energy balanced diet and physical activity
      recommendations. Parameters related to metabolic syndrome will be measured at the baseline
      and at the end of the study.
    


Intervention name(s): flaxseed; lifestyle modification
Intervention type(s): Dietary Supplement; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Docosahexenoic Acid (DHA) Supplementation and Cardiovascular Disease in Men With High Triglycerides
Condition: Hypertriglyceridemia
MeSH terms: Cardiovascular Diseases; Hypertriglyceridemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of supplementing diets of
      hyperlipidemic men with DHA (docosahexenoic acid) on risk factors for cardiovascular disease.
      We hypothesize that supplementing diets of hyperlipidemic men with DHA will decrease the
      plasma concentrations of CRP (C-reactive protein), inflammatory cytokines, and soluble
      adhesion molecules. We further hypothesize that DHA supplementation will decrease serum
      triglyceride concentrations and increase HDL concentration.
    

Detailed description: 
      Cardiovascular disease (CVD) and stroke are the leading causes of mortality in the United
      States, accounting for more than 38% of all deaths. Elevated total- and LDL- cholesterol,
      number of total and small dense LDL particles, triacylglycerols, and low HDL-C are
      established independent risk factors for the development of CVD. Additional novel blood lipid
      markers used as risk factors for CVD include, increased plasma concentration of remnant like
      particle-cholesterol (RLP-C), decreased ratio between plasma eicosapentaenoic acid (EPA) and
      arachidonic acd (AA), and decreased omega-3 index (sum of EPA and DHA as a percentage of
      total fatty acid content) of the red blood cells.

      Diets rich in omega-3 fatty acids have been shown to be cardio-protective; these diets
      decreased inflammation, platelet aggregation, cardiac arrhythmias, triglycerides, number of
      total LDL and small dense LDL particles, and increased omega-3 index, endothelial relaxation
      and atherosclerotic plaque stability. Most of the earlier studies regarding the effects of
      long chain n-3 PUFA on blood lipids were conducted with fish oils which contain a mixture of
      EPA and DHA. Recently a number of studies have been conducted with EPA and DHA individually.
      Results from studies with individual fatty acids show that EPA and DHA have similar effects
      on some of the lipid parameters, but they are assimilated to a different concentration in
      tissues and have different effects on lipoprotein particle size, heart rate and blood
      pressure. The main purpose of this study is to examine the effects of DHA supplementation on
      the above three risk factors.
    

Intervention name(s): Docosahexenoic acid (DHA); Olive oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The DHA group received 7.5 g/d DHA oil (DHA 3.0 g/d) which is produced in the microalga Crypthecodinium cohinii.; 7.5 g olive oil/day
Other intervention name(s): Martek Biosciences Corporation, Neuromins Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: docosahexenoic acid (DHA); dietary supplement; n-3 polyunsaturated fatty acid; cardiovascular disease
Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children
Condition: Lifestyle-related Condition; Overweight and Obesity; Essential Fatty Acid Deficiency
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      This study hypothesizes that supplementation of omega-3 fatty acids (OM3) can increase
      physical activity, inhibit rapid gain in body weight and BMI in both sedentary and normally
      active 8 year old children. The purpose is secondarily to explore patterns of associations
      between OM3 supplementation, baseline and follow-up levels in all studied parameters. The
      study also aims to study if basal levels of OM3 are correlated with physical activity and to
      study if there is an association between basal levels of OM3 and the effect of OM3
      supplementation on physical activity. To study if there is an effect of OM3 supplementation
      on triglyceride and LDL cholesterol levels and to study if there are more pronounced effects
      on children with higher levels. To study if OM3 supplementation, compared with placebo reduce
      weight increase among children at risk to become overweight. To study if there is an
      association between effects of OM3 on physical activity, weight and risk markers in blood. To
      study if there are any gender differences.
    


Intervention name(s): Omega-3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This group will receive capsules containing omega-3, omega-6 and vitamin E. The dosage is six capsules per day containing a total of 558 mg of eico-pentaenoic acid (EPA), 174 mg of docosahexaeonic acid (DHA), 60 mg of gamma-linolenic acid (GLA) and 9,6 mg vitamin E in natural form (alfa-tocopherol), gelatine, glycerol. Participants will be instructed to eat three capsules each morning and evening.; This group will receive capsules containing rape seed oil. Participants will be instructed to eat three capsules each morning and evening.
Other intervention name(s): OM3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Omega-3; physical activity; children; obesity; sedentary; accelerometry; BMI; fatty acids; inflammatory markers; intervention; randomized; double blind
Validation of Novel BTE and SP Hearing Aid Models
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Participants will wear one set of 2 different BTE hearing aid models based on the gain
      required by their hearing loss. The hearing aids will be programmed based on a prescriptive
      approach and participants will be sent out for either one home trial with the less powerful
      BTEs or for two home trials with the SP (super power) BTEs.
    

Detailed description: 
      During this study each participant will be asked to wear a set of BTE hearing aids home and
      wear them daily. We will be assessing their evaluation of the BTEs during and after their
      home field trial. They will be asked to report on their use with different apps/accessories.
      Subjective performance ratings will be collected.
    

Intervention name(s): BTE hearing aid
Intervention type(s): Device
Intervention description(s): Amplification
Intervention model: Single Group Assignment
Intervention model description: 2 groups based on hearing aid gain needs; one similar intervention
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose Study to Assess the Safety, Tolerability, Concentration in Body and Effect of BAF312
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and effect of oral BAF312 on
      bodily functions as well as the body's absorption, distribution, metabolism, and excretion of
      BAF312 in healthy volunteers
    


Intervention name(s): BAF 312
Intervention type(s): Drug
Intervention MeSH terms: Siponimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Safety, tolerability, pharmacokinetics, pharmacodynamics, oral, BAF312, healthy volunteers
Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      It should be shown that Cerebrolysin in combination with Alteplase, the medication that
      should recover the blood flow through the brain, is an effective and save medication to treat
      ischeamic stroke.
    

Detailed description: 
      The current trial should evaluate a combined treatment using Cerebrolysin immediately after
      thrombolysis to guarantee that the neurotrophic components are able to reach the endangered
      brain areas efficiently. An early start of treatment should guarantee rescue of most of the
      neurons reducing the overall damage.The study follows the design of pure thrombolytic trials
      to investigate, if the early neuroprotective treatment with Cerebrolysin is able to improve
      the overall outcome of patients at the day 90 evaluation visit. Due to the initial findings
      special emphasis will be also put on analysing the speed of recovery.
    

Intervention name(s): Cerebrolysin; 0.9% Saline Solution
Intervention type(s): Drug; Drug
Intervention description(s): Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.; 0.9% Saline Solution, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
Other intervention name(s): NaCl
Intervention MeSH terms: Cerebrolysin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebrolysin; Alteplase; Ischemic Stroke; Modified Rankin Scale; NIH Stroke Scale; Barthel Index; Glasgow Outcome Score
Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies
Condition: Colonoscopy
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study is to establish and identify the level of sedation that is performed in
      the endoscopy rooms of Galdakao Hospital. To do this, the investigators used the BIS
      monitoring system, which obtains objective values in real time from the anesthesia performed.
      The monitoring is completed with basic parameters validated by European guidelines (heart
      rate, blood pressure, oxygen saturation and respiratory rate), capnography and Ramsay
      sedation scale, widely validated for use outside the operating room. The main work hypothesis
      was that in at least 10% of the patients BIS values compatible with moderate or deep sedation
      would be obtained (BIS <65).
    

Detailed description: 
      Observational study in patients undergoing scheduled colonoscopy in endoscopy rooms of the
      Galdakao-Usansolo Hospital. The investigators objectified the level of sedation that was
      performed in these procedures using Bispectral Index Monitoring, as well as the total dose of
      medication required and the level of satisfaction obtained after completing the sedation. The
      incidence of hemodynamic and respiratory complications observed was included, as well as the
      treatment needed to solve them.

      A total of 196 patients were needed to obtain statistically significant results. Qualitative
      variables are expressed in the form of freguencies and percentages and continuous variables
      in the form of means and stnadard deviations. Comparisions of percentages were made by the
      Chi square test and the difference of means in the continuous variables by the t
      test.Stadistical significance will be assumed when p<0.05. All estadistical analyzes were
      carried out using SAS V9.4 (SAS Institute, Inc., Carey, NC).
    

Intervention name(s): BIS monitor
Intervention type(s): Device
Intervention description(s): The investigators placed on the forehead of all patients the sensor BIS quatroTM, that connects with the monitor, and they registered sedation and recorded the values obtained.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients from the general population, residents in the geographical area corresponding to
        the Hospital Galdakao Usansolo, who attended the endoscopy rooms. Were included to undergo
        a scheduled colonoscopy, either for monitoring, diagnostic or screening, and to meet the
        cited inclusion criteria.
      
Keywords: Sedation
Allergen Challenge Trial of IRL201104 in Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this allergen challenge study is to assess the efficacy of IRL201104 compared
      with placebo in adult participants with seasonal allergic rhinitis.
    


Intervention name(s): IRL201104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): lyophilised powder for reconstitution for IV dosing; Matching placebo for IRL201104
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of a Web-Based Alcohol Intervention for High School Students
Condition: Underage Drinking
MeSH terms: Underage Drinking
Study type: Interventional

Summary: 
      This study evaluates the efficacy of the eCHECKUP TO GO as an intervention to reduce underage
      drinking and the associated negative consequences among high school seniors. The aim of this
      project is to provide a brief, low cost intervention that can be easily disseminated as a
      school-based intervention to address this important public health problem.
    


Intervention name(s): eCHECKUP TO GO
Intervention type(s): Behavioral
Intervention description(s): eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Functional Imaging of Cerebellar Mutism Syndrome
Condition: Brain Mass
MeSH terms: Mutism
Study type: Observational

Summary: 
      The purpose of this study is to better understand why some children with cancer have
      difficulty speaking after brain surgery. Difficulty speaking may be due to known
      complications to the language centers in the brain. These language centers may be located in
      slightly different places in different people. This study will study which areas may be
      damaged.
    


Intervention name(s): MRI with DTI and fMRI
Intervention type(s): Procedure
Intervention description(s): When possible, the subject will undergo a post operative fMRI/ DTI scan as well as clinical language testing. If the subject develops CMS, the second fMRI will be performed as soon as possible. Some subjects may be severely impaired or have difficulty performing fMRI and clinical language testing tasks. In these instances, the fMRI and language testing may not be performed, or we may choose to perform resting state or passive fMRI tasks instead.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MSK clinics
      
Keywords: mass in posterior fossa; benign; malignant; surgical resection; MRI; fMRI; DTI; 12-121
Comprehensibility of Colorectal Cancer Screening Educational Materials: Effects on Patient Knowledge and Motivation
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a newly developed patient education
      document concerning colorectal cancer screening will be better understood and have greater
      effects on patient knowledge of and motivation for screening than a standard educational
      document.
    


Intervention name(s): New colorectal cancer screening patient education document; Traditional colorectal cancer screening education document
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The newly developed educational document was created accounting for health behavioral models (such as the Expanded Health Behavior Model, Social Cognitive Theory, and the Transtheoretical Model) and related research studies indicating the factors that most strongly and positively influence patients' cognitions regarding colorectal cancer screening and are, in turn, predictive of actual colorectal cancer screening behavior.; The traditional educational document is a slightly edited version of materials freely available on the National Cancer Institute (NCI) web site, used in this study with the permission of the NCI.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: health behavior; randomized controlled trials; self-efficacy; patient education; comprehension; mass screening; prevention and control
Effects of a Dual Task Protocol on Cognition and Functionality in Non-sedentary Older Adults
Condition: Non-sedentary
Study type: Interventional

Summary: 
      The purpose of this study is to analyze the effects of a dual task protocol on cognitive
      domains and functional capacity in non-sedentary older adults.

      The hypothesis of the present study is that older people undergoing to a dual task exercise
      protocol have greater benefits on cognition and functional performance, compared to a
      standard exercise protocol.
    


Intervention name(s): Dual task training; Conventional training
Intervention type(s): Other; Other
Intervention description(s): The dual task training consisted of individuals subjected to a multicomponent exercise program associated to cognitive tasks.; The conventional training consisted of individuals subjected to a multicomponent exercise program.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aged; Exercise; Cognition; Functional capacity