bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Prebiotic Intake on Adiposity, Satiety and Gut Microbiota in Overweight and Obese Children
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Currently, over one third of Canadian children and youth aged five to seventeen are
      overweight or obese. Childhood obesity leads to increased risks of co-morbidities such as
      type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers.
      Changes in the food supply have been linked to obesity and include a decrease in the intake
      of dietary fiber. Prebiotic fibers are a group of non-digestible carbohydrates that modulate
      the composition and actions of the gut microbiota and have been shown to reduce body fat and
      energy intake in overweight and obese adults. The investigators hypothesis is that prebiotic
      fiber intake in overweight and obese children will similarly result in improvements in body
      composition and reduced energy intake.
    

Detailed description: 
      Obesity in the pediatric population is a primary public health concern given that overweight
      and obesity in childhood continues into adulthood. Consumption of high-fat, calorie-dense
      diets do not provide individuals with the suggested daily intake of many important nutrients.
      This is especially true for dietary fiber which has positive health benefits such as roles in
      weight management. A form of dietary fiber with links to obesity treatment/prevention is
      prebiotic fiber. In the gut, there are many bacteria which have been shown to affect a
      person's health depending on the type and number of each type of bacteria. The role of
      prebiotic fiber is to increase the number of beneficial bacteria which in turn promotes
      health. Studies in humans have shown that prebiotic fiber is effective at reducing body fat
      and food intake in overweight and obese adults. The aim of this study is to see if prebiotic
      fiber can provide the same benefits to overweight and obese children. Since weight management
      becomes increasingly difficult as a person ages, treatments that promote weight maintenance
      at an early age are critically needed.
    

Intervention name(s): Prebiotic fiber; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dissolved in water.; Dissolved in water
Other intervention name(s): Synergy 1 (oligofructose enriched inulin); Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric; Overweight; Obesity; Gut microbiota; Adiposity; Prebiotic; Dietary fiber
Somatic Comorbidities in Psychiatric Patients
Condition: Schizophrenia; Major Depression Disorder; Bipolar Affective Disorder
MeSH terms: Schizophrenia; Mood Disorders; Bipolar Disorder
Study type: Observational

Summary: 
      Prevalence of somatic comorbidities in psychiatric patients hospitalized in Psychiatric
      hospital or treated ambulatory or in daily hospital. Comparison of prevalence of somatic
      comorbidities in psychiatric patients population and the general Croatian population.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Psychiatric patients
Study of Safe Blood Transfusion Volumes to Correct Acute Severe Anaemia
Condition: Severe Anaemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Greater volume of whole blood(30mls/kg compared to 20mls/kg) following standard calculations,
      given to children with severe anaemia will be beneficial in haematological correction and can
      be given safely since respiratory distress and haemodynamic changes result from acidosis and
      compensation in these children rather than from biventricular failure.
    

Detailed description: 
      Severe anemia (SA, hemoglobin <6 g/dl) is a leading cause of pediatric hospital admission in
      Africa, with significant in-hospital mortality. The underlying etiology is often infectious,
      but specific pathogens are rarely identified. Guidelines developed to encourage rational
      blood use recommend a standard volume of whole blood (20 ml/kg) for transfusion, but this is
      commonly associated with a frequent need for repeat transfusion and poor outcome. Evidence is
      lacking on what haemoglobin threshold criteria for intervention and volume are associated
      with the optimal survival outcomes.

      We evaluated the safety and efficacy of a higher volume of whole blood (30 ml/kg; Tx30: n =
      78) against the standard volume (20 ml/kg; Tx20: n = 82) in Ugandan children (median age 35.5
      months (interquartile range (IQR) 12.5 to 52.5)) for 24-hour anemia correction (hemoglobin >6
      g/dl: primary outcome) and 28-day survival.
    

Intervention name(s): Whole blood; Whole blood
Intervention type(s): Other; Other
Intervention description(s): 30mls/kg transfused over fours hours; 20mls/kg transfused over four hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of EDP-297 in Healthy Subjects
Condition: NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, double-blind, placebo-controlled study. It will assess the
      safety, tolerability, and pharmacokinetics of orally administered single and multiple doses
      of EDP-297 in healthy adult subjects.
    

Detailed description: 
      The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A
      "fasted" and "fed" two-part cohort will also assess food effect.

      The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in
      healthy subjects.

      Each cohort within each phase will enroll a total of 8 subjects who will be randomized to
      receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects
      randomized to receive EDP-297 or placebo
    

Intervention name(s): EDP-297; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EDP-297 Oral solution; placebo to match EDP-297
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: "First-in-Human"; Single Ascending Dose; Multiple Ascending Dose; Healthy Volunteer
Study of Single Doses of IV Aerucin in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety profile and pharmacokinetic behavior of a single
      administration of Aerucin in healthy adults at three different dosages.
    

Detailed description: 
      This Phase I trial will be conducted as an open label trial in 15 healthy adults. All
      subjects will receive a specific intravenous dose of Aerucin. There are three study groups,
      each with a specific dose of Aerucin. Study Group 1 will receive 2.0 mg/ kg of Aerucin .
      Study Group 2 will receive 8.0 mg/kg of Aerucin . Study Group 3 will receive 20 mg/kg of
      Aerucin . The dose levels of Aerucin are selected for this study based on animal studies
      showing protection in an animal model and absence of adverse effects in toxicological
      studies. Groups will be enrolled sequentially.
    

Intervention name(s): Aerucin 2.0mg/kg; Aerucin 8.0mg/kg; Aerucin 20.0 mg/kg
Intervention type(s): Biological; Biological; Biological
Intervention description(s): IV Aerucin 2.0 mg/kg over 1 hour; IV Aerucin 8.0 mg/kg over 1 hour; IV Aerucin 20 mg/kg over 1 hour
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject
Condition: Drug Use
Study type: Interventional

Summary: 
      The objective of this present study was to investigate whether Glufor® 500 (metformin
      hydrochloride 500 mg) film-coated tablets manufactured by PT. Pyridam Farma Tbk is
      bioequivalent to its reference product, Glucophage® 500 mg film-coated tablets manufactured
      by PT. Merck Tbk, Indonesia under licensed Merck Sante SAS, France.
    

Detailed description: 
      Twenty-four subjects were given a single dose of 500 mg Metformin film-coated tablet of
      either formulation (test or reference) with 240 mL of a 20% glucose solution in water.
    

Intervention name(s): Metformin Hydrochloride 500 MG
Intervention type(s): Drug
Intervention description(s): Metformin is an antihyperglycemic drug used in the management of type-2 diabetes. Metformin hydrochloride improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Metformin hydrochloride 500 mg; Bioequivalence study; Pharmacokinetics; Indonesian healthy subject
Ability of Mayo Clinic High-performance Liquid Chromatography (HPLC) Method to Measure Fecal Bile Acids
Condition: Diarrhea Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid
      excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of
      increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability
      of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with
      Colesevelam.
    

Detailed description: 
      This study will evaluate whether Colesevelam, a bile acid sequestrant, is able to reduce
      fecal bile acids and improve bowel function in patients with IBS-diarrhea and Mayo's HPLC
      method can demonstrate a response to the Colesevelam.

      The study design will be a single center, unblinded, single dose trial to study the ability
      to identify the effect of taking 1875 mg (3 tablets [625 mg/tablet]) of Colesevelam orally
      twice daily for ten days on fasting serum 7alphaC4 and total 48 hour fecal bile acid
      excretion. Stool and fasting serum samples will be collected predose and during final 48
      hours' dosing for assessment. Participants will also fill out an 8-day stool diary assessing
      frequency, consistency, ease of passage of bowel movements before and during treatment with
      Colesevelam.
    

Intervention name(s): Colesevelam
Intervention type(s): Drug
Intervention description(s): Subjects will receive 1875 mg of Colesevelam orally twice daily for 10 days
Other intervention name(s): Welchol
Intervention MeSH terms: Colesevelam Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of
      paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage
      Ic-IV ovarian cancer.
    

Detailed description: 
      Dose dense chemotherapy has been proven beneficial in various oncological settings. It is
      proposed that this concept be tested in ovarian cancer, with the support of growth factors.
      It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.
    

Intervention name(s): Paclitaxel; Carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): 175 mg/m2, I.V, every 2 weeks; Carboplatin AUC, I.V, 5 every 2 weeks
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Ovarian cancer; Dose-dense chemotherapy
Autologous Chondrocyte Implantation in the Patellofemoral Joint
Condition: Chondrosis; Patellar Articular Cartilage Lesions; Trochlear Articular Cartilage Lesions
Study type: Observational

Summary: 
      The purpose of this study is to measure the outcomes of patients who have articular cartilage
      lesions in the patellofemoral joint and are treated with the Autologous Chondrocyte
      Implantation.
    

Detailed description: 
      Cartilage restoration, in general, is a relatively new option for the treatment of articular
      cartilage lesions primarily of the knee. In the initial autologous cultured chondrocyte
      transplantation (ACT or, by others implantation, thus ACI) reported by Peterson et. al., the
      results of femoral lesions were favorable, while 5 of 7 patellofemoral treatments were poor.
      In the United States, the expedited FDA approval based on these results excluded the patella.
      As a result, in the United States, it has been difficult to further evaluate use of ACI at
      the patellofemoral joint in light of the exclusion of "off label" uses by many governmental
      and private insurance programs. Nevertheless, a growing body of knowledge is accumulating
      outside the United States that the use of ACI at the patella is a viable option and soon
      similar findings will be published in the US by Minas et. al. (accepted for publication)
    

Observational model: Defined Population
Time perspective: Retrospective
Keywords: Articular Cartilage Lesions; Patellar lesions; Trochlear lesions; Patellofemoral joint; Carticel; Autologous Chondrocyte Implantation
Drug-drug Interaction Study of CHF5993 With Cimetidine
Condition: COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic interaction when CHF5993
      (pressurized metered-dose inhaler (pMDI) is administered with Cimetidine (probe inhibitor of
      the organic cation transport in the kidneys), by comparing the systemic exposure (AUC0-t) of
      Glycopyrronium Bromide (GB), after a single dose of the fixed combination CHF 5993 pMDI
      administered alone or at steady-state of Cimetidine
    

Detailed description: 
      the safety and tolerability of study treatments based on evaluation of vital signs,
      electrocardiograms and clinical laboratory assessments will be also evaluated.
    

Intervention name(s): CHF 5993 pMDI; Cimetidine plus CHF5993 pMDI
Intervention type(s): Drug; Drug
Intervention description(s): 4 inhalations of CHF 5993 pMDI (BDP/FF/GB 100/6/25 micrograms per actuation) giving a total dose of 400, 24, 100 micrograms of BDP, FF, GB; Cimetidine 800 milligrams twice daily for 6 days. On the fourth day, in addition, 4 inhalations of CHF5993 pMDI (BDP/FF/GB total dose 400/24/100 micrograms)
Intervention MeSH terms: Cimetidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD- cimetidine- drug-drug interaction
Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      In a population of patients suffering from schizophrenia being treated for an episode of
      clinical destabilization and followed for a period of twelve months, the main objective is to
      evaluate the proportion of patients achieving functional remission and its relationship to
      clinical remission.
    

Detailed description: 
      Prospective, national, noninterventional study. One year follow up with three evaluation
      dates (D0, D180 and D360). The participation of a subject in this study will in no way impact
      the regular care of the subject or any benefits they are otherwise entitled to. All treatment
      decisions will be made at the discretion of the participating physician, in accordance with
      his clinical practice and with approved local prescribing information. Only data available
      from clinical practice will be collected. Evaluation methods: patient history and clinical
      examination, clinical global impression (CGI): Improvement in CGI, social performance
      evaluation [functional remission of general schizophrenia (FROGS scale)], clinical remission
      evaluation: 8 items of the Positive and negative syndrome (PANSS) Scale, psychosocial
      remission evaluation (PSP scale), current insight evaluation: insight scale for psychosis,
      subjective well being under neuroleptic treatment (SWN scale), health condition [Euro quality
      of life - 5 Dimensions (EQ-5D)]; Judgment Criteria: functional remission is defined as an
      overall score of greater than or equal to (>=) 57 on the FROGS scale, functional response is
      defined as improvement of >= 7 points on the FROGS scale. Safety evaluation: no tolerance
      analysis will be performed, adverse event (AE) and serious adverse event (SAE) with J&J
      products will be collected and transmitted according to J&J timelines/process.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are followed in hospital, CMP or clinics for at least 6 months and are likely to
        be followed by the same team within the next year.
      
Keywords: CNS; Antipsychotic; Functional remission; Observational study; FROGS; PSP; Functioning; Schizophrenia
Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine
Condition: Schizophrenia; Schizoaffective Disorders
MeSH terms: Weight Gain; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to answer the following questions:

        -  Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the
           weight gain that is associated with olanzapine

        -  Whether taking amantadine, metformin or zonisamide can help patients decrease or
           eliminate some of the changes in body that occur with weight gain

        -  How weight gain associated with olanzapine can affect people

        -  Whether treatment with amantadine, metformin or zonisamide can help eliminate weight
           gain associated with olanzapine and not interfere with the positive effects of
           olanzapine on functioning of people with schizophrenia and other diseases
    


Intervention name(s): olanzapine; amantadine; metformin; zonisamide; Wellness education
Intervention type(s): Drug; Drug; Drug; Drug; Behavioral
Intervention description(s): 5-20 milligrams (mg), oral, daily for 22 weeks.; Amantadine, 100 milligrams (mg), oral, 1 twice a day (BID). Patients who gained greater than 3 kilograms (kg) will switch to metformin. Patients who gained greater than 3 kg after switching to metformin will be switched to zonisamide.; Metformin, 500 mg, oral, twice a day (BID) for 2 weeks titrated to 500mg three times a day (TID) thereafter. Patients who gain greater than 3 kilograms (kg) will be switched to amantadine. Patients who gained greater than 3 kg after switching to amantadine will be switched to zonisamide.; Zonisamide, 100-400mg, oral, daily.; weight management
Other intervention name(s): LY170053; Zyprexa
Intervention MeSH terms: Metformin; Amantadine; Zonisamide; Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to verify the efficacy and investigate the safety of the study
      drug when ASP0456 is administered orally for 4 weeks and 52 weeks.
    

Detailed description: 
      This study consists of two parts. In Part I, ASP0456 or placebo will be administered orally
      in a blind manner. In Part II, the long-term safety and efficacy of ASP0456 will be evaluated
      in patients who have participated in the study and completed the Part I.
    

Intervention name(s): linaclotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration once daily; Oral administration once daily
Other intervention name(s): ASP0456
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic constipation; Linaclotide; ASP0456
COVID-19 in Osteoarthritis Patients
Condition: Osteoarthritis
MeSH terms: COVID-19; Osteoarthritis
Study type: Observational

Summary: 
      While the coronavirus pandemic has spread rapidly around the world, it has generated a
      considerable degree of fear, concern and anxiety among the population in general and among
      certain groups in particular, such as older persons. Initial findings from studies in China
      indicated the presence of moderate to severe psychological impact in a significant proportion
      of individuals and an increased prevalence of post-traumatic stress symptoms. It should also
      be noted that other types of symptoms, such as anxiety and depression, appeared to persist
      over time and to a greater extent.

      Osteoarthritis can develop in any joint, but most often affects the knees, hands and hips.
      People with osteoarthritis are often older and sometimes more frail than the general
      population. The main recommendations for non-drug treatment of osteoarthritis include
      education, physical activity and structured exercise programmes with or without weight
      reduction. Due to the confinement associated with COVID-19, many patients have had to stop
      exercise/physical activity and postpone prosthetic surgery. Apart from the context of delay
      in surgery, there is little data available on the impact of the pandemic on people with
      arthritis. Several questions are therefore still pending concerning the impact of the
      pandemic on these patients.

      The investigators hypothesise that the following therapeutic modalities have been disrupted
      during this period: access to care, scheduling of prosthetic surgery, consumption of
      painkillers or NSAIDs, recourse to physical activities, recourse to physiotherapy sessions,
      weight changes, level of pain.... Our objective is to evaluate the physical, social,
      psychological and behavioural consequences of the COVID-19 pandemic in a cohort of
      osteoarthritis patients.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with a physician-confirmed diagnosis of osteoarthritis of the lower limbs
      
Biospecimen description: 
      NC
    
Keywords: lower limbs; anxiety; stress; Covid19