bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
Condition: Otitis Media; Infections, Respiratory Tract; Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Otitis; Otitis Media
Study type: Interventional
Phase: Phase 4

Summary: 
      Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows
      administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses. Most
      physicians in India use the standard Augmentin (amoxicillin:clavulanic acid 7:1) (45/6.4
      mg/kg/day) formulation and double the dose to achieve higher dose of amoxicillin/clavulanic
      acid at 90 mg/kg/day in pediatric acute otitis media (AOM) due to non-availability of
      Augmentin (ES)-600. Using the 7:1 formulation causes unnecessary exposure to higher
      proportionate dose of clavulanic acid (12.8 mg/kg/day) as a unit dose of 6.4 mg/kg/day of
      clavulanic acid is only required for efficacy against beta-lactamase producing AOM pathogens.
      Hence, there is an unmet need for availability of Augmentin (ES)-600 in India. This is an
      open label, single arm, multicenter, non-comparative study in participants aged 6 months to
      12 years with AOM. It aims to assess the safety and clinical efficacy of Augmentin (ES)-600
      administered in two divided doses, every 12 hours in pediatric population in India. AUGMENTIN
      is a registered trademark of the GlaxoSmithKline group of companies.
    


Intervention name(s): Augmentin (ES)-600
Intervention type(s): Drug
Intervention description(s): Augmentin ES will be administered as reconstituted oral suspension containing Amoxicillin and Potassium Clavulanate 600 mg/42.9 mg per 5 milliliters.
Intervention MeSH terms: Amoxicillin-Potassium Clavulanate Combination
Intervention model: Single Group Assignment
Intervention model description: This is a single arm, multicenter, non-comparative study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute otitis media; Augmentin Extra Strength; Amoxicillin-clavulanic acid; Pediatric; Beta-lactamase
ACCEL-LOADING-ACS Study
Condition: Platelet Aggregation Inhibitors; Anti-inflammatory Agent; Myocardial Reperfusion Injury
MeSH terms: Reperfusion Injury; Myocardial Reperfusion Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether adjunctive cilostazol loading/maintenance
      to standard treatment (aspirin, clopidogrel, and statin) is effective in reduction of major
      adverse cardiovascular events, platelet activation, inflammation and myonecrosis in patients
      with non-ST-elevation acute coronary syndrome (ACS)undergoing percutaneous coronary
      intervention (PCI).
    

Detailed description: 
      In ACS patients, platelet activation, inflammation, and ischemia-reperfusion injury can be
      closely associated with the risk of post-PCI myonecrosis and ischemic events occurrence. In
      the ACCEL-AMI (Adjunctive Cilostazol versus high maintenance-dose ClopidogrEL in patients
      with Acute Myocardial Infarction)study, adjunctive cilostazol increased platelet inhibition
      compared with double-dose clopidogrel. Meanwhile, statins can reduce the extent of
      myonecrosis via limiting inflammation and myocardial infarct size by activating
      phosphatidylinositol-3-kinase (PI3K), ecto-5'-nucleotidase, Akt/endothelial nitric oxide
      synthase (eNOS), and the downstream effectors inducible nitric oxide synthase (iNOS) and
      cyclooxygenase-2 (COX-2). Inhibition of PI3K, adenosine receptors, eNOS, iNOS, or COX-2
      abrogates the protective effects of statins. In animal study, the combination of low-dose
      statin with cilostazol synergistically limits infarct size. Multiple studies have shown that
      cilostazol can influence inflammation and RISK pathway using the similar pathway with statin.
      This study will be performed to evaluate the role of adjunctive cilostazol in platelet
      inhibition, inflammation, and myonecrosis compared with standard treatment.
    

Intervention name(s): Dual Anti-Platelet Therapy (DAPT); Triple Anti-Platelet Therapy (TAPT)
Intervention type(s): Drug; Drug
Intervention description(s): Loading: aspirin 300mg + clopidogrel 600mg
Maintenance: aspirin 200mg/d + clopidogrel 75mg/d for 1 month; Loading: cilostazol 200mg + aspirin 300mg + clopidogrel 600mg
Maintenance: cilostazol 100mg bid+ aspirin 200mg/d+ clopidogrel 75mg/d for 1 month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cilostazol; Platelet; Inflammation; Myonecrosis
Characteristics of Gut Microbiota in Patients With Colon Cancer of Different Traditional Chinese Medicine Syndromes
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Guided by the idea of combining disease differentiation with syndrome differentiation in
      traditional Chinese medicine, this study used the form of questionnaire to summarize the
      changes of TCM syndromes, TCM constitution types in colorectal cancer patients before and
      after surgery. The Next-generation sequencing technology was used to explore the changes and
      differences of intestinal microorganisms before and after surgery. The correlation between
      changes of TCM syndromes, TCM constitution types, intestinal microbial evolution and tumor
      biological characteristics in colorectal cancer patients before and after surgery was
      analyzed. To explore the rationality of TCM in the prevention and treatment of colorectal
      cancer recurrence and metastasis in order to guide the individualized treatment and dietary
      regulation of TCM.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Colorectal cancer patients admitted to the first affiliated hospital of Harbin medical
        university
      
Biospecimen description: 
      fecal
    
Keywords: gut microbiota; 16s rDNA sequebcing; TCM sydromes; TCM Constitution Types
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to develop a better understanding of the safety, tolerability
      and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the
      treatment of Acute Otitis Media (AOM) in infants and children.
    


Intervention name(s): OP0201; Placebo; Amoxicillin-clavulanate
Intervention type(s): Combination Product; Combination Product; Drug
Intervention description(s): OP0201 20mg per day in two divided doses for 10 days; Placebo 0mg per day in two divided doses for 10 days; Oral Amoxicillin-clavulanate in two divided doses for 10 days
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Use of Hyaluronic Acid Injection in Lateral Patellar Compression With Femoral Condylar Degenerative Changes After Arthroscopic Release
Condition: Anterior Knee Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Interventional

Summary: 
      Ninety patients are involved in this study, who underwent arthroscopic lateral patellar
      release for lateral patellar compression syndrome and they had patellofemoral degenerative
      lesion, which diagnoses by MRI preoperatively and proved by arthroscopic examination to be
      early stages of degenerative changes with no loss of articular surface. The patients were
      divided in to two groups (A and B). Group A (45 patients) were treated by local injection of
      Hyaluronic acid intraarticularly, and Group B (45 patients) were no injection intraarticular.
    

Detailed description: 
      This study was done by one orthopedic surgeon in two hospitals. Ninety patients are involved
      in this study, who underwent arthroscopic lateral patellar release for lateral patellar
      compression syndrome and they had patellofemoral degenerative lesion, which diagnoses by MRI
      preoperatively and proved by arthroscopic examination to be early stages of degenerative
      changes with no loss of articular surface. The patients were divided in to two matched groups
      (A and B) regarding the age and gender; Group A (45 patients) were treated by local injection
      of Hyaluronic acid intraarticularly, 2 weeks after arthroscopy and were followed by VAS of
      knee pain for one year at (3) months, (6) months and (12) months, and Group B (45 patients)
      were no injection intraarticular. The study started on June (2017) and ends on March (2020).
      injection of Hyaluronic acid was used and followed in the same way. All patients presented
      with anterior knee pain which failed to respond to conservative treatment for 6 weeks or
      recurrent of symptoms after stopping of conservative treatment which involved changes of life
      style and NSAID. MRI done for all patients before operation.
    

Intervention name(s): Hyaluronic acid injection; No injection of Hyaluronic acid
Intervention type(s): Device; Device
Intervention description(s): Injection of Hyaluronic acid in knees of those who has degenerative changes after arthroscopic treatment of lateral patellar compression syndrome; No injection of Hyaluronic acid was done
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyaluronic acid injection; Knee Arthroscopy; lateral patellar retinaculae.; lateral patellar compression syndrome
An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of
      acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study
      will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for
      PF-02545920 compared to risperidone and placebo treatment.
    


Intervention name(s): PF-02545920; PF-02545920; Placebo; Risperidone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5 mg tablet every 12 hours for 28 days; 15 mg tablet every 12 hours for 28 days; One tablet/capsule every 12 hours for 28 days; 3 mg capsule every 12 hours for 28 days
Other intervention name(s): Risperdal
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia; acute exacerbation; inpatient
Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure
Condition: Hypoplastic Left Heart Syndrome
MeSH terms: Hypoplastic Left Heart Syndrome
Study type: Interventional

Summary: 
      Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart
      surgeries before they turn three years of age. The first surgery typically happens in the
      first two weeks of life. After this operation, babies come back to the intensive care unit
      with their chests open. Babies who have heart surgery retain body water after surgery and
      this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of
      the extra water. As a result, babies have to stay in the intensive care unit and on a
      breathing machine for longer.

      Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly
      cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD
      involves putting small amounts of special fluid into the belly through the catheter. This
      special fluid attracts water and is drained hourly. By allowing the belly cavity to drain,
      this helps both the heart and the lungs. This allows the chest to be closed and the breathing
      tube to be removed. The investigators are looking to see how quickly the babies, with and
      without PD, get rid of the extra water in turn shortening their stay in the intensive care
      unit and in the hospital. PD is not permanent, and only used for the first few days after the
      operation.
    


Intervention name(s): Peritoneal dialysis
Intervention type(s): Device
Intervention description(s): Prophylactic peritoneal dialysis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects randomized to peritoneal dialysis catheter (PDC) or no PDC and standard care.
Masking: None (Open Label)
Primary purpose: Treatment
Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment
      of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of
      double-blind treatment and 52 weeks of open-label extension.
    


Intervention name(s): RPC4046; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Thigh muscles flexibility deficits contribute to handicap in chronic low back pain patients.
      The study aims to evaluate the immediate effect of thigh muscles stretching in patients with
      chronic low back pain. The investigation team suppose that flexibility improvement could be
      detected by instrumented clinical measurements and such difference could be related to
      psycho-social factors evaluated by questionnaires.
    

Detailed description: 
      The primary objective of the study is to evaluate the immediate effect of the hamstring
      muscle stretching in patients presenting chronic low back pain. The secondary objectives are:
      (1) to evaluate intra- and interrater reliability, construct validity and responsiveness of
      the hamstring flexibility measurements (Active Knee Extension [AKE], Straight Leg Rise [SLR])
      realised with digital inclinometer, (2) to evaluate factors that potentially could influence
      immediate effect of the hamstring stretching, specifically psycho-social factors Fear
      Avoidance Belief Questionnaire (FABQ), Hospital Anxiety and Depression scale (HAD),
      neuropathic pain presence (DN4).
    

Intervention name(s): manual hamstring stretching
Intervention type(s): Other
Intervention description(s): Participants' lower limb will be positioned in maximal hip flexion and gradually moved to maximal knee extension by physical therapist. The procedure will take one minute for each lower limb.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic low back pain; Hamstring flexibility; Hamstring stretching; Immediate stretching effect
Preventing Bacterial and Viral Infections Among Injection Drug Users
Condition: Bacterial Infection; HIV
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Virus Diseases
Study type: Interventional

Summary: 
      We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an
      assessment-only condition (both groups receive rapid HIV testing, a review of testing
      results, and brief HIV prevention counseling) among 350 injection drug users recruited during
      an acute medical hospitalization at Boston Medical Center. In the general hospital setting,
      injection drug users who otherwise might not seek care are accessible and teachable, and the
      presence of a drug-related illness can set the stage for patients to be more receptive to
      interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-,
      3-, 6-, 9-, and 12-month(s) post-intervention.
    


Intervention name(s): SKIN Intervention; Treatment as Usual
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: injection drug use
Effect of Dietary Habits on Metabolic Health
Condition: Overweight; Obesity; Prediabetes; Meals
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The goal of this application is to understand the connection between people's eating habits
      and the risk for developing diabetes, obesity, and cardiovascular disease.
    

Detailed description: 
      More than a third of U.S. adults are obese (BMI greater than 30), 8-12% of adults suffer from
      type 2 diabetes, and up to 30% of adults have pre-diabetes. Recent research studies have
      suggested that it is not just what we eat, but also when we eat that may put us at risk for
      obesity and type 2 diabetes. Skipping breakfast and eating late at night have been associated
      with an increased risk for obesity and type 2 diabetes (T2D), substantiated by recent animal
      and human experimental studies showing that altered meal timing itself, without changes in
      caloric intake, can influence weight regulation and impaired glucose tolerance. This research
      will determine in prediabetic and non-diabetic participants whether delaying meal times
      worsens glucose tolerance, leads to physiological changes favoring a positive energy balance,
      and increases caloric intake. This research will provide mechanistic insights into the
      metabolic consequences of changing meal timing and may help in evidence-based approaches to
      improve dietary interventions in the fight against obesity and T2D.
    

Intervention name(s): Meal schedule
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Dietary Habits; Circadian; Metabolism; Feeding Behavior
Bioavailabity of the Major Metabolites of a Botanical Extract, in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      Scientific research on the beneficial effects of botanical extracts has led to a better
      understanding of the role of its bioactive compounds, but the bioavailability in human
      remains largely unknown. Indeed, the most of publications investigated the bioavailability of
      metabolites of spices in in vitro cells model or animal experiments but few clinical studies
      have been conducted.

      Therefore, the aim of this study is to characterize and quantify in blood, the main
      metabolite compounds of a botanical extract, following its administration by different routes
      (oral or sublingual) and with different preparations (extract or powder), in quantity
      equivalent to those having demonstrated biological properties.
    


Intervention name(s): SBE; DBE; BP
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Hard-shell capsule; Hard-shell capsule; Hard-shell capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
Condition: Meningococcal Infections; Meningitis
MeSH terms: Meningococcal Infections; Meningitis
Study type: Observational

Summary: 
      To evaluate the persistence of bactericidal antibodies in adolescents and adults who received
      one dose of Menactra® vaccine approximately four to eight years earlier
    

Detailed description: 
      Subjects who received one dose of Menactra® or Menomune® in study MTA04, MTA12, MTA19
      (NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study.
      All eligible subjects will provide a blood sample at Visit 1, after which their participation
      in the study will be terminated. An age-matched meningococcal-vaccine naïve control group
      will be recruited to provide a blood sample for baseline antibody level evaluation.

      No vaccine will be administered in this study.
    

Intervention name(s): Menactra®; Menomune®
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular (from a previous study); 0.5 mL, Intramuscular (from a previous study)
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects that previously received only one dose of meningococcal vaccine, Menactra® in
        Study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257); or Menomune® in Study
        MTA04 and age-matched meningococcal vaccine-naive controls.
      
Keywords: Menactra®; Menomune®; Meningitis; Meningococcal Infections
Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      Introduction Laparoscopic Sleeve Gastrectomy (LSG) is one of the most prevalent approaches to
      tackle obesity and its co-morbidities. The main complication following the LSG is
      Gastro-esophageal reflux disease (GERD), with most patients developing worsening symptoms of
      GERD, and a small number progressing to Barrett's esophagus. This retrospective analysis aims
      to assess the rate of GERD pre- and post- LSG as well as the rate of progression to
      Barrett's.

      Methods Data was collected from 1639 patients. 92 patients fit our inclusion criteria. Data
      was then analyzed and summarized against similar literature
    


Intervention name(s): Laparoscopic Sleeve Gastrectomy
Intervention type(s): Diagnostic Test
Intervention description(s): bariatric surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Data was collected from 1639 patients. 92 patients fit our inclusion criteria. Data was
        then analyzed and summarized against similar literature