bioihbjkbjnl/mcl2 huggingface dataset:
N2004-03: Intravenous Fenretinide in Treating Young Patients With Recurrent or Resistant Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase I trial is studying the side effects and best dose of intravenous
      fenretinide in treating young patients with recurrent or resistant neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the maximum tolerated dose of fenretinide when given as a continuous
           intravenous infusion in young patients with recurrent and/or resistant neuroblastoma.

        -  To define the toxicities of this drug in these patients.

        -  To determine the plasma pharmacokinetics of this drug in these patients.

      Secondary

        -  To determine the response rate in patients treated with this drug.

        -  To determine the bioavailability of fenretinide in normal peripheral blood mononuclear
           cells as a surrogate marker for drug bioavailability to tumor tissue.

      OUTLINE: This is a multicenter study.

      Patients receive fenretinide IV continuously over 120 hours on days 0-4. Treatment repeats
      every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

      Blood samples are collected periodically for pharmacokinetic analysis by high performance
      liquid chromatography.

      After completion of study treatment, patients are followed periodically.
    

Intervention name(s): fenretinide; high performance liquid chromatography; pharmacological study
Intervention type(s): Drug; Other; Other
Intervention MeSH terms: Fenretinide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent neuroblastoma
Dose-finding Study of KHK7791 in Hyperphosphatemia Patients
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.
    


Intervention name(s): KHK7791; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Tenapanor; Hyperphosphatemia; Hemodialysis
Biopsychosocial Factors' Influence on Shoulder Pain
Condition: Pain
MeSH terms: Shoulder Pain
Study type: Observational

Summary: 
      The purpose of this study is to determine which factors are associated with the development
      of chronic shoulder pain and disability.
    

Detailed description: 
      The purpose of this study is to determine which factors are associated with the development
      of chronic shoulder pain and disability. Previous studies have suggested that specific genes
      influence pain perception. Other studies have suggested that specific psychological factors
      influence pain perception. We plan to investigate both of these factors to see if they
      contribute to the development of chronic shoulder pain and disability.
    

Intervention name(s): pain perception
Intervention type(s): Behavioral
Intervention description(s): pain perception
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic shoulder pain and disability
Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic
      (PD) effects of RDEA3170 administered in combination with allopurinol compared with
      allopurinol administered alone in adult subjects with gout.
    


Intervention name(s): RDEA3170 2.5 mg; allopurinol 300 mg
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets).
Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets).; allopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets)
Intervention MeSH terms: Allopurinol; Verinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in the Paediatric A&E.
Condition: Community-Acquired Infections; Respiratory Tract Infections; Sepsis; Urinary Tract Infections; Meningitis; Gastroenteritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Respiratory Tract Infections; Community-Acquired Infections; Gastroenteritis; Meningitis
Study type: Observational

Summary: 
      Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely Ill
      Children in a High Prevalent Setting: The Paediatric Accidents & Emergencies through
      prospective observational data collection concerning specific items from the clinical and
      technical examination in diagnosing serious infections, such as meningitis, sepsis,
      pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to validate
      a vital signs and symptoms rule derived from multiple low to high prevalent settings of
      acutely ill children.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 1 month to 16 years, attending the A&E department of the UZLeuven Hospital
        with an acute illness episode of maximum 5 days
      
Keywords: serious infections; meningitis
A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma
Condition: Advanced Adult Hepatocellular Carcinoma; Hepatocellular Carcinoma Metastatic
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability,
      pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with
      advanced/metastatic hepatocellular carcinoma.
    

Detailed description: 
      A Phase I/Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability,
      Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9150 in Patients with
      Advanced/Metastatic Hepatocellular Carcinoma.
    

Intervention name(s): AZD9150
Intervention type(s): Drug
Intervention description(s): Intravenous infusion over 3 hours.
Other intervention name(s): ISIS 481464
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child-Pugh A to B7,; Advanced/Metastatic Hepatocellular Carcinoma,; AZD9150,; Antisense Oligonucleotide Inhibitor of STAT3
Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be
      dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month
      long-term Maintenance Phase.
    

Detailed description: 
      The study will start with the screening period, and all baseline parameters should be
      measured/collected up to 1 day prior to administration of first dose of study drug on
      Correction Phase Day 1. Subjects with 2 consecutive i-STAT potassium values ≥ 5.1 mmol/L will
      enter the Correction Phase and receive ZS 10 g TID for up to 72 hours, depending on potassium
      values. Once normokalemia (i-STAT potassium between 3.5 and 5.0 mmol/L, inclusive) is
      restored (whether after 24, 48 or 72 hours), subjects will be entered into the Maintenance
      Phase to be dosed with ZS at a starting dose of 5 g QD. Potassium (i-STAT and Central
      Laboratory) will be measured Days 1, 2, 5, 12, 19 and 26 throughout the first month of study
      and every 4 weeks thereafter until Day 362 (Visit 23) then patients will be required to
      complete the EOS visit which is 7±1 days after the last administration of study medication.
      For patients who do not enter the Maintenance Phase the last visit will be 7±1 day after the
      last treatment dose in the Correction Phase. The total expected study duration for an
      individual patient is approximately 53-54 weeks.
    

Intervention name(s): Zirconium Cyclosilicate
Intervention type(s): Drug
Intervention description(s): Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months.
Other intervention name(s): ZS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Study of the Neurobiology of Tourette Syndrome and Related Disorders
Condition: Tourette Syndrome; Obsessive Compulsive Disorder
MeSH terms: Tourette Syndrome; Syndrome; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      OBJECTIVES: I. Investigate the pathobiology of Tourette syndrome and related disorders by
      measuring various compounds of interest in cerebrospinal fluid, plasma, and urine of patients
      with Tourette syndrome, obsessive compulsive disorder, and/or chronic tics.

      II. Determine the pattern of familial aggregation of Tourette syndrome and obsessive
      compulsive disorder by systematic assessment of all first-degree family members of patients
      selected for cerebrospinal fluid studies.

      III. Establish the neurochemical and neuropeptide profile associated with the range of
      expression of the putative Tourette gene expression in adult and adolescent patients.
    

Detailed description: 
      PROTOCOL OUTLINE: All patients are screened with a complete physical and neurologic exam, and
      a semi-structured interview. Patients then receive a comprehensive assessment of systemic
      disease. Patients and first-degree family members also participate in a genetic study.

      Any patient who experiences an unusual exacerbation of symptoms or significant side effects
      is removed from the study.
    

Keywords: Tourette syndrome; anxiety disorder; disease-related problem/condition; neurologic and psychiatric disorders; obsessive compulsive disorder; oncologic disorders; rare disease
Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
Condition: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe and the United States of America (USA). The aim of this
      trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor
      XIII, catridecacog) administered following first time myocardial revascularization requiring
      cardiopulmonary bypass (CPB).
    


Intervention name(s): catridecacog; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).; Single doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lung Ultrasound in Children With Severe Malaria
Condition: Severe Malaria
MeSH terms: Malaria
Study type: Observational

Summary: 
      A prospective cohort study, with 171 children admitted for severe malaria that will be
      included in the cohort. The study will take place in Kinshasa, Democratic Republic of Congo.

      The primary objective is to evaluate the prevalence of five pre-specified pulmonary diagnoses
      that can be facilitated by the use of LUS (normal lung or acidotic breathing, ARDS,
      concomitant pneumonia, hydrostatic pulmonary oedema, pleural effusion).
    

Detailed description: 
      A prospective cohort study, with 171 children (between 1 - 14 years) admitted for severe
      malaria that will be included in the cohort. The study will take place at the Maluku District
      Hospital, located in Kinshasa, Democratic Republic of Congo.

      Lung ultrasound will be performed on admission, h24, and unscheduled timepoints (in case of
      respiratory deterioration during hospital stay). Lung auscultation and peripheral capillary
      oxygen saturation (SpO2) will be assessed at each time points. All children will be observed
      from admission to hospital discharge. At 30 days a phone call will be made by the study staff
      to follow up clinical conditions of the child.

      The total duration for each subject's participation in the study is approximately 1 month.
      The study period is approximately 12 months

      Funder: The Wellcome Trust (ITPA grant) WT-iTP-2019/005
    

Intervention name(s): lung ultrasound
Intervention type(s): Device
Intervention description(s): Lung ultrasound is performed using an 12-regions technique i.e. six areas on each side of the chest, two ventral, two lateral and two posterior. The lung ultrasound examination is estimated to take around 10 minutes of time.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children admitted for severe malaria
      
Keywords: severe malaria; lung ultrasound; prevalence of pulmonary diagnoses
Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
Condition: Lipedema; Obesity, Morbid
MeSH terms: Lipedema; Obesity, Morbid
Study type: Interventional

Summary: 
      Lipedema is a chronic disease with unproportional, symmetrical fat accumulation in the lower
      extremities. Patients experience pain in affected areas, and reduced quality of life. Today's
      treatment is physiotherapy and surgery (liposuction). Recent research shows that
      ketogenic-diet with low carbohydrate, high fat (LCHF) conant can lead to reduced pain,
      increased quality of life and change in body composition. Goals: Investigate the effect of
      LCHF diet on pain, quality of life and body composition.
    


Intervention name(s): Low carbohydrate high fat diet
Intervention type(s): Dietary Supplement
Intervention description(s): Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet
Other intervention name(s): ketogenic diet
Intervention model: Single Group Assignment
Intervention model description: prospective observational study with a diet intervention
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet, ketogenic; Pain; Quality of Life; Body Composition; Body Fat Distribution
Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease
Condition: Crohn´s Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland,
      only.

      This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO
      suspension vs. placebo for the induction of remission in Crohn's disease.
    


Intervention name(s): Low dose TSO; Medium dose TSO; High dose TSO; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Low dose TSO suspension; Medium dose TSO suspension; High dose TSO suspension; Placebo solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crohn´s disease; Trichuris suis; randomized; placebo; induction of remission; porcine whipworm
Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes
Condition: Postprandial Lipids Metabolism; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study will be to evaluate in patients with type 2 diabetes the effects on
      liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a
      diet rich in MUFA, either combined or not with a structured program of physical exercise,
      with emphasis on mechanisms possibly underlining these effects, namely changes in
      postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity,
      oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and
      endothelial function.
    


Intervention name(s): Rich in MUFA diet -PA; high fiber/low glycemic index diet + pa; Rich in MUFA diet+PA; High fibre/low glycemic index diet-PA
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The patients will follow a rich in MUFA diet without a physical activity program.; patients will follow for two months a high fibre/ low glycemic index diet with a physical activity program.; Patients will follow for two months a rich in MUFA diet with a physical activity program.; Patients will follow for two months a high fibre/low glycemic index diet without a physical activity program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver fat; postprandial lipids metabolism; diet; exercise; type 2 diabetes
Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported
      Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety,
      tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus
      extension) in patients with moderate to severe psoriasis.
    

Detailed description: 
      Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified
      Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab
      Administered Subcutaneously in Patients With Moderate to Severe Psoriasis
    

Intervention name(s): Secukinumab
Intervention type(s): Drug
Intervention description(s): weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.
Other intervention name(s): open label, no other intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriasis; Secukinumab; Simplified Psoriasis Index; CAIN457A; AIN457AFR01; AIN457A; Skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing/remitting psoriasis; immune-mediated systemic disease; skin lesions; red skin lesions; scaly patches; papules; plaques; itching
Efficacy and Safety of Dihydroartemisinin-piperaquine (DHP) for the Treatment of Uncomplicated Malaria
Condition: Plasmodium Falciparum Infection; Plasmodium Vivax Infection
MeSH terms: Infections; Communicable Diseases; Malaria
Study type: Observational

Summary: 
      This is an observational safety and efficacy study on dihydroartemisinin-piperaquine in
      Timika, Indonesia with a 42 day follow up period.
    

Detailed description: 
      Dihydroartemisinin-piperaquine (DHA-Pip) is part of the current national guidelines for the
      treatment of uncomplicated malaria in Indonesia. In order to guarantee safe and efficacious
      treatment for all patients diagnosed with uncomplicated malaria in the area, it is essential
      to monitor the effectiveness of the recommended treatment from a clinical perspective and
      assess whether the provided treatment is safe for recipients. This trial re-evaluates the
      local efficacy and safety of DHA-Pip for P. falciparum and P. vivax infections.

      Patients with uncomplicated malaria attending a public health care facility in Timika, Papua,
      Indonesia, who meet the study inclusion criteria will be enrolled, treated on site with
      DHA-Pip and followed up for 42 days. The follow-up will consist of a fixed schedule of
      check-up visits and corresponding clinical and laboratory examinations. On the basis of the
      results of these assessments, the patients will be classified as having therapeutic failure
      (early or late) or an adequate response. The proportion of patients experiencing therapeutic
      failure and drug related adverse events during the follow-up period will be used to estimate
      the efficacy and safety of the study drug. PCR analysis will be used to distinguish between a
      true recrudescence due to treatment failure and episodes of reinfection.

      The outcome of the proposed project will have a direct impact on the decision making process
      of the Indonesian Ministry of Health on whether there is a need to alter the existing
      antimalarial treatment guidelines.
    

Intervention name(s): Dihydroartemisinin-Piperaquine
Intervention type(s): Drug
Intervention description(s): Treatment according to national guidelines with follow up.
Intervention MeSH terms: Piperaquine; Artenimol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from uncomplicated Plasmodium falciparum / Plasmodium vivax infections
        attending the study hospital during the study period.
      
Biospecimen description: 
      Samples for genotyping of Plasmodium vivax and Plasmodium falciparum.
A Study in Healthy Male Volunteers to Test How the Test Medicine GLPG1972 is Taken up by the Body When Given by Mouth and Into the Vein as an Injection
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The sponsor wants to investigate in this study how well the test medicine is taken up by the
      body when given orally (by mouth) as a tablet and solution, and as a solution for infusion
      (into a vein). The oral solution and solution for infusion will be radiolabelled.
      'Radiolabelled' means that the test medicine has a radioactive component which helps us to
      track where the test medicine is in the body, what it is broken down into, and how it leaves
      the body.

      The sponsor will also look at the safety and tolerability of the test medicine.
    


Intervention name(s): GLPG1972 film-coated tablets; [14C]-GLPG1972 solution for infusion; [14C]-GLPG1972 oral solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral dose of GLPG1972; a 15-minute IV infusion [14C]-GLPG1972; single oral dose of [14C]-GLPG1972
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science