bioihbjkbjnl/mcl2 huggingface dataset:
Acute Supplementation With Beta-Alanine Improves Performance in Aerobic-anaerobic Transition Zones in Endurance Athletes
Condition: Beta-alanine
Study type: Interventional

Summary: 
      The use of beta-alanine (BA) to increase physical performance is widely documented. However,
      the acute effect of this amino acid on maximal tests in the aerobic-anaerobic transition zone
      is still uncertain. The objective of this study was to determine the acute effect of low and
      high-dose BA trials on maximal aerobic speed (MAS) in endurance athletes. We hypothesized
      that high doses of BA have a greater effect than low doses, both compared to baseline. Twelve
      male endurance athletes volunteered for the study. The experimental design applied was
      randomized cross-over, double-blind. Treatment included three 6-minute run tests (6-MRT), the
      first as a baseline, then randomized 6-MRT with low (30 mg·kg-1) and high (45 mg·kg-1) dose
      BA trials. The 6-MRTs were separated by 72 hours. The main variable of the study was the
      distance (m) performed in the 6-MRT. Differences between tests were established through ANOVA
      and Tukey's multiple comparison tests (p < 0.05).
    

Detailed description: 
      In this original research, we determined the acute effect of low (30 mg·kg-1) and high-dose
      (45 mg·kg-1) BA trials on maximal aerobic speed (MAS) in endurance athletes. At the same
      time, we compared the effect size with of BA.
    

Intervention name(s): beta alanine
Intervention type(s): Dietary Supplement
Intervention description(s): On day 1, all participants completed the 6-MRT corresponding to baseline. Then, on days 2 and 3, each participant performed the 6-MRT with 30 mg·kg-1 and 45 mg·kg-1 of BA (low and high-dose trials, respectively). BA was purchased in powder format from a factory specializing in sports supplements. BA was colorless when diluted in water and had a characteristic taste. This format of BA (powder) allowed personalized dosing for each participant. The research team performed the personalized dosing before the application of the treatment. Between the evaluation days, there was 72 hours difference. The 30 mg·kg-1 or 45 mg·kg-1 BA administration was done with a double-blind method. Thus, on day 2, 50% of the sample performed the 6-MRT supplemented with 30 mg·kg-1 BA, while the other 50% performed the 6-MRT with 45 mg·kg-1 BA. On day 3, those participants who completed the 6-MRT with 30 mg·kg-1 BA now performed with 45 mg·kg-1 BA and vice versa.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The experimental design applied was randomized cross-over and double-blind
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: beta-alanine; ergogenic aid; physical performance; aerobic-anaerobic transition zones; maximal aerobic speed
A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)
Condition: Premenstrual Dysphoric Disorder
MeSH terms: Premenstrual Dysphoric Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this phase IIb study is to evaluate the effect and safety of Sepranolone
      (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD).
      Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during
      the two weeks preceding the menstruation of three menstrual cycles. Effect (change from
      baseline) will be assessed by comparison of symptoms recorded daily by the patients using a
      validated rating scale for assessment of PMDD symptoms. Sepranolone is an endogenous steroid.
    

Detailed description: 
      The objective of this phase IIb study is to evaluate the effect and safety of two doses of
      Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder
      (PMDD) in comparison to placebo, administrated during the luteal phase of three consecutive
      menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the
      patients using a validated rating scale for assessment of PMDD symptoms and impairment of
      symptoms on daily life of the patients. The scale is Daily Record of Severity of Problems
      (DRSP). Preceding the treatment period, the diagnosis of PMDD will be established in the
      study participants by at lest two menstrual cycles of prospective DRSP ratings by the
      patients. This period will also constitute the baseline data. The effect of study medication
      will be assessed as the change in symptoms from baseline to during treatment. The Total
      symptom score of the DRSP will constitute the primary variable and the late luteal phase
      ratings in the respective menstrual cycles, before and during treatment, will be used.

      The study will also include a follow-up (no treatment) cycle before patients final visit.

      The study is conducted in four European countries (Sweden, Germany, Poland and United
      Kingdom) and will include up to 225 patients.
    

Intervention name(s): Sepranolone (UC1010) low dose; Sepranolone (UC1010) high dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous (SC) administration; Subcutaneous (SC) administration; Subcutaneous (SC) adminstration
Intervention MeSH terms: Pregnanolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia
Condition: Down Syndrome
MeSH terms: Dementia; Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, randomized, double-blind, placebo-controlled, parallel-group,
      three-arm, multicenter study of the safety and PK of ELND005 administered orally for 4 weeks.
      This study will enroll Down Syndrome patients 18 to 45 years of age (inclusive) without
      dementia.
    


Intervention name(s): ELND005; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Adult Patients With Allergic Grass Pollen Rhinoconjunctivitis
Condition: Allergic Rhinitis Due to Grass Pollens
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of
      grass pollen allergen extract compared to placebo in adult patient with allergic
      rhinoconjunctivitis.
    

Detailed description: 
      Allergy is one of the most common chronic disease in the world currently affecting between
      10% and 25% of the general population.

      Allergies to pollens characteristically result in seasonal rhinitis symptoms and allergic
      rhinoconjunctivitis is characterized by sneezing, congestion, rhinorrhea, nasal or palatal
      itching and itchy, watery, red and swollen eyes.

      Even if several drugs effectively manage allergic rhinoconjunctivitis symptoms, immunotherapy
      is considered more appropriate for patients in whom these symptoms are not optimally
      controlled with relief medications.

      In the study, each of the six rhinoconjunctivitis symptoms (sneezing, runny nose, itchy nose,
      nasal congestion, itchy eyes, watery eyes) will be evaluated daily and relief medication
      intake (oral antihistamines, eye drop antihistamine, nasal corticosteroid, oral
      corticosteroid) reported daily during the grass pollen season.

      Efficacy and good safety profile of 300IR SLIT tablet administered once per day for
      approximately six months (starting 4 months before and over the season) will be demonstrated
      during the grass pollen season compared to placebo.
    

Intervention name(s): 300 IR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 300 IR grass pollen allergen extract tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season; Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season
Other intervention name(s): Sublingual immunotherapy tablet; Sublingual placebo tablet
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinoconjunctivitis
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone
      propionate salmeterol in pediatric participants with a documented history of persistent
      asthma.
    


Intervention name(s): Fluticasone Propionate; Fluticasone Propionate/Salmeterol; Placebo MDPI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.; Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm.; Matching placebo was administered via MDPI per the schedule specified in the arm.
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare the Effectiveness of Adductor Canal Pain Catheters Following Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research is to study how well the adductor canal pain catheters works
      after a total knee arthroplasty or replacement of the knee joint. The catheter works by using
      either an intermittent bolus injection to provide a large dose of medication or continuous
      infusion of pain medicine, ropivacaine 0.2%, compared to a single-shot adductor canal block.
    


Intervention name(s): Ropivacaine Continuous Infusion; Ropivacaine Intermittent Bolus; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.2% continuous infusion 6mL/hr; 0.2% intermittent bolus infusion 8mL every 2 hours; Saline filled catheter
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Three-Arm, Double-Blinded, Randomized Controlled Trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
Condition: Crohn Disease in Remission
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      For patients with Crohn's diseases undergoing surgery，whether postoperative exclusive enteral
      nutrition(EEN) could delay the endoscopic relapse needs exploration.The trial will
      investigate the efficacy of postoperative EEN for maintaining disease remission.
    


Intervention name(s): 3 months exclusive enteral nutrition after surgery
Intervention type(s): Other
Intervention description(s): patients underwent intestinal resection and anastomosis in this arm will given over 3 months exclusive enteral nutrition,and free diet after 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Sinusitis in Children and the Nasopharyngeal Microbiome
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Observational

Summary: 
      The purpose of this study is to investigate the relationship between viral infections of the
      upper respiratory tract, perturbations of the nasopharyngeal microbiome in children, and the
      risk of acute bacterial sinusitis over a one year period. The investigators will determine
      the incidence of acute bacterial sinusitis post viral upper respiratory infection and
      identify the viral antecedent infections and other risk factors which predispose to infection
      and ultimately design strategies to reduce the burden of disease and antimicrobial
      resistance.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy children
      
Biospecimen description: 
      Nasopharyngeal microbiome samples
    
Keywords: sinusitis; upper respiratory infection
Quality Improvement Intervention in Colonoscopy Using Artificial Intelligence
Condition: Quality Control; Artificial Intelligence; Colonoscopy
Study type: Interventional

Summary: 
      Quality measures in colonoscopy are important guides for improving the quality of patient
      care. But quality improvement intervention is not taking place, primarily because of the
      inconvenience and expense. To address the difficulties above, we used artificial intelligence
      for quality control of colonoscopy.
    


Intervention name(s): quality improvement intervention using artificial intelligence
Intervention type(s): Other
Intervention description(s): Colonoscopists received performance measure monitoring and feedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms
Condition: Menstrual Pain; Menstrual Discomfort
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Dietary supplementation is widely used to alleviate various symptoms of PMS and menstruation
      such as bloating and cramping. Providing a combination of synergistic dietary supplements is
      hypothesized to significantly reduce self-reported PMS and menstrual discomfort when compared
      with a baseline without the intervention.
    

Detailed description: 
      This is an open-label observational trial to study the effectiveness of a commercial dietary
      supplement and its effect on common symptoms of normal menstrual discomfort.

      It is hypothesized that the dietary supplement marketed as Semaine PMS & Period Support will
      improve subjective wellbeing and biomarkers in trial participants.

      A total of 58 participants will be recruited for the trial following screening, with the
      expectation that at least 51 will complete the trial. The trial will be fully remote, and all
      participants will undergo a menstrual cycle without intervention to establish a baseline, and
      then will be given the intervention (dietary supplement) for a second menstrual cycle. For
      both menstrual cycles the participants will complete a subjective wellbeing survey and
      provide a blood sample for biomarker analysis.

      The biomarker analysis will be performed through an at-home fingerprick blood test. To
      maximize consistency, the tests should be performed on the same days of each cycle -
      preferably on days 4 or 5. If absolutely necessary, however one day of buffer on either side
      will be allowed.
    

Intervention name(s): Semaine
Intervention type(s): Dietary Supplement
Intervention description(s): The dietary supplement is designed, and marketed commercially to be taken in servings of two capsules per day, up to four times per day (a total of 8 capsules daily). Most consumers, however, will only take a serving three times per day, or one with each major meal (breakfast, lunch and dinner).
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PMS; Menstrual symptoms
Visual Attention to Text and Pictorial Food Labels: An Eye Tracking Experiment
Condition: Health Behavior
Study type: Interventional

Summary: 
      The goal of this study is to examine attention elicited by icon, text-only, and control
      front-of-package food labels. The study also aims to explore whether English language
      proficiency moderates the impact of icon vs. text-only labels on attention.
    

Detailed description: 
      In this study, participants will attend one in-person visit, lasting approximately 15 minutes
      after signing informed consent. First participants will complete an eye tracking task where
      their attention to study stimuli is measured objectively via an eye tracker (i.e., eye
      tracking task). The eye tracking task will take ~5 minutes. Then, participants will complete
      a brief ~10 minute self-administered survey on a computer.
    

Intervention name(s): Text only sodium label; Icon sodium label; Pictorial sodium label; Barcode label
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): "Warning: High in sodium." is shown in a black square label on the can of soup.; "Warning: High in sodium." is shown beneath a yellow triangle icon with an exclamation mark all in a black square label on the can of soup.; "Warning: High in sodium." is shown beneath an image of a spilled salt shaker, all in a black square label on the can of soup.; Barcode is shown in white square label on the can of soup
Intervention model: Single Group Assignment
Intervention model description: All participants will see the same 4 labels (3 sodium labels [text only, text + icon, and text + pictorial] and a control bar code label) in a random order.
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare characteristics and safety after oral administration
      of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets & Aspirin 100mg 2
      capsules coadministration in healthy male volunteers.
    


Intervention name(s): G0041(75/100mg); Clopidogrel & Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): G0041(75/100mg) 2 capsules(Clopidogrel 75mg & Aspirin 100mg in 1 capsule), PO; Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clopidogrel; Aspirin; coadministration
N. Meningitidis Carriage Study
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Observational

Summary: 
      This carriage study aims to evaluate the presence of meningococcus in Asian populations (and
      potential for disease) and explore the extent and serogroup distribution of meningococci
      circulating in the population.
    


Intervention name(s): Posterior pharyngeal swab; Data collection
Intervention type(s): Procedure; Other
Intervention description(s): Posterior pharyngeal swabs will be tested for the presence of N. meningitidis.; Collection of socio-demographic data and recording of serious adverse events by interview of subjects or subjects' parents/legally acceptable representatives.
Other intervention name(s): Throat swab
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects aged between 5 and 24 years attending a school or university in the
        Philippines.
      
Biospecimen description: 
      Throat swab
    
Keywords: Neisseria meningitidis; Philippines; carriage; meningococcus
Remote Observed Dosing to Increase Suboxone Compliance
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      The goal of this project is to test the feasibility, acceptability, and preliminary efficacy
      of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate
      dependence. To that end, 10 opiate dependent subjects will be recruited through the
      University of Pennsylvania's Treatment Research Center, an outpatient substance abuse
      treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted
      as needed according to individual requirements).
    


Intervention name(s): Remote Observed Dosing
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Skype; compliance; remote dosing; suboxone; opiate; opiates; heroin; oxycontin; Philadelphia
Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the therapeutic equivalence and safety of once-daily 9
      mg budesonide versus 3 g mesalazine in a 8-week treatment in patients with active ulcerative
      colitis.
    


Intervention name(s): budesonide; mesalazine
Intervention type(s): Drug; Drug
Intervention description(s): 3x 3mg budesonide capsules once daily; 3x 1000mg mesalazine onc daily
Other intervention name(s): Budenofalk 3mg capsules; Salofalk 1000mg granules
Intervention MeSH terms: Budesonide; Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 5-ASA; mesalamine; mesalazine; budesonide; ulcerative colitis