bioihbjkbjnl/mcl2 huggingface dataset:
The Influence of Probiotics in a Drinkable Yogurt on Skin Health
Condition: Skin Health
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to test if probiotics administered to healthy female subjects in a
      dairy format have any skin health benefits.
    

Detailed description: 
      This is a placebo-controlled, double blind, randomized, single center, human clinical trial
      aimed at assessing the influence of probiotics on skin health in healthy female subjects,
      when administered in a food matrix over a period of 5 months.

      It will consist of five groups(40 subjects/group). The first group (1) of subjects will
      receive acidified milk that does not contain bacterial strains. The second group (2) will
      receive acidified milk that contains one specific probiotic strain. The third group (3) will
      receive fermented milk that contains a standard mix of yogurt bacterial strains. The fourth
      group (4) will receive fermented milk, containing the same standard mix of yogurt bacterial
      strains as in group 3 plus the same specific probiotic strain as in group 2. Finally, the
      fifth group (5) will receive fermented milk, containing the same standard mix of yogurt
      bacterial strains as in group 3 and 4 plus the same specific probiotic strain as in group 2
      and 4 plus a mix of antioxidants.

      This study will address whether:

      A.The bioefficacy of a specific probiotic strain is influenced by a milk matrix.

      B.Whether other bacterial strains impact the bioefficacy of this specific probiotic strain,
      and validate whether or not the bioefficacy is related entirely to the activity of this
      specific probiotic strain.

      C.Whether nutritional supplements impact the bioefficacy of a specific probiotic strain.
    

Intervention name(s): no bacterial strains; One probiotic strain - Lactobacillus paracasei NCC2461; Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus; Vit B2, B3, C and E, Beta Carotene and Oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Glucono-Delta-Lactone acidified milk containing no bacterial strains; Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.; Fermented milk containing two standard yogurt bacterial strains.; Fermented milk containing nutritional supplements
Intervention MeSH terms: Beta Carotene; Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: skin health; probiotics; dairy; oral
Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Disease
Study type: Observational

Summary: 
      Vaccine responses in patients treated with anti-CD20 antibodies (ocrelizumab and ofatumumab)
      or S1P receptor modulators (fingolimod and siponimod) were evaluated before and after third
      SARS-CoV-2 vaccination as part of an ongoing longitudinal study. Total spike protein and
      spike receptor binding domain (RBD)-specific immunoglobulin G (IgG) responses were measured
      by Luminex bead-based assay. Spike-specific CD4+ and CD8+ T cell responses were measured by
      activation-induced marker expression.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This was a retrospective, noninterventional cohort study
Comparison of Intravascular Ultrasound-Guided vs. Angiography-guided Angioplasty and Dual-antiplatelet v. Triple-antiplatelet Therapy for Outcomes of Drug-coated Balloon in the Treatment of Femoropopliteal Artery Disease (IVUS-DCB)
Condition: Femoropopliteal Artery Disease
Study type: Interventional

Summary: 
      -  Prospective, randomized, controlled, multi-center study

        -  A total of 240 subjects with femoropopliteal artery disease will be included according
           to inclusion and exclusion criteria.

        -  Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided
           intervention group.

        -  Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or
           triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional

        -  All patients will be treated with drug-coated balloons (In.PACT Admiral) for
           femoropopliteal lesions.

        -  Bare metal self-expandable stents will be used in addition according to findings of IVUS
           or angiography such as severity of arterial dissection or residual stenosis.

        -  Patients will be followed clinically for 1 year after the procedure.

        -  Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be
           performed at 1 year.
    


Intervention name(s): IVUS-guided angioplasty; Angiography-guided angioplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. IVUS evaluation will be performed before predilation and after DEB treatment. In cases of stent implantation, additional IVUS evaluation will be performed after stenting. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of IVUS measurement. Implantation of stents will be left to the operator's decision after reviewing IVUS findings after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended.; Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of angiogram. Implantation of stents will be left to the operator's decision after reviewing the angiogram after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Femoropopliteal artery disease, drug-coated balloon, angioplasty, antiplatelet therapy
A Study to Evaluate the Effect of a Contraceptive Vaginal Ring LSP- 5415 on Ovarian Function in Healthy Adult Females
Condition: Pregnancy Prevention
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the inhibition of ovulation in Cohort #1
      (Body Mass Index of ≥ 18 kg/m2 to ≤ 30 kg/m2) after contraceptive vaginal ring LSP-5415
      application for 3 treatment cycles.
    

Detailed description: 
      This is an open-label study to evaluate inhibition of ovulation during treatment with
      LSP-5415 over a period of 3 treatment cycles (approximately 3 months) in healthy female
      volunteers with a documented ovulatory cycle (pre-treatment cycle). The study will consist of
      two subject cohorts; Cohort #1 will consist of a total of 16 healthy women aged 18-35 years
      with a BMI of ≥ 18 kg/m2 to ≤ 30 kg/m2, Cohort #2 will consist of up to 10 healthy women aged
      18-35 years with a BMI of > 30 kg/m2 to ≤ 35 kg/m2. The study will consist of 3 treatment
      cycles each consisting of a 26 day ring-insertion period followed by a 2-day ring-free
      period.
    

Intervention name(s): LSP-5415
Intervention type(s): Drug
Intervention description(s): pregnancy prevention
Intervention model: Single Group Assignment
Intervention model description: The study will consist of two subject cohorts; Cohort #1 will consist of a total of 16 healthy women aged 18-35 years with a BMI of ≥ 18 kg/m2 to ≤ 30 kg/m2, Cohort #2 will consist of up to 10 healthy women aged 18-35 years with a BMI of > 30 kg/m2 to ≤ 35 kg/m2. The study will consist of 3 treatment cycles each consisting of a 26 day ring-insertion period followed by a 2-day ring-free period.
Masking: None (Open Label)
Primary purpose: Prevention
PHENOTYPE. Therapeutic Study in Barcelona
Condition: Poor Mental Health; Natural Outdoor Environments
Study type: Observational

Summary: 
      The study aimed to explore therapeutic effects of natural environments. To do so, the
      investigators evaluated the immediate and sustained changes in several indicators of
      well-being while people (n=26) with poor mental health were engaged in unconstrained
      exposures to natural (green, blue) and urban environments. The indicators included:
      affection, cognition, physiological responses.

      Each participant was exposed to all environments for a period of 210 minutes between October
      2013 and January 2014. During the exposure period, participants were instructed to do what
      they would usually do in that environment. Before, during (at 30 and 210 minutes) and after
      each exposure, several psycho-physiological measures were taken: (i) heart rate variability
      and heart rate using a Holter monitor, (ii) blood pressure using a digital blood pressure
      monitor, (iii) physical activity using the CalFIT application installed in a Smartphone, (iv)
      lung function using a portable computerized spirometer, (v) stress level using salivary
      cortisol samples collected using Salivettes, (vi) affect, perceived restoration and social
      interactions using questionnaires, (vii) cognitive functioning using the backwards digit-span
      task test.
    


Intervention name(s): There was no intervention.
Intervention type(s): Other
Intervention description(s): Participants were transported one day to a urban setting, one day to a green space, one day to a beach. No intervention was done.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All the participants (n=26) were individuals that had previously participated in a survey
        of 1000 people in Barcelona city as part of the PHENOTYPE project. As part of the survey,
        they had answered the Mental Health Inventory (MHI-5) subscale from the SF-36 health
        questionnaire. The investigators purposively selected those individuals MHI-5 scored in the
        lower 50th percentile.
Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis
Condition: Airway Obstruction; Vocal Cord Paralysis
MeSH terms: Airway Obstruction; Vocal Cord Paralysis; Paralysis
Study type: Interventional

Summary: 
      Total arytenoidectomy is claimed to increase risk of aspiration and cause more voice loss
      than other operations performed for bilateral vocal fold paralysis (BVFP). However, objective
      evidence for such conclusion is lacking. There is no study comparing swallowing and voice
      after total and partial arytenoidectomy.
    

Detailed description: 
      Design: Prospective, randomized, double-blind, case-control Setting: Tertiary, referral,
      university Patients: Twenty patients with BVFP Intervention: Endoscopic total and partial
      arytenoidectomy
    

Intervention name(s): Total arytenoidectomy; Partial arytenoidectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Endoscopic total arytenoidectomy was performed on patients with bilateral vocal fold paralysis; Endoscopic partial arytenoidectomy was performed on patients with bilateral vocal fold paralysis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vocal cords; Vocal cord paralysis; Arytenoid cartilage
Study to Evaluate the Mass Balance and Biotransformation of [14C]SHR4640 in Chinese Healthy Adult Male Volunteers.
Condition: Healthy Adult Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]SHR4640 in
      Chinese healthy adult male volunteers.
    


Intervention name(s): [14C]SHR4640
Intervention type(s): Drug
Intervention description(s): Patients will receive single dose of orally [14C]SHR4640 on Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Chronic Intranasal Oxytocin Administration on Sexual Function in Pre- and Postmenopausal Women
Condition: Female Sexual Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether intranasal oxytocin is effective in
      comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal
      women.
    


Intervention name(s): Syntocinon Nasalspray; Placebo Nasalspray
Intervention type(s): Drug; Drug
Intervention description(s): Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.; Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly.
Other intervention name(s): Oxytocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
Condition: Coronary Disease; Arteriosclerosis; Diabetes Mellitus, Type 2
MeSH terms: Atherosclerosis; Coronary Disease; Arteriosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of low-dose aspirin for the primary
      prevention of vascular events in patients with type 2 diabetes in Japan.
    

Detailed description: 
      There is a worldwide epidemic of diabetes and the number of individuals with diabetes is set
      to increase further. As individuals with diabetes are at high risk of accelerated
      atherosclerosis and thrombotic vascular events, the significant proportion of the
      cardiovascular disease burden is projected to be among this population. JPAD is a multicenter
      study with a prospective randomized open, blinded end-point (PROBE) design. The doses
      administered are aspirin 81 mg/day or 100 mg/day, the latter being enteric-coated Aspirin.

      The primary objective was to compare the effect of aspirin on atherosclerotic events
      including cardiovascular events, cerebral vascular event, and other vascular events.

      We also analyze hemorrhagic events in this RCT.
    

Intervention name(s): Aspirin; No aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Aspirin 81 mg or 100 mg per day; No aspirin use
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: type 2 diabetes; coronary heart diseases; primary prevention; atherosclerosis; aspirin
Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study
Condition: Glioblastoma Multiforme of Brain
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the present study is to evaluate efficacy, safety and tolerability of 4:1
      ketogenic diet administered adjunctively to standard radiation and temozolomide chemotherapy
      in patients with GBM in a prospective, randomized open label study.
    

Detailed description: 
      Primary aims of the study will be to 1) To evaluate efficacy of ketogenic diet as adjunctive
      treatment of radiation treatment in glioblastoma multiforme. 2) To evaluate the safety of
      ketogenic diet as adjunctive treatment of radiation treatment in glioblastoma multiforme.
      Secondary aim will be to evaluate tolerability of ketogenic diet as adjunctive treatment of
      radiation treatment in glioblastoma multiforme.

      Participants will be seen at one, 2 weeks, and 4 weeks after KG diet initiation, and then
      monthly until month 6 after diet initiation, then every 2 months until 2 years after
      treatment initiation or death, then every 3 months until 3 years after treatment initiation
      or death. KD treatment will last for 6 months or until exit criteria are met, whichever comes
      first. Exit criteria are the primary outcome measures, the first of either (a) MRI tumor
      progression or (b) death. Secondary outcome measures will include treatment compliance,
      hunger scale scores, fasting serum glucose and BOH levels and occurrence of adverse events.

      Patients with documented tumor progression will receive standard care for progressive GBM as
      directed by their treating oncologist, independent of the study.
    

Intervention name(s): Ketogenic Diet; Standardized Diet
Intervention type(s): Other; Other
Intervention description(s): Treatment will consist of ketogenic diet. KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction.; Participants with GBM treated with radiation and temozolomide after surgical debulking treatment. The subjects will be taken standard diet in a 1:1 ratio. Diet will be started at the time of initiation of radiation treatment.
Other intervention name(s): KGD
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glioblastoma multigorme; Ketogenic Diet; radiotherapy; chemotherapy; safety; efficiency
ANX-042 Healthy Volunteer Dose Escalation Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to investigate the safety and tolerability of ANX-042 when
      administered by continuous intravenous (IV) infusion in healthy volunteers.
    

Detailed description: 
      Each participant received a total of two, approximately 12-hour continuous infusions of
      ANX-042 and one 12-hour continuous infusion of placebo, with a 36-hour washout period between
      treatments.

      This study was conducted by Anexon, Inc. at Celerion, in Lincoln, Nebraska.
    

Intervention name(s): ANX-042; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Reconstituted in Sterile Water for Injection, United States Pharmacopeia (USP) and administered by 12 hour continuous intravenous infusion with 5% dextrose in water (D5W), United States Pharmacopeia (USP); Administered once by 12 hour continuous intravenous infusion with D5W (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of NNZ-2566 in Patients With Traumatic Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether NNZ-2566 is safe and effective in the
      treatment of Traumatic Brain Injury (TBI).
    

Detailed description: 
      Moderate to severe traumatic brain injury frequently results in persistent problems with
      memory, attention span, mood and more complex brain functioning such as planning and
      organizing. There are currently no drugs available to reduce the brain damage or the
      persisting symptoms that result from TBI. The longer term goal of this study is to provide
      physicians with a safe and effective treatment for TBI.
    

Intervention name(s): NNZ-2566; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for intravenous infusion.
20 mg/kg intravenous bolus infusion over 10 minutes followed by a continuous intravenous infusion of 1, 3, or 6 mg/kg/h for a total of 72 consecutive hours.; Sodium Chloride 0.9% Injection
Other intervention name(s): Glycyl-L-2-Methylprolyl-L-Glutamic Acid; Sodium Chloride 0.9% Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Yoga for Persons With Severe Visual Impairment
Condition: Sleep Disturbance; Stress; Anxiety; Depression; Balance Impairment
MeSH terms: Dyssomnias; Parasomnias; Vision Disorders; Vision, Low
Study type: Interventional

Summary: 
      This study aims to provide novel information on the feasibility of yoga interventions for
      secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood
      states, fall risk and balance. This information will be important for determining safe,
      cost-effective and reliable practices for the benefits of yoga as an alternative means for
      improved health and well-being. A yoga intervention that is integrative and evidence-based
      will benefit the blind population through effective treatments and prevention of secondary
      symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in
      the future.
    

Detailed description: 
      This study aims to provide novel information on the feasibility of yoga interventions for
      secondary symptoms related to severe vision loss, such as sleep disturbances, negative mood
      states, fall risk and balance. This information will be important for determining safe,
      cost-effective and reliable practices for the benefits of yoga as an alternative means for
      improved health and well-being. A yoga intervention that is integrative and evidence-based
      will benefit the blind population through effective treatments and prevention of secondary
      symptoms as well as serve to inform rehabilitation specialists, educators, and clinicians in
      the future.
    

Intervention name(s): Yoga Intervention
Intervention type(s): Behavioral
Intervention description(s): Three yoga classes per week for 8 weeks.
Other intervention name(s): Yoga, Ashtanga
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment