bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Theophylline in the Treatment of Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Theophylline was well recommended in the treatment of chronic obstructive pulmonary disease
      (COPD) and asthma. However, there is no supporting evidence for their efficacy in the
      treatment of bronchiectasis. Our hypothesis is that theophylline will play a role in
      bronchiectasis. Our purpose is to examine the efficacy and safety of 24 weeks treatment with
      theophylline in subjects with non-cystic fibrosis bronchiectasis.
    

Detailed description: 
      For the reasons of lack of sufficient clinical trial evidences, there are no standard therapy
      recommendations for bronchiectasis. Currently the treatments for bronchiectasis are mostly
      based on experience gained from the treatment of COPD and cystic fibrosis(CF). The aims of
      treatment for bronchiectasis are to improve the health-related quality of life, to slow down
      the decrease of lung function, to reduce the exacerbation frequence and the mortality. The
      mechanism of treatment are including: treating the underlying disease; improving drainage of
      sputum; anti-infection; anti-inflammation; treating airway obstruction. A review written by
      Peter J. Barnes describes that as a bronchodilator in COPD, theophylline may relax human
      airways smooth muscle, have an anti-inflammation rols, and have an additional effect on
      mucociliary clearance. Besides, theophylline can improve the activity of histone deacetylase,
      which will reverse the resistant of corticosteroids. We hypothesis that theophylline will
      have the same effect in subjects with NCF-bronchiectasis as in subjects with COPD. Our trial
      may give an evidence of using theophylline in treatment of bronchiectasis.
    

Intervention name(s): Theophylline; Placebo(for Theophylline)
Intervention type(s): Drug; Drug
Intervention description(s): Theophylline 0.1 bid; Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet)
Other intervention name(s): Theophylline Sustained-Release Tablet.
Intervention MeSH terms: Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchiectasis; Theophylline; Therapeutic Uses; HDAC; HAT; Random placebo study
A Study in Healthy Men to Test How BI 765080 is Taken up in the Body When Given as an Injection Under the Skin Compared With an Infusion Into the Vein
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy man to investigate the absolute bioavailability of 100mg BI 765080, once
      administered as subcutaneous (SC) injection and once administered as intravenous infusion.
    


Intervention name(s): BI 765080
Intervention type(s): Drug
Intervention description(s): BI 765080
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a left ventricular rapid pacing using the
      valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the
      overall procedure duration in comparison with the conventional method.
    

Detailed description: 
      Use of temporary pacing via a right ventricular lead in TAVI is still mandatory to ensure
      transient cardiac standstill while predilatation is performed and the valve is being
      positioned and deployed. This requires an additional venous vascular access and a pacing
      catheter which are both likely to generate complications.

      This study compares the standard right ventricular rapid pacing to a new and simplified
      technique : a left ventricular rapid pacing is provided via the back-up 0.035 " guidewire.
      The cathode of an external pacemaker is placed on the tip of the 0.035" wire and the anode on
      a needle inserted into the groin. Insulation is ensured by the balloon or TAVI catheter.
    

Intervention name(s): pacing catheter; valve delivery guidewire
Intervention type(s): Device; Device
Intervention description(s): Rapid pacing during TAVI is required to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. In the right ventricular pacing arm, rapid pacing is provided by a standard right ventricular pacing catheter.; Rapid pacing during TAVI is required to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. In the Left ventricular pacing arm, rapid pacing is provided via the valve-delivery guidewire inserted into the left ventricle. The cathode of an external pacemaker is placed on the external end of the guidewire using an alligator clamp. The TAVI catheter provides the necessary insulation. The anode is attached directly to the subcutaneous tissue at the femoral entry site (also using an alligator clamp).
Other intervention name(s): transvenous stimulation electrode; pacing lead; pacing wire
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: TAVI; aortic valve bioprothesis; TAVI simplification; aortic stenosis; rapid left ventricular pacing; TAVR
Evaluation of Efficacy and Safety of AGP on Immune Enhancement
Condition: Immune Function
Study type: Interventional

Summary: 
      The researchers investigated the immune enhancing effects of AGP for Korean participants.
    

Detailed description: 
      The aim of the study is to investigate the effects of AGP on immune enhancement based on 8
      week, randomized, double-blind, placebo-controlled clinical trial.
    

Intervention name(s): AGP; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): take two tablets per day (500 mg/day) for 8 weeks; take two tablets per day (500 mg/day) for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Different Domains of Executive Function Dual Task Walking on Brain Activation and Gait Performance in Healthy Adults
Condition: Executive Function; Neurosciences
Study type: Observational

Summary: 
      The aim of this study is to investigate the effects of different domains of executive
      function (EF) during dual task walking condition on brain activation and gait performance in
      healthy adults. There are two experiments will be conducted in this study. Experiment 1 is a
      pilot study to determine the same level of difficulty in 3 EF domains, including inhibition,
      working memory and cognitive flexibility. Experiment 2 is carried out to investigate the
      effects of 3 different domains of EF which difficulties are controlled on gait performance
      and brain activation in dual task condition. 10 subjects will perform Stroop test (2s/3s/4s
      to change question), backward digit spans (3/4/5 digits) and naming test in Experiment 1. In
      Experiment 1, the primary outcome is the correct response speed (CRS) while secondary outcome
      will be the brain activity. In Experiment 2, 30 subjects will perform the single cognitive
      task A (SCTA, Stroop test), single cognitive task B (SCTB, backward digit spans), single
      cognitive task C (SCTC, naming test), single walking task (SWT), dual task A (DTA, walking
      while performing cognitive task A), dual task B (DTB, walking while performing cognitive task
      B) and dual task C (DTC, walking while performing cognitive task C). The CRS, gait
      performance, brain activity and the dual task costs (DTC) will be recorded in the Experiment
      2. Brain activities in prefrontal cortex (PFC), premotor cortex (PMC) and supplementary motor
      area (SMAs) will be measured by functional near-infrared spectroscopy (fNIRS) during this
      study. One-way ANOVA with Tukey post-hoc test will be performed to establish the effect of
      different type of executive task on CRS or the brain activity. The differences of gait
      parameters and brain activity in different condition in the Experiment 2 will be examined by
      one-way ANOVA with repeated measured. Furthermore, the Pearson correlation coefficient will
      be used to examine the correlation of brain activation and executive function performance or
      gait parameters.
    


Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population in this study are heathy adults.
      
Keywords: executive function; dual task walking; difficulty level; brain activity; motor performance
Pregnancy Outcomes in Infertile Patients After Treatment With Ulipristal Acetate.
Condition: Myoma;Uterus; Infertility, Female
MeSH terms: Leiomyoma; Myofibroma; Infertility; Infertility, Female
Study type: Observational

Summary: 
      The investigators analyzed a group of infertile women treated with Ulipristal Acetate (UA)
      for uterine fibroids at the Humanitas Fertility Center. All the patients' data were extracted
      from the Fertility Center external-audit-anonymized electronic research query system.
    

Detailed description: 
      In the recent years several large studies have been published on the efficacy of Ulipristal
      Acetate treatment of moderate to severe symptoms of uterine fibroids in adult women:
      initially proposed only as pre-surgical treatment, the UA was subsequently also used for the
      long-term treatment of uterine myomas symptoms.

      However, few data are available on the effects of UA in terms of increasing fecundability,
      implantation and pregnancy outcome and safety in the general population, and in infertile
      patients in particular.

      This retrospective study aims at describing the correlation between the use of Ulipristal
      Acetate and pregnancy outcome in infertile patients and at comparing the UA plus surgery
      approach to the UA-only treatment in terms of pregnancy outcome.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The women included were patients of the Humanitas Fertility Center; they all had a
        diagnosis of infertility and were trying to become pregnant. They received ≥1 month of
        therapy with UA 5 mg/day over the period 2013 - 2018
Real-time Amino Acid Profiling
Condition: Protein Digestion Kinetics
Study type: Interventional

Summary: 
      This study was designed to obtain information about the effect of new combinations of dairy
      proteins, in small servings with high protein concentrations, on postprandial amino acid
      kinetics in blood in an older population.
    


Intervention name(s): Casein; Dairy protein blend 1; Whey protein; Dairy protein blend 2; Dairy protein blend 3; Dairy protein blend 4
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): See arm description; See arm description; See arm description; See arm description; See arm description; See arm description
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is designed as a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 6 different dairy products.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Amino acids; Dairy proteins; Postprandial; Older adults
Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers
Condition: Asthma; Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the safety and tolerability of
      BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and
      healthy Japanese male volunteers following single oral administration and multiple
      administrations.
    


Intervention name(s): BI 671800; placebo
Intervention type(s): Drug; Drug
Intervention description(s): In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.; Subjects will receive according to the dose group matching number of placebo tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
"EspaiJove.Net"- a School-based Intervention Program to Promote Mental Health in Adolescent Population
Condition: Mental Health; Stigma, Social
Study type: Interventional

Summary: 
      Objective: To evaluate the efficacy of 3 sensitivity and mental health literacy programs for
      young students in the increase of mental health knowledge, to help seeking and reducing the
      stigma in order to prevent mental disorders and to reduce symptoms.

      Design: Multicenter randomized clinical trial school-based during 12 months follow up.
      Setting: Educational centers of secondary education (E.S.O) (public or private) of Barcelona.
      Subjects: 408 students between 13 and 18 years old who attend 3rt ESO in 8 randomized schools
      of Barcelona.

      Interventions: 3 intervention groups of ascending intensity: 1) Sensitivity Program Mental
      Health (SP)(1h); 2) Mental Health Literacy Program (MHLP) (6h); 3) MHLP more Stigma Reduction
      (ER) ( MHLP+RE)(7h).Control group: waiting List.

      Measures of results:1) Mental Health Literacy; 2) Stigma associated with mental health; 3)
      Mental Symptoms and Positive Mental Health (SDQ); 4) Bullying and Ciberbullying; 5) Quality
      of life (E-5D); 6) Intent to change; 7) Help Seeking (AHSQ); 8) Use of Health Services and
      Treatment and 9) Satisfaction.
    


Intervention name(s): "EspaiJove.net" mental health literacy program
Intervention type(s): Other
Intervention description(s): The "EspaiJove.net: a space for mental health" (EspaiJove.net) project is a MHL program which aims the promotion of mental health, the prevention of mental disorders, the facilitation of help-seeking behaviors and the eradication of stigma among secoundary students into the Spanish context.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: mental health; promotion; prevention; adolescence; school programs; intervention
Dose-finding Study for AdimrSC-2f Vaccine
Condition: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      AdimrSC-2f is a subunit protein-based vaccine produced using the baculovirus insect cells
      manufacturing process to prevent Coronavirus disease 2019 (COVID-19). The primary goal of
      this Phase I/II study is to evaluate the vaccine safety and immunogenicity of AdimrSC-2f in
      healthy adult individuals, as compared to placebo.
    

Detailed description: 
      This will be a Phase I/II, placebo-controlled, randomized, double-blind within dose cohort,
      dose-finding study to evaluate the safety, tolerability, and immune response of AdimrSC-2f
      vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in healthy
      adults aged from 18 to 60. Two hundred forty (240) subjects will be sequentially enrolled
      from low dose to high dose cohort and then randomized into AdimrSC-2f vaccine group or
      matched placebo in a 3:1 ratio. Each enrolled subject will receive a total of 3 doses with
      3-week apart by 0.5 mL intramuscular (IM) injection to the deltoid region of non-dominant arm
      preferably. All enrolled subjects will be follow their safety and immune response for six
      months.
    

Intervention name(s): AdimrSC-2f
Intervention type(s): Biological
Intervention description(s): IM injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-chamber Parenteral Nutrition Formulation
Condition: Nutrition Support
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared
      to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in
      hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or
      contraindicated.
    


Intervention name(s): Oliclinomel N4; Compounded ternary parenteral nutrition admixtures
Intervention type(s): Other; Other
Intervention description(s): Oliclinomel is a PN product which provides the macronutrients (e.g., dextrose, amino acids, and lipids) for patients when oral or enteral nutrition is not possible, insufficient, or contraindicated; Study treatment will be administered for a minimum of 5 days up to a maximum of 14 days
Other intervention name(s): Oliclinomel N4-550
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: (PN) Parenteral nutrition; oral/enteral not possible
Effect of High Caloric Diet on Brain Insulin Sensitivity and Inflammation
Condition: Obesity; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Obesity if known to be associated with brain insulin resistance in humans and evidence is
      rapidly accumulating that brain insulin resistance influences peripheral metabolism, eating
      behavior and cognition. A reduced insulin response in the brain is found mainly in people
      with a metabolically unfavorable fat distribution - high visceral fat. Visceral fat produces
      inflammatory mediators and elevated inflammatory levels are closely linked to insulin
      resistance. Inflammation of the brain (i.e., neuroinflammation) has been proposed as a
      possible cause of brain insulin resistance. Interestingly, rodent models of a high calorie
      diet show that these inflammatory mechanisms occur rapidly in the brain, even prior to weight
      gain of the animals. Among other things, it has been shown in humans that a short-term
      increase in calories, especially carbohydrates and fats, reduces insulin sensitivity in the
      body and increases inflammatory parameters in the blood. Whether a high-calorie diet triggers
      insulin resistance or inflammation in the human brain is currently unknown.

      Aim of study:

      The aim of the study is to investigate the effects of a five-day high calorie diet in healthy
      young male volunteers on peripheral and brain insulin sensitivity as well as on eating
      behavior, mood and cognition. Brain insulin sensitivity, peripheral metabolism and different
      behavioral assessments will be evaluated before, 1 week and 2 weeks after high caloric diet.
    


Intervention name(s): High caloric diet
Intervention type(s): Other
Intervention description(s): After dietary counseling, subjects will receive high caloric snacks for five days.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
Condition: Otitis Media With Effusion in Children; Otitis Media Recurrent
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to
      tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
    


Intervention name(s): EXE844 Sterile Otic Suspension, 0.3%; Tympanostomy Tube Insertion
Intervention type(s): Drug; Procedure
Intervention description(s): Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
SAL-0951 Tablets in the Treatment of Renal Anemia in Non-dialysis Chronic Kidney Disease
Condition: Renal Anemia in Non-dialysis Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase 3 randomized, double-blind, placebo-controlled clinical study to
      evaluate the efficacy and safety of SAL-0951 in CKD-anemia patients in Non-dialysis,
      comprising 8 weeks of double-blind treatment period followed by an open-label treatment
      period, making up a total of 27 weeks.
    


Intervention name(s): SAL-0951; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAL-0951：
initial phase：4mg QD for 8 weeks
subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks; SAL-0951 placebo：
initial phase：4mg QD for 8 weeks
subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
Other intervention name(s): SAL-0951 group; Placebo phase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Beta Cell Restoration Through Fat Mitigation
Condition: Prediabetes; Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Weight loss achieved through gastric banding will be superior to treatment with metformin in
      preserving or restoring pancreatic beta cell function in people with prediabetes or mild type
      2 diabetes.
    

Detailed description: 
      BetaFat is a 2-arm, unblinded study to compare gastric banding to treatment with metformin
      over a 24-month period in moderately obese adults with pre- or mild type 2 diabetes. The
      primary outcome will be change in β-cell compensation for insulin resistance, which the
      investigators will compare between groups. Secondary analyses will include other potential
      markers of β-cell health and potential mediators of treatment-specific effects. The main
      focus will be on mediators related to obesity. Clinically, the project will serve as a test
      of concept for use of gastric banding relatively early in the spectrum of obesity and β-cell
      disease. Biologically, the results will provide crucial information on potential mediators of
      β-cell failure and its arrest or reversal in the context of obesity. Those mediators will
      guide the development of more effective treatment and monitoring for the β-cell disease that
      causes type 2 diabetes.
    

Intervention name(s): Metformin; gastric banding
Intervention type(s): Drug; Device
Intervention description(s): metformin 1000 mg bid; LAP-BAND
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: type 2 diabetes; prediabetes; obesity; gastric banding; metformin