bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study of the DIAMOND System to Treat Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System
      (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured
      as A1c, FBG and Post-Prandial Glucose levels.

      The study hypothesis is that HbA1c will show greater improvement in patients receiving 12
      months of therapy by the DIAMOMD System than in patients not receiving this therapy.
    

Detailed description: 
      The study protocol will also apply measures to better understand the mechanism of action of
      the effect.
    

Intervention name(s): DIAMOND System
Intervention type(s): Device
Intervention description(s): Electrical stimulation to the fundus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DIAMOND System; T2DM; Randomized study; Electrical stimulation; Fundus
Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of food on the absorption of the drug as well as safety
      and tolerability of the novel 30 mg tablet (administered as 120 mg dose) in adults suffering
      from chronic Chagas' disease when administered after a high-fat / high-calorie test meal
      (American breakfast) compared to a fasting state. This study is required as part of the
      clinical development of an age appropriate pediatric oral dosage form for the treatment of
      Chagas' disease in endemic countries according to the recommendations provided by current
      international guidelines (EMA Guideline on Clinical Development of Medicinal Products, EMA
      Note for Guidance on Oral Dosage Forms).
    


Intervention name(s): Nifurtimox (BAYa2502)
Intervention type(s): Drug
Intervention description(s): Oral Intake of 4 x 30 mg nifurtimox tablets
Intervention MeSH terms: Nifurtimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress
Condition: The Primary Condition Studied for This Trial is Acute Stress
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the STRESS trial is to investigate in a mode of action setting the effect of
      Zeller Entspannung film coated tablets on saliva cortisol response versus Placebo after acute
      stress in healthy male volunteers. In addition, data on safety and tolerability of Zeller
      Entspannung will be obtained.

      A third arm including no treatment is tested as well. Approximately 72 healthy volunteers
      will be included into this randomized, double blind study. Study duration will be 7 days,
      study medication intake will be over 4 days: participants will take the medication one tablet
      three times a day (morning, midday, evening) the first 3 days, whereas on day 4 only two
      tablets will be taken (morning and midday).
    


Intervention name(s): Zeller Entspannung film coated tablet; Placebo; No Treatment
Intervention type(s): Drug; Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
PAXIL CR Bioequivalence Study
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to determine if controlled release paroxetine tablets manufactured at two
      different sites behave similarly in healthy volunteers.
    


Intervention name(s): Paxil CR
Intervention type(s): Drug
Intervention description(s): Paxil CR 37mg tablet manufactures at two different sites
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: healthy volunteers; paroxetine
Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss
Condition: Inadequate Initial Weight Loss; Persistent Clinically Severe Obesity
MeSH terms: Obesity, Morbid; Body Weight; Weight Loss
Study type: Observational

Summary: 
      The main aim of this study is to analyze and report traditional, patient-centered, and
      composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass
      surgery for inadequate initial weight loss.
    

Detailed description: 
      There is lack of standardization of primary and revisional bariatric surgery compounded by a
      scant long-term outcome data. The treatment of inadequate weight loss, weight recidivism, and
      most severe technical complications after primary bariatric surgery remains refractory to
      non-operative treatment. Failure rates have been reported up to 20% and 35% for the morbidly
      obese (MO) and super obese (SO), respectively at 2 to 3 years after surgery. The indication
      for further surgical intervention remains controversial, as does what type of revisional
      procedure, both operative and endoscopic, to recommend. Furthermore, there is no
      standardization of the limb lengths, pouch size or the use of prosthetic reinforcement.
      Therefore the approach to these patients must be as individualized as their original
      operations. We formally analyze our experience with all laparoscopic revisional strategies
      for Inadequate Initial Weight Loss after failed Roux-en-Y gastric bypass(RYGB).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that underwent laparoscopic revision gastric bypass after previously failed
        Roux-en-Y gastric bypass "RYGB" with an Inadequate initial weight loss "IIWL" pattern.
      
Keywords: Inadequate Initial Weight Loss; Inadequate weight loss; Poor weight loss; Failed gastric bypass; Revision gastric bypass
Effects of Sucralose on Glucose Metabolism
Condition: Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      In this study the effects of sucralose on insulin sensitivity, beta-cell response and
      appetite regulating hormones will be evaluated.
    

Detailed description: 
      The consumption of non-nutritive sweeteners has a high prevalence. The effect of
      non-nutritive sweeteners in both beta-cell function and insulin resistance it is unknown.

      Previous studies performed in animal models and humans with diverse characteristics have
      shown variable effects of different non-nutritive sweeteners in variables related to glucose
      metabolism.

      Due to the high consumption of non-nutritive sweeteners it is relevant to know its effect in
      beta cell-function and insulin sensitivity.

      In this study the effects of sucralose, a non-nutritive sweetener that is highly consumed in
      the population, on insulin sensitivity and beta-cell function will be evaluated.

      54 participants with normal glucose tolerance, normal weight, and without chronic diseases
      with a low consumption of non-nutritive sweeteners will be included. The participants will be
      randomly assigned to consume sucralose or to a control group.

      During the first visit an oral glucose tolerance test with 75 g of glucose will be performed.
      Fasting and 2-hour glucose will be measured in order to rule-out diabetes, abnormal fasting
      glucose, or glucose intolerance.

      During the second visit a three-hour IV glucose tolerance test will be performed
      administering 0.3 g/kg of glucose and insulin 0.03 U/kg. Samples will be taken following the
      minimal model described by Bergman.

      After this visit, the group assigned to receive sucralose will ingest 15% of the adequate
      daily intake (ADI) of sucralose and the control group will abstain of any non-nutritive
      sweetener consumption during 14 days. At the end of this period a third visit to repeat the
      IV glucose tolerance test will be performed.

      Samples will be analyzed measuring glucose and insulin concentrations to evaluate acute
      insulin response (AIR), glucose effectiveness (SG), first phase pancreatic response (ф1), and
      second phase pancreatic response (ф2). In addition, hormones involved in appetite and satiety
      (leptin, ghrelin, and peptide tyrosine tyrosine) will be quantified at the beginning and end
      of the intervention.
    

Intervention name(s): Sucralose
Intervention type(s): Other
Other intervention name(s): Non-nutritive sweetener
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: sucralose; insulin sensitivity; beta-cell response; appetite regulating hormone
Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study
Condition: Retinoblastoma
MeSH terms: Retinoblastoma
Study type: Interventional

Summary: 
      To study the effectiveness and safety profiles of photodynamic therapy (PDT) for the
      treatment of human retinoblastoma.
    

Detailed description: 
      Retinoblastoma is the commonest primary intraocular malignancy in infancy and early
      childhood. Ophthalmologist are trying to seek other more safe and effective treatment
      modalities to well control the tumor and preserve the visual function. Photodynamic therapy
      (PDT) is a potentially therapeutic approach for retinoblastoma which has been underestimated.
      In this study, we are gonging to investigate the the effectiveness and safety profiles of
      photodynamic therapy (PDT) for the treatment of human retinoblastoma.
    

Intervention name(s): photodynamic therapy
Intervention type(s): Drug
Intervention description(s): PDT with Visudyne® was performed under general anesthesia according to the standard TAP study with some modifications: Verteporfin (6 mg/m2, Visudyne®; Novartis International AG, Basel, Switzerland) was injected intravenously with a standard 10-min infusion followed by followed by application of diode laser (Opal Photoactivator; Coherent Medical Group, Santa Clara, USA) (689 nm, 50 J/cm2, 600 mW/cm2) for 200 seconds to generate 120 J/cm2.
Other intervention name(s): systemic chemotherapy; Laser photocoagulation; Cryotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Photodynamic therapy; Retinoblastoma; Visudyne; Verteporfin
Methylene Blue in Early Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Septic shock is a subset of sepsis characterized by a decrease in vascular tone, which
      contributes to impaired regional blood flow distribution, and leads to organic failure.
      Besides intravenous fluids and adequate antimicrobial therapy, patients with septic shock
      require vasopressor support, which can lead to many adverse effects, therefore,
      non-vasopressor agents that can improve hemodynamic status are needed. In this randomized
      controlled-study, the investigators will address the efficacy and safety of infusion with
      methylene blue in patients with septic shock.
    

Detailed description: 
      Unlike sepsis, septic shock mortality is not declining for the last decade, and is still
      around 40%. After restoring intravascular volume, many patients need vasopressor agents to
      maintain arterial blood pressure, which leads to improvement of perfusion at some vascular
      beds, however some organs may suffer from maldistribution of blood flow. These changes of
      regional blood flow may compromise oxygen delivery and perpetuate the inflammation and tissue
      damage associated with the state of shock.

      One of the main mechanisms of vasodilation after inflammatory insults, is the activation of
      the inducible isoform of Nitric Oxide Synthase (iNOS), and the subsequent increase in the
      levels of nitric oxide, which even reduces the response to vasoconstrictor agents. Methylene
      blue (MB) is a selective inhibitor of iNOS, which has been used successfully in patients with
      post-cardiopulmonary bypass associated vasoplegia, however, the evidence of the use of MB in
      septic shock patients is limited to case reports, observational and small studies. In this
      randomized controlled trial, the investigators will compare the efficacy and safety outcomes
      of repeated doses of MB in patients with septic shock.
    

Intervention name(s): 0.9% sodium chloride; Methylene Blue
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of 500 cc of 0.9% sodium chloride solution for 6 h, once a day for a total of 3 doses.; Intravenous infusion of 100 mg methylene blue in 500 cc of 0.9% sodium chloride solution for 6 h, once a day for a total of 3 doses.
Intervention MeSH terms: Methylene Blue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Septic shock; Methylene blue; Norepinephrine
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets
      under fed conditions
    


Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): 750 mg tablet
Other intervention name(s): KEPPRA
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence
Condition: Obesity; Cardiovascular Risk
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the study is to determine the genetic influence on short-, middle- and
      longterm effects of an inpatient lifestyle therapy program in overweight and obese children
      and adolescents.
    

Detailed description: 
      In Germany, as in other countries, overweight and obesity affects a growing number of
      children and adolescents. Obesity-related diseases such as arterial hypertension, disorders
      of glucose and lipid metabolism and an increase in inflammation markers are associated with
      higher morbidity and mortality in early life, therefore effective therapy concepts are
      needed.

      The aim of this study is to evaluate the effects of a 4-6 week inpatient obesity lifestyle
      therapy program over 10 years and the genetic influence on the short-, middle- and longterm
      outcome.

      The lifestyle intervention consists of physical exercise, nutrition education and behaviour
      therapy based on the criterions developed by the German Obesity Group (degree of weight
      reduction, improvement of comorbidity and health behaviour, minimising of side effects).
    

Intervention name(s): LOGIC
Intervention type(s): Behavioral
Intervention description(s): Experimental group:
Diet (1200-1800 kcal/d), Exercise: 11 h/wk physical activity, Behavioural therapy (group training, 1-3h/wk individualized personal instructions, 2 h parents work)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; overweight; childhood; adolescence; inpatient therapy; lifestyle intervention; cardiovascular risk; gene-lifestyle-interaction; Obesity and associated cardiovascular risk in childhood and adolescence,; health behaviour
Text Messaging and Cognitive Behavioral Therapy for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study aims to asses whether adding automated text messaging to group cognitive
      behavioral therapy for depression increases engagement which may lead to improved outcomes.
    

Detailed description: 
      Background: Cognitive Behavioral Therapy (CBT) for depression is efficacious, but
      effectiveness is limited when implemented in low-income settings due to engagement
      difficulties including nonadherence with skill-building homework and early discontinuation of
      treatment. Automated messaging can be used in clinical settings to increase dosage of
      depression treatment and encourage sustained engagement with psychotherapy.

      Objectives: The aim of this study was to test whether a text messaging adjunct (mood
      monitoring text messages, treatment-related text messages, and a clinician dashboard to
      display patient data) increases engagement and improves clinical outcomes in a group CBT
      treatment for depression. Specifically, the investigators aim to assess whether the text
      messaging adjunct led to an increase in group therapy sessions attended, an increase in
      duration of therapy attended, and reductions in Patient Health Questionnaire-9 item (PHQ-9)
      symptoms compared with the control condition of standard group CBT in a sample of low-income
      Spanish speaking Latino patients.

      Methods: Patients in an outpatient behavioral health clinic were assigned to standard group
      CBT for depression (control condition; n=40) or the same treatment with the addition of a
      text messaging adjunct (n=45). The adjunct consisted of a daily mood monitoring message, a
      daily message reiterating the theme of that week's content, and medication and appointment
      reminders. Mood data and qualitative responses were sent to a Web-based platform (HealthySMS)
      for review by the therapist and displayed in session as a tool for teaching CBT skills.
    

Intervention name(s): Group CBT for Depression with MoodText; Group CBT for Depression
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.; Standard group CBT for depression using BRIGHT manual
Other intervention name(s): Group CBT for Depression with HealthySMS
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: mhealth; depression; latinos; text messaging; CBT; SMS
Ibuprofen and Paracetamol Pharmacokinetic Study
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol
      formulations.
    


Intervention name(s): Ibuprofen Acid; Ibuprofen Lysine; Ibuprofen Sodium; Ibuprofen Liquid Capsules; Paracetamol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Excretion Balance and Metabolism After a Single Oral Dose of 14C-Labelled ORM-12741
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is conducted to examine absorption of C14-ORM-12741 from intestine to bloodstream,
      distribution to bloodstream, metabolism in the liver and excretion of the parent drug and
      metabolites to faeces, urine and expired air
    

Detailed description: 
      Six healthy males will receive 3 mg of ORM-12741 as a single oral solution(0.1mg/mL). The
      oral dose contains 0.73 mg of 14C-ORM-12741 (2.5 MBq), 1 mg of 13C-ORM-12741 and 1.27 mg of
      ORM-12741.

      Subjects will be confined to the study site from Day -1 (the afternoon prior to the day of
      dosing) up to at least 168 hours following drug administration (Day 8). Subjects will be
      discharged on Day 8 if radioactivity in urine and faeces meet pre-defined criteria (urinary
      excretion <0.5% and faecal excretion <0.5% of the dose per 24 hours based on 14C
      radioactivity quick counts, which will be measured from Day 7 onwards). If on Day 8 these pre
      defined criteria are not met, subjects will remain hospitalised for a maximum of seven more
      days (Day 15) until the criteria are met (daily check on quick counts). If on Day 15 these
      pre defined criteria are not met, subjects will be discharged and requested to collect a
      24-hour sample of urine and/or faeces at home once per week and to deliver this to the
      clinical research unit in Zuidlaren. These weekly collections will be continued until the
      criteria are met. The total duration of the study will be approximately 5 - 6 weeks for each
      subject.
    

Intervention name(s): ORM-12741
Intervention type(s): Drug
Intervention description(s): 3 mg of ORM-12741 as a single dose. Contains 0.73 mg (2.5 MBq) 14C labelled ORM-12741
Other intervention name(s): healthy volunteer
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 3098004; Healthy volunteers
Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to determine whether glatiramer acetate (Copaxone) will induce
      anti-inflammatory type II monocyte development during treatment of MS, and if these antigen
      presenting cells (APC) will promote Th2 and Treg differentiation of naïve T cells.
    


Intervention name(s): Glatiramer acetate
Intervention type(s): Drug
Intervention description(s): 20 mg daily subcutaneous injection. Six-month duration.
Other intervention name(s): Copaxone
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Relapsing-remitting multiple sclerosis patients at the UCSF Multiple Sclerosis Center.
      
Biospecimen description: 
      Peripheral blood mononuclear cells (PBMC) Serum RNA
    
Keywords: relapsing-remitting; multiple sclerosis; Copaxone; glatiramer acetate; MS