bioihbjkbjnl/mcl2 huggingface dataset:
Probiotic S. Salivarius K12 for the Prevention of Upper Respiratory Tract Infection in Nursery-age Children
Condition: Upper Respiratory Tract Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

Summary: 
      The purpose of this retrospective study is to assess the treatment benefits of probiotic
      Streptococcus salivarius K12 for the prevention of recurrent bacterial and viral infections
      of the pharynx, tonsils and ears in children under 3 years of age.
    

Detailed description: 
      Recurrent bacterial and viral infections of the pharynx, tonsils and ears are a problem that
      can affect children of all ages. The persistence of these infections can lead to an overuse
      of drugs such as antibiotics, antipyretics and anti-inflammatories, with the possible
      consequent presence of side effects and above all an increase in antibiotic resistance, a
      global public health issue.

      In search at reducing the use of antibiotics and antivirals, there is currently a great
      scientific interest in probiotic therapies for the oral cavity infection.

      The aim of this retrospective, controlled, multicenter, non-profit study is to evaluate the
      efficacy and safety of the administration of Streptococcus salivarius K12 in pediatric
      patients attending the 1st or 2nd year of nursery school (< 3 years of age ), in the
      prophylaxis of the most common bacterial or viral respiratory infections, assessing the
      consequent reduction in the use of antibiotics, antivirals or other therapies compared to
      children.
    

Intervention name(s): Probiotic Streptococcus salivarius K12; No probiotic supplementation
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Oral 1 billion CFU of Probiotic Streptococcus salivarius K12; Children who did not receive any probiotic supplementation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and
      insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of
      insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30
      (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to
      four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high
      concentration were explorative formulations, not similar to the proposed commercial
      formulation.
    


Intervention name(s): insulin degludec; insulin degludec/insulin aspart 30; insulin degludec/insulin aspart 40; insulin degludec/insulin aspart 45; insulin degludec/insulin aspart 55; insulin aspart; biphasic insulin aspart 30; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin).; A single dose administered subcutaneously (s.c., under the skin).; A single dose administered subcutaneously (s.c., under the skin).; A single dose administered subcutaneously (s.c., under the skin).; A single dose administered subcutaneously (s.c., under the skin).; A single dose administered subcutaneously (s.c., under the skin).; A single dose administered subcutaneously (s.c., under the skin).; A single dose administered subcutaneously (s.c., under the skin).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transtibial Versus Anteromedial Femoral Tunnel Technique in ACL Reconstruction
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional

Summary: 
      The anteromedial (AM) portal technique was introduced to position the femoral tunnel in
      anterior cruciate ligament (ACL) reconstruction to more closely replicate the original
      footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated
      differences in these techniques with respect to clinical outcomes. The purpose of this study
      was to determine if there are any differences in clinical outcome between the AM and TT
      approaches.
    

Detailed description: 
      The anteromedial (AM) portal technique was introduced to position the femoral tunnel in
      anterior cruciate ligament (ACL) reconstruction to more closely replicate the original
      footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated
      differences in these techniques with respect to clinical outcomes. The purpose of this study
      was to determine if there are any differences in clinical outcome between the AM and TT
      approaches.
    

Intervention name(s): Femoral tunnel creation
Intervention type(s): Procedure
Intervention description(s): Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a single-center, open label, 4-month study, designed to evaluate the safety and
      treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to
      previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study
      medication. Study treatment will be administered by intravitreal injections.
    


Intervention name(s): RBM-007 Injectable Solution
Intervention type(s): Drug
Intervention description(s): Sterile solution
Intervention model: Single Group Assignment
Intervention model description: All subjects receive the study treatment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-Drug Interaction Between Rifampin and Fluvastatin
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of organic anion transporting polypeptide 1B1 (OATP1B1) transporter inhibition at
      clinical doses of fluvastatin, a biopharmaceutics drug disposition classification system
      (BDDCS) class 1 drug, has not been studied to date. A single dose of IV rifampin can be used
      as model OATP1B1 inhibitor to evaluate the significance of OATP1B1 transporter effects on
      fluvastatin disposition. A preinduction regimen of oral rifampin followed by a single IV
      infusion of rifampin can be used to evaluate the combined effects of enzyme induction and
      OATP1B1 transporter inhibition on fluvastatin disposition. A two arm, randomized, open label,
      crossover clinical study in healthy, volunteers will be conducted to evaluate the effects of
      IV rifampin on fluvastatin disposition in both hepatically induced and uninduced subjects.
    

Detailed description: 
      The effect of rifampin on the pharmacokinetics of fluvastatin will be studied in healthy
      volunteers in a two arms, two-period, randomized, unblinded, crossover clinical trial. In the
      first arm, subjects will be randomized to one of two treatment groups:

      (i)fluvastatin (Lescol®) 20mg capsule (ii) one oral dose of fluvastatin (Lescol®) 20mg
      capsule immediately following a 30-min intravenous infusion of rifampin 600mg in 10ml Normal
      Saline.

      In the second arms, patients will be pretreated with 600mg oral rifampin (two 300mg rifadin
      capsule) once daily to induce hepatic enzymes (and transporters) for 5 years. Subjects will
      be randomized to one of two treatment groups:

      (i) one oral dose of fluvastatin (Lescol®) 20mg capsule (ii) one oral dose of fluvastatin
      (Lescol®) 20mg capsule immediately following a 30-min intravenous infusion of rifampin 600mg
      in 10ml Normal Saline
    

Intervention name(s): rifampin IV; Rifadin 300Mg Capsule; Fluvastatin 20 MG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A 30-min intravenous infusion of rifampin 600mg in 10ml Normal Saline will be used to inhibit hepatic OATP1B1 transporters.; Rifadin 600mg by mouth as two 300mg rifadin capsules; one oral dose of fluvastatin (Lescol ) 20mg capsule
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a two arm, randomized, open label, crossover, clinical trial. Arm 1 will be conducted in normal healthy volunteers; Arm 2 will be conducted in hepatically induced (by oral rifampin) healthy volunteers.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug-drug interaction; statin; rifampin
Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the
      treatment of moderate to severe dry eye disease .
    

Detailed description: 
      A multicenter,randomized, double-blind, vehicle-controlled Study.Subjects will be randomly
      assigned to the experimental group and the control group,experimental group: CsA eye gel: 0.3
      g: 0.15 mg, once daily;One drop into each eye when you use it.hypromellose eye
      drops:10ml：50mg,three times a day Control group: vehicle. One drop into the eye, once
      daily;One drop into each eye when you use it.hypromellose eye drops:10ml：50mg,three times a
      day
    

Intervention name(s): CsA Ophthalmic Gel; Placebo; Hypromellose Eye Drop
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The CsA eye gel of 0.3 g: 0.15 mg; Placebo; Hypromellose Eye Drops of 10ml：50mg, 3 times daily, 1-2 drop
Other intervention name(s): CsA gel; zhenshishuang
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Breakfast Cereals Consumed in Dairy and Non-dairy Medium: the Effects on Blood Glucose, Satiety and Food Intake
Condition: Blood Glucose; Eating; Food
Study type: Interventional

Summary: 
      The effects of dairy-free products consumed with a breakfast meal on food intake and
      glycaemic regulation remain unexplored. It is known that dairy products are an excellent
      source of protein, low glycaemic sugar lactose, calcium, and vitamin D. In our recent study
      the consumption of a dairy snack with high protein content resulted in reduced blood glucose
      response compared to non-dairy snack with the similar amount of available carbohydrate. The
      investigators hypothesize that the ad libitum intake of breakfast cereals served with a
      high-protein fermented dairy product will result in reduced and sustained blood glucose
      response compared to non-dairy control. The objective of this study is to investigate how
      dairy and non-dairy cultured products used as carriers for breakfast granola cereals and
      consumed ad libitum affect short-term food intake, satiety, and glycaemia within two hours.
    


Intervention name(s): Food
Intervention type(s): Other
Intervention description(s): The intervention represents a breakfast meal (cereals with cultured products) or breakfast skipping (water control)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Breakfast; Blood glucose; Food intake; Satiety
Thoracic Paravertebral Blocks in Open Nephrectomy
Condition: Nephrectomy; Analgesia
Study type: Interventional
Phase: Phase 2

Summary: 
      60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two
      groups, namely group A (n=30), where a thoracic paravertebral block will be performed
      preoperatively and a paravertebral catheter for continuous and patient controlled bolus local
      anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be
      administered at the beginning and the end of operation and postoperatively through patient
      controlled IV doses. NRS scores in static and dynamic conditions, complications, patient
      satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde)
      and NGAL pre- and postoperatively, will be recorded.
    


Intervention name(s): Ropivacaine; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): Paravertebral block using ropivacaine preoperatively and postoperatively; Morphine intraoperatively and postoperatively
Intervention MeSH terms: Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Inhibition of Sterile Inflammation by Digoxin
Condition: Inflammatory Response
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of digoxin on pyruvate kinase isoform 2 (PKM2) binding to
      pro-inflammatory loci and innate immune inflammatory responses in the peripheral blood in
      healthy subjects.
    

Detailed description: 
      To investigate the effect of orally administered digoxin on innate immune inflammatory
      responses in the peripheral blood of healthy subjects. We hypothesize the reduction in innate
      immune inflammatory responses will be expected in the peripheral blood with the effect of
      oral digoxin.

      To investigation of how human peripheral blood immune cells change their inflammatory
      responses after exposure to digoxin in vitro.
    

Intervention name(s): Digoxin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Different doses of oral digoxin to test if digoxin has an effect on the immune response of peripheral blood levels (PBLs).; Oral placebo
Intervention MeSH terms: Digoxin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Adherence Intervention for Minority Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      To evaluate the effectiveness of a Head Start-based early intervention for designed to
      improve asthma management skill and practices of parents, pre-school children and Head Start
      staff.
    

Detailed description: 
      BACKGROUND:

      While increased asthma morbidity and mortality have been observed across all ethnicities,
      results from several studies have found that asthma morbidity has increased
      disproportionately in low-income African American children. Elementary school-based asthma
      education programs have shown promise in improving asthma management, and reducing asthma
      morbidity in this high-risk population, however, the fastest growing asthma risk is
      associated with children young than six. By elementary age many parents and children with
      asthma have well-established patterns of inappropriate asthma management that may be
      difficult to change. To date, no research has examined the impact of early intervention for
      asthma management in low-income, high-risk children.

      DESIGN NARRATIVE:

      The primary outcome that the study was designed to evaluate medical record documented
      emergency care for asthma at the JHPED over the eighteen-month follow-up period.

      The secondary outcomes Adherence with asthma therapy based on Medicaid pharmacy claims for
      asthma medications, other asthma health care (urgent and primary), self-reported medication
      adherence, barriers to health care, restricted activity, nighttime symptoms, asthma
      medications, self and family asthma management behaviors, asthma management self-efficacy,
      functional status, and quality of life.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): Home-based adherence monitoring
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment
Study to Evaluate Safety and Efficacy of Oral MP1032 in Psoriasis Patients
Condition: Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase IIa study is designed to assess the safety, tolerability and pharmacokinetics of
      oral MP1032 in patients with moderate to severe psoriasis over a period of 6 weeks. Secondary
      endpoints to evaluate clinical parameters for psoriasis during the 6 week treatment period
      and a 4-week follow up will provide an opportunity to perform a first assessment of oral
      MP1032's clinical efficacy in the treatment of moderate to severe psoriasis.

      The study population will consist of 44 enrolled (40 completed) patients with moderate to
      severe chronic plaque psoriasis. Patients must be able to provide written consent and meet
      all the inclusion criteria and none of the exclusion criteria.
    

Detailed description: 
      This study is a randomized, double-blind, parallel, placebo-controlled exploratory pilot
      study to evaluate safety, pharmacokinetics and efficacy of systemic oral (po) administration
      of 100 mg MP1032 bid in adult patients with moderate to severe chronic plaque psoriasis.

      The study design consists of a 28-day screening/run-in period, a 42-day treatment period, 1
      day for the End of Treatment visit, and a 28-day follow-up period. Forty-four patients who
      meet the entry criteria will be randomized on Day 1 in a 1:1 ratio to receive either 100 mg
      MP1032 or placebo orally twice daily for 42 days. The goal is to have 40 patients (20 in each
      treatment group) complete the study.

      Pharmacokinetic sampling will occur on 3 designated study days. Safety will be monitored from
      the signing of the informed consent form (ICF) until the last follow-up visit on Day 71.

      Efficacy will be assessed on 6 designated study days using the following assessments: PASI,
      PGA, DLQI, mNAPSI, and EQ-5D 5L (VAS).
    

Intervention name(s): MP1032; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hard gelatine capsules containing 50 mg MP1032 as active ingredient; hard gelatine capsules without active ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Plaque psoriasis; chronic; moderate; severe; Plaque
Changing Lifestyles for Better Health
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this research collaboration between Dr. William Tamborlane, Deputy Directory
      of the Yale Center for Clinical Investigation (YCCI) and Fair Haven Community Health Center's
      (FHCHC) Diabetes Prevention Team is to determine the efficacy of an intensive life-style
      intervention (ILI) program that has been developed and implemented at the FHCHC to prevent
      the development of diabetes.
    

Detailed description: 
      This project is a clinical outcome study that merges the expertise of a senior Yale clinical
      investigator, the clinical and translational research resources of YCCI, the clinical and
      community expertise of the FHCHC Diabetes Team, and the high-need patient population of
      FHCHC. In addition to determining the efficacy and cost-effectiveness of an ILI for diabetes
      prevention in an inner-city community health center setting, this project will evaluate the
      effectiveness of pooling academic expertise with direct clinical services to disadvantaged,
      at-risk populations.
    

Intervention name(s): Intensive Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): Women with pre-diabetes randomized to the ILI will attend an intensive 12-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes; Lifestyle Intervention
Transcranial Direct Current Stimulation (tDCS) in Treatment-resistant Depression
Condition: Therapy Resistant Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      tDCS applies a small amount of direct electric current (DC) to the brain by means of two
      electrodes: the one is an active electrode, localized on the effective site, and the other is
      a reference electrode, localized on some "silent" part of the body. Anodal transcranial
      direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPFC) has been
      associated with working memory enhancement and improvement of mood. This study will
      investigate the possible antidepressant effects of tDCS in patients with therapy resistant
      major depressive episodes.
    

Detailed description: 
      Transcranial direct current stimulation (tDCS) is a non-invasive method that shifts membrane
      potential towards hypo- or hyperpolarization and therefore leads to functional changes in a
      discrete area of the cerebral cortex.

      Neurophysiological studies have shown that slow changes in cortical scalp potential reflect
      overall activity of cortical neuronal networks. These scalp potentials reflect shifts in
      membrane potentials of the cortical neurons. Over the past 7 years tDCS has evolved as an
      important tool to non-invasively manipulate specific neural circuits of the human brain.

      The purpose of this study is an investigation of tDCS applied to 20 therapy-resistance major
      depressive patients. Our hypothesis is that tDCS may exert an antidepressant effect and/or
      enhances the medication effect. tDCS will be examined in the framework of a
      placebo-controlled clinical pilot-study investigating effectiveness, safety and influence on
      EEG parameters. Patients will receive anodal DC stimulation or sham stimulation (extra
      designed placebo-stimulator) in a double-blind design over 10 days for each condition.
      Outcomes will be evaluated using several clinical, psychiatric and neuropsychological rating
      scales.
    

Intervention name(s): Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator
Intervention type(s): Device
Intervention description(s): real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)
Other intervention name(s): Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS, major depression